AUTO-LYTE PCP EIA, MODEL #1254U

K982801 · OraSure Technologies, Inc. · LCM · Nov 4, 1998 · TX

Device Facts

• Record ID: K982801
• Device Name: AUTO-LYTE PCP EIA, MODEL #1254U
• Applicant: OraSure Technologies, Inc.
• Product Code: LCM · TX
• Decision Date: Nov 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

The STC AUTO-LYTE® PCP EIA is intended for use in the qualitative determination of phencyclidine in urine. This test is intended for in vitro diagnostic use.

Device Story

AUTO-LYTE® PCP EIA is an in vitro diagnostic immunoassay for qualitative detection of phencyclidine in human urine. Device operates via enzyme immunoassay (EIA) technology; utilizes specific antibodies to bind phencyclidine in patient samples. Performed in clinical laboratory settings by trained laboratory personnel. Output is qualitative (positive/negative result based on established cutoff concentration). Results assist healthcare providers in identifying phencyclidine presence, supporting clinical assessment of drug use or intoxication.

Clinical Evidence

No clinical data provided; device clearance based on analytical performance characteristics typical of in vitro diagnostic immunoassays.

Technological Characteristics

Enzyme immunoassay (EIA) technology; qualitative detection; in vitro diagnostic use; manual or automated laboratory instrumentation platform.

Indications for Use

Indicated for the qualitative detection of phencyclidine (PCP) in human urine samples for in vitro diagnostic use. Intended for prescription use.

Submission Summary (Full Text)

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4 1998 NOV

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: K982801 Trade Name: AUTO-LYTE® PCP EIA (Urine) Regulatory Class: II Product Code: LCM Dated: October 7, 1998 Received: October 16, 1998

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 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). 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 regulation 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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## STATEMENT OF INDICATIONS FOR USE

| 510(k) Number (if known): | k 982801 |
|---------------------------|--------------------|
| Device Name: | AUTO-LYTE® PCP EIA |

Indications For Use: The STC AUTO-LYTE® PCP EIA is intended for use in the qualitative determination of phencyclidine in urine. This test is intended for in vitro diagnostic use.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|

| (Division Sign-Off)<br>Division of Clinical Laboratory | |
|--------------------------------------------------------|---------|
| 510(k) Number | K982801 |

| Prescription Use<br>(Per 21 CFR 801.109) | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use |
|------------------------------------------|-----------------------------------------|----|----------------------|
|------------------------------------------|-----------------------------------------|----|----------------------|

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