CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02

K991109 · A.P. Total Care, Inc. · CGX · May 25, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991109
• Device Name: CREATININE REAGENT, PRODUCT NO CR105-01, CREATININE REAGENT, PRODUCT NO CR105-02
• Applicant: A.P. Total Care, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: May 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Picric Acid (R2), product No. CA105-02 are intended for Invitro Diagnostic use in the automated, quantitative determination of creatinine in serum.

Device Story

Creatinine Reagent system consists of Alkaline Diluent (R1) and Picric Acid (R2). Used in clinical laboratories for automated, quantitative measurement of creatinine in serum samples. Operates via Jaffe reaction principle; reagents mixed with patient serum sample in automated analyzer; colorimetric change measured photometrically. Output provides creatinine concentration values used by clinicians to assess renal function. Intended for prescription use in professional laboratory settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic reagent kit for creatinine measurement. Utilizes Jaffe reaction (alkaline picrate method). Designed for use on automated clinical chemistry analyzers. Reagents: Alkaline Diluent (R1) and Picric Acid (R2).

Indications for Use

Indicated for in vitro diagnostic, automated, quantitative determination of creatinine in serum for clinical laboratory 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.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

MAY 25 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

A.P. Total Care, Inc. Luis P. Leon c/o Catachem, Inc. 70 Hawley Avenue P.O. Box 6216 Bridgeport, CT

Re: K991109 Trade Name: CREATININE Reagent Regulatory Class: II Product Code: CGX March 25, 1999 Dated: April 1, 1999 Received:

Dear Mr. Leon:

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 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). 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 aqainst 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 Regulations, 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 In addition, FDA may publish further regulatory action. announcements 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.

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

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/dsma/dsmamain.html".

Sincerely yours,

Steven Putman

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

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

| 510(k) Number (if known): | K991109 |
|---------------------------|------------|
| Device Name: | CREATININE |

Indications For Use:

The creatinine reagents: Alkaline Diluent(R1), product No. CA105-01 and Piccio Acid
ed the second of a CA105-02-are intended for Invitro Diagnostic use in the automated, The creatinine reagents: Alkaline Diluent(R1), product No. CH10507 use in the automated,
(R2), product No. CA105-02 are intended for Invitro Diagnosic use in the automated, (R2), product No. CA105-02 are intended for Interest of the

Jean Coope

(Division Sign-Off)
Division of Clinical Laboratory Devices

91109

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

510(k) Number.

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use U (Per 21 CFR 801.109)

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)