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Amedica Drug Screen Thc/Coc, OP1300, Ppx, Oxy, Bar/Bzo Test

by Amedica Biotech, Inc.

510(k) K040464

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040464 Date17 May 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LDJ
Device Class
Class II
Regulation
21 CFR Part 862.3870
Advisory Committee
Clinical Toxicology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The AMEDICA DRUG SCREEN THC/COC, OP1300, PPX, OXY, BAR/BZO TEST is an in vitro diagnostic test for the rapid detection of specific substances in human urine. It detects THC, benzoylecgonine, morphine, propoxyphene, oxycodone, secobarbital and oxazepam at defined cut-off concentrations. The device is classified under enzyme immunoassay technology and falls within the clinical toxicology specialty.

This single-use diagnostic test is designed for point-of-care or laboratory settings and is supplied as a ready-to-use assay. It is regulated under FDA 510(k) clearance with product code LDJ and is intended for in vitro use only. The device is not evaluated for MRI compatibility and should be stored according to manufacturer specifications. Authorizations include FDA 510(k) with decision date 2004-05-17 and substantial equivalence determination.

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