The Nova Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic use by health care professionals and for point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in heparinized whole blood; Na+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma. Total Bilirubin (tBil) was not evaluated on neonatal samples.

The Nova Stat Profile pHOx Ultra Analyzer without CO-Oximeter is intended for in vitro diagnostic use by health care professionals and/or point-of-care usage in the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova STP pHOx Ultra Calibrator Cartridge is for the quantitative determination of pH, PCO2, PO2, SO2%, Hematocrit (Hct), Hemoglobin (Hb) in heparinized whole blood; Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate (Lac), BUN (Urea), and Creatinine (Creat) in heparinized whole blood, serum, or plasma.

The intended use of the Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Calibrator Cartridge with Bilirubin and Deproteinizing Solution is for the quantitative determination of total Hemoglobin (tHb), Oxyhemoglobin (O2Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), Deoxyhemoglobin (HHb), and total bilirubin (tBil) in human blood using the Nova Stat Profile pHOx Ultra Analyzer System with CO-Oximeter.

Nova Stat Profile pHOx Ultra Analyzer CO-Oximeter Controls and Autocartridge QC are intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Nova Stat Profile pHOx Ultra Analyzer.

Device Description

As in the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830) predicate device, the Nova Stat Profile pHOx Ultra Analyzer System combines Blood Gas/pH, Chemistry, bilirubin and CO-Oximetry testing into one Point-of-Care Analyzer. This device is analyte configurable by the end user, based on tests needed.

As with the predicate, this device is microprocessor-based and incorporates:

traditional electrode technology to measure blood pH, pCO2, pO2 .
Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
conductivity/Na+ correction for hematocrit .
multi-wavelength reflectance/conductivity correction for hemoglobin. .

Calibration standards with dissolved gases are provided in sealed pouches eliminating the need for users to calibrate the blood qas electrodes using external compressed gas cylinders. Quality control materials are available as external ampules and as internal auto-cartridge quality control packs. Sampling, calibration and quality control are fully automated.

Nova will market the Nova Stat Profile pHOx Ultra Analyzer System in two configurations. The proposed Nova Stat Profile pHOx Ultra Analyzer System with CO-Ox module (Catalog #42013) will be offered with all the parameters listed above. A second configuration will be offered, called the Nova Stat Profile pHOx Ultra Analyzer System without the CO-Ox module (Catalog #42014). This configuration will not have the capability to measure Oxyhemoglobin (O₂Hb), Carboxyhemoglobin (COHb), Methemoglobin (MetHb), and Reduced Hemoglobin (HHb) or bilirubin.

AI/ML Overview

This 510(k) summary (K110648) describes the Nova Stat Profile pHOx Ultra Analyzer System as substantially equivalent to the predicate device, the Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830). The submission primarily focuses on demonstrating equivalence due to component obsolescence, rather than presenting a study to prove new performance criteria.

Therefore, the acceptance criteria are implicitly those established for the predicate device, and the "study" is a comparison and verification that the changes to the Nova Stat Profile pHOx Ultra Analyzer System did not affect the performance and maintain equivalence.

Here's the information broken down based on the provided text, recognizing the nature of this 510(k) (substantial equivalence based on component updates):

1. Table of Acceptance Criteria and Reported Device Performance

(Note: Since this is a substantial equivalence claim based on component changes, explicit acceptance criteria values for each analyte are not provided in this document. Instead, the "acceptance criteria" for the new device is to perform equivalently to the predicate. The reported device performance is that it met this equivalence.)

Characteristic	Acceptance Criteria (based on predicate performance)	Reported Device Performance (Nova Stat Profile pHOx Ultra)
Analyte Measurement	Performance equivalent to predicate for all analytes (pH, PCO2, PO2, SO2%, Hct, tHb, O2Hb, COHb, MetHb, HHb, tBil, Na+, K+, Cl-, Ca++, Mg++, Glu, Lac, BUN, Creat)	"the results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device."
User Interface	Functionality equivalent to predicate	"Functionality is equivalent to the predicate."
Accuracy	Equivalent to predicate	Confirmed through performance verification testing
Precision	Equivalent to predicate	Confirmed through performance verification testing
Reproducibility	Equivalent to predicate	Confirmed through performance verification testing
Software Validation	All software requirements met	Successfully validated
Performance Verification	All performance specifications met against predicate	Successfully verified

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size or data provenance (country of origin, retrospective/prospective) for the "performance verification testing." Given the nature of a 510(k) for component changes, this testing would typically involve a series of internal laboratory tests comparing the updated device's output to the predicate's output across a range of relevant samples (e.g., blood controls, patient samples).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This type of 510(k) submission, focused on component equivalence for an in vitro diagnostic device, typically relies on established reference methods or calibrated controls as the "ground truth" rather than expert consensus on individual cases. The document does not specify the use of "experts" to establish ground truth for a test set in the traditional sense of clinical imaging or diagnostic interpretation.

4. Adjudication Method for the Test Set

Not applicable. This submission does not describe a process involving adjudication of test results, as it is focused on technical equivalence to a predicate device rather than human interpretation or complex diagnostic assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an IVD device for quantitative measurements, not an AI-assisted diagnostic imaging device. An MRMC study is not relevant to this submission.

6. Standalone Performance Study

Yes, in essence, a "standalone" performance verification for the new device was implicitly conducted against the predicate device. The submission states: "The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device." This indicates that the device was tested to ensure its standalone performance matches that of the predicate.

7. Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

Traceability to Reference Methods: Calibrators and controls used for the device would be traceable to recognized reference measurement procedures or certified reference materials for each analyte.
Comparison to Predicate Device: The primary "ground truth" in this context is the established performance of the legally marketed predicate device (Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System). The new device's performance was verified to be equivalent.

8. Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that relies on a "training set" to learn. It is a measurement device with established electrochemical and optical principles.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of IVD device.

Summary

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K110648

AUG 2 9 2011

510(k) Summary

510(K) Owner:	Nova Biomedical Corporation
Registration Number:	1219029
Address:	200 Prospect St.Waltham, MA 02454
Phone:	781-894-0800
Fax Number:	784-891-4806
Contact Person:	Paul W. MacDonald
Date Prepared:	08/24/2011

Proprietary Name: Nova Stat Profile pHOx Ultra Analyzer System

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

Classification Name: Multiple

Classification Names:	Class No.	Reg. No.	Class
Blood Gases and Blood pH system	75CHL	862.1120	II
Sodium Test System	75JGS	862.1665	II
Potassium Test System	75CEM	862.1600	II
Calcium Test System	75JFP	862.1145	II
Chloride Test System	75CGZ	862.1170	II
Creatinine Test System	75CGL	862.1225	II
Magnesium Test System	75CFA	862.1495	I
Glucose Test System	75CGA	862.1345	II
Lactic Acid Test System	75KHP	862.1450	I
Urea Nitrogen System	75CDS	862.1770	II
Oxygen Saturation (SO2%)	91JKS	862.3220	I
Hematocrit Measuring Device	81JPI	864.6400	II
Hemoglobin System	81GKR	864.5620	II
Oxyhemoglobin	91JKS	862.3220	I
Carboxyhemoglobin	81GHS	864.7425	II
Methemoglobin	81JBJ	864.7360	II
Hemoglobin Standards and Controls	81JPK	864.8625	II
Hemoglobin Calibrator	81KRZ	864.8165	II
Calibrators	75JIX	862.1150	II
Quality Control Materials	81JJS	862.1660	I

Product Codes: CHL, JGS, CEM, JFP, CGZ, CGL, CFA, CGA,KHP,CDS, JKS, GHS, JPI, GKR, JKS, JBJ, JPK,KRZ,JIX, JJS

Predicate Device: Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System (K061830)

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Device Description:

As with the predicate, this device is microprocessor-based and incorporates:

traditional electrode technology to measure blood pH, pCO2, pO2 .
Nova Biomedical proprietary optical reflectance technology for the measurement of oxygen . saturation
ion selective electrode technology to measure blood sodium, chloride, ionized . calcium, ionized magnesium
enzyme/amperometric technology for glucose, urea nitrogen, lactate and creatinine . measurements
conductivity/Na+ correction for hematocrit .
multi-wavelength reflectance/conductivity correction for hemoglobin. .

Summary of the Technological Characteristics:

The Nova Stat Profile pHOx Ultra Analyzer System is identical to the previously cleared for market Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System in intended use. Modifications were made necessary due to the obsolescence and availability of certain components and hardware, which required minor modifications to the device software to support these changes. The software algorithms used in performing the analysis of samples are unchanged from the predicate device. Minor modifications have been made to simplify the User Interface. The same reagents, calibrators, and controls are used for all of the analytes. The comparison table below compares the Nova Stat Profile pHOx Ultra Analyzer System to the predicate Nova Stat Profile Critical Care Xpress (CCX), Model 1+ Analyzer System.

The results of software validation and performance verification testing confirmed that the modifications made to the hardware and software of the Nova Stat Profile pHOx Ultra Analyzer System did not affect the safety, efficacy or performance of the system is substantially equivalent to the predicate device.

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Comparison Table

Characteristic	PredicateStat Profile Critical Care Xpress with COOXAnalyzer System	ProposedStat Profile pHOx Ultra with COOX AnalyzerSystem
Intended Use	The Stat Profile Critical Care Xpress (STPCCX) Analyzer with CO-Oximeter is intendedfor in vitro diagnostic use by health careprofessionals and for point-of-care usage in thequantitative determination of pH, PCO2, PO2,SO2%, Hematocrit (Hct), total Hemoglobin(tHb), Oxyhemoglobin (O2Hb),Carboxyhemoglobin (COHb), Methemoglobin(MetHb), Deoxyhemoglobin (HHb), and totalbilirubin (tBil) in heparinized whole blood; Na+,K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate(Lac), BUN (Urea), and Creatinine (Creat) inheparinized whole blood, serum, or plasma.Total Bilirubin (tBil) was not evaluated onneonatalThe STP CCX Analyzer without CO-Oximeteris intended for in vitro diagnostic use by healthcare professionals and/or point-of-care usagein the quantitative determination of pH, PCO2,PO2, SO2%, Hematocrit (Hct), Hemoglobin(Hb) in heparinized whole blood; Na+, K+, Cl-,Ca++, Mg++, Glucose (Glu), Lactate (Lac),BUN (Urea), and Creatinine (Creat) inheparinized whole blood, serum, or plasmasamples.The intended use of the Nova STP CCX CO-Oximeter Calibrator Cartridge with Bilirubin andDeproteinizing Solution is for the quantitativedetermination of total Hemoglobin (tHb),Oxyhemoglobin (O2Hb), Carboxyhemoglobin(COHb), Methemoglobin (MetHb),Deoxyhemoglobin (HHb), and total bilirubin(tBil) in human blood using the STP CCXAnalyzer with CO-Oximeter.Nova STP CCX CO-Oximeter Controls andAutocartridge QC are intended for in vitrodiagnostic use by healthcare professionals formonitoring the performance of Nova STP CCXAnalyzers.	The Stat Profile pHOx Ultra Analyzer with CO-Oximeter is intended for in vitro diagnostic useby health care professionals and for point-of-care usage in the quantitative determination ofpH, PCO2, PO2, SO2%, Hematocrit (Hct), totalHemoglobin (tHb), Oxyhemoglobin (O2Hb),Carboxyhemoglobin (COHb), Methemoglobin(MetHb), Deoxyhemoglobin (HHb), and totalbilirubin (tBil) in heparinized whole blood; Na+,K+, Cl-, Ca++, Mg++, Glucose (Glu), Lactate(Lac), BUN (Urea), and Creatinine (Creat) inheparinized whole blood, serum, or plasma.Total Bilirubin (tBil) was not evaluated onneonatal samples.The Stat Profile pHOx Ultra Analyzer withoutCO-Oximeter is intended for in vitro diagnosticuse by health care professionals and/or point-of-care usage in the quantitative determinationof pH, PCO2, PO2, SO2%, Hematocrit (Hct),Hemoglobin (Hb) in heparinized whole blood;Na+, K+, Cl-, Ca++, Mg++, Glucose (Glu),Lactate (Lac), BUN (Urea), and Creatinine(Creat) in heparinized whole blood, serum, orplasma.The intended use of the Nova STP pHOx UltraCalibrator Cartridge is for the quantitativedetermination of pH, PCO2, PO2, SO2%,Hematocrit (Hct), Hemoglobin (Hb) inheparinized whole blood; Na+, K+, Cl-, Ca++,Mg++, Glucose (Glu), Lactate (Lac), BUN(Urea), and Creatinine (Creat) in heparinizedwhole blood, serum, or plasma.The intended use of the Nova STP pHOxUltra/CCX CO-Oximeter Calibrator Cartridgewith Bilirubin and Deproteinizing Solution is forthe quantitative determination of totalHemoglobin (tHb), Oxyhemoglobin (O2Hb),Carboxyhemoglobin (COHb), Methemoglobin(MetHb), Deoxyhemoglobin (HHb), and totalbilirubin (tBil) in human blood using STP pHOxUltra/CCX Analyzers with CO-OximeterNova STP pHOx Ultra/CCX ABG and CO-Oximeter Controls and Autocartridge QC areintended for in vitro diagnostic use byhealthcare professionals for monitoring theperformance of Nova STP pHOx Ultra/CCXAnalyzers.
Analyzer	Nova Stat Profile Critical Care Xpress (CCX),Model 1+ Analyzer System with CO-OX -37413Nova Stat Profile Critical Care Xpress (CCX),Model 1+ Analyzer System - 35942	Nova Stat Profile pHOx Ultra Analyzer Systemwith CO-OX - 42013Nova Stat Profile pHOx Ultra Analyzer System- 42014
Consumables
Calibrators	ABG, SO2, CO-Ox	Same
Controls	ABG Gas, ABG Chem, CO-Ox, External LinStandards	Same
Sensors	PH, PCO2, PO2, SO2, Na+, K+, Cl-, Ca++,Mg++, Glu, Lac, Creat, BUN, REF	Same
Membranes	Glu, Lac, Creat, BUN, PCO2, PO2	Same
Characteristic	PredicateStat Profile Critical Care Xpress with COOXAnalyzer System	ProposedStat Profile pHOx Ultra with COOX AnalyzerSystem
Pump Tubing	ABG, CO-Ox	Same
Acceptable Samples	Syringe, Capillary	Same
Sample Volumes
ABG Only	150μL	Same
CO-Ox Only	100μL	Same
Combined Analysis	210µL	Same
Micro SampleVolumes
Full	120µL	Same
ABG	60µL	Same
ABG Plus	70µL	Same
ABG Nano	70µL	Same
Sensor Slope Limits
pH	8.7 - 11.6	Same
PCO2	7.9 - 12.6	Same
PO2	15.0 - (-1.6)	Same
SO2	8.0 - 18.0	Same
Hct	14.0 - 45.0	Same
Hb	40.0 - 98.0	Same
Na+	8.8 - 11.0	Same
K+	8.3 - 12.1	Same
Cl-	7.7 - 13.2	Same
Ca++	8.3 - 12.6	Same
Mg++	9.5 - 15.0	Same
Glu	5.0 - 60.0	Same
Lac	6.0 - 100.0	Same
Creat	3.0 - 25.0	Same
BUN	9.3 - 13.5	Same
Principles ofMeasurement
pH	Hydrogen ion-selective glass sensor	Same
PCO2	Severinghaus-type sensor	Same
PO2	Polarographic Clark-type sensor	Same
SO2	Reflectance photometry (fiber optics)	Same
Hct	Impedance sensor	Same
Hb	Impedance sensor	Same
Na+	Sodium ion-selective glass sensor	Same
K+	Potassium ion-selective sensor	Same
Cl-	Chloride ion-selective sensor	Same
Ca++	Calcium ion-selective sensor	Same
Mg++	Magnesium ion-selective sensor	Same
Glu	Enzymatic sensor	Same
Lac	Enzymatic sensor	Same
Creat	Enzymatic sensor	Same
BUN	Enzymatic sensor	Same
THb	Spectrophotometric	Same
O2Hb	Spectrophotometric	Same
COHb	Spectrophotometric	Same
MetHb	Spectrophotometric	Same
TBil	Spectrophotometric	Same
Design
Touch Screen	10.4" LCD, 640x480 pixel, Resistive Touch	12.1" LCD, 1024x768 pixel, Resistive Touch
Menu	Fully configurable test menu based on abovesensors	Test menu has not changed.
Printer	4.25" Roll, Thermal Transfer	2" Roll, Thermal Transfer
Characteristic	Predicate	Proposed
Chassis	Stat Profile Critical Care Xpress with COOX Analyzer System	Stat Profile PHOx Ultra with COOX Analyzer System
	Molded GF PC Base w/ Aluminum Welded Frame and Molded ABS/PC Cover.	Aluminum Riveted and Welded Base and Frame w/ Aluminum Cover
ABG System
ABG Sensor Module	Combined Flow-through/Flow-by w/ optical SO2	Same
ABG Probe/S-Line	Stainless Probe w/ Polyurethane and Saran flexible tubing, In-Line Air detector	No Polyurethane used, shorter stainless steel portion dictated use of less gas permeable material.
ABG Pump	Peristaltic Pump w/ Pressure Plate, TPE Tubing (Pharmed BPT)	Same
Reagent Valves	Ceramic Shear Valves	Same
Other Valves	Pinch Style, Extruded TPE and Molded Silicone Tubing	Same
CO-Ox System
CO-Ox Probe/S-Line	Stainless Probe w/ Polyurethane and Saran flexible tubing, In-Line Air detector	No Polyurethane used, shorter stainless steel portion dictated use of less gas permeable material.
CO-Ox Pump	Peristaltic Pump w/o Pressure Plate, Molded Silicone Tubing (Q7-4840)	Peristaltic Pump w/ Pressure Plate, Extruded TPE Tubing (Pharmed BPT)
Reagent Valves	Ceramic Shear Valves	Same
Spectrophotometer	Broad Spectrum Spectrometer	Same
Lamp House	Krypton Calibration Lamp / LED Light Source	Same
Cuvette Slide	Machined aluminum pre-heated slide w/ acrylic	Cast aluminum pre-heated slide w/ acrylic and
Assembly	and sapphire cuvette assembly	sapphire cuvette assembly
Analog Board	precision low level analog front end w/amperometric and potentiometric amplifiers, air detector circuitry and temperature control circuitry	Same
Deproteinizing	"bleach type" agent can be scheduled to run	Same process, but spectrophotometer
Algorithm	through COOX branch for regulardeproteinization	compares cuvette absorbance before and after sample, and schedules immediate deproteinization if difference is detected.
CoHb algorithm	Multi-wavelength Linear RegressionChemometrics	Same
tBil algorithm	Multi-wavelength Linear RegressionChemometrics	Same
Hemolyzer	Chemically Lysed with mechanical mixing	Same
Software/HWArchitecture
Graphical User	CCX user interface	Interface updated and tested as part of software validation. Functionality is equivalent to the predicate.
Interface (GUI)
Storage media	IDE Hard Drive	SATA Hard Drive
Operating System	Windows 2000 Embedded	Windows 7 Embedded
Host Computer	ibase IB880	Axiomtek 84831

, •

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・

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Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like bird symbol on the right side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the left side of the seal. The text is in all capital letters.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Silver Spring, MD 20993

Food and Drug Administration

10903 New Hampshire Avenue

Nova Biomedical Corporation c/o Paul W. MacDonald 200 Prospect St. Waltham, MA 02454

AUG 2 9 2011

Re: K110648

Trade/Device Name: Nova Stat Profile pHOx Ultra Analyzer System with CO-OX Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, CGZ, JFP, CFA, NGD, CDS, CGL, GGZ, GLY, GKK, GHS, GJC, JJB, CGA, BXX, JIX Dated: 2 August 2011 Received: 4 August 2011

Dear Dr. MacDonald:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation (27 CFK Pat(1) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding of reference to prematics of prematics under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillace.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolli-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

: 1441

Enclosure

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Indications for Use Form

510(k) Number (if known):	K110648
---------------------------	---------

Nova Stat Profile pHOx Ultra Analyzer System Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Qus

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110648

Page 1 of 2

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Indications for Use Form

510(k) Number (if known): K110648

Nova Stat Profile pHOx Ultra Analyzer System Device Name:

Indications for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K110648

Page 2 of 2

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.