(66 days)
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.
pH, PCO2, 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 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.
The Stat Profile Prime Calibrator Cartridge ABG is intended for the calibration of pH, PCO₂, and PO₂ using the Stat Profile Prime ABG Analyzer.
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.
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
Liquid 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 gas 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.
Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: 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: 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. (Similar indications are provided for the QC and Calibrator cartridges, intended for monitoring performance and calibration, respectively).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria values for bias, precision, or linearity. Instead, it presents the study results for these performance metrics and implies their acceptability by concluding the device is "substantially equivalent" to predicate devices. For the purpose of this table, "Reported Device Performance" will reflect the ranges found in the study results. The ranges provided are from the various analyzers tested (Analyzer #1, #2, #3).
| Metric / Parameter | Acceptance Criteria (Implied by Conclusion of Substantial Equivalence) | Reported Device Performance (Range across 3 analyzers) |
|---|---|---|
| Method Comparison (vs. Predicate) | ||
| pH (Whole Blood) | Adequate correlation; small bias at medical decision levels | Slope: 0.9933 - 0.9987Intercept: 0.0042 - 0.0433r: 0.9971 - 0.9986 |
| pCO2 (Whole Blood) | Adequate correlation; small bias at medical decision levels | Slope: 0.9834 - 0.9923Intercept: 0.5996 - 1.8045r: 0.9940 - 0.9975 |
| pO2 (Whole Blood) | Adequate correlation; small bias at medical decision levels | Slope: 1.0074 - 1.0141Intercept: -0.6862 - 0.8237r: 0.9975 - 0.9991 |
| Run-to-Run Precision (Whole Blood - Syringe Mode) | ||
| pH | Low standard deviation | SD: 0.007 - 0.010 |
| pCO2 | Low CV% | CV%: 2.3 - 2.5% |
| pO2 | Low CV% | CV%: 1.3 - 1.4% |
| Run-to-Run Precision (Whole Blood - Capillary Mode) | ||
| pH | Low standard deviation | SD: 0.005 - 0.006 |
| pCO2 | Low CV% | CV%: 3.0 - 3.5% |
| pO2 | Low CV% | CV%: 1.1 - 1.8% |
| Run-to-Run Precision (Control Solutions) | ||
| pH (All Levels) | Low Total Imprecision SD | Total SD: 0.004 - 0.008 |
| pCO2 (All Levels) | Low Total Imprecision CV% | Total CV%: 1.59 - 3.33% |
| pO2 (All Levels) | Low Total Imprecision CV% | Total CV%: 2.53 - 3.87% |
| Within-Run Precision (Whole Blood - Syringe Mode) | ||
| pH | Low standard deviation | SD: 0.004 - 0.005 |
| pCO2 | Low CV% | CV%: 0.9 - 1.1% |
| pO2 | Low CV% | CV%: 1.3 - 1.4% |
| Within-Run Precision (Whole Blood - Capillary Mode) | ||
| pH | Low standard deviation | SD: 0.004 - 0.005 |
| pCO2 | Low CV% | CV%: 1.5 - 1.7% |
| pO2 | Low CV% | CV%: 1.9 - 2.0% |
| Within-Run Precision (Control Solutions) | ||
| pH (All Levels) | Low standard deviation | SD: 0.001 - 0.002 |
| pCO2 (All Levels) | Low CV% | CV%: 0.6 - 1.7% |
| pO2 (All Levels) | Low CV% | CV%: 0.3 - 1.1% |
| Linearity (Whole Blood) | Good correlation (r close to 1, slope close to 1) | |
| pH | Slope: 0.9915 - 0.9997Intercept: 0.0006 - 0.0632r: 0.9997 - 0.9998 | |
| pCO2 | Slope: 0.9934 - 1.0017Intercept: -0.5304 - 2.2697r: 0.9975 - 0.9990 | |
| pO2 | Slope: 0.9936 - 1.0204Intercept: -1.9551 - 0.1656r: 0.9994 - 0.9996 |
Note: The document explicitly states "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." and "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." indicating that the reported performance met the unstated acceptance criteria for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Method Comparison (Whole Blood Patient Specimens):
- Sample Size: A minimum of 150 whole blood specimens were analyzed for each parameter (pH, pCO2, pO2). The exact 'N' values vary slightly for each parameter and analyzer combination (e.g., pH: 170-187, pCO2: 161-168, pO2: 153-165).
- Additionally, "altered samples" were included: pH (14-18), pCO2 (10-16), pO2 (9-11).
- Data Provenance: Retrospective, from hospital patients ("Discarded heparinized arterial whole blood specimens from hospital patients"). Some samples were also prospectively collected and altered ("venous whole blood from male and female donors was tonometered to cover the analytical measurement range"). The country of origin of the data is not specified but is implied to be from the USA given the FDA submission.
- Sample Size: A minimum of 150 whole blood specimens were analyzed for each parameter (pH, pCO2, pO2). The exact 'N' values vary slightly for each parameter and analyzer combination (e.g., pH: 170-187, pCO2: 161-168, pO2: 153-165).
- Precision/Reproducibility Studies:
- Run-to-Run Precision (Whole Blood): Single whole blood sample analyzed in triplicate over 10 separate runs (N=30 per analyzer for each parameter).
- Run-to-Run Precision (Control Solutions): Quality Control solutions (3 levels) analyzed in duplicate, two runs per day for a total of 40 runs (N=240 per parameter/level).
- Within-Run Precision (Whole Blood & Control Solutions): One run of 20 replicates (N=20 per analyzer for each parameter/level).
- Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned for the device's intended use, suggesting an internal lab setting for these studies.
- Linearity Testing:
- Sample Size: 10-14 levels were prepared for each parameter. Each level was analyzed in duplicate on each of the three test analyzers.
- Data Provenance: Not explicitly stated, but implied to be from an internal lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document describes performance testing against a "reference analyzer" (Stat Profile Prime CCS Comp analyzers) for method comparison and linearity studies.
- Method Comparison and Linearity: The ground truth was established by the Stat Profile Prime CCS Comp analyzers. These are other devices from the same manufacturer, acting as the reference method.
- Precision Studies: The ground truth for precision studies is the measurement itself, demonstrating the device's consistency, not comparison to an expert.
No human experts were used to establish the ground truth for the test set. The comparative method was another medical device.
4. Adjudication Method for the Test Set
Since the ground truth was established by a reference medical device (Stat Profile Prime CCS Comp analyzers), no human adjudication method was employed. The quantitative measurements from the test device were compared directly to the quantitative measurements from the reference device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This document pertains to an in vitro diagnostic (IVD) device for quantitative biochemical measurements, not an image-based diagnostic or AI-assisted diagnostic device where human reader performance is typically assessed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance evaluations of the device (analyzer and its consumables/controls). The method comparison, precision, and linearity studies directly assess the device's analytical performance without human intervention in the measurement process itself or its interpretation for the purpose of the study. The device is intended for use by healthcare professionals in clinical laboratory settings, implying that human professionals operate the device and interpret its results within a clinical context. However, the performance studies outlined here are standalone in terms of the device's measurement accuracy and precision.
7. The Type of Ground Truth Used
- Method Comparison and Linearity: The ground truth was established by comparison to a legally marketed predicate device (Stat Profile® Prime CCS Analyzer System) acting as the reference method. The document states: "The Prime CCS Comp analyzers were used to establish the target value of each blood level for each parameter."
- Precision/Reproducibility: The ground truth for these studies is the measured value itself, with the goal of demonstrating consistency and repeatability, rather than accuracy against an external standard. For control solutions, the "Target Range" acts as a reference for expected values.
- Traceability: For pH, pCO2, and pO2, the standards and reagents are traceable to NIST (National Institute of Standards and Technology) primary reference materials. This establishes a higher-level metrological ground truth for calibration.
8. The Sample Size for the Training Set
This document describes the regulatory submission for a medical device (a blood gas analyzer). It does not discuss a "training set" in the context of an AI/machine learning model. The device uses traditional sensor technology and algorithms, not machine learning that would require a separate training phase with a distinct dataset.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, there is no "training set" in the context of AI/ML for this device. The device relies on established electrochemical and optical principles for measurement. Its calibration system for the training set (if we interpret "training set" loosely as the data used to fine-tune the device's internal calibration parameters during development) would have been established using reference materials traceable to NIST standards. However, this is part of standard IVD development and not ML training.
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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
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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
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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.
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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:
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| Characteristic | Predicate: K131703 Stat Profile® Prime CCS Analyzer | Proposed:Stat Profile®Prime ABGAnalyzer |
|---|---|---|
| Indication for Use | pH, PCO2, PO2: Whole blood measurement of blood gases is used in thediagnosis and treatment of life-threatening acid-base disturbances. | Same |
| Acceptable Samples | Lithium heparinized whole blood from syringes, open tubes, small cups, andcapillary 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 potentiometricamplifiers, 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 isintended for in vitro diagnostic use by health careprofessionals in clinical laboratory settings for thequantitative determination of pH, PCO2, PO2, Hct,Na+, K+, Cl-, iCa, and Glu (Glucose), in heparinizedwhole blood. | The Stat Profile Prime ABG Analyzer System isintended for in vitro diagnostic use by health careprofessionals in clinical laboratory settings for thequantitative determination of pH, PCO2, and PO2 inheparinized whole blood. | |
| Indication For Use | HctNa+K+ | Hct Whole blood measurements of the packedred cell volume of a blood sample areused to distinguish normal from abnormalstates, such as anemia and erythrocytosis(an increase in the number of red cells).Na+ Sodium measurement is used in thediagnosis and treatment of aldosteronism,diabetes insipidus, adrenal hypertension,Addison's disease, dehydration, ordiseases involving electrolyte imbalance.K+ Potassium Measurement is used tomonitor electrolyte balance in thediagnosis and treatment of diseaseconditions characterized by low or highpotassium levels. | N/AN/AN/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 |
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rison of Stat Profile® Primo ARG Analyzor to the prodicato Diffe (
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| Comparison of Stat Profile® Prime Calibrator Cartridge ABG to the predicate - Similarities | ||
|---|---|---|
| Characteristic | Predicate: K131703 Stat Profile Prime Calibrator Cartridge CCS | Proposed: Stat Profile PrimeCalibrator Cartridge ABG |
| Configuration | 2 level calibration standards per analyte, and reference solution | Same |
| Packaging | Liquid in Mylar bags inside cardboard container. Includes a wastecollection 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 PrimeAuto QC Cartridge ABG |
| Configuration | 3 level aqueous electrolyte, metabolite and gas solutions. | Same |
| Packaging | Cartridge: Solution in Mylar bags inside cardboard container. Includes awaste 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 PrimeAmpuled 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 ForUse | 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. |
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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 | # alteredspecimens | specimenrange | 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 |
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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
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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 | PooledMean | N | Within run SD (Sr) | Within run% CV | Total imprecisionSD (St) | TotalImprecision%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 | PooledMean(mmHg) | N | Within run SD (Sr) | Within run% CV | Total imprecisionSD (St) | TotalImprecision%CV | Target RangemmHg |
| 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 | PooledMean(mmHg) | N | Within run SD (Sr) | Within run% CV | Total imprecisionSD (St) | TotalImprecision%CV | Target RangemmHg |
| 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
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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 |
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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
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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 | SpecimenRange | 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.
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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 |
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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).
§ 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.