TECO HOMOCYSTEINE ENZYMATIC ASSAY

K063701 · Teco Diagnostics · LPS · Apr 11, 2007 · Clinical Chemistry

Device Facts

• Record ID: K063701
• Device Name: TECO HOMOCYSTEINE ENZYMATIC ASSAY
• Applicant: Teco Diagnostics
• Product Code: LPS · Clinical Chemistry
• Decision Date: Apr 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

Teco Enzymatic Homocysteine assay is intended for in vitro quantitative determination of total homocysteine in serum or plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia. Note: Specimens from patients who are on drug therapy involving S-adenosylmethionine may show falsely elevated levels of homocysteine. Patients, who are taking methotrexate, carbamazepine, phenytoin, nitrous oxide, anticonvulsants or 6-azuridinetriacetate, may have elevated levels of homocysteine due to their effect on the pathway. Refer to limitations/interfering substance section in this assay package insert.

Device Story

Teco Homocysteine Enzymatic Assay is an in vitro diagnostic reagent kit for quantitative measurement of total homocysteine in serum or plasma. The assay utilizes recombinant homocysteinase (rHCYase) to degrade homocysteine, producing hydrogen sulfide, alpha-ketobutyrate, and ammonia. Ammonia reacts with alpha-ketobutyrate in the presence of Glutamate Dehydrogenase and NADH; the resulting decrease in NADH absorbance at 340 nm is measured via spectrophotometry (e.g., Beckman Coulter CX7 or Teco TC 84). The device is used in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing hyperhomocysteinemia. The assay is intended for prescription use.

Clinical Evidence

No clinical data provided in the document; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

In vitro diagnostic enzymatic assay for total homocysteine. Reagent-based chemistry for serum and plasma analysis. No software, electronic, or mechanical components described.

Indications for Use

Indicated for the in vitro quantitative determination of total homocysteine in human serum and plasma to aid in the diagnosis and treatment of hyperhomocysteinemia.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## APR 1 1 2007

Teco Diagnostics 1268 North Lakeview Avenue Anaheim, CA 92807 ATTN: Jian Vaeches

Re: k063701 Trade/Device Name: Teco Enzymatic Homocysteine Assay Regulation Number: 21 CFR 862.1377 Regulation Name: Urinary homocystine (non-quantitative) test system. Regulatory Class: Class II Product Codes: LPS Dated: February 21, 2007 Received: February 21, 2007

Dear Ms. Vaeches:

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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

k063701 510(k) Number (if known):

Device Name: Teco Enzymatic Homocysteine Assay

Indications for Use:

Teco Enzymatic Homocysteine Assay is in vitro quantitative determination of total homocysteine in serum and plasma. Homocysteine measurements are used in the diagnostics and treatment of hyperhomocysteinemia.

Prescription Use V

AND/OR

Over-The-Counter Use

(Part 21 CFR 801.109) (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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Carol C. Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K063701