DS30 HCY HOMOCYSTEINE ASSAY KIT

K982003 · Drew Scientific , Ltd. · LPS · Feb 11, 1999 · Clinical Chemistry

Device Facts

• Record ID: K982003
• Device Name: DS30 HCY HOMOCYSTEINE ASSAY KIT
• Applicant: Drew Scientific , Ltd.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Feb 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

In vitro quantitative measurement of total homocysteine (tHcy) concentration in plasma for detection of hyperhomocysteinemia.

Device Story

The DS30 Hcy Homocysteine Assay Kit is an in vitro diagnostic reagent system used for the quantitative measurement of total homocysteine (tHcy) in human plasma. It is intended for use in clinical laboratory settings by trained laboratory personnel. The assay measures tHcy levels to assist in the detection of hyperhomocysteinemia. The output is a quantitative concentration value provided to clinicians to aid in the assessment of patient metabolic status. The device is used in professional clinical environments; results are interpreted by healthcare providers to inform clinical decision-making regarding patient health.

Clinical Evidence

No clinical data provided in the document; the submission relies on the determination of substantial equivalence to legally marketed predicate devices.

Technological Characteristics

In vitro diagnostic assay kit for quantitative measurement of total homocysteine in plasma. Technical specifications and materials are not detailed in the provided text.

Indications for Use

Indicated for the in vitro quantitative measurement of total homocysteine (tHcy) concentration in human plasma to aid in the detection 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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FEB 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Andrew Kenney Research & Development Director Drew Scientific Limited Sowerby Woods Industrial Estate Barrow-in-Furness Cumbria LA14 4QR UK ENGLAND

Re: K982003

Trade Name: DS30 Hcy Homocysteine Assay Kit Regulatory Class: II Product Code: LPS Dated: January 27, 1999 Received: February 1, 1999

Dear Dr. Kenney:

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 (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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 predicate device results in a classification 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Butman

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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| 510(k) Number (if known): | K982003 |
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| Device Name: | |

Indications For Use:

Drew Scientific Limited

Indication for use 11.0

ﺮ ﺗﻘ

In vitro quantitative measurement of total homocysteine (tHcy) concentration in
plasma for detection of hyperhomocysteinemia.

Jein Cooper
(Division Sign-Off)

Division of Clinical Laboratory Devices K987.003 510(k) Number _

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

O

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OR

Over-The-Counter Use

(Optional Format 1-2-96)