(51 days)
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse. The proposed Abuscreen ONLINE Cocaine Metabolite test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abuscreen ONLINE® Cocaine Metabolite device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section. However, by comparing the proposed device's performance to the predicate device, we can infer that the acceptance criteria for the new device align with demonstrating substantial equivalence to the predicate, particularly in the key performance characteristics. The table below summarizes the reported performance for the new device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's, considering the specified cutoff levels.
| Performance Characteristic | Acceptance Criteria (Implied, based on Predicate) | Reported Device Performance (Proposed: Abuscreen ONLINE Cocaine for Hitachi 917) |
|---|---|---|
| Precision Qualitative (300 ng/mL Cutoff): | ||
| >95% negative at 225 ng/mL | >95% negative at 240 ng/mL | >95% negative at 225 ng/mL |
| >95% positive at 375 ng/mL | >95% positive at 360 ng/mLL | >95% positive at 375 ng/mL |
| Within Run Precision (Qualitative - OD): | Similar CV% to predicate (not explicitly stated, but implied goal is low CV%) | |
| 150 ng/mL (Mean OD, CV%) | Not explicitly stated | 6245, 1.3 % |
| 225 ng/mL (Mean OD, CV%) | Not explicitly stated | 4436, 1.0 % |
| 300 ng/mL (Mean OD, CV%) | Not explicitly stated | 2746, 1.1 % |
| 375 ng/mL (Mean OD, CV%) | Not explicitly stated | 1907, 1.4 % |
| 450 ng/mL (Mean OD, CV%) | Not explicitly stated | 1708, 1.9 % |
| Day-to-Day Precision (Qualitative - OD): | Similar CV% to predicate | |
| 150 ng/mL (Mean OD, CV%) | Not explicitly stated | 6178, 1.7 % |
| 225 ng/mL (Mean OD, CV%) | Not explicitly stated | 4379, 2.0 % |
| 300 ng/mL (Mean OD, CV%) | Not explicitly stated | 2696, 2.4 % |
| 375 ng/mL (Mean OD, CV%) | Not explicitly stated | 1873, 2.9 % |
| 450 ng/mL (Mean OD, CV%) | Not explicitly stated | 1661, 2.5 % |
| Precision Quantitative (300 ng/mL Cutoff): | Similar CV% to predicate (e.g., 50 Pos., 0 Neg. (100% agreement) | |
| Limit of Detection (LoD): |
§ 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).