(82 days)
The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. For In Vitro Diagnostic Use.
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This is a very old document (1998) and describes the clearance of an in vitro diagnostic device, specifically an EIA (enzyme immunoassay) for cocaine metabolites in oral fluid. The information provided is typical for a 510(k) clearance letter and an Indications for Use statement, but it does not contain the detailed study results, acceptance criteria, or most of the very specific information you are requesting about AI/algorithm performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes for test/training sets, experts, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are largely relevant to more modern AI/ML device submissions and are not included in this type of 1998 clearance document.
However, I can extract the following relevant information from the provided text:
- Device Name: STC Cocaine Metabolite Micro-Plate EIA
- Intended Use: Qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. For In Vitro Diagnostic Use.
- Regulatory Class: II
- Product Code: DIO
To answer your request based on the lack of this specific information, here's what I can deduce:
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A table of acceptance criteria and the reported device performance:
- N/A. This document is a 510(k) clearance letter and "Indications for Use" statement. It does not include the detailed performance study results or predefined acceptance criteria (e.g., sensitivity, specificity thresholds) that would have been part of the 510(k) submission itself. For an in vitro diagnostic device, the acceptance criteria would typically relate to analytical performance (e.g., detection limit, precision, accuracy/agreement with a reference method) and clinical performance (e.g., sensitivity, specificity against a confirmed drug use status). These metrics would have been compared to a legally marketed predicate device to establish substantial equivalence.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This information is not present in the provided document. The sample size and data provenance for the clinical studies would have been included in the 510(k) submission. For IVD devices, clinical samples would be tested to evaluate performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. This information is not present in the provided document. For a drug metabolite test, the "ground truth" would typically come from confirmatory laboratory methods (e.g., GC/MS or LC/MS/MS) on the same or split samples, not from human experts interpreting images or signals in the same way a radiologist would.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This information is not present in the provided document. "Adjudication" often refers to resolving discrepancies between human readers, which is not directly applicable to the primary analytical performance evaluation of this type of in vitro diagnostic device.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is an in vitro diagnostic immunoassay kit, not an AI/ML-based device that assists human readers. Therefore, an MRMC study and the concept of "human improvement with AI" are not relevant to this product.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit, but not in the AI/ML context. The STC Cocaine Metabolite Micro-Plate EIA is a test kit designed to provide a result (qualitative determination of cocaine metabolites) based on biochemical reactions, without a human "algorithm" or interpretation in the way AI systems operate. Its performance would be evaluated as a standalone product. However, this is not an "algorithm" in the modern AI sense.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Likely confirmatory laboratory methods (e.g., GC/MS, LC/MS/MS). For drug metabolite detection, the gold standard for ground truth is typically a highly sensitive and specific mass spectrometry-based method performed on the same biological samples. This is superior to "expert consensus" in this context.
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The sample size for the training set:
- N/A. This concept of a "training set" is specific to machine learning algorithms. This device is a biochemical assay kit and does not involve an AI/ML algorithm that requires training data.
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How the ground truth for the training set was established:
- N/A. As above, the concept of a training set and its ground truth is not applicable to this type of in vitro diagnostic assay.
In summary, this document pertains to a traditional in vitro diagnostic device from 1998, and thus most of your detailed questions regarding AI/ML device study design and performance criteria are not applicable. The 510(k) clearance process for such devices focused on demonstrating substantial equivalence to a legally marketed predicate device through analytical and clinical performance studies, the details of which are not described in this high-level clearance letter.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three overlapping wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 25 1998
R. Sam Niedbala, Ph.D. · Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
K982061 Re : STC Cocaine Metabolite Micro-Plate EIA Regulatory Class: II Product Code: DIO Dated: August 3, 1998 August 11, 1998 Received:
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 requlations 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 requlation 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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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 leqally 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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 Cocaine Metabolite Micro-Plate EIA
Indications For Use: The STC Cocaine Metabolite Micro-Plate EIA is intended for use in the qualitative determination of cocaine and cocaine metabolites in oral fluid collected with the OraSure® Oral Specimen Collection Device. 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 Devices
510(k) Number 1982061
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).