(93 days)
The STC AUTO-LYTE® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. This test is intended for in vitro diagnostic use.
Not Found
I apologize, but the provided text from the FDA 510(k) summary (K982831/S2 for the AUTO-LYTE® Benzodiazepine EIA) does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the format requested.
The document is an FDA clearance letter and an "Indications For Use" statement. It confirms the device's substantial equivalence to a predicate device and its intended use for the qualitative detection of benzodiazepines in urine. However, it does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test and training sets, or data provenance.
- Details about experts, ground truth establishment, or adjudication methods.
- Information about MRMC studies or standalone algorithm performance.
To obtain this information, one would typically need to refer to the full 510(k) submission document or a detailed performance study report, which are not included in the provided text.
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NOV 1 2 1998
R. Sam Niedbala, Ph.D., BCFE Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
Re : K982831/S2
AUTO-LYTE® Benzodiazepine EIA (Urine) Trade Name: Requlatory Class: II Product Code: JXM October 7, 1998 Dated: 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 Requlations, 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 (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 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 requlation (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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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® Benzodiazepines EIA________________________________________________________________________________________________________________________________
Indications For Use: The STC AUTO-LYTE® Benzodiazepines EIA is intended for use in the Indications I of OSC. The DFC TOTO Cepines in urine. 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 vice:
510(k) Number K982831
Prescription Use
(Per 21 CFR 801.109)
✓
OR
Over-The-Counter Use ____________
c:\fda\indica.doc
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).