Cleared Traditional

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

K023869 is an FDA 510(k) clearance for 'RAPIDTEC'-5M-MULTIPLE DIP TEST, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with 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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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

FDA 510(k) Submission Details - K023869

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
Combination Product No
PCCP Authorized No
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.

DJR Device Classification - Class 2, Special Controls

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 54
Devices cleared under the same product code (DJR) and FDA review panel - the closest regulatory comparables to K023869.
METHADONE METABOLITE (EDDP) ENZIME IMMUNOASSAY, CAT. NO. 190 (500 TEST KIT), NO. 191 (5000 TEST KIT)
K031797 · Lin-Zhi International, Inc. · Oct 2003
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY
K023617 · Microgenics Corp. · Aug 2003
VISUALINE METHADONE DIPSTRIPTEST
K023856 · Sun Biomedical Laboratories, Inc. · Aug 2003
METHADONE ENZYME IMMUNOASSAY
K023317 · Lin-Zhi International, Inc. · Dec 2002
ONLINE DAT II METHADONE II
K021505 · Roche Diagnostics Corp. · Jul 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · Roche Diagnostics Corp. · Jul 2002