OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3

K982024 · Medical Analysis Systems, Inc. · DIF · Jun 29, 1998 · Clinical Toxicology

Device Facts

• Record ID: K982024
• Device Name: OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
• Applicant: Medical Analysis Systems, Inc.
• Product Code: DIF · Clinical Toxicology
• Decision Date: Jun 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3280
• Device Class: Class 1

Indications for Use

Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Device Story

Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3 are liquid quality control samples used in clinical laboratory settings. These controls contain known concentrations of opiates and are processed alongside patient urine specimens during drug-of-abuse testing. By including these controls in the assay workflow, laboratory personnel monitor the consistency and accuracy of the testing conditions. The output is a reference value used to validate that the assay is performing within expected parameters, thereby ensuring the reliability of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-based quality control material containing known concentrations of opiates. Designed for use in quantitative and qualitative urine drug-of-abuse assays.

Indications for Use

Indicated for use as quality control samples for monitoring assay performance in quantitative and qualitative testing of human urine specimens for opiates.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 9 1998

Scot D. Kinghorn Director, Quality and Regulatory Affairs Medical Analysis Systems, Inc. Lincoln Technology Park 542 Flynn Road Camarillo, California 93012-8058

Re : K982024 Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3 Regulatory Class: I Product Code: DIF Dated: June 5, 1998 Received: June 9, 1998

Dear Mr. Kinghorn:

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 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ಗ್ 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 In addition, FDA may publish further announcements action. 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 requlations.

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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 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 gener 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 "[e-mail]".

Sincerely yours,

Steven Autman

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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## MEDICAL ANALYSIS SYSTEMS, INC.

510(k) Number: K982024 Device Name: Opiates 2000 Liquid Opiates Drugs of Abuse Control Levels 2 and 3

## STATEMENT OF INDICATIONS FOR USE

Opiates 2000 Drugs of Abuse Controls are intended for use as a consistent test sample of known concentration for monitoring assay conditions in quantitative and qualitative analyses of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Carol C. Benson / Alfred Montgomery

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982024

\Prescription Use

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