(217 days)
The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of amphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. For In Vitro Diagnostic Use.
The STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of amphetamine in oral fluid collected with the Intercept™ DOA Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an EIA well containing an oral fluid specimen positive for amphetamine, there is a competition between the drug and the enzyme-labeled hapten to bind the antibody fixed onto the EIA wells are then washed, substrate is added, and color is produced. The absorbance measured for each well at 450 mm is inversely proportional to the amount of amphetamine present in the specimen or calibrator/control.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a numerical or pass/fail format for clinical performance. Instead, it presents various analytical performance characteristics and clinical study results. For the purpose of this response, I infer the "acceptance criteria" based on the comparisons made to the predicate device and the presented study outcomes.
| Performance Metric | Acceptance Criteria (Inferred from Predicate/Context) | Reported Device Performance (STC Amphetamine-Specific Intercept™ MICRO-PLATE EIA) |
|---|---|---|
| Analytical Sensitivity (Limit of Detection - LOD) | Comparable to predicate device ( |
§ 862.3100 Amphetamine test system.
(a)
Identification. An amphetamine test system is a device intended to measure amphetamine, a central nervous system stimulating drug, in plasma and urine. Measurements obtained by this device are used in the diagnosis and treatment of amphetamine use or overdose and in monitoring levels of amphetamine to ensure appropriate therapy.(b)
Classification. Class II (special controls). An amphetamine 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).