DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR

K061296 · Diazyme Laboratories · LPS · Jun 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K061296
• Device Name: DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR
• Applicant: Diazyme Laboratories
• Product Code: LPS · Clinical Chemistry
• Decision Date: Jun 13, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

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

Device Story

In vitro diagnostic assay for quantitative measurement of total L-homocysteine in human serum or plasma; intended for clinical laboratory use on Cobas Integra® automated chemistry analyzers. Assay utilizes enzymatic methodology to determine homocysteine levels; results assist clinicians in diagnosing and monitoring hyperhomocysteinemia and homocystinuria. Device provides quantitative data to healthcare providers to inform clinical decision-making regarding patient metabolic status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Enzymatic assay; reagents applied to Cobas Integra analyzer. Specimen type: serum or heparinized plasma. Fundamental technology unchanged from predicate.

Indications for Use

Indicated for quantitative determination of total L-homocysteine in human serum or heparinized plasma for diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## JUN 1 3 2006

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

Re: k061296

> Trade/Device Name: Diazyme Homocysteine Enzymatic Assay for Cobas Integra® Regulation Number: 21 CFR8862.1377 Regulation Name: Urinary homocystine (nonquantitative) test system Regulatory Class: Class II Product Code: LPS Dated: May 23, 2006 Received: May 26, 2006

Dear Mr. Strickland:

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).

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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/industry/support/index.html.

Sincerely yours,

Alberto Gutierrez

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): k061296

Device Name: Diazyme Homocysteine Enzymatic Assay for Cobas Integra®

Indications for Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use . (21 CFR 801 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)

G.C.
Division

Device

10/06/2021

510(K)

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