DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT

K042448 · General Atomics · JJX · Oct 29, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042448
• Device Name: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT
• Applicant: General Atomics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can in diagnosis and treatment of patients suspected in having assist hyperhomocysteinemia and homocystinuria. Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples. Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.

Device Story

The Diazyme Homocysteine Enzymatic Assay is an in vitro diagnostic kit used to measure total L-homocysteine levels in serum and heparin plasma samples. The assay utilizes enzymatic reagents to quantify homocysteine concentrations, aiding clinicians in diagnosing and monitoring patients with suspected hyperhomocysteinemia or homocystinuria. The kit includes a single calibrator for generating calibration points and controls for verifying assay functionality at normal and abnormal serum levels. It is intended for professional use in clinical laboratory settings. Results are used by healthcare providers to inform clinical decision-making regarding patient metabolic health.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and performance characteristics of the enzymatic assay.

Technological Characteristics

Quantitative indirect enzymatic assay. Reagents: S-adenosylmethionine, NADPH, 2-oxoglutarate, homocysteine methyltransferase, glutamate dehydrogenase, adenosine deaminase, s-adenosylhomocysteine hydrolase. Detection: Spectrophotometric measurement of NADPH consumption at 340nm. Instrument: Cobas Mira clinical chemistry analyzer. Calibration: Single-point gravimetric calibrator. Controls: Two-level assayed controls. Performance evaluated per NCCLS EP5-A.

Indications for Use

Indicated for in vitro quantitative determination of total L-homocysteine in serum and heparin plasma to assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The caduceus is depicted with a series of curved lines that form a stylized bird-like shape, representing health and well-being. The overall design is simple and professional, reflecting the department's role in public health and human services.

OCT 2 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Huan Tran Quality Assurance Manager Diazyme Laboratories 3550 General Atomics Court San Diego, CA 92121

Re: k042448

Trade/Device Name: Diazyme Homocysteine Enzymatic Assay Kit Diazyme Homocysteine Controls Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system Regulatory Class: Class II Product Code: LPS, JJX Dated: September 7, 2004 Received: September 9, 2004

Dear Mr. Tran:

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,

Seain M. Corgan 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}------------------------------------------------

## Indications for Use

510(k) Number:

Device Name: Diazyme Homocysteine Enzymatic Assay Kit

Indications for Use:

Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can in diagnosis and treatment of patients suspected in having assist hyperhomocysteinemia and homocystinuria.

Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.

Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Alberto

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K042448