MAR 2 5 2014 YC'§f 623

510(k) Summary

510O(K) Owner: Nova Biomedical CorporationRegistration Number: 1219029Address: 200 Prospect St.

Waltham, MA 02454Phone: 781-894-0800Fax Number: 784-891-4806Contact Person: Paul W. MacDonaldDate Prepared: 21 March 2014

Proprietary Name: Stat Profile® Prime OCS Analyzer System, Stat Profile Prime Auto QCCartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime CalibratorCartridge CCS/CCS Comp and Linearity Standard Set A

Common or Usual Name: Blood Gas/Electrolyte/Metabolite/CO-Oximetry Analyzer

Classification Name: Multiple

Classification Names: Class No. Reg. No. ClassBlood Gases and Blood pH system 75CHL 862.1120 11Sodium Test System 75JGS 862.1665 11Potassium Test System 75CEM 862.1600 11Calcium Test System 75JFP 862.1145 11Chloride Test System 75CGZ 862.1170 11Glucose Test System 75CGA 862.1345 11Instrument, Hematocrit, Automated 81GKF 864.5600 11Calibrators 75JIX 862.1150 11Quality Control Materials 75JJS 862.1660 1

Product Codes: CHL, JGS, CEM, JFP, CGZ, CGA, GKF, JIX, JJS

Predicate Device: K1 10648 - Nova Stat Profile pHOx Ultra Analyzer System (including controls,calibrators and Linearity Standards)

Device Description:

The Stat Profile Prime CCS Analyzer is a small, low cost blood gas, metabolite and electrolyteanalyzer for laboratory use. The sensors and flow path have been integrated into onereplaceable microsensor card, which is replaced periodically according to usage. The product,consumnables, installation instructions and packaging are designed for easy customer installation.

Whole blood specimens are aspirated into the analyzer's microsensor card from syringes, tubes,or capillary blood collection devices using a peristaltic pump and a sampling probe. Thedisposable microsensor card contains the analytical flowpath and all of the measurement sensors(pH, PCO2, P02, Hct, Nat, K+, Cl-, iCa, and Glu (Glucose). Once the analysis measurement iscomplete, the whole blood specimen is automatically flushed out of the microsensor cardflowpath and into a self contained waste collection bag contained within the disposable calibratorcartridge.

The Stat Profile Prime CCS Analyzer will have an enhanced test menu and multiple qualitycontrol options. Both traditional Internal and External liquid QC shall be offered, as well as an on-board Quality Management System (QMS), an electronic monitoring approach that insures theanalyzer is working properly.

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As with the predicate, the Stat Profile Prime COS Analyzer is microprocessor-based andincorporates:

* traditional sensor technology to measure blood P02* ion selective electrode technology to measure pH, PC02, blood sodium, potassium,

chloride, and ionized calcium* enzyme/Amperometric technology for glucose measurements

Liquid quality control materials are available as internal auto-cartridge quality control packs andas external ampules. The sampling, calibration and quality control functions are fully automated.

Internal Calibration standards with dissolved gases are provided in sealed pouches eliminatingthe need for users to calibrate the blood gas electrodes using external compressed gas cylinders.The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in acardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is piercedduring the insertion of the cartridge into the analyzer. The Calibration Cartridge aqueoussolutions allow for 2 point calibration of each parameter as follows:

* Calibrator A -pH, PCO 2, Na, K, Cl, iCa, and Glu (Volume> 500 mL)* Calibrator B - pH, P02, Na, K, Cl, iCa, and Glu (Volume > 250 mL)* Calibrator F - PCO 2, P02 (Volume > 720 mL)* Reference Solution - KCI (Volume > 300 mL)

The external glass ampule controls contain a buffered bicarbonate solution with a known pH andknown levels of Na, K, Cl, iCa, and Glu. The solutions are equilibrated with known levels of 02,C02, and N2. Each ampule contains 1.7 ml volume.

The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bagcontains an aqueous quality control material for monitoring the measurement of pH, PCO2, P02,hematocrit (Hct) Na, K, Cl, iCa, and Glucose (Glu). The aqueous quality control materials arecomposed of a buffered bicarbonate solution, each with a known pH and known level of Na, K,Cl, iCa, and Glu. Solutions are equilibrated with known levels of 02, C02, and N2. Each bagcontains a minimum volume of 100 mL. The aqueous quality control materials are formulated atthree levels:

" Control 1: Acidosis, with High Electrolyte, Low Normal Glu* Control 2: Normal pH, Low-Normal Hot, Normal Electrolyte, High Glu* Control 3: Alkalosis, High Hct, Low Electrolyte, High Abnormal Glu,

Linearity Standard Set A consists of ampuled buffered solutions containing Ca++, Glu, K+, andCI-. Each ampule contains 1.8 ml volume.

The Stat Profile Analyzer accepts Lithium helparin whole blood sample from syringes, open tubes,small cups, and capillary tubes. The minimum sample size for both syringe and capillary samplesanalysis is 100 pL.

Measured Parameters:

The Stat Profile Prime CCS Analyzer measures pH, PC02, P02, Hct, Na+, K+, Cl-, iCa, and Glu(Note: Glucose is optional).

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Calculated Parameters:

" pH, PC0 2, P0 2 (corrected to patient temperature)* Bicarbonate level (HCOr)" Total Carbon Dioxide (TCO 2)* Base Excess of the blood (BE-b)" Base Excess of extracellular fluid (BE-ecf)* Standard Bicarbonate Concentration (SBO)* Oxygen Content (O2Ct)* Oxygen Capacity (O2Cap)" Alveolar Oxygen (A)* Arterial Alveolar Oxygen Tension Gradient (AaDO 2)* Arterial Alveolar Oxygen Tension Ratio (a/A)* Respiratory Index (RI)* P50" PO2/FIO 2 ratio* Oxygen Saturation (802%)" Hemoglobin* Anion Gap* Normalized Calcium, nCa

Intended Use:

The Stat Profile Prime CCS Analyzer System is intended for in vitro diagnostic use by health careprofessionals in clinical laboratory settings for the quantitative determination of pH, PCO2, P02,Hct, Nat, K+, Cl-, iCa, and Glu (Glucose), in heparinized whole blood.

PCO2, WIhole brood measurement of certain gases in whole blood, or pH of whole blood, is used in theP02, diagnosis and treatment of life-threatening acid-base disturbances.pHHct Whole blood measurements of the packed red cell volume of a blood sample are used to

distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in thenumber of red cells).

Na+ Sodium measurement is used in the diagnosis and treatment of aldosteronism, diabetesinsipidus, adrenal hypertension, Addison's disease, dehydration, or diseases involvingelectrolyte imbalance,

K+ Potassium Measurement is used to monitor electrolyte balance in the diagnosis and treatment ofdisease conditions characterized by low or high potassium levels.

Cl- Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolicdisorders such as cystic fibrosis and diabetic acidosis.

Ca Calcium measurements are used in the diagnosis and treatment of parathyroid disease, avariety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions orspasms).

Glu Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolismdisturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemnia,and of pancreatic islet cell carcinoma,

Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitrodiagnostic use by healthcare professionals for monitoring the performance of the Stat ProfilePrime COS Analyzer.

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Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitrodiagnostic use by healthcare professionals for monitoring the performance of Stat Profile PrimeCCS Analyzer.

Stat Profile Prime Calibrator Cartridge 008 is intended for the calibration of pH, PCO 2, P02, Hct,Na', K+, C1, iCa, and Glucose, using the Stat Profile Prime 008 Analyzer.

Linearity Standard Set A is intended for in vitro diagnostic use with Stat Profile Prime CCSAnalyzers to verify calibration, analytical linearity, estimate test imprecision, and detectsystematic analytical deviations that may arise from calibrator cartridge or analytical instrumentvariation.

Summary of the Technological Characteristics:

The Stat Profile Prime 008 Analyzer is substantially equivalent to the previously cleared formarket Nova Stat Profile pHOx Ultra Analyzer System in intended use. It uses the same sensortechnology and measurement algorithms, and the formulations of the internal and externalcontrols and the calibration cartridge are the same for the tested parameters. The LinearityStandard Set A for use with the Stat Profile Prime CCS Analyzer is identical to those cleared foruse with the predicate Nova Stat Profile pHOx Ultra Analyzer System.

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Summary of Performance Testing:

Bench testing was completed to demonstrate that the Stat Profile Prime CCS Analyzer issubstantially equivalent in performance, safety and efficacy to the Stat Profile pHOx UltraAnalyzer System.

The bench testing included:

* Method Comparison Studies* Precision/Reproducibility Studies* Run to Run Precision* Within Run Precision* Linearity Testing* Specificity / Interference Testing* Detection Limit

The results of the testing confirmed that the performance of the Stat Profile Prime OCS AnalyzerSystem is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System(predicate device).

Conclusion:

The results of software validation and performance verification testing confirmed that the StatProfile Prime OCS Analyzer is safe and effective for its intended purpose and that the Stat ProfilePrime GCS Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOxUltra Analyzer System K1 10648 (predicate device).

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>04 DEPARTMENT OF HEALTH & HIUMAN SERVICES Public Health Service

C:Silver Spring. MD 29300

NOVA BIOMEDICAL CORPORATION Mrh2,2014

PAUL MACDONALDCHIEF OFFICER, QA & REG. AFFAIRS200 PROSPECT STWALTHAM MA 02454

Re: KI13l703

Trade/Device Name: Nova Stat Profile Prime CCS Analyzer System, Stat Profile PrimeAuto QC Cartridge CCS, Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile PrimeAmpuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp,Nova Linearity Standard Set ARegulation Number: 21 CFR 862.1120Regulation Name: Blood gases (PCO2, P02) and blood pH test systemRegulatory Class: 11Product Code: CHL, .105, CEM, .JFP, CGZ, CGA, GKF, JIX, JJSDated: February 19, 2014Received: February 20, 2014

Dear Mr. MacDonald:

We have reviewed your Section 5 10(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of the Act. Thegeneral controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting ofmedical device-related adverse events) (21 CER 803); good manufacturing practice requirements

Page 2-Mr. MacDonald

as set forth in the quality systems (QS) regulation (21 CFR Part 820); and iI'applicable, theelectronic product radiation control provisions (Sections 53 1-542 of the Act); 21 CFR lOGO-1050.

If you desire sfpecilic advice for your device onl our labeling regulations (21 CFR Parts 801 and809). please contact the Division of Smnall Manufacturers, International and ConsumerAssistance at its toll-free number (800) 638 2-04 1 or (301) 796-7 100 or at its Internet addresslittn://vww.f'da.gov/MediicaIlevices/IRCSOLurceslbor)'o/ndstr%,/del',ullthitiii Also, please notethe regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tolhttp://vww.lfdai.Lov/MedicalDevices/Safbctv/RZeportallroblein/delhzult.litni for the CDR-I's Officeof Surveillance and Biometrics/Division of Postrnarkct Surveillance.

You may obtain other general inforniation Onl your responsibilities tinder the Act fromt theDivision of Small Manufacturers. International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7 100 or at its Internet addresslhttp://vww.fdaa.z-ov/MedicealIDeviCeS/1RCSOutreCSf'olYoL/induistrv /de'lLit.litni

Sincerely yours.

Courtney H. Lias -SCourtney 11. Lias. Phi.D.D~irectorDivision of Chemistry and Toxicology DevicesOffice ofl'n Vitro Diagnostics

and Radiological HealthCenter for Devices and Radiological Health

Enclosure

510(k) Number (f known)

K131703

Device Name

Stat ProfleO Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled ControlABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Linearity Standard Set A

Indications for Use (Describe)

The Stat Profile Prime CCS Analyzer System Is Intended for In vitro diagnostic use by health care professionals In clinicallaboratory settings for the quantitative determination of PH, PCOZ, P02, Hct, Nat, K+, Cl-, iCa, and Glu (Glucose), inheparinized whole blood.

PCOZ, P02, pH: Whole blood measurement of certain gases In whole blood, or PH of whole blood, Is used In thediagnosis and treatment of life-threatening acid-base disturbances.

Ndt: Whole blood measurements of the packed red cell volume of a blood sample are used to distinguishnormal from abnormal states, such as anemia and erythrocytosis (an Increase In the number of red cells).

Na+: Sodium measurement is used in the diagnosis and treatment of aldlosteronism, diabetes insipidlus, adrenalhypertension, Addison's disease, dehydration, or diseases Involving electrolyte Imbalance.

K+: Potassium Measurement Is used to monitor electrolyte balance in the diagnosis and treatment of diseaseconditions characterized by low or high potassium levels.

Cl-: Chloride measurement Is used in the diagnosis and treatment of electrolyte and metabolic disorders such ascystic fibrosis and diabetic acidosis.

IlCa: Calcium measurements are used In the diagnosis and treatment of parathyroid disease, a variety of bonediseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Glu: Glucose measurement Is used In the diagnosis and treatment of carbohydrate metabolism disturbancesIncluding diabetes mellitus, neonatal hypoglycemia, and Idiopathic hypoglycemia, and of pancreatic Islet cellcarcinoma.

The Stat Profile Prime Auto QC Cartridge caS is a quality control material Intended for In vitro diagnostic use byhealthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer.

The Stat Profile Prime Ampuled Control ABG/CCS Is a quality control material Intended for In vitro diagnostic use byhealthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer.

FORM FDA 3881 (1/14) Page I of 3 m1tn-QO 4-4OE

510(k) Number (if known)

K131703

Device Name

Stat ProfileO Prime CCS Analyzer System, Stat Profile Prime Auto QC Cartridge CCS, Stat Profile Prime Ampuled Control

ABG/CCS, Stat Profile Prime Calibrator Cartridge CCS/CCS Comp and Linearity Standard Set A

The Stat Profile Prime Calibrator Cartridge CGS Is Intended for the calibration of PH, PC02, P02, Hct, Nat, K+, Cl-, iCa,

and Glucose using the Stat Profile Prime CCS Analyzer.

Linearity Standard Set A Is Intended for In vitro diagnostic use with Stat Profile Prime CCS Analyzers to verify calibration,

analytical linearity, estimate test Imprecision, and detect systematic analytical deviations that may arise from calibrator

cartridge or analytical Instrument variation.

Type of Use (Select one or both, as applicable)

E] Prescuiption Use (Part 21 CFR 801 Subpart D) 0Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center fbr Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14) Page 2 of 3

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FORM FDA 3881 (1114) Page 3 of 3