Cleared Traditional

K030835 - 'RAPID ONE' - PROPOXYPHENE TEST

K030835 is an FDA 510(k) clearance for 'RAPID ONE' - PROPOXYPHENE TEST, manufactured by American Bio Medica Corp.. The device is a Class 2 Toxicology device with product code JXN cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K030835 · American Bio Medica Corp. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
66d
Days
Class 2
Risk

K030835 is an FDA 510(k) clearance for the 'RAPID ONE' - PROPOXYPHENE TEST. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by American Bio Medica Corp. (Columbia, US). The FDA issued a Cleared decision on May 22, 2003 after a review of 66 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3700 - 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

FDA 510(k) Submission Details - K030835

510(k) Number K030835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date May 22, 2003
Days to Decision 66 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
21d faster than avg
Panel avg: 87d · This submission: 66d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXN Device Classification - Class 2, Special Controls

Product Code JXN Enzyme Immunoassay, Propoxyphene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3700
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 - JXN Enzyme Immunoassay, Propoxyphene

All 19
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K030835.
PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL
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K040445 · ACON Laboratories, Inc. · May 2004
PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)
K023795 · Lin-Zhi International, Inc. · Jan 2003
INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
K022915 · Alfa Scientific Designs, Inc. · Nov 2002
VERDICT-II PROPOXYPHENE
K020787 · Medtox Diagnostics, Inc. · May 2002