(106 days)
The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "AUTO-LYTE® Cocaine Metabolite EIA." It confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain the acceptance criteria, details of a study that proves the device meets acceptance criteria, or any of the specific information requested in your prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).
The document only states the "Indications For Use" for the device, which is: "The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use."
To provide the information you requested, I would need access to the actual 510(k) submission document (K982759) or supporting clinical/technical documentation, which is not available in these provided pages.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 20 1998
R. Sam Niedbala, Ph.D., BCFE Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, PA 18018-1799
Re: K982759
Trade Name: AUTO-LYTE® Cocaine Metabolite EIA Model # 1222U Regulatory Class: II Product Code: DIO Dated: November 4, 1998 Received: November 9, 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 (770)488-7655.
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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or at (301) 443-6597 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):
Device Name: _ AUTO-LYTE® Cocaine Metabolite EIA
Indications For Use: The STC AUTO-LYTE® Cocaine Metabolite EIA is intended for use in the qualitative determination of benzoylecgonine in urine using a 300 ng/mL cutoff. This test is intended for in vitro diagnostic use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory L. evices
510(k) Number K982759
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _
c:\fda\indica.doc
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).