Cleared Traditional

K073078 - RAPID TOX CUP

K073078 is an FDA 510(k) clearance for RAPID TOX CUP, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with 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

FDA 510(k) Submission Details - K073078

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
Combination Product No
PCCP Authorized No
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.

LAG Device Classification - Class 2, Special Controls

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