(99 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 EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.
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Below is an analysis of Acceptance Criteria and the study from the provided document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or a detailed performance table. However, it does indicate the device is intended for "qualitative determination of cocaine and cocaine metabolites in oral fluid." The FDA's letter states the device is "substantially equivalent" to predicate devices. This implies that its performance is considered acceptable based on comparison to existing, legally marketed devices.
To infer potential acceptance criteria and reported performance, we can assume that "substantial equivalence" in a qualitative test means the device demonstrated comparable accuracy (sensitivity and specificity) to a predicate device for detecting cocaine metabolites in oral fluid. Without the specific predicate device or the detailed 510(k) submission, we cannot provide exact numbers.
Inferred Table:
| Performance Metric | Acceptance Criteria (Inferred from Substantial Equivalence to a Qualitative Test) | Reported Device Performance (Inferred from FDA Clearance) |
|---|---|---|
| Qualitative Detection of Cocaine Metabolites in Oral Fluid | Comparable Sensitivity to Predicate Device | Deemed Sufficient for "Substantial Equivalence" |
| Qualitative Detection of Cocaine Metabolites in Oral Fluid | Comparable Specificity to Predicate Device | Deemed Sufficient for "Substantial Equivalence" |
2. Sample Size for the Test Set and Data Provenance:
The provided documents (FDA 510(k) clearance letter and Indications for Use statement) do not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This information would typically be detailed in the 510(k) submission itself, which is not included here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. For a qualitative diagnostic device detecting drug metabolites, the ground truth would likely be established through a confirmatory test method (e.g., GC/MS), not strictly by human expert consensus on interpretations of the initial test.
4. Adjudication Method for the Test Set:
Given the nature of a qualitative test for drug metabolites, an adjudication method like 2+1 or 3+1 typically used for image interpretation or subjective assessments is unlikely to be directly applicable. The ground truth would most probably be established by an objective, gold-standard laboratory method. The document does not specify any adjudication method used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study (comparing human readers with and without AI assistance) is not applicable and was not performed/reported for this device. This device is an "in vitro diagnostic" (IVD) test, specifically a micro-plate EIA for qualitative determination. It's a laboratory test, not an AI-assisted diagnostic imaging or interpretation tool for human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):
This device is an "in vitro diagnostic" (IVD) kit. Its performance, as an EIA (Enzyme Immunoassay), is inherently standalone in the sense that the assay itself produces a result (e.g., optical density reading) which is then interpreted against a cut-off to determine a qualitative positive or negative. There isn't an "algorithm only" component separate from the physical assay. The study would have focused on the performance of the entire assay system (reagents, plates, reader, interpretation) in detecting the target analyte.
The FDA's "substantial equivalence" determination implies that the standalone performance of the device was found to be comparable to predicate devices. However, the document does not detail the specific standalone performance study.
7. Type of Ground Truth Used:
While not explicitly stated in the provided text, for a device intended for "qualitative determination of cocaine and cocaine metabolites," the ground truth for performance studies would almost certainly be established by a confirmatory analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS). These are considered gold-standard methods for drug detection and quantification in biological samples.
8. Sample Size for the Training Set:
The document does not provide information regarding the sample size used for the training set. For IVD devices, a "training set" in the context of machine learning (AI) is not typically applicable. If any "training" occurred, it would be related to optimization of reagents, cut-off values, or assay conditions during development, not in the sense of an AI model's training data. The primary performance evaluation would be done on independent test sets.
9. How the Ground Truth for the Training Set Was Established:
As mentioned in point 8, the concept of a "training set" with established ground truth in the AI context isn't directly applicable here. If referring to the process of developing the assay and establishing its optimal cut-off, the ground truth would again rely on a gold-standard confirmatory method (e.g., GC/MS or LC/MS) to calibrate the assay's response and set the appropriate thresholds for positive/negative results. The document does not detail this developmental process.
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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 features a stylized eagle with three stripes forming its body and wings. The eagle is oriented towards the upper right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
JAN - 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
R.Sam Niedbala, Ph.D. . Executive Vice President STC Technologies, Inc. 1745 Eaton Avenue Bethlehem, Pennsylvania 18018-1799
K973651 Re: STC Cocaine Metabolite Micro-Plate EIA Requlatory Class: II Product Code: DIO Dated: November 14, 1997 November 20, 1997 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, qood 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 regulation 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 obliqation 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 (CHIA-607) Chilo device maj Logia-or, 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 fire leed in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinding of bubbeandad oquresults in a classification for your markets produce, 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): _ K 9 736 s )
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 EpiScreen™ 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)
AH
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K973651
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).