Cleared Traditional

K041712 - 'RAPIDTEC 4' TEST

K041712 is the FDA 510(k) clearance for 'RAPIDTEC 4' TEST by American Bio Medica Corp.. It is a Class 2 Toxicology device (product code DIS) cleared through the Traditional 510(k) pathway after a 133-day FDA review.

K041712 · American Bio Medica Corp. · Toxicology device
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Nov 2004
Decision
133d
Days
Class 2
Risk

K041712 is an FDA 510(k) clearance for the 'RAPIDTEC 4' TEST. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on November 3, 2004 after a review of 133 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 K041712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2004
Decision Date November 03, 2004
Days to Decision 133 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
46d slower than avg
Panel avg: 87d · This submission: 133d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 - DIS Enzyme Immunoassay, Barbiturate

All 58
Devices cleared under the same product code (DIS) and FDA review panel - the closest regulatory comparables to K041712.
ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICE
K050593 · ACON Laboratories, Inc. · May 2005
ONLINE DAT BARBITURATES PLUS
K043211 · Roche Diagnostics Corp. · Dec 2004
RANDOX BARBITURATE ASSAY
K041143 · Randox Laboratories, Ltd. · Nov 2004
ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
K023946 · ACON Laboratories, Inc. · Feb 2003
BARBITURATES
K012996 · Abbott Laboratories · Mar 2002
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE
K012824 · ACON Laboratories, Inc. · Nov 2001