(157 days)
The Immunalysis Cocaine ELISA test system utilizes an Enzyme Linked Immunoassay (ELISA) for the qualitative detection of cocaine and cocaine metabolites at a cutoff of 20 ng/mL in ORAL FLUID SAMPLES COLLECTED WITH THE QUANTISAL™ ORAL FLUID COLLECTION DEVICE ONLY. This in-vitro diagnostic device is intended for clinical laboratory use only.
The Immunalysis Cocaine/Cocaine metabolite ELISA Kit provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/ mass spectrometry (GS-MS) is the preferred confirmatory method. Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
Not Found
This document describes the FDA clearance of the Immunalysis Cocaine/Cocaine Metabolite ELISA for Oral Fluids. This is an immunoassay device, not an AI/ML device, so many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set information) are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Qualitative detection of cocaine and cocaine metabolites | Detects cocaine and cocaine metabolites in oral fluid samples at a cutoff of 20 ng/mL. |
| Use with specific collection device | Intended for use with the Quantisal™ Oral Fluid Collection Device ONLY. |
| Intended Use | Clinical laboratory use only. |
| Confirmatory Method | Requires a more specific alternate chemical method (preferred: Gas chromatography/mass spectrometry (GC-MS)) to obtain a confirmed analytical result. |
| Clinical/Professional Judgment | Clinical and Professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document.
- Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). Immunoassay studies typically involve spiked samples for analytical performance and clinical samples for clinical performance, but details are not provided here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for an immunoassay device. The "ground truth" for chemical detection is typically established by reference methods like GC-MS.
4. Adjudication method for the test set
- Not applicable for an immunoassay device.
5. 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
- Not applicable. This is an immunoassay device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This device is inherently "standalone" in its analytical performance (i.e., it provides a test result without human interpretation of complex patterns). However, the document emphasizes the need for subsequent confirmatory testing and clinical judgment, which are human-in-the-loop components for definitive diagnosis.
7. The type of ground truth used
- The implicit ground truth for this device's performance would be established by comparing its qualitative detection results against a "gold standard" confirmatory method, such as Gas chromatography/mass spectrometry (GC-MS), as explicitly mentioned in the indications for use.
8. The sample size for the training set
- Not applicable. This is an immunoassay device, not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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).