Cleared Traditional

K053422 - RAPIDONE-COCAINE-150 TEST

K053422 is the FDA 510(k) clearance for RAPIDONE-COCAINE-150 TEST by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K053422 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
189d
Days
Class 2
Risk

K053422 is an FDA 510(k) clearance for the RAPIDONE-COCAINE-150 TEST. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on June 15, 2006 after a review of 189 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3250 - 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 K053422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2005
Decision Date June 15, 2006
Days to Decision 189 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
102d slower than avg
Panel avg: 87d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3250
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 - DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

All 83
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