RANDOX LIPOPROTEIN

K011568 · Randox Laboratories, Ltd. · JIS · Sep 28, 2001 · Clinical Chemistry

Device Facts

• Record ID: K011568
• Device Name: RANDOX LIPOPROTEIN
• Applicant: Randox Laboratories, Ltd.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic reagent for the quantitative determination of Lipoprotein (a) in serum and plasma. The method is an immunoturbidimetric assay in which agglutination occurs due to an antigenantibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample. Lp(a) determination is intended for use in conjunction with clinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations. This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions

Device Story

In vitro diagnostic reagent kit for quantitative measurement of Lipoprotein (a) in serum and plasma samples. Operates via immunoturbidimetric assay; antigen-antibody reaction between sample Lp(a) and latex-adsorbed anti-Lp(a) antibodies causes agglutination. Agglutination measured as absorbance change at 700nm, proportional to Lp(a) concentration. Designed for use on Hitachi 717 analyzer. Operated by qualified laboratory personnel in clinical laboratory settings. Output provides quantitative Lp(a) levels to clinicians for integration with patient history, lipid profiles, and risk assessment for coronary heart disease and lipid metabolism disorders.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay; latex particle-enhanced. Measures absorbance at 700nm. Designed for use on Hitachi 717 analyzer. Reagent-based diagnostic test.

Indications for Use

Indicated for quantitative determination of Lipoprotein (a) in serum and plasma to evaluate lipid metabolism disorders and assess coronary heart disease risk in clinical populations.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 2 8 2001

Dr. Heather Anderson Regulatory Affairs Randox Laboratories, Ltd. Ardmore, Diamond Rd., Crumlin Co. Antrim, United Kingdom, BT29 4QY

k011568 Re:

> Trade/Device Name: Lipoprotein (a) Regulation Number: 21 CFR 862.1150; 21 CFR 866.5600; 21 CFR 862.1660 Regulation Name: Calibrator; Low density lipoprotein immunological test system; Quality control material (assayed and unassayed) Regulatory Class: Class II; Class II; Class I, reserved Product Code: JIS; DFC; JJS Dated: August 2, 2001 Received: August 3, 2001

Dear Dr. Anderson:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 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 i 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 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): NOT KNOWN K011568

Device Name:

Lipoprotein (a)

## Indications For Use :

The Randox Laboratories Ltd. Lipoprotein (a) test kit is an in vitro diagnostic reagent for the quantitative determination of Lipoprotein (a) in serum and plasma.

The method is an immunoturbidimetric assay in which agglutination occurs due to an antigenantibody reaction between Lp(a) in a sample and anti-Lp(a) antibody adsorbed to latex particles. The agglutination is detected as an absorbance change at 700nm proportional to the concentration of Lp(a) in the sample.

Lp(a) determination is intended for use in conjunction with clinical evaluation, patient risk assessment and other lipid tests to evaluate disorders of lipid metabolism and lto assess coronary heart disease in specific populations.

\This Application Sheet has been developed for the Hitachi 717 analyser and must be used by suitably qualified laboratory personnel under appropriate laboratory conditions

(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)

OR

Kesia Alexander for Sean Cooper
(Division Sign-Off)

(Division Sign-Off) Division of Clinical 510(k) Number .

Over-The-Counter Use (Optional format 1-2-96)