Cleared Traditional

K990820 - RAPIDONE - OPIATES TEST

K990820 is the FDA 510(k) clearance for RAPIDONE - OPIATES TEST by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 126-day FDA review.

K990820 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
126d
Days
Class 2
Risk

K990820 is an FDA 510(k) clearance for the RAPIDONE - OPIATES TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Washington, US). The FDA issued a Cleared decision on July 15, 1999 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all American Bio Medica Corp. devices

Submission Details

510(k) Number K990820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date July 15, 1999
Days to Decision 126 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 87d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Toxicology devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 108
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K990820.
URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A
K000464 · Dade Behring, Inc. · Apr 2000
ROCHE COBAS INTEGRA OPIATES 300/2000
K992890 · Roche Diagnostics Corp. · Nov 1999
ACCUSIGN DOA3,DOA, COC/THC/OPI2000 DOA3
K992422 · Princeton BioMeditech Corp. · Aug 1999
SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT
K984152 · Beckman Coulter, Inc. · Jan 1999
MODIFICATION OF EMIT D.A.U. OPIATES ASSAY
K984232 · Syva Co. · Jan 1999
ACCUSIGN MOP, BIOSIGN MOP, STAUS DS MOP
K981771 · Princeton BioMeditech Corp. · Jun 1998