ABL8X7 FLEX

K051968 · Radiometer Medical Aps · CGL · Oct 16, 2006 · Clinical Chemistry

Device Facts

• Record ID: K051968
• Device Name: ABL8X7 FLEX
• Applicant: Radiometer Medical Aps
• Product Code: CGL · Clinical Chemistry
• Decision Date: Oct 16, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

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. Creatinine 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.

Device Story

The ABL837 Flex Analyzer is an in vitro diagnostic tool for measuring creatinine in heparinized whole blood, plasma, and serum. Samples are injected into an instrument port; the device utilizes two immobilized enzyme electrochemical sensors. One sensor measures total creatine and creatinine; the second measures only creatine. The instrument calculates creatinine concentration by subtracting the creatine measurement from the total measurement. The device is used in clinical settings; it supports manual or automatic sample processing via barcode identification. The analyzer performs automated calibration and quality control based on pre-programmed schedules. Healthcare providers use the reported creatinine values to diagnose and treat renal diseases and monitor dialysis. The device provides a quantitative result, aiding clinical decision-making regarding renal function.

Clinical Evidence

Bench testing only. Precision assessed via 624 whole blood measurements and 20-day plasma/QC studies (CVs 1.89-3.14%). Linearity validated against HPLC (r-squared 0.9989-0.9994). Method comparison performed against predicates (k973292, k024098) using 55 whole blood and 104 serum samples, showing high correlation (slopes 0.99-1.02, r-squared >0.99). Interference testing conducted per CLSI EP-7A for various endogenous/exogenous substances.

Technological Characteristics

Electrochemical sensors for creatinine detection. Architecture based on ABL800 FLEX series. Connectivity via network interfaces to RADIANCE STAT management system and hospital LIS/HS systems.

Indications for Use

Indicated for in vitro testing of heparinized whole blood, plasma, and serum to measure creatinine concentration for the diagnosis and treatment of renal diseases and monitoring of renal dialysis in patients.

Regulatory Classification

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.

Predicate Devices

• i-STATA System Creatinine Test (k973292)
• Roche Integra Creatinine plus version 2 (k024098)

Submission Summary (Full Text)

{0}------------------------------------------------

RADIOMETER COPENHAGEN

Page 1 of 2

## 510(k) Summary

OCT 16 2006

| Submitter: | Radiometer Medical ApS |
|------------------------|----------------------------------------------------------------|
| Address: | Åkandevej 21, DK-2700 Brønshøj, Denmark |
| Phone: | [phone] or [phone] (direct) |
| Fax: | [phone] |
| 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<br>Analyzer |
| Classification Name: | Creatinine Test System<br>(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.

{1}------------------------------------------------

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.

{2}------------------------------------------------

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).

{3}------------------------------------------------

#### Page 2 -

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.

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

{4}------------------------------------------------

# Indications for Use

510(k) Number:

K051968

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