CREATININE

K061193 · Abbott Laboratories, Inc. · CGX · Jun 23, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061193
• Device Name: CREATININE
• Applicant: Abbott Laboratories, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

A creatinine test system is a device intended to measure creatinine levels in serum. 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

Device Story

Liquid, ready-to-use, two-reagent kit (Sodium Hydroxide, Picric Acid) for quantitative measurement of creatinine in human serum, plasma, or urine. Used on Abbott Aeroset and Architect c8000 Systems. Principle: alkaline pH reaction of creatinine with picrate to form creatinine-picrate complex; rate of absorbance increase at 500 nm proportional to creatinine concentration. Operated by laboratory professionals in clinical settings. Output provides quantitative creatinine levels to assist clinicians in diagnosing/treating renal disease and monitoring dialysis.

Clinical Evidence

Bench testing only. Performance established via precision studies (CLSI EP5-A, EP10-A), linearity, limit of detection/quantitation (CLSI EP17-A), and interference testing. Method comparison against predicate showed high correlation (r=0.995-0.999) for serum and urine across both Aeroset and Architect systems.

Technological Characteristics

Quantitative colorimetric assay; Modified Jaffe method. Reagents: Sodium Hydroxide (0.8 mol/L) and Picric Acid (25.0 mmol/L). Energy source: photometric detection at 500 nm. Form factor: liquid reagent kit for automated clinical chemistry analyzers. Connectivity: integrated with Abbott Aeroset and Architect c8000 systems.

Indications for Use

Indicated for patients requiring creatinine measurement in serum, plasma, or urine for diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for other urine analytes. For professional use.

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

• Roche creatinine assay (k941837)

Submission Summary (Full Text)

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# 510(k) Summary

| Submitter's Name/Address | Contact Person |
|--------------------------|---------------------------------------|
| Abbott Laboratories | Linda Morris |
| 1921 Hurd Drive | Senior Regulatory Specialist, MS 2-11 |
| Irving, TX 75038 | Regulatory Affairs |
| | [phone] |
| | Fax [phone] |

| Date of Preparation of this Summary: | April 26, 2006 |
|-----------------------------------------------------|-------------------|
| Device Trade or Proprietary Name: | Creatinine |
| Device Common/Usual Name or<br>Classification Name: | Creatinine |
| Classification Number/Class: | Class II 862.1125 |
| Product Code: | CGX |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K 06 11 93

#### Test Description:

Creatinine is an in vitro diagnostic assay for the quantitative analysis of creatinine in human serum, plasma, or urine. At an alkaline pH, creatinine in the sample reacts with picrate to form a creatinine-picrate complex. The rate of increase in absorbance at 500 nm due to the formation of this complex is directly proportional to the concentration of creatinine in the sample.

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#### Substantial Equivalence:

The Creatinine assay is substantially equivalent to the Roche Creatinine assay (K941837) on the Hitachi 917 Analyzer. Both assays yield similar Performance Characteristics.

#### Similarities:

- . Both assays can be used for the quantitation of creatinine,
- . Both assays yield similar results.
- Both assays are based on the modified Jaffe (creatinine alkaline picrate) methodology. .
- Both assays use serum, plasma, and urine .

#### Differences:

None

#### Intended Use:

The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine.

#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET® System. The Creatinine assay method comparison yielded acceptable correlation with the Creatinine assay on the Hitachi 917 Analyzer. The AEROSET System showed a correlation coefficient of 0.9996, slope of 0.98, and Y-intercept of - 0.19 mg/dL for the serum application and a correlation coefficient of 0.9992, slope of 0.94, and Y-intercept of - 3.66 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9993, slope of 0.96, and Y-intercept of - 0.24 mg/dL for the serum application and a correlation coefficient of 0.9990, slope of 0.93, and Y-intercept of - 4.16 mg/dL for the urine application when compared to the Hitachi 917 Analyzer. The ARCHITECT c8000 System showed a correlation coefficient of 0.9996, slope

Creatinine - Conc. 510(k) - R2 June 13, 2006

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of 0.98, and Y-intercept of - 0.06 mg/dL for the serum application and a correlation coefficient of 0.9997, slope of 0.99, and Y-intercept of - 0.51 mg/dL for the urine application when compared to the AEROSET System. The Creatinine assay method comparison vielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System.

Precision studies were conducted using the Creatinine assay. On the AEROSET System, the total %CV for Level 1 is 4.95%, and Level 2 is 3.18% for the serum application and the total %CV for Level 1 is 2.41%, and Level 2 is 2.41% for the urine application. On the ARCHITECT c8000 System, the total %CV for Level 1 is 3.10%, and Level 2 is 1.54% for the serum application and the total %CV for Level 1 is 0.94%, and Level 2 is 0.99% for the urine application.

The Creatinine assay is linear from 0.20 to 37.00 mg/dL for the serum application. The Creatinine assay is linear from 5.0 to 740.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL for the serum application, and 2.0 mg/dL for the urine application.

These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Creatinine assay on the Hitachi 917 Analyzer.

#### Conclusion:

The Creatinine assay on the AEROSET and the ARCHITECT c8000 Systems is substantially equivalent to the Roche Creatinine assay on the Hitachi 917 Analyzer as demonstrated by results obtained in the studies.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the text "U.S. Department of Health and Human Services, USA" is arranged in a circular pattern around the eagle. The eagle is depicted in a minimalist style, with simple lines forming its body and wings.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

### JUN 2 3 2006

Ms. Linda Morris Sr. Regulatory Specialist ADD Regulatory Affairs Abbott Laboratories Inc. 1921 Hurd Drive Irving, TX 75038

Re: k061193

Trade/Device Name: Abbott Clinical Chemistry Creatinine Regulation Number: 21 CFR§862.1225 Regulation Name: Creatine test system Regulatory Class: Class II Product Code: CGX Dated: April 26, 2006 Received: April 28. 2006

Dear Ms. Morris:

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 (D114). 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 misbrandi, noand 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 EDA 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 maurements not hit . . cr 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 proctice requirements as set forth in the quality systems (QS) regulation (21 CFR Party 800).

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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,

Alberto Gutt

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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## Indications for Use

510(k) Number (if known):

Device Name: Abbott Clinical Chemistry Creatinine

Indications For Use:

A creatinine test system is a device intended to measure creatinine levels in serum. 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

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 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)

G.C.

-nos of in Vitro Diagnostic 1 . duation and Safi

042 K001493

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