(453 days)
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No
The document describes an electrochemical sensor-based analyzer for measuring creatinine and does not mention any AI or ML components.
No
The device is described as an analyzer that measures creatinine levels in blood, plasma, or serum. This is an in vitro diagnostic function used for diagnosis and monitoring, not a therapeutic function that treats a condition.
Yes
The device is intended for in vitro testing of samples to measure creatinine, and these measurements are used in the "diagnosis and treatment of renal diseases and in monitoring renal dialysis," explicitly stating a diagnostic purpose.
No
The device description explicitly details hardware components, including an analyzer, wet section, measuring module, electrodes, and electrochemical sensors. This indicates it is a physical device with integrated software, not a software-only medical device.
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 device is intended for "in vitro testing of samples of heparinized whole blood, plasma and serum". "In vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Sample Type: The device analyzes biological samples (whole blood, plasma, and serum), which is characteristic of IVD devices.
- Purpose: The measurements are used in the "diagnosis and treatment of renal diseases and in monitoring renal dialysis," which are clinical purposes for which IVD devices are used.
- Device Description: The description details the components and function of an analyzer designed to measure a specific analyte (creatinine) in these biological samples.
All of these points align with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
CGL
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
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ABL800 FLEX (K041874), ABL800 FLEX with FLEXQ Module (K043218), ABL700 Series Upgrade (K002290), i-STAT System Creatin'no Test (K973292)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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RADIOMETER COPENHAGEN
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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 Metabolite |
| Analyzer | |
| 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)
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Office of In Vitro Diagnostic Device Evaluation and Safety