(34 days)
CR3 Keyless Split Sample Cup Amphetamine-Cocaine is a rapid test for the qualitative detection of d-Amphetamine (major metabolite of Amphetamine) and Benzoylecgonine (major metabolite of Cocaine) in human urine at a cutoff concentration of 1000ng/mL and 300ng/mL, respectively.
The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.
The CR3 Keyless Split Sample Cup Amphetamine-Cocaine test uses immunochromatographic assays for amphetamine and cocaine. The test is a lateral flow, one step system for the qualitative detection of d-Amphetamine (major metabolite of Amphetamine) and Benzoylecgonine (major metabolite of Cocaine) in human urine.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for CR3 Keyless Split Sample Cup Amphetamine-Cocaine
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a formal table of "acceptance criteria" with specific thresholds for sensitivity, specificity, accuracy, etc., that the device must meet. Instead, the performance characteristics section describes the results of various studies, implying that these results are considered acceptable for demonstrating substantial equivalence.
Here's a summary of the reported device performance for Amphetamine (AMP) and Cocaine (COC) testing, based on the precision, cut-off verification, and comparison studies:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (AMP) | Reported Device Performance (COC) |
|---|---|---|---|
| Precision (Cut-off) | Consistent and expected results around the cut-off. | For cut-off (1000 ng/mL), 42-43 out of 50 tests were positive across 3 lots (84-86% positive). | For cut-off (300 ng/mL), 41-43 out of 50 tests were positive across 3 lots (82-86% positive). |
| Precision (+25% Cut-off) | All positive at +25% of cut-off. | 50/50 positive across 3 lots (100%). | 50/50 positive across 3 lots (100%). |
| Precision (-25% Cut-off) | All negative at -25% of cut-off. | 50/50 negative across 3 lots (100%). | 50/50 negative across 3 lots (100%). |
| Cut-off Verification | All positive at +25% and +50% cut-off; all negative at -25% and -50% cut-off. | Pass: All positive at +25% & +50%; all negative at -25% & -50%. | Pass: All positive at +25% & +50%; all negative at -25% & -50%. |
| Interference | No interference from common substances at 100 ug/mL. | Wide range of listed substances showed no interference. | Wide range of listed substances showed no interference. |
| Specificity (Cross-reactivity) | Detailed cross-reactivity for related compounds with % values. | d-Amphetamine: 100%, l-Amphetamine: 2%, d,l-Amphetamine: 33%, MDA: 20%, Phentermine: 33%, others |
§ 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).