Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a microprocessor-based analyzer using traditional electrode and optical reflectance technologies for quantitative measurements. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of various parameters in blood, serum, or plasma. It is used for diagnosis and monitoring, not for treating a disease or condition.

Diagnostic

Yes.

The "Intended Use / Indications for Use" section explicitly states that the device 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." This clearly indicates its role in diagnosing and monitoring medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as electrodes, optical reflectance technology, ion selective electrode technology, and enzyme/amperometric technology, indicating it is a physical analyzer system, not software only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section explicitly states for both configurations of the analyzer and the associated calibrator and control cartridges that they are "intended for in vitro diagnostic use".
Measurement of Analytes in Biological Samples: The device measures various analytes (pH, PCO2, PO2, etc.) in biological samples (whole blood, serum, or plasma). This is a core characteristic of an in vitro diagnostic device.
Use by Healthcare Professionals: The intended user is stated as "health care professionals", which aligns with the typical use of IVD devices in a clinical setting.
Point-of-Care Usage: While not exclusively for laboratory use, point-of-care testing is a common application for IVD devices, allowing for rapid results closer to the patient.

The device description further supports this by detailing the technologies used to measure these analytes in the provided biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

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

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care professionals and for point-of-care usage

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

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

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

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)

1

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.

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.

2

Comparison Table

| Characteristic | Predicate
Stat Profile Critical Care Xpress with COOX
Analyzer System | Proposed
Stat Profile pHOx Ultra with COOX Analyzer
System |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Stat Profile Critical Care Xpress (STP
CCX) 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+,
K+, 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
The STP CCX 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
samples.
The intended use of the Nova STP CCX 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 STP CCX
Analyzer with CO-Oximeter.
Nova STP CCX CO-Oximeter Controls and
Autocartridge QC are intended for in vitro
diagnostic use by healthcare professionals for
monitoring the performance of Nova STP CCX
Analyzers. | The 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+,
K+, 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 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 STP pHOx
Ultra/CCX 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 STP pHOx
Ultra/CCX Analyzers with CO-Oximeter
Nova STP pHOx Ultra/CCX ABG and CO-
Oximeter Controls and Autocartridge QC are
intended for in vitro diagnostic use by
healthcare professionals for monitoring the
performance of Nova STP pHOx Ultra/CCX
Analyzers. |
| Analyzer | Nova Stat Profile Critical Care Xpress (CCX),
Model 1+ Analyzer System with CO-OX -
37413
Nova Stat Profile Critical Care Xpress (CCX),
Model 1+ Analyzer System - 35942 | Nova Stat Profile pHOx Ultra Analyzer System
with CO-OX - 42013
Nova Stat Profile pHOx Ultra Analyzer System

42014 |
| Consumables | | |
| Calibrators | ABG, SO2, CO-Ox | Same |
| Controls | ABG Gas, ABG Chem, CO-Ox, External Lin
Standards | 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 | Predicate
Stat Profile Critical Care Xpress with COOX
Analyzer System | Proposed
Stat Profile pHOx Ultra with COOX Analyzer
System |
| 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 Sample
Volumes | | |
| 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 of
Measurement | | |
| 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 above
sensors | 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 regular
deproteinization | compares cuvette absorbance before and after sample, and schedules immediate deproteinization if difference is detected. |
| CoHb algorithm | Multi-wavelength Linear Regression
Chemometrics | Same |
| tBil algorithm | Multi-wavelength Linear Regression
Chemometrics | Same |
| Hemolyzer | Chemically Lysed with mechanical mixing | Same |
| Software/HW
Architecture | | |
| 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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3

4

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5

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.

6

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

7

Indications for Use Form

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

Nova Stat Profile pHOx Ultra Analyzer System Device Name:

Indications for Use:

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.

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

8

Indications for Use Form

510(k) Number (if known): K110648

Nova Stat Profile pHOx Ultra Analyzer System Device Name:

Indications for Use:

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.

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

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