Cleared Traditional

K980872 - RAPID DRUG SCREEN' 8 PANEL

K980872 is the FDA 510(k) clearance for RAPID DRUG SCREEN' 8 PANEL by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DIO) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K980872 · American Bio Medica Corp. · Toxicology device
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Mar 1998
Decision
14d
Days
Class 2
Risk

K980872 is an FDA 510(k) clearance for the RAPID DRUG SCREEN' 8 PANEL. Classified as Enzyme Immunoassay, Cocaine And Cocaine Metabolites (product code DIO), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Washington, US). The FDA issued a Cleared decision on March 20, 1998 after a review of 14 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all American Bio Medica Corp. devices

Submission Details

510(k) Number K980872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1998
Decision Date March 20, 1998
Days to Decision 14 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 87d · This submission: 14d
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 65
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