(145 days)
The OTI Benzodiazepines Intercept® MICRO-PLATE EIA is intended for use by clinical laboratories in the qualitative determination of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device using a 1.0 ng/mL cutoff. FOR IN VITRO DIAGNOSTIC USE.
The OTI Benzodiazepines Intercept® MICRO-PLATE EIA provides only a preliminary analytical test result. A more specific alternative chemical method should be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry/mass spectrometry (GC/MS/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when a preliminary, positive result is observed.
The OT1 Benzodiazepines Intercept® MICRO-PLATE EIA is a competitive micro-plate immunoassay for the detection of benzodiazepines in oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. Specimen or standard is added to an EIA well in combination with an enzyme-labeled hapten derivative. In an ELA well containing an oral fluid specimen positive for benzodiazepines, there is a competition between the drug and the enzymelabeled 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 benzodiazepines present in the specimen or calibrator/control. Because currently there are no SAMHSA assigned cutoffs for benzodiazepines testing using oral fluid, OTI recommends a cutoff of 1.0 ng/mL when testing oral fluid collected with the Intercept® Oral Fluid Drug Test Oral Specimen Collection Device. This cutoff is within the limit of detection by the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.
Here's an analysis of the provided text regarding the OTI Benzodiazepines Intercept® MICRO-PLATE EIA, focusing on acceptance criteria and the supporting study:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a set of predefined thresholds that the device must meet. Instead, it presents performance characteristics of the proposed device alongside those of a legally marketed predicate device (Abuscreen ONLINE® kit for Benzodiazepines). The implication is that the proposed device's performance should be "essentially equivalent" to the predicate. Therefore, the "acceptance criteria" are inferred to be the performance ranges/values of the predicate device for each characteristic, and the "reported device performance" is the measured performance of the OTI Benzodiazepines Intercept® MICRO-PLATE EIA.
| Performance Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (OTI Benzodiazepines Intercept® MICRO-PLATE EIA) |
|---|---|---|
| Precision | ||
| Intra-assay %CV range | 2-7% | 4.9-6.5% |
| Inter-assay %CV range | 2-10% | 7.6-11.4% |
| Limit of Detection |
§ 862.3170 Benzodiazepine test system.
(a)
Identification. A benzodiazepine test system is a device intended to measure any of the benzodiazepine compounds, sedative and hypnotic drugs, in blood, plasma, and urine. The benzodiazepine compounds include chlordiazepoxide, diazepam, oxazepam, chlorzepate, flurazepam, and nitrazepam. Measurements obtained by this device are used in the diagnosis and treatment of benzodiazepine use or overdose and in monitoring levels of benzodiazepines to ensure appropriate therapy.(b)
Classification. Class II (special controls). A benzodiazepine 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).