(127 days)
No
The document does not mention AI, ML, or related terms, and the device description focuses on data management and remote control, not advanced analytical capabilities typically associated with AI/ML in medical devices.
No
The device is intended for in vitro diagnostic testing of blood and expired air samples, which means it is used to analyze bodily fluids and gases for diagnostic purposes (measuring parameters), not to treat a condition.
Yes
The device is intended for in vitro testing of various parameters in whole blood and expired air samples, which are used to provide diagnostic information about a patient's physiological state.
No
The device description explicitly states that RADIANCE v2.5 is a software application that is "added to ABL800 FLEX," which is a blood-gas analyzer (a hardware device). The software enables remote data entry and control of compatible blood-gas analyzers. Therefore, it is a software component of a larger hardware system, not a standalone software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Indications for Use" explicitly states that the device is intended for "in vitro testing of samples of whole blood" and "in vitro testing of samples of expired air". This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body.
- Parameters Tested: The device measures various parameters (pH, pO2, pCO2, electrolytes, glucose, lactate, bilirubin, and co-oximetry parameters) in these samples, which are typical analyses performed in a clinical laboratory setting for diagnostic purposes.
- Device Description: While the RADIANCE software is described as a server-based application for data management, it is a "modification" added to the ABL800 FLEX, which is the core analytical instrument performing the in vitro testing. The combination is intended for diagnostic use.
- Predicate Device: The predicate device listed (K041874; ABL800 FLEX) is also a blood gas analyzer, which are generally classified as IVD devices.
The information provided clearly indicates that the primary function of this device is to perform diagnostic tests on biological samples outside of the body, which is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids.
Product codes
CHL, JGS, CEM, JFP, CGZ, CGA, CIG, GHS, KQI, KHP, MQM
Device Description
RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).
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
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.
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510(k) Summary As required by 807.92 For RADIANCE v2.5 modification to ABL800 FLEX (K041874) Prepared on March 30, 2005
Submitted by: Radiometer Medical ApS Akandevei 21 DK-2700 Bronshoj, Denmark
Tel. 45 38 27 38 27 Fax: 45 38 27 27 36
Contact Person: Kirsten Rono
Device Trade Name: RADIANCE 2.5 modification to ABL800 FLEX
Common Name: Blood Gas, Co-0ximetry, Electrolyte and Metabolite Analyzer
Classification: Blood gases and blood pH test system, Class II Sec. 21 CFR 862.1120
Predicate Device: ABL800 FLEX K041874
Manufactured by: Radiometer Medical ApS Akandevej 21 DK-2700 Bronshoj, Denmark
Description of the Device: RADIANCE v2.5 is a Windows-based software application that runs on an independent server and, when added to ABL800 FLEX, enables remote data entry and control of compatible blood-gas analyzers connected to a laboratory information system (LIS) and/or a hospital information system (HIS).
Intended Use for the Device: The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2 pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and cooximetry paramenters (total hemoglobin, ox ygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids
Substantial Equivalence to Predicate Device: ABL800 FLEX modified by the addition of RADIANCE v2.5 has many similarities to the predicate device which previously
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received 510(k) clearance. It has the same intended use and the same fundamental scientific technology. Design control information ensures substantial equivalence.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services (USA). The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.
Public Health Service
AUG 1 1 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kirsten Rønø Director of Quality and Regulatory Affairs Radiometer Medical ApS Åkandevej 21 Brønshøj Denmark DK-2700
Re: K050869
Trade/Device Name: ABL800 Flex modified by RADIANCE v2.5 Regulation Number: 21 CFR 862.1120 Regulation Name: Blood gases (pCO2, pO2) and blood pH test system Regulatory Class: Class II Product Code: CHL, JGS, CEM, JFP, CGZ, CGA, CIG, GHS, KQI, KHP, MQM Dated: July 12, 2005 Received: July 12, 2005
Dear Ms. Rønø:
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 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); 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,
Carol C. Benson
Carol C. Benson, M.A. Acting 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 Statement
| 510(k) Number (if known) | K050869 |
|---|---|
| Device Name | ABL800 FLEX modified by RADIANCE v2.5 |
| Indications for Use | Indications : The ABL800 FLEX with RADIANCE v2.5 modification is intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry paramenters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO₂Hb, FCOHb, FMetHb, FHHb and FHbF). In addition, the ABL800 Flex with RADIANCE v2.5 modification is intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2. The ABL800 FLEX with RADIANCE v2.5 modification includes an AutoCheck Module to perform automated analysis of quality control fluids. |
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | OR | Over-The-Counter Use ______ |
|---|---|---|
| -------------------------------------------- | ---- | ----------------------------- |
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(Per 21 CFR 801. 109)
(Division Sign-Off)
Division of Clinical Laboratory Devices ﺮ 186 KOSC 510(k) Number .