(453 days)
The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine measurements measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
The ABL837 FLEX is an analyzer with the capability of measuring creatinine. The wet section of the ABL837 FLEX analyzer is structured as the wet section of the ABL800 FLEX and ABL800 FLEX with FLEXQ Module analyzers, but includes a measuring module comprising the measurement system for the creatinine parameter. This measuring system compissing electrodes, one of which measures creatine and the other of which measures creating and creatinine. The creatinine parameter value is determined as a difference measure of the output of these two new electrodes. The two electrodes are developed based on the concept of the existing Radiometer Medical ApS glucose and lactate electrodes. The sensors for measuring creatinine are electrochemical sensors.
Here's an analysis of the provided text regarding the ABL837 FLEX device, focusing on the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The provided text does not explicitly state numerical acceptance criteria for the ABL837 FLEX. Instead, it describes a "comparison test" against a predicate device and states that the ABL837 FLEX performed "equivalent" to that device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as numerical criteria. The overarching acceptance criterion appears to be "equivalence" to the predicate device. The text mentions several performance aspects were tested. | Equivalent performance to the predicate device, i-STAT System Creatinine Test. The device also demonstrated:LinearityPrecisionDetection limitsInterference (presumably acceptable levels) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified. It does not mention the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this type of device and study. The ABL837 FLEX is an in vitro diagnostic device for measuring creatinine. Ground truth for such devices is typically established through reference methods, calibrated standards, or comparison to an established, legally marketed predicate device, rather than expert consensus on image interpretation or similar qualitative assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for studies involving human interpretation (e.g., medical imaging) where there might be disagreement among readers on a diagnosis or finding. For an objective measurement device like the ABL837 FLEX, performance is evaluated by comparing its output to a known standard or a predicate device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done, and this type of study is not applicable here. MRMC studies are used to evaluate human reader performance, often in diagnostic imaging, and to assess the impact of AI assistance on that performance. The ABL837 FLEX is an automated analyzer, not an AI system assisting human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, a "standalone" or algorithm-only performance assessment was done. The "Performance Test" section describes tests performed directly on the ABL837 FLEX analyzer (linearity, precision, detection limits, interference, and comparison to the predicate device). As a fully automated analyzer, its performance is inherently standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the comparison test was the i-STAT System Creatinine Test, which is a legally marketed predicate device (K973292). For linearity, precision, and detection limits, the ground truth would typically be established using calibrated reference materials or gold-standard laboratory methods. The document doesn't explicitly detail the specific gold standards used for these individual tests, but the overall claim of "equivalence" is relative to the i-STAT device.
8. The sample size for the training set
Not applicable/Not mentioned. This device does not use machine learning in a way that would typically involve a "training set" in the context of AI algorithms. It is an electrochemical sensor-based analyzer.
9. How the ground truth for the training set was established
Not applicable. As stated above, there is no mention of a training set for this type of device.
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RADIOMETER COPENHAGEN
Page 1 of 2
510(k) Summary
OCT 16 2006
| Submitter: | Radiometer Medical ApS |
|---|---|
| Address: | Åkandevej 21, DK-2700 Brønshøj, Denmark |
| Phone: | +45 3827 3827 or +45 3827 3390 (direct) |
| Fax: | +45 3827 2736 |
| Contact Person: | Ms. Kirsten Rønø |
| Date Summary Prepared: | September 18, 2006 |
| Device Trade Name(s): | ABL837 FLEX |
| Common name: | Blood Gas, Co-oximetry, Electrolyte and MetaboliteAnalyzer |
| Classification Name: | Creatinine Test System(21 CFR Section 862.1225) |
Predicate Devices
ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creatin'no Test (K973292) by i-STAT.
Device Description
The ABL837 FLEX is an analyzer with the capability of measuring creatinine. The wet section of the ABL837 FLEX analyzer is structured as the wet section of the ABL800 FLEX and ABL800 FLEX with FLEXQ Module analyzers, but includes a measuring module comprising the measurement system for the creatinine parameter. This measuring system compissing electrodes, one of which measures creatine and the other of which measures creating and creatinine. The creatinine parameter value is determined as a difference measure of the output of these two new electrodes. The two electrodes are developed based on the concept of the existing Radiometer Medical ApS glucose and lactate electrodes
Intended Use
The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter creatinine.
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RADIOMETER COPENHAGEN
Statement of Indication for Use
Creatinine (cCrea): The creatinine measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of readlined and in monitoring renal dialysis.
Clinical Interpretation
Creatinine (cCrea): Common causes of low creatinine may be small stature, debilitation, decreased muscle mass, or severe hepatic disease. Common causes of high creatinine may be renal diseases, urinary tract obstruction, rhabdomyolysis, acute necrotizing pancreatitis, diarrhoea, vomiting, or decreased intake.
Performance Test
Several tests have been performed to determine the linearity, precision, detection limits and interference of the creatinine measurements. A comparison test between the ABL837 FLEX and the i-STAT System Creatinine Test has shown that the ABL837 FLEX porforms equivalent to the predicate device i-STAT System Creatinine Test.
Summary of Technological Characteristics
The sensors for measuring creatinine are electrochemical sensors.
The ABL837 FLEX analyzer may be interfaced with the RADIANCE STAT analyzer management system software as well as with the hospital LIS/HS systems through network interfaces.
Conclusion
The ABL837 FLEX analyzer is substantially equivalent in features and characteristics to the predicate devices, ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290) all by Radiometer Medical ApS and i-STAT System Creatinine Test (K973292) by i-STAT.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Lene Meineche Marnaes Regulatory Affairs Officer Akandevei 21 Bronshoj Denmark, DK-2700
OCT 16 2006
Re: K051968
Trade/Device Name: ABL837 FLEX Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGL Dated: September 18, 2006 Received: September 20, 2006
Dear Ms. Marnaes:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition. FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements af 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Alberto G
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number:
Device Name: ABL837 FLEX
Indications for Use:
The ABL837 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood, plasma and serum for the parameter Creatinine measurements measurements measure the concentration of creatinine in blood. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
C
Division Sign-Off
510(k)
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.