CREA

K981799 · Abbott Laboratories · CGX · Jul 22, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981799
• Device Name: CREA
• Applicant: Abbott Laboratories
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jul 22, 1998
• Decision: SESE
• Submission Type: Traditional
• 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. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Device Story

In vitro diagnostic clinical chemistry assay for quantitative creatinine measurement in human serum, plasma, or urine. Principle: alkaline picrate reaction; creatinine reacts with picrate to form a creatinine-picrate complex. Device measures rate of increase in absorbance at 500 nm; rate is directly proportional to creatinine concentration. Used in clinical laboratory settings by trained personnel. Output provides creatinine concentration values used by clinicians to assess renal function, diagnose renal disease, and monitor dialysis patients.

Clinical Evidence

Bench testing only. Method comparison against predicate (Hitachi 717) showed correlation coefficients of 0.9997 (serum) and 0.9947 (urine). Precision studies (within-run, between-run, between-day) yielded total %CVs of 2.6-3.0% for serum and 1.6-2.1% for urine. Linearity established up to 38.7 mg/dL (serum) and 757.0 mg/dL (urine). Limit of quantitation is 0.10 mg/dL.

Technological Characteristics

In vitro diagnostic clinical chemistry assay. Uses alkaline picrate colorimetric method. Measures absorbance at 500 nm. Designed for use on automated clinical chemistry systems (e.g., AEROSET System).

Indications for Use

Indicated for the quantitative determination of creatinine in human serum, plasma, or urine to aid in the diagnosis and treatment of renal diseases and monitoring of 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

• Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer (K812095)

Submission Summary (Full Text)

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# 510(k) Summary

K981799
July 22, 1998

#### Submitter's Name/Address Abbott Laboratories 1920 Hurd Drive

Irving, Texas 75038

## Contact Person

Mark Littlefield Section Manager MS 1-8 ADD Regulatory Affairs [phone] Fax [phone]

| Date of Preparation of this Summary: | May 20, 1998 |
|--------------------------------------------------|----------------|
| Device Trade or Proprietary Name: | Crea |
| Device Common/Usual Name or Classification Name: | Creatinine |
| Classification Number/Class: | 75C6X/Class II |

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:

#### Test Description:

Creatinine is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma, or urine. The Creatinine assay is a clinical chemistry assay in which the creatinine in the sample, at an alkaline pH, 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 amount of creatinine in the sample.

## Substantial Equivalence:

The Creatinine assay is substantially equivalent to the Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer (K812095) for the serum, plasma, or urine applications .

Creatinine 510(k) May 20, 1998 Creatf.lwp

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These assays vield similar Performance Characteristics.

Similarities to Boehringer Mannheim:

- Both assays are in vitro clinical chemistry methods. .
- Both assays can be used for the quantitative determination of creatinine. .
- Both assays vield similar clinical results. .

Differences to Boehringer Mannheim:

- . There is a minor difference between the assay range.
#### 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 Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications. For the serum application, the correlation coefficient = 0.9997, slope = 0.873, and Y-intercept = 0.078 mg/dL. For the urine applications, the correlation coefficient = 0.9947, slope = 1.056, and Y-intercept = -2.410 mg/dL. Precision studies were conducted using the Creatinine assay. Within-run, between-run, and between-day studies were performed using two levels of control material. For the serum application, the total %CV for Level 1/Panel 101 is 3.0% and Level 2/Panel 102 is 2.6%. For the urine application, the total %CV for Level 1/Panel 201 is 1.6% and Level 2/Panel 202 is 2.1%. The Creatinine assay is linear up to 38.7 mg/dL for the serum application, and 757.0 mg/dL for the urine application. The limit of quantitation (sensitivity) of the Creatinine assay is 0.10 mg/dL. These data demonstrate that the performance of the Creatinine assay is

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substantially equivalent to the performance of the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications.

### Conclusion:

The Creatinine assay is substantially equivalent to the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the serum and urine applications as demonstrated by results obtained in the studies

Creatinine 510(k)
May 20, 1998 Creatf.lwp

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 22 1998

Mark Littlefield Mark British Manager, Regulatory Affairs Abbott Laboratories 1920 Hurd Drive Irving, Texas 75038

K981799 Re : Crea Requlatory Class: II Product Code: CGX Dated: May 20, 1998 Received: May 21, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to we have reviewed jeeferenced above and we have determined the market is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing-Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in
vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification™ (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Litman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Creatinine Device Name:

Indications For Use:

The Creatinine assay is used for the quantitation of creatinine in human serum, plasma, or urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases and in monitoring renal dialysis.

Sign-Off)
Clinical Laboratory Devices
O(k) Number K981799

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Concarrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use ----OR (Per 21 CFR 801.109)

(Optional Format 1-2-96)