SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298

K091742 · Beckman Coulter, Inc. · JFY · Aug 14, 2009 · Clinical Chemistry

Device Facts

• Record ID: K091742
• Device Name: SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298
• Applicant: Beckman Coulter, Inc.
• Product Code: JFY · Clinical Chemistry
• Decision Date: Aug 14, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX® PRO Systems). 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, or urine; utilizes multi-step enzymatic method ending in photometric end-point reaction. Designed for use on SYNCHRON LX, UniCel DxC 600/800, and SYNCHRON CX PRO clinical systems. Operated by laboratory personnel in clinical settings. Input: patient sample (serum, plasma, or urine) mixed with reagent; system performs automated photometric analysis at 560 nm. Output: creatinine concentration value. Healthcare providers use results to diagnose/treat renal disease and monitor dialysis. Benefits include accurate renal function assessment.

Clinical Evidence

Bench testing only. Method comparison studies (N=78-80 for serum, N=66 for urine) against predicate showed high correlation (R=0.998-1.000). Precision studies (N=80 per sample) demonstrated within-run CVs of 0.3-2.1% and total imprecision CVs of 0.5-2.5% across serum and urine levels.

Technological Characteristics

Enzymatic creatinine assay; photometric end-point detection at 560 nm. Reagent kit includes two 200-test cartridges. Compatible with SYNCHRON LX, UniCel DxC 600/800, and SYNCHRON CX PRO systems. Calibration frequency: 14 days.

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 Systems Creatinine (CR-S) Reagent (K071283)

Submission Summary (Full Text)

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K091742

# Summary of Safety & Effectiveness SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent

### 1.0 Submitted By:

Marine Bovaiian Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 200 S. Kraemer Blvd., W-110 Brea, California 92822-8000 Telephone: [phone] FAX: [phone]

## Date Submitted: 2.0

June 11, 2009

## 3.0 Device Name(s):

- 3.1 Proprietary Names SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent
- 3.2 Classification Name Enzymatic Method Creatinine (21 CFR § 862.1225)

### 4.0 Predicate Device:

| Candidate(s) | Predicate | Manufacturer | Docket<br>Number |
|------------------------------------------------------------|-----------------------------------------------|-------------------------|------------------|
| SYNCHRON Systems<br>Enzymatic Creatinine (CR-E)<br>Reagent | SYNCHRON Systems<br>Creatinine (CR-S) Reagent | Beckman<br>Coulter, Inc | K071283 |

## 5.0 Description:

CR-E reagent is used to measure the creatinine concentration by an enzymatic method. This enzymatic creatinine method utilizes a multi-step approach ending with a photometric end-point reaction.

The SYNCHRON Enzymatic Creatinine (CR-E) Reagent is designed for optimal performance on the SYNCHRON LX®, UniCel® DxC 600/800, and SYNCHRON CX® PRO Clinical Systems. The reagent kit contains two 200-test cartridges that are packaged separately from the associated calibrator.

#### 6.0 Intended Use:

CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) concentration in human serum, plasma or urine (urine is not available on the SYNCHRON CX® PRO Systems).

# 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.

AUG 1 4 2009

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## Comparison to Predicate(s): 7.0

The following table shows similarities and differences between the candidate Enzymatic Creatinine (CR-E) Reagent and the predicate identified in Section 4.0 of this summary.

| | Similarities | |
|---------------------------------------------------------------------|----------------------------------------|-------------------------------------------------------------------------------------------------------------|
| SYNCHRON<br>Systems<br>Enzymatic<br>Creatinine<br>(CR-E)<br>Reagent | Intended Use | Same |
| | Sample Types | Same for the LX/DxC Systems |
| | Instrument Platforms | Same |
| | Calibrator | Same |
| | Analytical range (Urine) | Same |
| | Differences | |
| SYNCHRON<br>Systems<br>Enzymatic<br>Creatinine<br>(CR-E)<br>Reagent | Analytical range<br>(Serum and Plasma) | CR-E Reagent: 0.2 - 25.0 mg/dL |
| | | CR-S Reagent: 0.3 - 25.0 mg/dL |
| | Sample Types | CR-E Reagent: Plasma and Serum for CX Systems |
| | | CR-S Reagent: Plasma, Serum and Urine for CX<br>Systems |
| | Sample volume | CR-E Reagent: 10 µl (Serum, Plasma and Urine)<br>Urine sample is diluted by the<br>system at ratio of 1:10. |
| | | CR-S Reagent: 20 µl Serum and Plasma, 3 µl Urine |
| | Reaction Type<br>(Methodology) | CR-E Reagent: Enzymatic method |
| | | CR-S Reagent: Modified rate Jaffe method |
| | Calibration Frequency | CR-E Reagent: Every 14 days |
| | | CR-S Reagent: Every 5 days on LX/DxC Systems<br>Every 7 days on CX Systems |
| | Detection Wavelength | CR-E Reagent: 560 nm (Primary Wavelength) |
| | | CR-S Reagent: 520 nm (Primary Wavelength) |

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## 8.0 Summary of Performance Data:

The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. Equivalence is demonstrated through method comparison, stability, linearity, and imprecision experiments.

# Serum Method Comparison Summary

| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|-------------------------------------------|----------|-------|-----------|-------|----|--------------------------------------------------|
| Enzymatic<br>Creatinine<br>(CR-E) Reagent | CX7 PRO | 0.997 | -0.002 | 1.000 | 78 | SYNCHRON<br>Systems Creatinine<br>(CR-S) Reagent |
| | DxC800 | 0.991 | 0.012 | 1.000 | 80 | |

Urine Method Comparison Summary

| Candidate | Platform | Slope | Intercept | R | N | Predicate Method |
|-------------------------------------------|----------|-------|-----------|-------|----|--------------------------------------------------|
| Enzymatic<br>Creatinine<br>(CR-E) Reagent | DxC800 | 0.988 | -3.096 | 0.998 | 66 | SYNCHRON<br>Systems Creatinine<br>(CR-S) Reagent |

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# SYNCHRON Systems Enzymatic Creatinine (CR-E) Reagent Precision Study Results

| Sample | Mean<br>(mg/dL) | S.D. | %C.V. | N |
|------------------------|-----------------|------|-------|----|
| Within-Run Imprecision | | | | |
| Level 1 | 0.62 | 0.01 | 1.4 | 80 |
| Level 2 | 4.16 | 0.02 | 0.5 | 80 |
| Level 3 | 7.69 | 0.02 | 0.3 | 80 |
| Human Pool | 1.50 | 0.02 | 1.0 | 80 |
| Total Imprecision | | | | |
| Level 1 | 0.62 | 0.01 | 1.5 | 80 |
| Level 2 | 4.16 | 0.02 | 0.6 | 80 |
| Level 3 | 7.69 | 0.04 | 0.5 | 80 |
| Human Pool | 1.50 | 0.02 | 1.0 | 80 |

Precision Study Results on SYNCHRON CX7 PRO Clinical System

Precision Study Results on UniCel DxC 800 SYNCHRON Clinical System

F

| | Sample | Mean<br>(mg/dL) | S.D. | %C.V. | N |
|------------------------|------------|-----------------|------|-------|----|
| Within-Run Imprecision | | | | | |
| Serum | Level 1 | 0.64 | 0.01 | 2.1 | 80 |
| | Level 2 | 4.09 | 0.01 | 0.3 | 80 |
| | Level 3 | 7.56 | 0.03 | 0.3 | 80 |
| | Human Pool | 1.50 | 0.01 | 0.7 | 80 |
| Urine | Level 1 | 66.45 | 0.31 | 0.5 | 80 |
| | Level 2 | 146.61 | 0.60 | 0.4 | 80 |
| Total Imprecision | | | | | |
| Serum | Level 1 | 0.64 | 0.02 | 2.5 | 80 |
| | Level 2 | 4.09 | 0.03 | 0.7 | 80 |
| | Level 3 | 7.56 | 0.06 | 0.8 | 80 |
| | Human Pool | 1.50 | 0.01 | 0.9 | 80 |
| Urine | Level 1 | 66.45 | 0.68 | 1.0 | 80 |
| | Level 2 | 146.61 | 1.47 | 1.0 | 80 |

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

. `

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

Beckman Coulter, Inc. c/o Ms. Marine Boyajian Senior Regulatory Affairs Specialist 200 S Kraemer Blvd., M/S W-110 Brea, CA 92822

AUG 1 4 2009

Re: k091742

> Trade Name: Synchron Systems Enzymatic Creatinine (CR-E) Reagent Regulation Number: 21 CFR §862.1225 Regulation Name: Creatinine Test System Regulatory Class: Class II Product Codes: JFY Dated: June 11, 2009 Received: June 16, 2009

Dear Ms. Boyajian:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

G.C.H.

Courtney C. Harper, Ph.D. 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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# Indication for Use

# 510(k) Number (if known):

091742

Device Name: SYNCHRON® Systems Enzymatic Creatinine (CR-E) Reagent

Indication For Use:

CR-E reagent, when used in conjunction with SYNCHRON® Systems, UniCel® DxC Systems and SYNCHRON® Systems AQUA CAL 1 and 2 and SYNCHRON CX® Calibrator Level 1 and 2, is intended for the quantitative determination of creatinine (CR-E) soncentration in human serum,
plasma or urine (urine is not available on the SYNCHRON CX PRO Systems).

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 _ _ X (21 CFR Part 801 Subpart D)

Over the

Over the Counter Use (21 CFR Part 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K091742

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