DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL

K071971 · Diazyme Laboratories · LPS · Sep 17, 2007 · Clinical Chemistry

Device Facts

• Record ID: K071971
• Device Name: DIAZYME HOMOCYSTEINE 2 REAGENT ENZYMATIC ASSAY KIT, AND CALIBRATORS, MODEL(S) DZXXXA, DZXXXA-CAL
• Applicant: Diazyme Laboratories
• Product Code: LPS · Clinical Chemistry
• Decision Date: Sep 17, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism. Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.

Device Story

In vitro diagnostic reagent system; modified to combine reagent R2 and R3 into single reagent with added stabilizers; adapted for use on Olympus AU400 analyzer. Used in clinical laboratory settings by trained technicians. Input: patient serum/plasma samples; output: quantitative clinical chemistry results. Modification maintains fundamental scientific technology of previously cleared device; intended use remains unchanged. Benefits include streamlined reagent handling and expanded compatibility with specific automated analyzer platforms.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

In vitro diagnostic chemical reagent; modified formulation combining R2 and R3 with stabilizers. Designed for automated clinical chemistry analysis on Olympus AU400 platform. No changes to fundamental scientific technology.

Indications for Use

Indicated for use as an in vitro diagnostic reagent for clinical chemistry analysis on the Olympus AU400 analyzer.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Diazyme Laboratories c/o Mr. Charles Lu Quality System Manager 12889 Gregg Court Poway, CA 92064

SEP 1 7 2007

k071971 Re:

> Trade Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay Regulation Number: 21 CFR 8862.1377 Regulation Name: Urinary Homocysteine (nonquantiative) test system Regulatory Class: Class II Product Code: LPS, JIX Dated: August 20, 2007 Received: August 21, 2007

Dear Mr. Lu:

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 10(x) marketed predicate device results in a classification for your device and than bernetted 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 une [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., 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

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Indications for Use

510(k) Number (if known):

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Device Name: Diazyme Homocysteine 2 Reagent Enzymatic Assay

Indications for Use: Diazyme homocysteine 2 reagent assay is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only. The reagents can assist in the diagnosis and treatment of patients suspected of having hyperhomocyone . Inc creating and homocystinuria. Patients who are taking methotrexate, carbamazepine, phenytoin, nitrovos oxide, anticonvulsants, or 6-azuridine triacetate, may have higher levels of Homocysteine due to metabolic interference with Homocysteine metabolism.

Device Name: Diazyme Homocysteine Calibrators

Indications for Use: Diazyme homocysteine Calibrators is intended for the in vitro quantitative determination of total L-homocysteine in serum or plasma. For in-vitro diagnostic use only.

Prescription Use X (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)

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ିffice of In Vitro Diagnostic Device I Waluation and Safety

K07/971