(66 days)
No
The description focuses on traditional sensor technology, microprocessor control, and automated processes, with no mention of AI or ML.
No
The device is an in vitro diagnostic (IVD) device used for quantitative determination of pH, PCO2, and PO2 in heparinized whole blood, which is for diagnosis and treatment of acid-base disturbances, not for direct therapeutic intervention on the patient.
Yes.
The "Intended Use / Indications for Use" section explicitly states "The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use..." and further mentions that the measurement of blood gases is "used in the diagnosis and treatment of life-threatening acid-base disturbances." This clearly indicates its role as a diagnostic device.
No
The device description clearly outlines hardware components such as sensors, a peristaltic pump, a sampling probe, and a microsensor card, indicating it is a physical analyzer system, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings. It also describes the use of the quality control materials (Stat Profile Prime Auto QC Cartridge ABG and Stat Profile Prime Ampuled Control ABG/CCS) and the calibrator cartridge (Stat Profile Prime Calibrator Cartridge ABG) as being for in vitro diagnostic use.
- Function: The device is designed to perform quantitative determination of pH, PCO2, and PO2 in heparinized whole blood, which are measurements used in the diagnosis and treatment of medical conditions. This is a core function of an in vitro diagnostic device.
- Specimen Type: It analyzes whole blood specimens, which are biological samples taken from the human body.
- Setting: It is intended for use by healthcare professionals in clinical laboratory settings, a typical environment for IVD use.
The description of the device, its components (microsensor card, calibrator cartridge, quality control materials), and the performance studies all further support its classification as an IVD.
N/A
Intended Use / Indications for Use
The Stat Profile® Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.
Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer.
Stat Profile Prime Ampuled Control ABG/CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer.
Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2, using the Stat Profile Prime ABG Analyzer.
PCO2, PO2, pH: Whole blood measurement of blood gases is used in the diagnosis and treatment of life threatening acid-base disturbances.
Product codes
CHL, JIX, JJS
Device Description
The Stat Profile® Prime ABG Analyzer System is a small, low cost blood gas analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation. The Stat Profile® Prime ABG Analyzer System is not intended for Point of Care Use.
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. The disposable microsensor card contains the analytical flow path and the measurement sensors (PCO2, PO2, and pH). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.
As in the predicate Stat Profile® Prime CCS Analyzer System (K131703), the Stat Profile Prime ABG Analyzer will have an enhanced test menu and multiple quality control 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 the analyzer is working properly.
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 in clinical laboratory settings
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
Bench testing was completed to demonstrate that the Stat Profile Prime ABG Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile Prime CCS Analyzer System.
Method Comparison Studies
Study type: Method Comparison
Sample size: A minimum of 150 whole blood specimens were analyzed for pH, pCO2 and pO2.
Data source: Discarded heparinized arterial whole blood specimens from hospital patients. Venous whole blood from male and female donors tonometered to cover the analytical measurement range for all analytes.
Key results: The correlation coefficients (r) for pH ranged from 0.9971 to 0.9986, for pCO2 ranged from 0.9940 to 0.9975, and for pO2 ranged from 0.9975 to 0.9991. The data indicated good correlation between the test analyzers and the comparative method.
Precision/Reproducibility Studies
Run to Run Precision
Whole Blood:
Study type: Run to Run Precision
Sample size: 30 replicates for each analyzer for pH, pCO2, and pO2 in both syringe and capillary modes.
Data source: A single whole blood sample.
Key results: For pH in syringe mode, SD ranged from 0.007 to 0.010. For pCO2, CV% ranged from 2.3% to 2.5%. For pO2, CV% ranged from 1.3% to 1.4%. In capillary mode, for pH, SD ranged from 0.005 to 0.007. For pCO2, CV% ranged from 3.0% to 3.5%. For pO2, CV% ranged from 1.1% to 1.8%.
Control Solutions:
Study type: Run to Run Precision
Sample size: 240 replicates for each QC level across all parameters.
Data source: Stat Profile Prime Quality Control solutions (3 levels for each parameter).
Key results: For pH, Total imprecision SD ranged from 0.004 to 0.008. For pCO2, Total imprecision %CV ranged from 1.59% to 3.33%. For pO2, Total imprecision %CV ranged from 2.53% to 3.87%.
Within Run Precision
Whole Blood:
Study type: Within Run Precision
Sample size: 20 replicates per run for whole blood analyzed from syringe and capillary containers.
Key results: For pH in syringe mode, SD ranged from 0.004 to 0.005. For pCO2, CV% ranged from 0.9% to 1.1%. For pO2, CV% ranged from 1.3% to 1.4%. In capillary mode, for pH, SD ranged from 0.004 to 0.005. For pCO2, CV% ranged from 1.5% to 1.7%. For pO2, CV% ranged from 1.9% to 2.0%.
On Board Quality Control:
Study type: Within Run Precision
Sample size: 20 replicates for each QC level across all parameters for each analyzer.
Key results: For pH, Pooled SD ranged from 0.002 to 0.005. For pCO2, Pooled CV% ranged from 0.8% to 1.9%. For pO2, Pooled CV% ranged from 0.9% to 3.0%.
Linearity Testing
Study type: Linearity Testing
Sample size: 10 – 14 levels. Each bloody level was analyzed in duplicate on each of the three (3) test analyzers.
Data source: Whole blood prepared by tonometering, spiking or diluting.
Key results: Correlation coefficients (r) were: pH (0.9997-0.9998), pCO2 (0.9975-0.9990), and pO2 (0.9994-0.9996). Conclusion states "The comparison data for all parameters for the Stat Profile Prime analyzers shows good correlation with the reference analyzer across the claimed measurement range for all parameters."
Key Metrics
Method Comparison Studies: Wholde Blood Patient Specimen
pH:
- Analyzer #1: Slope = 0.9987, Intercept = 0.0042, r = 0.9971
- Analyzer #2: Slope = 0.9933, Intercept = 0.0431, r = 0.9978
- Analyzer #3: Slope = 0.9937, Intercept = 0.0433, r = 0.9986
pCO2 (mmHg): - Analyzer #1: Slope = 0.9899, Intercept = 0.7042, r = 0.9972
- Analyzer #2: Slope = 0.9834, Intercept = 0.5996, r = 0.9975
- Analyzer #3: Slope = 0.9923, Intercept = 1.8045, r = 0.9940
pO2 (mmHg): - Analyzer #1: Slope = 1.0141, Intercept = -0.6862, r = 0.9975
- Analyzer #2: Slope = 1.0074, Intercept = 0.8237, r = 0.9985
- Analyzer #3: Slope = 1.0080, Intercept = 0.7950, r = 0.9991
Run to Run Precision: Whole Blood (Syringe Mode)
pH Precision Data:
- Analyzer #1: Mean = 7.339, SD = 0.010
- Analyzer #2: Mean = 7.337, SD = 0.007
- Analyzer #3: Mean = 7.336, SD = 0.009
pCO2 Precision Data: - Analyzer #1: Mean = 49.3, SD = 1.2, CV% = 2.4
- Analyzer #2: Mean = 49.6, SD = 1.2, CV% = 2.5
- Analyzer #3: Mean = 50.0, SD = 1.2, CV% = 2.3
pO2 Precision Data: - Analyzer #1: Mean = 34.2, SD = 0.5, CV% = 1.4
- Analyzer #2: Mean = 35.1, SD = 0.5, CV% = 1.3
- Analyzer #3: Mean = 36.6, SD = 0.5, CV% = 1.3
Run to Run Precision: Whole Blood (Capillary Mode)
pH Precision Data:
- Analyzer #1: Mean = 7.205, SD = 0.006
- Analyzer #2: Mean = 7.204, SD = 0.007
- Analyzer #3: Mean = 7.176, SD = 0.005
pCO2 Precision Data: - Analyzer #1: Mean = 73.0, SD = 2.2, CV% = 3.0
- Analyzer #2: Mean = 74.1, SD = 2.6, CV% = 3.5
- Analyzer #3: Mean = 69.7, SD = 2.4, CV% = 3.5
pO2 Precision Data: - Analyzer #1: Mean = 61.7, SD = 0.7, CV% = 1.2
- Analyzer #2: Mean = 64.2, SD = 1.2, CV% = 1.8
- Analyzer #3: Mean = 61.6, SD = 0.7, CV% = 1.1
Run to Run Precision: Control Solutions
pH Precision Data:
- QC Level 1: Pooled Mean = 7.151, Within run SD (Sr) = 0.001, Total imprecision SD (St) = 0.004
- QC Level 2: Pooled Mean = 7.358, Within run SD (Sr) = 0.000, Total imprecision SD (St) = 0.006
- QC Level 3: Pooled Mean = 7.569, Within run SD (Sr) = 0.000, Total imprecision SD (St) = 0.008
pCO2 Precision Data (mmHg): - QC Level 1: Pooled Mean = 57.0, Within run SD (Sr) = 0.33, Within run % CV = 0.58, Total imprecision SD (St) = 0.92, Total Imprecision %CV = 1.61
- QC Level 2: Pooled Mean = 39.7, Within run SD (Sr) = 0.27, Within run % CV = 0.68, Total imprecision SD (St) = 0.63, Total Imprecision %CV = 1.59
- QC Level 3: Pooled Mean = 24.0, Within run SD (Sr) = 0.19, Within run % CV = 0.79, Total imprecision SD (St) = 0.80, Total Imprecision %CV = 3.33
pO2 Precision Data (mmHg): - QC Level 1: Pooled Mean = 57.4, Within run SD (Sr) = 0.43, Within run % CV = 0.75, Total imprecision SD (St) = 2.22, Total Imprecision %CV = 3.87
- QC Level 2: Pooled Mean = 101.5, Within run SD (Sr) = 0.29, Within run % CV = 0.29, Total imprecision SD (St) = 2.57, Total Imprecision %CV = 2.53
- QC Level 3: Pooled Mean = 137.2, Within run SD (Sr) = 0.34, Within run % CV = 0.25, Total imprecision SD (St) = 3.51, Total Imprecision %CV = 2.56
Within Run Precision: Whole Blood Syringe Mode
pH:
- Analyzer #1: Mean = 7.367, SD = 0.005
- Analyzer #2: Mean = 7.356, SD = 0.004
- Analyzer #3: Mean = 7.370, SD = 0.004
pCO2 (mmHg): - Analyzer #1: Mean = 40.7, SD = 0.4, CV% = 1.1
- Analyzer #2: Mean = 41.9, SD = 0.4, CV% = 0.9
- Analyzer #3: Mean = 41.0, SD = 0.5, CV% = 1.1
pO2 (mmHg): - Analyzer #1: Mean = 86.2, SD = 1.2, CV% = 1.4
- Analyzer #2: Mean = 88.6, SD = 1.2, CV% = 1.3
- Analyzer #3: Mean = 86.5, SD = 1.2, CV% = 1.3
Within Run Precision: Whole Blood Capillary Mode
pH:
- Analyzer #1: Mean = 7.349, SD = 0.005
- Analyzer #2: Mean = 7.335, SD = 0.005
- Analyzer #3: Mean = 7.348, SD = 0.004
pCO2 (mmHg): - Analyzer #1: Mean = 39.3, SD = 0.6, CV% = 1.5
- Analyzer #2: Mean = 40.9, SD = 0.7, CV% = 1.7
- Analyzer #3: Mean = 39.8, SD = 0.6, CV% = 1.5
pO2 (mmHg): - Analyzer #1: Mean = 92.4, SD = 1.8, CV% = 2.0
- Analyzer #2: Mean = 94.0, SD = 1.8, CV% = 1.9
- Analyzer #3: Mean = 92.9, SD = 1.9, CV% = 2.0
Within Run Precision: On Board Quality Control Level 1
pH:
- Pooled: Mean = 7.148, SD = 0.002, CV% = 0.8
pCO2 (mmHg): - Pooled: Mean = 57.9, SD = 0.5, CV% = 0.8
pO2 (mmHg): - Pooled: Mean = 60.8, SD = 1.8, CV% = 3.0
Within Run Precision: On Board Quality Control Level 2
pH:
- Pooled: Mean = 7.353, SD = 0.002, CV% = 1.0
pCO2 (mmHg): - Pooled: Mean = 40.6, SD = 0.4, CV% = 1.0
pO2 (mmHg): - Pooled: Mean = 98.8, SD = 2.0, CV% = 2.0
Within Run Precision: On Board Quality Control Level 3
pH:
- Pooled: Mean = 7.560, SD = 0.005, CV% = 1.9
pCO2 (mmHg): - Pooled: Mean = 25.0, SD = 0.5, CV% = 1.9
pO2 (mmHg): - Pooled: Mean = 134.4, SD = 1.1, CV% = 0.9
Linearity Testing
pH:
- Analyzer #1: Slope = 0.9915, Intercept = 0.0632, r = 0.9998
- Analyzer #2: Slope = 0.9948, Intercept = 0.0432, r = 0.9997
- Analyzer #3: Slope = 0.9997, Intercept = 0.0006, r = 0.9998
pCO2 (mmHg): - Analyzer #1: Slope = 1.0017, Intercept = -0.5304, r = 0.9982
- Analyzer #2: Slope = 0.9939, Intercept = 0.8671, r = 0.9975
- Analyzer #3: Slope = 0.9934, Intercept = 2.2697, r = 0.9990
pO2 (mmHg): - Analyzer #1: Slope = 0.9936, Intercept = -1.7134, r = 0.9994
- Analyzer #2: Slope = 1.0204, Intercept = -1.9551, r = 0.9996
- Analyzer #3: Slope = 1.0035, Intercept = 0.1656, r = 0.9995
Predicate Device(s)
K131703 - Stat Profile® 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
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected by a flowing line that resembles a ribbon or wave.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 17, 2014
NOVA BIOMEDICAL CORPORATION PAUL W. MCDONALD CHIEF QUALITY ASSURANCE AND REGULATORY AFFAIRS OFFICER 200 PROSPECT ST WALTHAM MA 02454
Re: K142220 Trade/Device Name: Stat Profile® Prime ABG Analyzer System. Stat Profile® Prime Auto OC Cartridge ABG, Stat Profile® Prime Ampuled Control ABG/CCS, Stat Profile® Prime Calibrator Cartridge ABG Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (PCO2, PO2) and blood pH test system Regulatory Class: II Product Code: CHL, JIX, JJX, JJS Dated: August 29, 2014 Received: September 2, 2014
Dear Mr. Paul W. McDonald:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
1
electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events 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 Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Courtney H. Lias -S
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142220
Device Name
Stat Profile® Prime ABG Analyzer System, Stat Profile Prime Auto QC Cartridge ABG, Stat Profile Prime Ampuled Control ABG/ CCS, Stat Profile Prime Calibrator Cartridge ABG
Indications for Use (Describe)
The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PO2 in heparinized whole blood.
Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer.
Stat Profile Prime Ampuled Control ABG/CCS is a quality control intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer.
Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2, using the Stat Profile Prime ABG Analyzer.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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PCO2, PO2, pH: Whole blood measurement of blood gases is used in the diagnosis and treatment of life threatening acid-base disturbances.
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510(k) Summary
1. Submitter
| 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: | October 3, 2014 |
-
- Device:
Proprietarv Name:
Stat Profile® Prime ABG Analyzer System. Stat Profile Prime Auto QC Cartridge ABG. Stat Profile Prime Ampuled Control ABG/CCS, Stat Profile Prime Calibrator Cartridge ABG
Common or Usual Name: Blood gases (PCO2, PO2) and blood pH Test System
Classification Name: Multiple
| Classification Names: | Class No. | Reg. No. | Class |
|---|---|---|---|
| Blood Gases and Blood pH system | 75CHL | 862.1120 | II |
| Calibrators | 75JIX | 862.1150 | II |
| Quality Control Materials | 75JJS | 862.1660 | I |
Product Codes: CHL, JIX, JJS
3. Predicate Device:
K131703 - Stat Profile® 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
4. Device Description:
The Stat Profile® Prime ABG Analyzer System is a small, low cost blood gas analyzer for laboratory use. The sensors and flow path have been integrated into one replaceable microsensor card, which is replaced periodically according to usage. The product, consumables, installation instructions and packaging are designed for easy customer installation. The Stat Profile® Prime ABG Analyzer System is not intended for Point of Care Use.
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. The disposable microsensor card contains the analytical flow path and the measurement sensors (PCO2, PO2, and pH). Once the analysis measurement is complete, the whole blood specimen is automatically flushed out of the microsensor card flow path and into a self-contained waste collection bag contained within the disposable calibrator cartridge.
As in the predicate Stat Profile® Prime CCS Analyzer System (K131703), the Stat Profile Prime ABG Analyzer will have an enhanced test menu and multiple quality control 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 the analyzer is working properly.
4
As with the predicate, the Stat Profile Prime ABG Analyzer is microprocessor-based and incorporates:
- traditional sensor technology to measure blood pO₂
- . ion selective electrode technology to measure PCO2 and, pH
Liguid quality control materials are available as internal auto-cartridge quality control packs and as external ampules. The sampling, calibration and quality control functions are fully automated.
Internal 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. The Calibration Cartridges contain aqueous solutions within individual flexible bags housed in a cardboard box and a flexible waste bag. Each bag includes a fitment with a septa that is pierced during the insertion of the cartridge into the analyzer.
The external glass ampule controls contain a buffered bicarbonate solution with a known pH level. The solutions are equilibrated with known levels of O2, CO2, and N2. Each ampule contains 1.7 ml volume.
The internal auto QC cartridge consists of 3 flexible bags within a cardboard carton. Each bag contains an aqueous quality control material for monitoring the measurement of pH, PCO2 and PO2. The aqueous quality control materials are composed of a buffered bicarbonate solution, with a known pH. Solutions are equilibrated with known levels of O2, CO2, and N2. Each bag contains a minimum volume of 100 mL.
The Stat Profile Prime ABG Analyzer accepts Lithium heparin whole blood sample from syringes, open tubes, small cups, and capillary tubes. The minimum sample size for both syringe and capillary samples analysis is 50 µL.
Measured Parameters:
The Stat Profile Prime ABG Analyzer measures pH. PCO2, and PO2.
5. Indications for Use:
The Stat Profile Prime ABG Analyzer System is intended for in vitro diagnostic use by health care professionals in clinical laboratory settings for the quantitative determination of pH, PCO2, and PQ2 in heparinized whole blood.
- pH, PCQ2, PO2: Whole blood measurement of blood gases is used in the diagnosis and treatment of life-threatening acid-base disturbances.
The Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer.
The Stat Profile Prime Ampuled Control ABGICCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer.
The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO₂, and PO₂ using the Stat Profile Prime ABG Analyzer.
6. Comparison of Technological Characteristics with the predicate device:
Both the Stat Profile® Prime ABG Analyzer System and the predicate Stat Profile® Prime CCS Analyzer System (K131703) are small, low cost blood gas analyzer for laboratory use. The sensors for measurement of pH, PCO2, and PO2 are identical. They both use disposable sensor cartrols and calibrator packs. A comparison of the similarities and differences between the two systems is provided in the following tables:
5
| Characteristic | Predicate: K131703 Stat Profile® Prime CCS Analyzer | Proposed:
Stat Profile®
Prime ABG
Analyzer |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Indication for Use | pH, PCO2, PO2: Whole blood measurement of blood gases is used in the
diagnosis and treatment of life-threatening acid-base disturbances. | Same |
| Acceptable Samples | Lithium heparinized whole blood from syringes, open tubes, small cups, and
capillary tubes. | Same |
| Measurement Range | | |
| pH | 6.500-8.000 | Same |
| PCO2 | 3.0 -200 mmHg | Same |
| PO2 | 5-765 mmHg | Same |
| Principles of Measurement | | |
| pH | Hydrogen ion-selective sensor | Same |
| PCO2 | Severinghaus-type sensor | Same |
| PO2 | Polarographic Clark-type sensor | Same |
| Touch Screen | 5.7" VGA full color display with LED backlight and integrated touch panel | Same |
| Menu | Fully configurable test menu based on above sensors | Same |
| Bar Code Scanner | Internal Integrated 1D/2D | Same |
| Printer | 2" Roll, Thermal Transfer | Same |
| Pump | Peristaltic Pump w/ Pressure Plate, TPE Tubing (Pharmed BPT) | Same |
| Analog Board | Precision low level analog front end w/ amperometric and potentiometric
amplifiers, air detector circuitry and temperature control circuitry | Same |
| Comparison of Stat Profile® Prime ABG Analyzer to the predicate - Differences | |||
|---|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile® Prime CCS Analyzer | Proposed: Stat Profile® Prime ABG Analyzer | |
| Intended Use | The Stat Profile Prime CCS Analyzer System is | ||
| intended for in vitro diagnostic use by health care | |||
| professionals in clinical laboratory settings for the | |||
| quantitative determination of pH, PCO2, PO2, Hct, | |||
| Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinized | |||
| whole blood. | The Stat Profile Prime ABG Analyzer System is | ||
| intended for in vitro diagnostic use by health care | |||
| professionals in clinical laboratory settings for the | |||
| quantitative determination of pH, PCO2, and PO2 in | |||
| heparinized whole blood. | |||
| Indication For Use | Hct | ||
| Na+ | |||
| K+ | Hct 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 the number of red cells). |
Na+ Sodium measurement is used in the
diagnosis and treatment of aldosteronism,
diabetes insipidus, adrenal hypertension,
Addison's disease, dehydration, or
diseases involving electrolyte imbalance.
K+ Potassium Measurement is used to
monitor electrolyte balance in the
diagnosis and treatment of disease
conditions characterized by low or high
potassium levels. | N/A
N/A
N/A |
| Characteristic | Predicate: K131703 Stat Profile® Prime CCS Analyzer | Proposed: Stat Profile® Prime ABG Analyzer | |
| Cl- | Chloride measurement is used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. | N/A | |
| iCa | Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). | N/A | |
| Glu | Glucose measurement is used in the diagnosis and treatment of carbohydrate metabolism disturbances including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. | N/A | |
| Sample Volumes | 100µL (syringe and capillary) | 50µL (syringe and capillary) | |
| Measurement Range | | | |
| Hct | 12%-70% | N/A | |
| Na+ | 80-200 mmol/L | N/A | |
| K+ | 1.0-20.0 mmol/L | N/A | |
| Cl- | 50-200 mmol/L | N/A | |
| iCa (Ca++) | 0.20-2.70 mmol/L | N/A | |
| Glu | 15-500 mg/dL | N/A | |
| Principles of Measurement | | | |
| Hct | Impedance sensor | N/A | |
| Na+ | Sodium ion-selective sensor | N/A | |
| K+ | Potassium ion-selective sensor | N/A | |
| Cl- | Chloride ion-selective sensor | N/A | |
| iCa (Ca++) | Calcium ion-selective sensor | N/A | |
| Glu | Glucose Oxidase Enzymatic sensor | N/A | |
6
rison of Stat Profile® Primo ARG Analyzor to the prodicato Diffe (
7
| Comparison of Stat Profile® Prime Calibrator Cartridge ABG to the predicate - Similarities | ||
|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile Prime Calibrator Cartridge CCS | Proposed: Stat Profile Prime |
| Calibrator Cartridge ABG | ||
| Configuration | 2 level calibration standards per analyte, and reference solution | Same |
| Packaging | Liquid in Mylar bags inside cardboard container. Includes a waste | |
| collection bag. Self-contained, disposable packaging. | Same | |
| Comparison of Stat Profile® Prime Calibrator Cartridge ABG to the predicate - Differences | ||
| Characteristic | Predicate: K131703 Stat Profile Prime Calibrator Cartridge CCS | Proposed: Stat Profile Prime Calibrator Cartridge ABG |
| Indication For Use | The Stat Profile Prime Calibrator Cartridge CCS is intended for the calibration of pH, PCO2, PO2, Hct, Na+, K+, Cl-, iCa, and Glucose using the Stat Profile Prime CCS Analyzer. | The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO2, and PO2, using the Stat Profile Prime ABG Analyzer. |
| Comparison of Stat Profile Prime Auto QC Cartridge ABG to the predicate - Similarities | ||
|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile Prime Auto QC Cartridge CCS | Proposed: Stat Profile Prime |
| Auto QC Cartridge ABG | ||
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Cartridge: Solution in Mylar bags inside cardboard container. Includes a | |
| waste collection bag. Self- contained, disposable packaging. | Same | |
| Comparison of Stat Profile Prime Auto QC Cartridge ABG to the predicate - Differences | ||
| Characteristic | Predicate: K131703 Stat Profile Prime Auto QC Cartridge CCS | Proposed: Stat Profile Prime Auto QC Cartridge ABG |
| Indication For Use | The Stat Profile Prime Auto QC Cartridge CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime CCS Analyzer. | The Stat Profile Prime Auto QC Cartridge ABG is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of the Stat Profile Prime ABG Analyzer. |
| Comparison of Stat Profile Prime Ampuled Control ABG/CCS to the predicate - Similarities | ||
|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile Prime Ampuled Control ABG/CCS | Proposed: Stat Profile Prime |
| Ampuled Control ABG/CCS | ||
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Ampules: Each glass ampule contains 1.7 ml volume. | Same |
| Comparison of Stat Profile Prime Ampuled Control ABG/CCS to the predicate - Differences | ||
|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile Prime Ampuled Control ABG/CCS | Proposed: Stat Profile Prime Ampuled Control ABG/CCS |
| Indication For | ||
| Use | The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime CCS Analyzer. | The Stat Profile Prime Ampuled Control ABG/CCS is a quality control material intended for in vitro diagnostic use by healthcare professionals for monitoring the performance of Stat Profile Prime ABG Analyzer and the Stat Profile Prime CCS Analyzer. |
8
7. Summary of Performance Testing:
Bench testing was completed to demonstrate that the Stat Profile Prime ABG Analyzer is substantially equivalent in performance, safety and efficacy to the Stat Profile Prime CCS Analyzer System.
7.1. Method Comparison Studies
Whole Blood Patient Specimens:
Discarded heparinized arterial whole blood specimens from hospital patients were analyzed in duplicate on the three test analyzers and two reference analyzers. In order to cover the hard to find sample range, venous whole blood from male and female donors was tonometered to cover the analytical measurement range for all analytes. These samples were identified and noted as altered samples in the results. The number of data points (N) varies for each parameter due to error, calibration status, or insufficient sample volume to complete analysis.
Svringe Samples: A minimum of 150 whole blood specimens were analyzed for pH, pCO2 and pO2. The samples were analyzed on each of the test analyzers and on the Stat Profile Prime CCS Comp analyzers and compared for each parameter. The first replicate test analyzer result from each test system was compared to the average of the two results from the comparative method.
Results: The data for the whole blood method comparison of the Stat Profile Prime ABG vs. the Stat Profile Prime CCS Comp is summarized in Table 1 and contains the following information:.
- slope and intercept of the fitted line •
- . total number of points used in the regression
- . bias calculated from the regression line at medical decision levels
- . range of data
- correlation coefficient
- . number of altered samples
Table 1: Stat Profile Prime ABG vs. Stat Profile Prime CCS Comp Whole Blood Method Comparison
| Parameter | Analyzer | total #
specimens | # altered
specimens | specimen
range | Slope | Intercept | r |
|----------------|----------|----------------------|------------------------|-------------------|--------|-----------|--------|
| pH | #1 | 170 | 17 | 6.771 - 7.796 | 0.9987 | 0.0042 | 0.9971 |
| | #2 | 175 | 14 | 6.768 - 7.789 | 0.9933 | 0.0431 | 0.9978 |
| | #3 | 187 | 18 | 6.776 - 7.799 | 0.9937 | 0.0433 | 0.9986 |
| pCO2
(mmHg) | #1 | 161 | 16 | 22.7 - 174.1 | 0.9899 | 0.7042 | 0.9972 |
| | #2 | 163 | 12 | 24.0 - 185.4 | 0.9834 | 0.5996 | 0.9975 |
| | #3 | 168 | 10 | 22.4 - 178.1 | 0.9923 | 1.8045 | 0.9940 |
| pO2
(mmHg) | #1 | 153 | 10 | 8.8 - 728.3 | 1.0141 | -0.6862 | 0.9975 |
| | #2 | 165 | 11 | 10.2 - 677.6 | 1.0074 | 0.8237 | 0.9985 |
| | #3 | 165 | 9 | 9.3 - 687.1 | 1.0080 | 0.7950 | 0.9991 |
9
7.2. Precision/Reproducibility Studies
Run to Run Precision
Whole Blood: Estimates of the run to run precision were determined for each of the Stat Profile Prime analyzers by analyzing a single whole blood sample in triplicate over ten (10) separate runs during a single day. The run to run precision was measured on blood analyzed from a syringe and also from capillary containers. The analyzers were re-calibrated before each triplicate run.
Results: Estimates of the run to run precision were determined for the Stat Profile Prime ABG analyzers for blood analyzed in syringe and capillary modes. Statistical analysis for each parameter included mean, SD, CV% (pH excluded), and N for all analyzers. The data is summarized in Table 2
| Syringe Mode | |||||
|---|---|---|---|---|---|
| pH Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 7.339 | 0.010 | ||
| #2 | 30 | 7.337 | 0.007 | 7.332 | |
| #3 | 30 | 7.336 | 0.009 | ||
| pCO2 Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 49.3 | 1.2 | 2.4 | 51.2 |
| #2 | 30 | 49.6 | 1.2 | 2.5 | |
| #3 | 30 | 50.0 | 1.2 | 2.3 | mmHg |
| pO2 Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 34.2 | 0.5 | 1.4 | 32.9 |
| #2 | 30 | 35.1 | 0.5 | 1.3 | |
| #3 | 30 | 36.6 | 0.5 | 1.3 | mmHg |
| Capillary Mode | |||||
| pH Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 7.205 | 0.006 | ||
| #2 | 30 | 7.204 | 0.007 | 7.195 | |
| #3 | 30 | 7.176 | 0.005 | ||
| pCO2 Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 73.0 | 2.2 | 3.0 | |
| #2 | 30 | 74.1 | 2.6 | 3.5 | 75.3 |
| #3 | 30 | 69.7 | 2.4 | 3.5 | mmHg |
| pO2 Precision Data | |||||
| Analyzer | N | Mean | Standard Deviation | CV% | Target |
| #1 | 30 | 61.7 | 0.7 | 1.2 | |
| #2 | 30 | 64.2 | 1.2 | 1.8 | 59.8 |
| #3 | 30 | 61.6 | 0.7 | 1.1 | mmHg |
Table 2: Stat Profile Prime ABG Whole Blood Run to Run Precision Summary
10
Control Solutions: Estimates of the run to run precision were determined for each of the Stat Profile Prime analyzers by analyzing Stat Profile Prime Quality Control solutions (3 levels for each parameter in QC mode) in duplicate, two runs per day for a total of forty (40) runs. The data is summarized in Table 3
Results: Estimates of the run to run precision were determined for the Stat Profile Prime ABG analyzers for each level of Quality Control. Statistical analysis for each parameter included pooled mean, Sr, ST, CV% (pH excluded), and N for all analyzers. .
| pH Precision Data | |||||||
|---|---|---|---|---|---|---|---|
| Sample | Pooled | ||||||
| Mean | N | Within run SD (Sr) | Within run | ||||
| % CV | Total imprecision | ||||||
| SD (St) | Total | ||||||
| Imprecision | |||||||
| %CV | Target Range | ||||||
| QC Level 1 | 7.151 | 240 | 0.001 | --- | 0.004 | --- | 7.134-7.184 |
| QC Level 2 | 7.358 | 240 | 0.000 | --- | 0.006 | --- | 7.342-7.392 |
| QC Level 3 | 7.569 | 240 | 0.000 | --- | 0.008 | --- | 7.549-7.599 |
| pCO2 Precision Data | |||||||
| Sample | Pooled | ||||||
| Mean | |||||||
| (mm | |||||||
| Hg) | N | Within run SD (Sr) | Within run | ||||
| % CV | Total imprecision | ||||||
| SD (St) | Total | ||||||
| Imprecision | |||||||
| %CV | Target Range | ||||||
| mmHg | |||||||
| QC Level 1 | 57.0 | 240 | 0.33 | 0.58 | 0.92 | 1.61 | 52.2-67.2 |
| QC Level 2 | 39.7 | 240 | 0.27 | 0.68 | 0.63 | 1.59 | 34.2-45.2 |
| QC Level 3 | 24.0 | 240 | 0.19 | 0.79 | 0.80 | 3.33 | 18.9-27.9 |
| pO2 Precision Data | |||||||
| Sample | Pooled | ||||||
| Mean | |||||||
| (mm | |||||||
| Hg) | N | Within run SD (Sr) | Within run | ||||
| % CV | Total imprecision | ||||||
| SD (St) | Total | ||||||
| Imprecision | |||||||
| %CV | Target Range | ||||||
| mmHg | |||||||
| QC Level 1 | 57.4 | 240 | 0.43 | 0.75 | 2.22 | 3.87 | 50.0-66.0 |
| QC Level 2 | 101.5 | 240 | 0.29 | 0.29 | 2.57 | 2.53 | 90.8-106.8 |
| QC Level 3 | 137.2 | 240 | 0.34 | 0.25 | 3.51 | 2.56 | 125.7-149.7 |
Table 3: Stat Profile Prime ABG Quality Control Run to Run Precision Summary
11
Within Run Precision
One run of each, 20 replicates per run, of the following materials was performed:
- Whole Blood analyzed from syringe •
- . Whole Blood - analyzed from capillary containers
- Stat Profile Prime Quality Control Level 1
- Stat Profile Prime Quality Control Level 2
- . Stat Profile Prime Quality Control Level 3
Results: The average, SD, CV% and N for each analyzer, sample type, and parameter was calculated. The data is summarized in Table 4.
| Table 4: Stat Profile Prime ABG With-in Run Precision - Whole Blood | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| --------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- | -- | -- | -- |
| Stat Profile Prime ABG With-in Run Precision | |||||
|---|---|---|---|---|---|
| Whole Blood Syringe Mode | |||||
| Parameter | n = 20 | Analyzer # 1 | Analyzer # 2 | Analyzer # 3 | Target |
| pH | Mean | 7.367 | 7.356 | 7.370 | 7.359 |
| SD | 0.005 | 0.004 | 0.004 | ||
| pCO2 | |||||
| (mmHg) | Mean | 40.7 | 41.9 | 41.0 | 40.8 |
| SD | 0.4 | 0.4 | 0.5 | ||
| CV% | 1.1 | 0.9 | 1.1 | ||
| pO2 | |||||
| (mmHg) | Mean | 86.2 | 88.6 | 86.5 | 90.2 |
| SD | 1.2 | 1.2 | 1.2 | ||
| CV% | 1.4 | 1.3 | 1.3 |
| Whole Blood Capillary Mode | |||||
|---|---|---|---|---|---|
| ---------------------------- | -- | -- | -- | -- | -- |
| Parameter | n = 20 | Analyzer # 1 | Analyzer # 2 | Analyzer # 3 | Target |
|---|---|---|---|---|---|
| pH | Mean | 7.349 | 7.335 | 7.348 | 7.351 |
| SD | 0.005 | 0.005 | 0.004 | ||
| pCO2 | |||||
| (mmHg) | Mean | 39.3 | 40.9 | 39.8 | 40.4 |
| SD | 0.6 | 0.7 | 0.6 | ||
| CV% | 1.5 | 1.7 | 1.5 | ||
| pO2 | |||||
| (mmHg) | Mean | 92.4 | 94.0 | 92.9 | 91.5 |
| SD | 1.8 | 1.8 | 1.9 | ||
| CV% | 2.0 | 1.9 | 2.0 |
12
Results: The average, SD, CV% and N for each analyzer for each QC level and parameter was calculated. The pooled average, SD, CV% and N from all 3 analyzers for each QC level and parameter was calculated. The data is summarized in Table 5.
| On Board Quality Control Level 1 | ||||||
|---|---|---|---|---|---|---|
| Parameter | n = 20 | Analyzer # 1 | Analyzer # 2 | Analyzer # 3 | Pooled | Target Range |
| pH | Mean | 7.149 | 7.146 | 7.150 | 7.148 | 7.134-7.184 |
| SD | 0.001 | 0.001 | 0.001 | 0.002 | ||
| CV% | 0.8 | 0.7 | 0.6 | 0.8 | ||
| pCO2 (mmHg) | Mean | 58.0 | 58.1 | 57.6 | 57.9 | 52.2-67.2 |
| SD | 0.4 | 0.4 | 0.3 | 0.5 | ||
| CV% | 0.8 | 0.7 | 0.6 | 0.8 | ||
| pO2 (mmHg) | Mean | 58.3 | 62.1 | 62.1 | 60.8 | 50.0-66.0 |
| SD | 0.6 | 0.3 | 0.3 | 1.8 | ||
| CV% | 1.1 | 0.5 | 0.5 | 3.0 | ||
| On Board Quality Control Level 2 | ||||||
| Parameter | n = 20 | Analyzer # 1 | Analyzer # 2 | Analyzer # 3 | Pooled | Target Range |
| pH | Mean | 7.355 | 7.350 | 7.355 | 7.353 | 7.342-7.392 |
| SD | 0.001 | 0.001 | 0.001 | 0.002 | ||
| CV% | 1.2 | 1.0 | 0.9 | 1.0 | ||
| pCO2 (mmHg) | Mean | 40.5 | 40.7 | 40.7 | 40.6 | 34.2-45.2 |
| SD | 0.5 | 0.4 | 0.3 | 0.4 | ||
| CV% | 1.2 | 1.0 | 0.9 | 1.0 | ||
| pO2 (mmHg) | Mean | 97.2 | 101.5 | 97.8 | 98.8 | 90.8-106.8 |
| SD | 0.5 | 0.3 | 0.3 | 2.0 | ||
| CV% | 0.5 | 0.3 | 0.3 | 2.0 | ||
| On Board Quality Control Level 3 | ||||||
| Parameter | n = 20 | Analyzer # 1 | Analyzer # 2 | Analyzer # 3 | Pooled | Target Range |
| pH | Mean | 7.563 | 7.554 | 7.563 | 7.560 | 7.549-7.599 |
| SD | 0.001 | 0.002 | 0.002 | 0.005 | ||
| CV% | 1.7 | 1.7 | 2.1 | 1.9 | ||
| pCO2 (mmHg) | Mean | 24.8 | 25.2 | 25.0 | 25.0 | 18.9-27.9 |
| SD | 0.4 | 0.4 | 0.5 | 0.5 | ||
| CV% | 1.7 | 1.7 | 2.1 | 1.9 | ||
| pO2 (mmHg) | Mean | 133.0 | 134.9 | 135.4 | 134.4 | 125.7-149.7 |
| SD | 0.5 | 0.6 | 0.4 | 1.1 | ||
| CV% | 0.4 | 0.4 | 0.3 | 0.9 |
Table 5: Stat Profile Prime ABG With-in Run Precision - Controls
13
Linearity Testing
10 – 14 levels were prepared by tonometering, spiking or diluting whole blood to span the analytical measurement range for each parameter. Each blood level was analyzed in duplicate on each of the three (3) test analyzers and on the Stat Profile Prime CCS Comp analyzers. The Prime CCS Comp analyzers were used to establish the target value of each blood level for each parameter. The observed values from each test analyzer were compared to the results from the comparative method.
Results: Least squares linear regression analysis of the test results vs. the reference analyzer results was performed. The data is summarized in Table 6 and contains the following information:
- slope and intercept of the fitted line
- . total number of points used in the regression
- . range of data
- . correlation coefficient
Conclusion: The comparison data for all parameters for the Stat Profile Prime analyzers shows good correlation with the reference analyzer across the claimed measurement range for all parameters.
| Individual Analyzer Performance Data | ||||||
|---|---|---|---|---|---|---|
| Parameter | total # | |||||
| levels | Specimen | |||||
| Range | Analyzer | Slope | Intercept | r | ||
| pH | 13 | 6.555 - 8.221 | #1 | 0.9915 | 0.0632 | 0.9998 |
| 13 | 6.558 - 8.250 | #2 | 0.9948 | 0.0432 | 0.9997 | |
| 13 | 6.531 - 8.230 | #3 | 0.9997 | 0.0006 | 0.9998 | |
| pCO2 | ||||||
| (mmHg) | 14 | 0.9 - 230.8 | #1 | 1.0017 | -0.5304 | 0.9982 |
| 15 | 0.3 - 228.1 | #2 | 0.9939 | 0.8671 | 0.9975 | |
| 15 | 1.0 - 229.3 | #3 | 0.9934 | 2.2697 | 0.9990 | |
| pO2 | ||||||
| (mmHg) | 13 | 8.3 - 719.7 | #1 | 0.9936 | -1.7134 | 0.9994 |
| 13 | 9.7 - 721.2 | #2 | 1.0204 | -1.9551 | 0.9996 | |
| 13 | 9.3 - 728.8 | #3 | 1.0035 | 0.1656 | 0.9995 |
Table 6: Stat Profile Prime ABG Whole Blood Linearity
Interference Testing
As described above, the measuring technology, physical characteristics, composition, and measurement surface area of the pH, pCO2,and pO2 sensors of the candidate device that are in direct contact with the sample are identical to the sensors of the predicate device. The device software was changed to allow for testing of pH, pCO2, and pO2 only with the candidate device, but this software change did not affect the pH, pCO2, and pO2 measurements. Therefore, evaluation of potential interferents was not repeated for the candidate device since this study was performed previously for the predicate device in K131703.
14
8. Traceability
pH
The pH standards and reagents used for Nova Biomedical products are traceable to NIST primary pH reference material SRM 2186I and 2186II.
PCO2/PO2
PCO2/PO2 controls and reagents are measured against Nova Biomedical CO2/02 gases traceable to NIST's SRM 2191A and 1702A.
9. Stability and Value Assignment for Internal and External Controls
Stability/Shelf Life:
- Stat Profile Prime Calibrator Cartridge ABG 18 month shelf life for the when stored unopened. .
- Stat Profile Prime Auto QC Cartridge ABG 18 month shelf life when stored unopened at 2-8°C. .
- Stat Profile Prime Ampuled Control ABG/CCS 18 month shelf life .
Value Assignment:
| Stat Profile Prime Auto QC Cartridge ABG | ||
|---|---|---|
| Lot 401741 | Insert Sheet Range | |
| Level 1 | pH | 7.134-7.184 |
| pCO2 | 52.2-67.2 mmHg | |
| pO2 | 50.0-66.0 mmHg | |
| Level 2 | pH | 7.342-7.392 |
| pCO2 | 34.2-45.2 mmHg | |
| pO2 | 90.8-106.8 mmHg | |
| Level 3 | pH | 7.549-7.599 |
| pCO2 | 18.9-27.9 mmHg | |
| pO2 | 125.7-149.7 mmHg |
| Stat Profile Prime Ampuled Controls ABG | ||
|---|---|---|
| Lot 309702 | Insert Sheet Range | |
| Level 1 | pH | 7.118-7.168 |
| pCO2 | 58.6-73.6 mmHg | |
| pO2 | 50.2-66.2 mmHg | |
| Level 2 | pH | 7.333-7.383 |
| pCO2 | 39.6-50.6 mmHg | |
| pO2 | 95.9-111.9 mmHg | |
| Level 3 | pH | 7.548-7.598 |
| pCO2 | 19.3-28.3 mmHg | |
| pO2 | 121.7-145.7 mmHg |
| Stat Profile Prime ABG Target Calibrator Values | ||||
|---|---|---|---|---|
| Cal A | Cal B | Cal F | Soln R | |
| pH | 7.354 | 6.840 | ||
| pCO2 | 25 mmHg | 50 mmHg | ||
| pO2 | 100 mmHg | |||
| 2 mol/L KCl |
15
10. Software Verification and Validation
The software incorporated into the Stat Profile Prime ABG Analyzer was developed and documented in compliance with the internal design control and software verification procedures of Nova Biomedical.
11. Electromagnetic Compatibility and Electrical Safety
Electromagnetic Compatibility and electrical safety tests were performed on the Stat Profile Prime ABG Analyzer System to demonstrate compliance with current standards applicable to the device listed in section 12 below.
12. Standard/Guidance Documents Referenced
- CLSI EP09-A2 Method Comparison and Bias Estimation Using Patient Samples; Approved . Guideline - Second Edition
- . NCCLS EP5-A2 - Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition
- . NCCLS, EP6-A - Evaluation of the Linearity of Quantitative Measurement Procedures: A Statistical Approach; Approved Guideline
- EN 61010-1/A2:2001 Safety Requirements for Electrical Equipment ●
- EN 61010-2-081:2003 Particular requirements for automatic and semi-automatic laboratory ● equipment for analysis and other purposes
- . EN 61010-2-101:2002 - Particular requirements for in vitro diagnostic (IVD) medical equipment
13. Conclusion:
The Stat Profile Prime ABG Analyzer System is substantially equivalent to the previously cleared for market Stat Profile Prime CCS Analyzer System in intended use. It uses the same sensor technology and measurement algorithms for pH, PCO2, and the formulations of the internal and external controls and the calibration cartridge are the same for the tested parameters
The results of software validation and performance verification testing confirmed that the Stat Profile Prime ABG Analyzer is safe and effective for its intended purpose and that the Stat Profile Prime ABG Analyzer System is substantially equivalent to that of the predicate Stat Profile Prime CCS Analyzer System (K131703).