MODIFICATION TO ABL800 FLEX

K050869 · Radiometer Medical Aps · CIG · Aug 11, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050869
• Device Name: MODIFICATION TO ABL800 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 11, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1110
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

RADIANCE v2.5 is a Windows-based software application running on an independent server; interfaces with ABL800 FLEX blood-gas analyzers. Enables remote data entry and control of analyzers connected to laboratory (LIS) or hospital (HIS) information systems. Includes AutoCheck Module for automated quality control fluid analysis. Used by laboratory personnel to manage analyzer data and connectivity; facilitates centralized monitoring and control of diagnostic testing workflows.

Clinical Evidence

No clinical data provided; substantial equivalence based on design controls and technological similarity to the predicate device.

Technological Characteristics

Windows-based software application; server-based architecture; connectivity to LIS/HIS; includes AutoCheck Module for automated quality control analysis.

Indications for Use

Indicated for in vitro diagnostic testing of whole blood and expired air samples for blood gas, electrolyte, metabolite, and co-oximetry parameters in clinical settings.

Regulatory Classification

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.

Predicate Devices

• K041874

Submission Summary (Full Text)

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K050869

## 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. [phone] Fax: [phone]

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 [phone]. 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 [phone] or [phone] 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 <img src="checkbox.png"/> | 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 .