# K013882: Oti Benzodiazepines Intercept Micro-Plate Eia Model #1110I

- Pathway: 510(k) (Traditional)
- Applicant: OraSure Technologies, Inc.
- Decided: Apr 17, 2002 after 145 days
- Product code: JXM (Enzyme Immunoassay, Benzodiazepine)
- Device class: 2
- Regulation: 21 CFR 862.3170
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K914509 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914509: Abuscreen (R) Online (TM) for Benzodiazepines, Roche Diagnostic Systems, Inc. (1991) Summary page 1.

## Recalls of this device
- Jul 13, 2020 · Class III · Z-2876-2020: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box
- Jul 13, 2020 · Class III · Z-2877-2020: Incorrect lot number for Standard Oral Fluid Negative Calibrator on specification sheet included in kit and/or additionally same error on unit box

## Indications for use
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.

Source page: https://510kreport.com/device/K013882
Methodology: https://510kreport.com/methodology