RANDOX HUMAN ASSSAYED DRUG CONTROL

K012319 · Randox Laboratories, Ltd. · DIF · Aug 24, 2001 · Clinical Toxicology

Device Facts

• Record ID: K012319
• Device Name: RANDOX HUMAN ASSSAYED DRUG CONTROL
• Applicant: Randox Laboratories, Ltd.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Aug 24, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on lyophilised human serum and have been developed for the control of accuracy and precision in clinical chemistry, at three constituent concentrations for drug monitoring. The Randox Human Drug Controls should only be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

Device Story

Human Drug Controls (Levels I, II, and III) consist of lyophilized human serum containing specific drug constituents at three concentrations. Used in clinical laboratories by qualified personnel to verify accuracy and precision of drug monitoring assays. Serves as a reference material to ensure clinical chemistry test performance; helps healthcare providers validate diagnostic results for patient drug monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Lyophilized human serum-based control material. Provided at three constituent concentrations for drug monitoring. Class I, reserved device (21 CFR 862.3280).

Indications for Use

Indicated for use as a quality control material for monitoring accuracy and precision in clinical chemistry drug monitoring assays. Intended for use by qualified laboratory personnel in a clinical laboratory setting.

Regulatory Classification

Identification

A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.

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 is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines forming the body and wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 4 2001

Dr. Pauline Armstrong Regulatory Affairs Randox Laboratories Ltd. Ardmore, Diamond Road Crumlin, Co. Antrim United Kingdom BT29 4QY

Re: K012319

Trade/Device Name: Human Drug Controls Levels I, II and III Regulation Number: 21 CFR 862.3280 Regulatory Class: I, reserved Product Code: DIF Dated: July 11, 2001 Received: July 23, 2001

Dear Dr. Armstrong:

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 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 1 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/cdrb/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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510(k) Number (if known) Kol2319

HUMAN DRUG CONTROLS Device Name

LEVELS I, II and III

## Indications For Use :

The Randox Laboratories Limited Drug Controls (Levels I, II and III) are based on Ivophilised The Handox Laboratories Linked Drug Cruit of Loth accuracy and precision in human serum and have been developed for the control drug monitoring. These control officul chomistry, at three constituent concentrations.

The Randox Human Drug Controls should only 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)

Kesia Alexander Archer Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K012319

Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional format1-2-96)