Auto-Lyte Benzodiazepines EIA Model Number 1210U
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K982831 FDA 510(k)
- FDA Product Code
- JXM FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.3170 FDA 510(k)
- Regulation Number
- 862.3170 FDA 510(k)
- Advisory Committee
- Clinical Toxicology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Auto-Lyte Benzodiazepines EIA is an in vitro diagnostic assay that uses enzyme immunoassay technology to detect the presence of benzodiazepines in human urine. It provides qualitative or semi‑quantitative results that help healthcare providers identify benzodiazepine exposure.
The assay is intended for laboratory use by trained personnel and is supplied as a single‑use test kit. It is classified as a Class II device (product code JXM) and received traditional 510(k) clearance (K982831) on 12 Nov 1998. The device is identified by model number 1210U and is regulated under FDA 510(k) requirements.
Frequently asked questions
What is the Auto-Lyte Benzodiazepines EIA used for?
The Auto-Lyte Benzodiazepines EIA is an in vitro diagnostic assay that uses enzyme immunoassay technology to detect the presence of benzodiazepines in human urine. It provides qualitative or semi-quantitative results to help healthcare providers identify benzodiazepine exposure.
How is the Auto-Lyte Benzodiazepines EIA supplied?
The assay is supplied as a single-use test kit intended for laboratory use by trained personnel. It is classified as a Class II device with product code JXM and is identified by model number 1210U.
What is the regulatory status of the Auto-Lyte Benzodiazepines EIA?
The device received traditional 510(k) clearance with number K982831 on November 12, 1998. It is regulated under FDA 510(k) requirements and is classified as a Class II device for clinical toxicology testing.
Is the Auto-Lyte Benzodiazepines EIA reusable or single-use?
The Auto-Lyte Benzodiazepines EIA is supplied as a single-use test kit. Each kit is designed for one testing procedure and should not be reused to ensure accurate and reliable results.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Device Listing 1123585146 - FDA.report, fda.innolitics.com, ORASURE TECHNOLOGIES, INC. FDA Filings - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982831 | Class II | Active |
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Manufacturer
- Manufacturer
- OraSure Technologies, Inc.
Sources (1)
- FDA 510(k) K982831 24 fields · synced Oct 1, 2026