SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

K071280 · Beckman Coulter, Inc. · CGX · Jun 1, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071280
• Device Name: SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
• Applicant: Beckman Coulter, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jun 1, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

CRE3 reagent, when used in conjunction with SYNCHRON CX® Delta System(s) SYNCHRON® Systems CX Calibrator 1 and 2. is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine. Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

Device Story

Clinical chemistry analyzer system; determines creatinine concentration via Jaffe rate method. Input: human serum, plasma, or urine sample injected into reaction cup with CRE3 reagent (picric acid). Operation: absorbance measured at 520 nm between 19-25 seconds post-injection. System uses aqueous-based calibrators (levels 1, 2, 3) traceable to NIST reference materials. Output: quantitative creatinine concentration. Used in clinical laboratory settings by trained personnel. Output used by clinicians to diagnose/monitor renal disease and dialysis. Modification involves updating calibrator set points in chemistry database to align with Isotope Dilution Mass Spectrometry (IDMS) values.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control procedures (21 CFR 820.30) to confirm performance following calibration traceability update.

Technological Characteristics

Jaffe rate method; absorbance measured at 520 nm. Aqueous-based calibrators traceable to NIST reference materials. System utilizes chemistry database for parameter storage. No changes to materials or hardware; software update only for calibrator value assignment.

Indications for Use

Indicated for quantitative determination of creatinine in human serum, plasma, or urine for diagnosis and treatment of renal diseases and monitoring renal dialysis.

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 CX Delta Clinical System (K950958)

Submission Summary (Full Text)

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K071280

## 510(k) Summary

JUN - 1 2007

#### 1.0 Submitted Bv:

Tara M. Viviani Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd. W-110 Brea, CA 92822-8000 Telephone: [phone] FAX: [phone]

#### 2.0 Date Submitted

May 4, 2007

#### 3.0 Device Name(s):

- 3.1 Proprietary Names
SYNCHRON® CX Delta Clinical System SYNCHRON® CX Calibrator 1, 2 &3

3.2 Classification Names

Creatinine test system (21 CFR § 862.1225) Calibrator, Multi-Analyte Mixutre (21 CFR § 862.1150)

#### 4.0 Legally Marketed Device

The SYNCHRON CX Delta Clinical Systems, claims substantial equivalence to the Beckman Coulter SYNCHRON CX Delta Clinical System currently in commercial distribution, FDA 510(k) Number K950958.

#### 5.0 Device Description

The SYNCHRON CX Delta System determines creatinine concentration by means of the Jaffe rate method. A precise volume of sample is injected into the reaction cup with CRE3 reagent containing picric acid. Absorbance readings are taken at 520 nm between 19 to 25 seconds after sample introduction. The SYNCHRON CX Delta System utilizes a two level calibrator for the creatinine test. SYNCHRON CX

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Calibrator is designed for optimal performance on the SYNCHRON CX Delta Clinical Systems. CX Calibrator is an aqueous based calibrator made by New England Reagent Laboratory (NERL) to Beckman Coulter specifications, This product is tested during manufacturing using standards traceable to National Institute of Standard and Technology (NIST) reference materials. The creatinine concentrations are established based on addition of weighed-in specific quantities of creatinine to achieve the appropriate level of each calibrator. Each calibrator level is packaged individually in 25 mL bottles, 6 to a package.

#### 6.0 Intended Use

CRE3 reagent, when used in conjunction with SYNCHRON CX® Delta System(s) SYNCHRON® Systems CX Calibrator 1 and 2. is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.

Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

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

The modification to the creatinine module (CRE3) involves modification of the calibrator set points coded in the chemistry database. No formulation changes or system parameters have been modified with the exception of the calibrator set points. The modification to the CX Calibrator 1, 2 & 3 set points involves value assignment of the creatinine levels to values determined by a one time correlation of serum creatinine sample set to Isotope Dilution Mass Spectometery (IDMS). These new calibrator set points will replace the current values contained in the chemistry database. The product will continue to be manufactured in the same

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manner as it is today. The creatinine level in each calibrator will still be based on addition of weighed-in specific values of creatinine.

.

#### Summary of Performance Data 8.0

Performance data from validation testing supports equivalency.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Beckman Coulter, Inc. c/o Ms. Tara M. Viviani, Senior Regulatory Affairs Specialist 200 South Kraemer Blvd., M/S W-110 Brea, CA 92821

Re: k071280

> Trade/Device Name: Synchron® CX Delta Clinical Systems Regulation Number: 21 CFR§ 862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Code: CGX, JIX Dated: May 04, 2007 Received: May 07, 2007

Dear Ms. Viviani:

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.

JUN - 1 2007

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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 (if known): K071280

SYNCHRON® CX Delta Clinical Systems, Creatinine Test Device Name: Systems

### Indications for Use:

Beckman Coulter SYNCHRON CX Calibrators 1, 2, and 3 are to be used for calibrating SYNCHRON CX Delta, CX® CE, and CX PRO Systems only.

CRE3 reagent, in conjunction with SYNCHRON CX® Delta Systems and SYNCHRON CX® Calibrators 1, 2 and 3 is intended for the quantitative determination of Creatinine (CRE3) in human serum, plasma or urine.

# CLINICAL SIGNIFICANCE

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.

1 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)

Division Sign-Off

Office of In Vitro Dlagr

510(k) K071382

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