CREATININE (CREA)

K981240 · Abbott Laboratories · CGX · May 29, 1998 · Clinical Chemistry

Device Facts

• Record ID: K981240
• Device Name: CREATININE (CREA)
• Applicant: Abbott Laboratories
• Product Code: CGX · Clinical Chemistry
• Decision Date: May 29, 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

Creatinine assay is an in vitro diagnostic clinical chemistry test; measures creatinine levels in human serum, plasma, or urine. Principle of operation: creatinine reacts with picrate at alkaline pH to form a creatinine-picrate complex; rate of increase in absorbance at 500 nm is measured; absorbance increase is directly proportional to creatinine concentration. Used in clinical laboratory settings; operated by laboratory technicians or clinicians. Output is a quantitative creatinine value; assists healthcare providers in diagnosing renal disease, monitoring renal function, and managing dialysis patients. Benefits include accurate assessment of kidney function to guide clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison studies performed on the ADCYON Analyzer. Serum application: correlation coefficient 0.9993, slope 0.980, y-intercept -0.150 mg/dL. Urine application: correlation coefficient 0.9995, slope 1.060, y-intercept 4.637 mg/dL. Precision studies (within-run, between-run, between-day) showed total %CV ranging from 2.1% to 4.5% across two control levels for both serum and urine. Linearity established up to 42 mg/dL; limit of quantitation (sensitivity) is 0.3 mg/dL.

Technological Characteristics

In vitro clinical chemistry assay; utilizes alkaline picrate reaction; measures absorbance at 500 nm. Quantitative, colorimetric method. Designed for use on automated chemistry analyzers (e.g., ADCYON Analyzer).

Indications for Use

Indicated for patients requiring quantitative determination of creatinine in serum, plasma, or urine for 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

• Roche Cobas Mira Plus Automated Chemistry System Creatinine assay (K941837)
• Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer (K812095)

Submission Summary (Full Text)

{0}------------------------------------------------

K981240

MAY 2 9 1998

# 510(k) Summary

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: | April 2, 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 following devices:

- Roche® Cobas Mira® Plus Automated Chemistry System Creatinine assay . (K941837) for the serum application
Creatinine 510(k) April 3, 1998 CreatE2.lwp

Section II Page 1

## 0000013

{1}------------------------------------------------

- Boehringer Mannheim® Creatinine assay on the Hitachi® 717 Analyzer . (K812095) for the urine application
These assays yield similar Performance Characteristics.

Similarities to Roche:

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

Differences to Roche:

- There is a minor difference between the assay range. .
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 yield 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 ADCYON™ Analyzer. The Creatinine assay method comparison yielded acceptable correlation with the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application. For the serum application, the correlation coefficient = 0.9993, Slope = 0.980, and Y-intercept = - 0.150 mg/dL. For the urine

Section II Page 2

## 0000014

{2}------------------------------------------------

applications, the correlation coefficient = 0.9995, slope = 1.060, and

Y-intercept = 4.637 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 111 is 4.5% and Level 2/Panel 112 is 2.2%. For the urine application, the total %CV for Level 1/Panel 131 is 2.1% and Level 2/Panel 132 is 2.5%. The Creatinine assay is linear up to 42 mg/dL. The limit of quantitation (sensitivity) of the Creatinine assay is 0.3 mg/dL. These data demonstrate that the performance of the Creatinine assay is substantially equivalent to the performance of the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application.

### Conclusion:

The Creatinine assay is substantially equivalent to the Roche Cobas Mira Plus Automated Chemistry System Creatinine assay for the serum application and the Boehringer Mannheim Creatinine assay on the Hitachi 717 Analyzer for the urine application as demonstrated by results obtained in the studies.

Creatinine 510(k) April 3, 1998 CreatE2.lwp

Section II Page 3

Image /page/2/Picture/6 description: The image shows the number 0000015. The number is written in a bold, sans-serif font. The digits are evenly spaced and aligned horizontally. The number is likely a serial number or identification code.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird with outstretched wings, depicted in a minimalist, abstract design.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY 2 9 1998

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

K981240 Re: Creatinine Regulatory Class: II Product Code: CGX Dated: April 3, 1998 Received: April 6, 1998

Dear Mr. Littlefield:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 regulation (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 regulation 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 regulations.

{4}------------------------------------------------

Page 2

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 Sitman

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

{5}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Creatinine 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.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------|----------|----------------------|
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) | | |
| (Division Sign-Off) | | |
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K 98/240 | |
| | 0000007 | |