(51 days)
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 methadone use or abuse.
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 methadone use or abuse. The proposed Abuscreen ONLINE Methadone 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 Methadone test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. 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 Abuscreen ONLINE® Methadone device, focusing on its acceptance criteria and the supporting study:
The document is a 510(k) summary for a medical device called "Abuscreen ONLINE® Methadone," an in vitro diagnostic test for detecting methadone in human urine. The submission date is October 20, 1998, and it was reviewed by the FDA, resulting in a substantial equivalence determination on December 11, 1998.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the performance characteristics presented for the "Proposed: Abuscreen ONLINE Methadone for Hitachi 917" device, which are compared to a "Previously Cleared: (K930928) Abuscreen ONLINE Methadone (1000 Test Kit)" predicate device. The goal of the study is to demonstrate that the new device performs equivalently to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Qualitative Precision (300 ng/mL Cutoff): | ||
| Negative at 225 ng/mL | >95% negative at 240 ng/mL | >95% negative at 225 ng/mL |
| Positive at 375 ng/mL | >95% positive at 360 ng/mL | >95% positive at 375 ng/mL |
| Quantitative Precision (300 ng/mL Cutoff): | ||
| Within Run: | ||
| 150 ng/mL Mean (ng/mL) | 152 | 148 |
| 150 ng/mL CV% | 4 | 2.4 |
| 225 ng/mL Mean (ng/mL) | 235 (at 240 ng/mL conc.) | 220 |
| 225 ng/mL CV% | 3 (at 240 ng/mL conc.) | 3.2 |
| 300 ng/mL Mean (ng/mL) | 301 | 299 |
| 300 ng/mL CV% | 1 | 1.5 |
| 375 ng/mL Mean (ng/mL) | 340 (at 340 ng/mL conc.) | 411 |
| 375 ng/mL CV% | 1 (at 340 ng/mL conc.) | 1.0 |
| Day-to-Day: | ||
| 150 ng/mL Mean (ng/mL) | 151 | 151 |
| 150 ng/mL CV% | 4 | 4.2 |
| 225 ng/mL Mean (ng/mL) | 236 (at 240 ng/mL conc.) | 222 |
| 225 ng/mL CV% | 3 (at 240 ng/mL conc.) | 3.7 |
| 300 ng/mL Mean (ng/mL) | 297 | 303 |
| 300 ng/mL CV% | 3 | 2.2 |
| 375 ng/mL Mean (ng/mL) | 340 (at 340 ng/mL conc.) | 407 |
| 375 ng/mL CV% | 1 (at 340 ng/mL conc.) | 2.0 |
| Accuracy (300 ng/mL Cutoff): | ||
| Confirmed Positive results | 73 Positive, 0 Negative (from N=73 Confirmed Pos.) | 50 Positive, 0 Negative (from N=50 Confirmed Pos.) |
| Limit of Detection |
§ 862.3620 Methadone test system.
(a)
Identification. A methadone test system is a device intended to measure methadone, an addictive narcotic pain-relieving drug, in serum and urine. Measurements obtained by this device are used in the diagnosis and treatment of methadone use or overdose and to determine compliance with regulations in methadone maintenance treatment.(b)
Classification. Class II (special controls). A methadone 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).