AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10

K033921 · Diagnostic Chemicals , Ltd. · JIF · Mar 10, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033921
• Device Name: AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIF · Clinical Chemistry
• Decision Date: Mar 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1065
• Device Class: Class 1

Intended Use

The Ammonia-L3K® Assay is a testing device for the quantitative determination of Ammonia in plasma. Ammonia measurements are used in the diagnosis and treatment of sever liver disorders, such as cirrhosis, hepatitis, and Reye’s Syndrome. For In Vitro Diagnostic use only. Prescription Use

Device Story

Ammonia-L3K Assay is an in vitro diagnostic reagent for quantitative ammonia measurement in plasma. Input: plasma sample; processed via Hitachi 911 analyzer. Principle: enzymatic colorimetric reaction; ammonia reacts with alpha-ketoglutarate and reduced cofactor (NADPH analog) catalyzed by glutamate dehydrogenase (GLDH); decrease in absorbance at 340 nm monitored; absorbance change proportional to ammonia concentration. Used in clinical laboratory settings by trained technicians. Output: quantitative ammonia concentration value. Assists clinicians in diagnosing and monitoring liver disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reagent contains buffer (pH 8.0), 10 mmol/L alpha-ketoglutarate, >=6 KU/L microbial GLDH, 0.2 mmol/L NADPH analog, stabilizers, and preservative. Enzymatic colorimetric sensing principle. Designed for use on Hitachi 911 analyzer. No software/algorithm complexity beyond standard photometric absorbance monitoring.

Indications for Use

Indicated for quantitative determination of ammonia in plasma for patients with suspected or diagnosed severe liver disorders, including cirrhosis, hepatitis, and Reye’s Syndrome.

Regulatory Classification

Identification

An ammonia test system is a device intended to measure ammonia levels in blood, serum, and plasma, Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 1 0 2004

Ms. Nancy Olscamp External Regulatory Affairs Coordinator Diagnostic Chemicals Limited 16 Mc Carville Street Charlottetown, PE CANADA CIE 2A6

Re: k033921

> Trade/Device Name: Ammonia-L-3K® Assay Regulation Number: 21 CFR 862.1065 Regulation Name: Ammonia test system Regulatory Class: Class I Product Code: JIF Dated: December 17, 2003 Received: January 7, 2004

Dear Ms. Olscamp:

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).

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

## 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,

Jean M. Cooper, MS, DVM.

Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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

510(K) Notification

Diagnostic Chemicals Limited

Ammonia-L3K @ Assay, Cat. No. 233

Image /page/2/Picture/3 description: The image shows a black and white logo with the letters 'ddj' in a stylized font. The letters are bold and blocky, with a thick black line underlining them. The letters are connected to each other, forming a single, unified design.

## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

For the IN VITRO quantitative determination of Ammonia in plasma.

Anmonia measurements are used in the clagaosis and treatment of severe liver disorders, such as circhosis, and Reve s Syndrome. For the IN VITRO quantitative dctermination of Anumonia in plasma

## LEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF EEDED)

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

Prescription Use

A N D / O R

Over-The-Counter Use

(21 CFR 807 Subpart C)

(Per 21 CFR 801.109

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 丈03521