Cleared Traditional

K992720 - RAPIDONE- BENZODIAZEPINE TEST

K992720 is an FDA 510(k) clearance for RAPIDONE- BENZODIAZEPINE TEST, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K992720 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
234d
Days
Class 2
Risk

K992720 is an FDA 510(k) clearance for the RAPIDONE- BENZODIAZEPINE TEST. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Washington, US). The FDA issued a Cleared decision on April 3, 2000 after a review of 234 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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 - K992720

510(k) Number K992720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1999
Decision Date April 03, 2000
Days to Decision 234 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
147d slower than avg
Panel avg: 87d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 80
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K992720.
INSTANT-VIEW BENZODIAZEPINE (BZD) URINE CASSETTE TEST
K003881 · Alfa Scientific Designs, Inc. · May 2001
EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229
K011306 · Syva Co., Dade Behring, Inc. · May 2001
URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A
K000458 · Dade Behring, Inc. · Apr 2000
SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL
K993985 · Syva Co. · Jan 2000
ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ)
K991443 · Roche Diagnostics Corp. · Jun 1999
ACCUSIGN BZO, BIOSIGN BZO, STATUS BZO
K991079 · Princeton BioMeditech Corp. · Apr 1999