Cleared Traditional

K023869 - 'RAPIDTEC'-5M-MULTIPLE DIP TEST

K023869 is the FDA 510(k) clearance for 'RAPIDTEC'-5M-MULTIPLE DIP TEST by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DJR) cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K023869 · American Bio Medica Corp. · Toxicology device
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Optimized for regulatory review, auditing and printing
Apr 2003
Decision
161d
Days
Class 2
Risk

K023869 is an FDA 510(k) clearance for the 'RAPIDTEC'-5M-MULTIPLE DIP TEST. Classified as Enzyme Immunoassay, Methadone (product code DJR), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on April 30, 2003 after a review of 161 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3620 - 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 K023869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2002
Decision Date April 30, 2003
Days to Decision 161 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
74d slower than avg
Panel avg: 87d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJR Enzyme Immunoassay, Methadone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3620
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 - DJR Enzyme Immunoassay, Methadone

All 39
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K023869.
VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & V
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RANDOX METHADONE ASSAY
K040570 · Randox Laboratories, Ltd. · May 2004
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp. · Aug 2003
ONLINE DAT II METHADONE II
K021505 · Roche Diagnostics Corp. · Jul 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp. · Jul 2002
METHADONE
K013001 · Abbott Laboratories · Mar 2002