SYNCHRON SYSTEMS CREATININE (CREA) REAGENT

K060935 · Beckman Coulter, Inc. · CGX · Apr 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060935
• Device Name: SYNCHRON SYSTEMS CREATININE (CREA) REAGENT
• Applicant: Beckman Coulter, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application. 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.

Device Story

Reagent kit for quantitative creatinine measurement in human serum/plasma/urine; used on UniCel DxC 600/800 systems. Modification introduces CRTX application using sample-blanked reaction trigger cycle to reduce bilirubin interference. System performs automated analysis; healthcare providers use results for renal disease diagnosis/monitoring. Reduced sample throughput compared to standard bar-coded assay due to blanking cycle. Benefits include improved accuracy in presence of bilirubin.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures (21 CFR 820.30) to assess impact of modification on assay performance and bilirubin interference mitigation.

Technological Characteristics

In vitro diagnostic reagent kit; two 300-test cartridges. Uses sample-blanked reaction trigger cycle for bilirubin interference reduction. Designed for UniCel DxC 600/800 instrument platforms. Quantitative colorimetric/enzymatic assay principle.

Indications for Use

Indicated for the measurement of creatinine in serum and plasma samples.

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

• SYNCHRON Systems Creatinine Reagent (K042291)

Submission Summary (Full Text)

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L0600935

# 510(k) SUMMARY

### 1.0 Submitted By:

2002 8 2000

Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted

April 4, 2006

### 3.0 Device Name(s):

- 3.1 Proprietary Names SYNCHRON Systems Creatinine Reagent
- 3.2 Classification Names [862.1225 Creatinine test system]

#### 4.0 Legally Marketed Device

SYNCHRON Systems Creatinine Reagent claims substantial The equivalence to the SYNCHRON Systems Creatinine Reagent currently in commercial distribution. FDA 510(k) Number K042291.

### 5.0 Device Description

The SYNCHRON Systems Creatinine (CREA) reagent is designed for optimal performance on SYNCHRON CX and UniCel DxC SYNCHRON instrument models. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.

The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.

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## 6.0 Intended Use

CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application.

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.

## 7.0 Comparison to the Predicate (Description of the Modification to the Legally Marketed Device)

The creatinine-triggered assay offers an alternative parameter set designed to work with the existing SYNCHRON Creatinine Reagent. The creatinine-triggered reagent application effectively reduces the interference seen with bilirubin when using the creatinine assay for serum and plasma samples. The creatinine-triagered assay uses a reaction trigger cycle employed for sample blanking. Use of the trigger cycle will reduce the sample throughput when compared to the system bar-coded creatinine assay.

## 8.0 Summary of Performance Data

Performance data from verification testing supports equivalency.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 8 2006

Ms. Annette Hellie Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. M/S W-110, PO Box 8000 Brea, CA 92822-8000

Re: k060935

> Trade/Device Name: SYNCHRON® Systems Creatinine (CREA) Reagent Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX Dated: April 4, 2006 Received: April 5, 2006

Dear Ms. Hellie:

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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## 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 Ivqally 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 other 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 tolloffree miber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

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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page 1 of 1

510(k) Number (if known): K060935

SYNCHRON® Systems Creatinine (CREA) Reagent Device Name:

Indications for Use:

CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), and SYNCHRON® Systems Multi Calibrator, is intended for the quantitative determination of Creatinine concentration in human serum, plasma or 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.

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)

Carol C. Benson

ty
K060935

Beckman Coulter, Inc., Special 510(k) Device Modification SYNCHRON® Systems Creatinine Reagent File: CTRX s510k supplement.doc, 3/06