LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644

K984071 · Bio-Rad · JJX · Dec 3, 1998 · Clinical Chemistry

Device Facts

• Record ID: K984071
• Device Name: LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644
• Applicant: Bio-Rad
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 3, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

Device Story

Liquichek Homocysteine Control is an assayed quality control serum used to monitor the precision of laboratory testing procedures for homocysteine. The device is prepared from human serum with added homocysteine and contains <0.1% sodium azide as a preservative. It is provided in liquid form for convenience. The control is used by laboratory personnel to verify the performance and precision of homocysteine measurement assays. By comparing the measured values of the control against established ranges, clinicians and laboratory technicians can ensure the accuracy and reliability of patient test results, thereby supporting clinical decision-making regarding homocysteine levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human serum-based control material; liquid form; contains <0.1% sodium azide preservative. Analyte: Homocysteine. Storage: -10 to -20°C. Open vial stability: 14 days at 2-8°C.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine in clinical laboratory settings.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Axis Homocysteine EIA Control Kit (K980907, K980812)

Submission Summary (Full Text)

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NOV-30-98 16:48 From:BIO-RAD

9495981555

T-016 P.03/04 Job-771
K984071

DEC 3 1998

Image /page/0/Picture/4 description: The image shows the logo for BIO-RAD. The logo is white text on a black rounded rectangle. The text is in all caps and has a bold, sans-serif font.

Bio-Rad Laboratories Diagnostics Group 500 Jeronimo Road Irvine, California 92618-201 Telaphone: [phone]

## 510(k) Summary

Submitter Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA [phone] Fax [phone]

Contact Person Elizabeth Platt

Date of Summary Preparation November 30, 1998

Device (Trade & Common Name) Liguichek Homocysteine Control

Classification Name CFR 862.1660: Quality Control Material (Assayed and Unassayed)

Devices to Which Substantial Equivalence is Claimed Axis Homocysteine EIA Control Kit Axis Biochemicals ASA, P.O. Box 206 Okern, Oslo K980907, K980812

### Statement of Intended Use

Liquichek Hornocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

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9495981555

Image /page/1/Picture/3 description: The image shows the logo for Bio-Rad Laboratories, a company that manufactures and distributes products for the life science research and clinical diagnostics markets. The logo is in black and white, with the words "BIO-RAD" in bold, sans-serif letters. The logo is simple and recognizable. The text is white and the background is black.

Bio-Rad Laboratories Diagnostics Group 9500 Jeronimo Road Irvina, California 92618-2017 Telephone: [phone]

## Description of the Device

Description of the Device
Liquichek Homocysteine Control is prepared from human serum with added Liquichek Homocystellie Control is propared from hands been is provided in liquid form for convenience.

form for convenience.
This product contains <0.1% sodium azide as a preservative.

# Statement of How Technological Characteristics Compare to Substantial Equivalence Device

A table is provided below comparing the similarities between the Bio-Rad Liquicherse is claimed A table is provided below companing the similanties some in the substantial equivalence is claimed.

| | Axis Homocysteine EIA<br>Control Kit | Bio-Rad Liquichek<br>Homocysteine Control |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use | a quality control material<br>used as a control of the<br>procedure and the product<br>for enzyme immunoassay<br>measurement of<br>homocysteine. | an assayed quality control<br>serum to monitor the<br>precision of laboratory<br>testing procedures for<br>homocysteine. |
| Form | Liquid | Liquid |
| Matrix | Human Serum | Human Serum |
| Storage | 2-8°C | -10 to -20°C |
| Analytes | Homocysteine | Homocysteine |
| Open Vial<br>Claim | Per expiration date | 14 Days at 2-8°C |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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DEC - 3 1998

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Elizabeth Platt Staff Regulatory Affairs Representative BIO-RAD LABORATORIES 9500 Jeronimo Road Irvine, CA 92618-2017

Re: K984071 Trade Name: Liquichek Homocysteine Control Requlatory Class: I Product Code: 75 JJX November 6, 1998 Dated: November 16, 1998 Received:

Dear Ms. Platt:

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 aqainst 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. this response to your premarket notification Please note: 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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Paqe 2

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 diaqnostic 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, "Misbrandinq 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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Page 1 of 1

K98407 510(k) Number: Device Name: Liquichek Homocysteine Control

Indications for Use:

Liquichek Homocysteine Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for homocysteine.

signature

(Division Sarradi) Division of Chineal Caborator 510(k) Number.

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

(Concurrence of CDRH, Office of Device Evaluation)

Prescription Use

OR Over-The Counter Use