HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT

K011692 · Intersect Systems, Inc. · LPS · Jul 25, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011692
• Device Name: HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT
• Applicant: Intersect Systems, Inc.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Jul 25, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Device Story

Homogeneous Enzymic Homocysteine Reagent is an in vitro diagnostic assay for quantitative measurement of total homocysteine in serum or plasma. Used in clinical laboratory settings to assist physicians in diagnosing and managing hyperhomocysteinemia. The assay utilizes an enzymatic reaction principle to determine homocysteine levels. Results are provided to healthcare providers to inform clinical decision-making regarding patient metabolic health and cardiovascular risk assessment.

Technological Characteristics

In vitro diagnostic reagent system; enzymatic assay methodology; intended for use with serum or plasma samples; classified under 21 CFR 862.1377 (Product Code LPS).

Indications for Use

Indicated for the quantitative measurement of total homocysteine in serum or 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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUL 2 5 2001

Ms. Joan Cathey Ouality Systems Director Intersect Systems, Inc. PO Box 2219 Longview, WA 98632

Re: 510(k) Number: K011692 Trade/Device Name: Homogeneous Enzymic Homocysteine Reagent Regulation Number: 862.1377 Regulatory Class: II Product Code: LPS Dated: May 25, 2001 Received: May 31, 2001

Dear Ms. Cathey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510(K) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The FDA mining of baction for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and il you desire specific advice for your actic devices), please contact the Office of Compliance at additionally 807.10 for mirrido diaglestions on the promotion and advertising of your device, [phone]. Additionally, 18. quee at [phone]. Also, please note the regulation please contact the Orneo or Compilance (21CFR 807.97). Other general entitled, TMIsoranding of reference to perched to persons of our the Division of Small
information on your responsibilities under the Act may 1001 - 1001 - 100 - 1607 miormation on your responsibilities areas and in [phone] or [phone] or at its Maindractdrors 115615x4200ww.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

#### Trade Name of the Device:

Homogeneous Enzymic Homocysteine Reagent

510(k) Number: KOII 692

## Classification Name; Number:

Urinary Homocystine (Nonquantitative) Test System; 21 CFR §862.1377

## Indications for Use

A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Good Luck

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