RANDOX VALPROIC ACID

K011649 · Randox Laboratories, Ltd. · LEG · Jan 15, 2002 · Clinical Toxicology

Device Facts

• Record ID: K011649
• Device Name: RANDOX VALPROIC ACID
• Applicant: Randox Laboratories, Ltd.
• Product Code: LEG · Clinical Toxicology
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3645
• Device Class: Class 2

Intended Use

The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample. Measurements obtained by this device are used in the diagnosis and treatment of valproic acid wse or overdose and in monitoring levels of valproic acid to ensure appropriate therapy. These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers r noo must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

In vitro diagnostic reagent kit for quantitative serum valproic acid measurement; utilizes latex-enhanced immunoturbidimetric assay principle. Input: patient serum sample; process: agglutination reaction between valproic acid and antibody solution, inhibited by presence of valproic acid in sample; output: change in scattered light measured as absorbance change, inversely proportional to valproic acid concentration. Used in clinical laboratory settings by qualified personnel on automated analyzers (Hitachi 717, Advia 1650). Output assists clinicians in assessing therapeutic levels and managing potential overdose.

Clinical Evidence

No clinical data provided; device performance is based on analytical validation of the immunoturbidimetric assay method.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay; reagent-based chemistry. Measures scattered light/absorbance changes. Designed for use on automated clinical chemistry analyzers (Hitachi 717, Advia 1650).

Indications for Use

Indicated for the quantitative determination of valproic acid in human serum to aid in the diagnosis and treatment of valproic acid use or overdose and for monitoring therapeutic levels. For use by qualified laboratory personnel.

Regulatory Classification

Identification

A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.

Reference Devices

• Hitachi 717
• Advia 1650

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

JAN 1 5 2002

k011649 Re:

> Trade/Device Name: Valproic Acid Regulation Number: 21 CFR 862.3645 Regulation Name: Neuroleptic drugs radioreceptor assay test system Regulatory Class: Class II Product Code: LEG Dated: December 17, 2001 Received: December 20, 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 This letter will and in your you substantial equivalence of your device to a legally marketed nonication. The I Dr I interestion 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 1 If you dosire specific as a vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, (301) 59 r 1500 - 1 raceration 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/cdrb/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 |
|---------------------------|---------------|
| | K011649 |
| Device Name: | VALPROIC ACID |

## Indications For Use :

The Randox Laboratories Ltd. Valproic Acid Test Kit is an in vitro diagnostic reagent for the quantitative determination of valproic acid in serum. The method is a latex-enhanced immunoturbidimetric assay based on the principle of measuring changes in scattered light. inthunotational with valproic acid which, in the presence of valproic acid antibody solution, rapidly agglutinate. When a sample containing valproic acid is introduced the agglutination reaction is partially inhibited, slowing down the agglutination process. The rate of agglutination is inversely dependent on the concentration of valproic acid in the sample. By aggraination the change in scattered light as a change in absorbance, a concentration curve can montoning the onling in absorbance is inversely proportional to the concentration of valbroic acid in the sample.

Measurements obtained by this device are used in the diagnosis and treatment of valproic acid wse or overdose and in monitoring levels of valproic acid to ensure appropriate therapy.

These Application Sheets have been developed for the Hitachi 717 and Advia 1650 analysers r noo 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) | |
|------------------------------------------|--------------------------------------------------------|---------------------------------------------------|
| | Jean Coope | |
| | (Division Sign-Off) | |
| | Division of Clinical Laboratory Devices | |
| 510(k) Number | K0111649 | |
| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use_<br>(Optional format 1-2-96) |