CREATININE

K083809 · Abbott Laboratories · CGX · Apr 7, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083809
• Device Name: CREATININE
• Applicant: Abbott Laboratories
• Product Code: CGX · Clinical Chemistry
• Decision Date: Apr 7, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

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

Device Story

Creatinine assay is an in vitro diagnostic reagent for quantitative analysis of creatinine in human serum, plasma, or urine. Device operates on automated clinical chemistry analyzers (AEROSET and ARCHITECT cSystems). Sample reacts with picrate at alkaline pH to form a creatinine-picrate complex; rate of increase in absorbance at 500 nm is measured. Absorbance rate is directly proportional to creatinine concentration. Used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing/treating renal disease and monitoring dialysis. Modifications include transition to linear calibration for urine and use of NIST SRM 914 reference standard.

Clinical Evidence

Bench testing only. Method comparison studies performed on AEROSET and ARCHITECT c8000 systems against Roche Creatinine assay on Hitachi 917. Results showed high correlation (r=0.9990 to 0.9992). Linearity established from 5.00 to 740.00 mg/dL. Limit of quantitation is 5.00 mg/dL. Precision studies on ARCHITECT c8000 demonstrated total %CV of 1.34% (Level 1) and 1.27% (Level 2).

Technological Characteristics

In vitro diagnostic reagent; modified Jaffe (alkaline picrate) methodology. Measures absorbance at 500 nm. Calibrated using NIST SRM 914. Designed for use on automated clinical chemistry analyzers (AEROSET, ARCHITECT cSystems).

Indications for Use

Indicated for measurement of creatinine levels in serum, plasma, and urine. Used for diagnosis and treatment of renal diseases, monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

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

• Creatinine assay (K061193)
• Roche Creatinine assay (K941837)

Submission Summary (Full Text)

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# Special 510(k) Summary

APR - '7 2009

Submitter's Name/Address Abbott Laboratories 1921 Hurd Drive Irving, TX 75038

Contact Person Linda Morris Senior Regulatory Specialist, MS 2-11 Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | December 15, 2008 |
|-----------------------------------------------------|--------------------|
| Device Trade or Proprietary Name: | Creatinine |
| Device Common/Usual Name or<br>Classification Name: | Creatinine Reagent |
| Classification Number/Class: | Class II 862.1225 |
| Product Code: | CGX |

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990, 21 CFR 807.92, and the guidance document, "The New 510(k) Paradigm, Alternate Approaches to Demonstrating Substantial Equivalence in Pre-market Notification" dated March 20,1998.

The assigned 510(k) number is: KO83809

#### 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 in the reagent 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 modified Creatinine assay is substantially equivalent to the cleared Creatinine assay (K061193) on the Abbott AEROSET® System and ARCHITECT® cSystems. The modifications to the urine application include changes to the calibration and assay parameters. The Use-factor calibration has been changed to a Linear calibration that allows for a separate urine calibration curve. In addition, the modified Creatinine assay urine application uses NIST SRM 914 as the reference standard rather than the serum standard, NIST SRM 967, both of which are IDMS traceable standards. These modifications did not significantly change the safety and effectiveness profile of the device as demonstrated in the Performance Characteristics Summary.

The modified Creatinine assay urine application is substantially equivalent to the Roche Creatinine assay urine application (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.

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#### Performance Characteristics:

Comparative performance studies were conducted using the AEROSET System and the ARCHITECT c8000 System. The Creatinine assay urine application method comparison yielded acceptable correlation with the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the AEROSET System showed a correlation coefficient of 0.9992, slope of 1.01, and Y-intercept of -0.43 mg/dL when compared to the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the ARCHITECT c8000 System showed a correlation coefficient of 0.9990, slope of 0.97, and Y-intercept of 0.36 mg/dL when compared to the Roche Creatinine assay urine application on the Hitachi 917 Analyzer. The urine application on the ARCHITECT c8000 System showed a correlation coefficient of 0.9992, slope of 0.96, and Y-intercept of 1.23 mg/dL when compared to the AEROSET System. The Creatinine assay method comparison yielded acceptable correlation between the AEROSET System and the ARCHITECT c8000 System for the urine application.

The Creatinine assay is linear from 5.00 to 740.00 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 5.00 mg/dL for the urine application.

Precision studies conducted using the Creatinine assay urine application on the ARCHITECT c8000 System showed the total %CV for Level 1 to be 1.34%, and for Level 2 to be 1.27% for the urine application.

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

.

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## Conclusion:

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

.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

#### Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Abbott Laboratories c/o Linda Morris Senior Regulatory Specialist, 1921 Hurd Drive Irving, TX 75038

APR - 7 2009

Re: k083809

Trade/Device Name: Creatinine Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: CGX Dated: March 7, 2009 Received: March 10, 2009

Dear Linda 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 (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 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/dsma/dsmamain.html.

Sincerely yours,

Corg C. He

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

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### Indication for Use

510(k) Number (if known): K08 3809

Device Name: Creatinine

Indication 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_ X (21 CFR Part 801 Subpart D)

And/Or

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

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

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

Division Sign-Off

Office of the Vitro Diagnostic Device Evaluation and Safety

510(k) *to83804*