Cleared Traditional

K990820 - RAPIDONE - OPIATES TEST

K990820 is an FDA 510(k) clearance for RAPIDONE - OPIATES TEST, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K990820

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
Combination Product No
PCCP Authorized No
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.

DJG Device Classification - Class 2, Special Controls

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 169
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K990820.
QUICKPAC II ONE STEP OPIATES TEST
K993491 · Syntron Bioresearch, Inc. · Oct 1999
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · Phamatech · Oct 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
DBEST OPIATES TEST KIT
K983190 · Ameritek, Inc. · Nov 1998