STC CANNABINOIDS MICRO-PLATE EIA

K973750 · OraSure Technologies, Inc. · LDJ · Feb 13, 1998 · Clinical Toxicology

Device Facts

• Record ID: K973750
• Device Name: STC CANNABINOIDS MICRO-PLATE EIA
• Applicant: OraSure Technologies, Inc.
• Product Code: LDJ · Clinical Toxicology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3870
• Device Class: Class 2

Intended Use

The STC Cannabinoids Micro-Plate EIA is intended for use in the qualitative determination of cannabinoids in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Device Story

The STC Cannabinoids Micro-Plate EIA is an in vitro diagnostic assay designed for the qualitative detection of cannabinoids in oral fluid. The device utilizes the EpiScreen™ Oral Specimen Collection Device for sample acquisition. The assay operates on an enzyme immunoassay (EIA) principle, performed in a micro-plate format. It is intended for use by clinical laboratory professionals to assist in the identification of cannabinoid presence in collected specimens. The output provides a qualitative result indicating the presence or absence of cannabinoids, which healthcare providers use to support clinical decision-making regarding substance use. The device is intended for prescription use.

Clinical Evidence

No clinical data provided in the document; the submission relies on the 510(k) substantial equivalence determination process.

Technological Characteristics

Micro-plate enzyme immunoassay (EIA) format for in vitro diagnostic use. The device is a chemical assay system; no electronic, software, or mechanical components are described.

Indications for Use

Indicated for the qualitative detection of cannabinoids in oral fluid specimens collected via the EpiScreen™ Oral Specimen Collection Device. Intended for in vitro diagnostic use.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. 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, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 3 1998

R.Sam Niedbala, Ph.D. · Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799

Re : K973750 STC Cannabinoids Micro-Plate EIA Regulatory Class: II Product Code: LDJ December 11, 1997 Dated: Received: December 12, 1997

Dear Dr. Niedbala:

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. प्रे 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 requlation entitled, "Misbranding 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/dsmamain.html" .

Sincerely yours,
Steven Litman

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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## STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name: STC Cannabinoids Micro-Plate EIA

Indications For Use: The STC Cannabinoids Micro-Plate EIA is intended for use in the qualitative determination of cannabinoids in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number k973750

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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