Cleared Traditional

K062575 - MODIFICATION TO: ACCUSIGN RC DOA 10 (ME...

K062575 is an FDA 510(k) clearance for MODIFICATION TO: ACCUSIGN RC DOA 10 (ME..., manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code LAG cleared through the Traditional 510(k) pathway after a 452-day FDA review.

K062575 · Princeton BioMeditech Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Nov 2007
Decision
452d
Days
Class 2
Risk

K062575 is an FDA 510(k) clearance for the MODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMP. Classified as High Pressure Liquid Chromatography, Methamphetamine (product code LAG), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on November 26, 2007 after a review of 452 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Toxicology submissions.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K062575

510(k) Number K062575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date November 26, 2007
Days to Decision 452 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
365d slower than avg
Panel avg: 87d · This submission: 452d
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 K062575.
RAPID TOX CUP
K073078 · American Bio Medica Corp. · May 2008
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