Cleared Traditional

K073078 - RAPID TOX CUP

K073078 is the FDA 510(k) clearance for RAPID TOX CUP by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code LAG) cleared through the Traditional 510(k) pathway after a 212-day FDA review.

K073078 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
212d
Days
Class 2
Risk

K073078 is an FDA 510(k) clearance for the RAPID TOX CUP. Classified as High Pressure Liquid Chromatography, Methamphetamine (product code LAG), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Logan Township, US). The FDA issued a Cleared decision on May 30, 2008 after a review of 212 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3610 - 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 K073078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2007
Decision Date May 30, 2008
Days to Decision 212 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
125d slower than avg
Panel avg: 87d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LAG High Pressure Liquid Chromatography, Methamphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3610
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 - LAG High Pressure Liquid Chromatography, Methamphetamine

Devices cleared under the same product code (LAG) and FDA review panel - the closest regulatory comparables to K073078.
MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP
K062575 · Princeton BioMeditech Corp. · Nov 2007
ACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP, BIOSIGN DOA10, BIOSIGN MET/OPI/
K990786 · Princeton BioMeditech Corp. · Mar 1999
ACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP,BIOSIGN DOA 10, BIOSIGN MET/OPI/COC/
K983501 · Princeton BioMeditech Corp. · Dec 1998