HOMOCYSTEINE MICROTITER PLATE ASSAY

K032012 · Diazyme Laboratories · LPS · Sep 3, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032012
• Device Name: HOMOCYSTEINE MICROTITER PLATE ASSAY
• Applicant: Diazyme Laboratories
• Product Code: LPS · Clinical Chemistry
• Decision Date: Sep 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

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

Device Story

The Homocysteine Microplate HPB Assay is an EIA-like diagnostic test for measuring total L-homocysteine (tHcy) in human serum or plasma. The process begins with the pretreatment of plasma samples using a reducing agent, TCEP, to convert protein-bound homocysteine into free homocysteine. Subsequently, SAH hydrolase converts the free homocysteine into S-adenosyl-L-homocysteine (SAH). The assay utilizes a genetically engineered Homocysteine Binding Protein (HBP) as a capturing reagent in a competition assay between the sample's SAH and a tracer SAH-HRP conjugate. The resulting signal is quantitated to determine tHcy levels. The device is intended for clinical laboratory use to assist healthcare providers in diagnosing and managing patients with suspected hyperhomocysteinemia and homocystinuria.

Clinical Evidence

No clinical studies performed. Performance established via bench testing: precision (intra-assay CV 3.8-4.6%, inter-assay CV 6.7-9.2%), linearity (r²=0.99, range 1.5-60 μmol/L), and method comparison against predicate (n=107, Y=0.95X+0.72, r=0.96). Analytical specificity and interference testing conducted.

Technological Characteristics

EIA-like competitive assay; utilizes genetically engineered Homocysteine Binding Protein (HBP) as a capturing reagent; TCEP reducing agent; SAH hydrolase enzyme; microtiter plate format.

Indications for Use

Indicated for the quantitative determination of total L-homocysteine in human serum or plasma to assist in the 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.

Predicate Devices

• Axis Homocysteine EIA (k980907)

Submission Summary (Full Text)

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SEP - 3 2003

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032012

3550 General Atomics Ct. San Diego, CA 92121 Tel: [phone] Fax: [phone]

## SUMMARY

Submitter's name: Address: Phone: Fax number:

Diazyme Laboratories 3550 General Atomics Ct. 858-455-4754 858-455-4750

Name of contact person:

Greg Holland Regulatory Specialists, Inc 3722 Ave. Sausalito Irvine, CA 92606 Phone: [phone] fax: [phone]

Date the summary was prepared: June 18, 2003

| Name of the device: | Homocysteine Microtiter Plate Assay |
|----------------------------|------------------------------------------------------------------|
| Trade or proprietary name: | Homocysteine Microplate HPB Assay |
| Common or usual name: | Homocysteine Microtiter Plate Assay |
| Classification name: | Single (specified analyte controls (per 2 CFR section 862.1660)) |

The legally marketed device to which we are claiming equivalence [807.92(a)(3)]:

> Axis Homocysteine EIA, manufactured by Axis Biochemicals, AS. The clearance number is K980907.

Description of the device:

Homocysteine Microplate HPB Assay is an EIA-like assay for the determination of tHcy (L-homocysteine) in blood. The assay employs a genetically engineered Homocysteine Binding Protein (HBP) as the capturing reagent. Plasma samples are pretreated in vials with a reducing agent, TCEP, to reduce the protein bound Hcy to free Hcy that is subsequently converted to S-adenosyl-L-homocysteine (SAH) by SAH hydrolase and quantitated by the HBP in a competition assay between free SAH from samples and tracer SAH-HRP conjugate.

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Intended use of the device:

The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.

The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Summary of the technological characteristics of our device compared to the predicate device:

The Diazyme Homocysteine Microtiter Plate Assay and the Axis Homocysteine EIA have similar technological characteristics and have been shown to be substantial equivalent.

The following areas were evaluated and shown to be substantially equivalent comparisons to the predicate:

- Indications for Use Methodology Test Objective Type of Test Specimen Type Product Type Reagents Performance

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol consists of four abstract shapes resembling birds in flight, stacked on top of each other.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP - 3 2003

Diazyme Laboratories c/o Mr. Greg Holland Regulatory Specialists, Inc. 3722 Avenue Sausalito Irvine, CA 92606

k032012 Re:

Trade/Device Name: Homocysteine Microtiter Plate Assay Regulation Number: 21 CFR 862.1377 Regulation Name: Single (specified) analyte controls Regulatory Class: Class II Product Code: LPS: JJX Dated: June 27, 2003 Received: July 2, 2003

Dear Mr. Holland:

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/dsma/dsmamain.html.

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K032012

Device Name: Homocysteine Microtiter Plate Assay

Indications For Use:

The Homocysteine Microtiter Plate Assay is intended for the quantitative determination of total L-homocysteine in human serum or plasma.

The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ahets Suts
Division Sign Off for Lean Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k032012

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use_ (Optional Format 1-2-96)