Cleared Traditional

K111363 - PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL

K111363 is an FDA 510(k) clearance for PPX REAGENT, manufactured by Medica Corp.. The device is a Class 2 Chemistry device with product code JXN cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K111363 · Medica Corp. · Chemistry device
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Dec 2011
Decision
204d
Days
Class 2
Risk

K111363 is an FDA 510(k) clearance for the PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIAL. Classified as Enzyme Immunoassay, Propoxyphene (product code JXN), Class II - Special Controls.

Submitted by Medica Corp. (Bedford, US). The FDA issued a Cleared decision on December 6, 2011 after a review of 204 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3700 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Medica Corp. devices

FDA 510(k) Submission Details - K111363

510(k) Number K111363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date December 06, 2011
Days to Decision 204 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 88d · This submission: 204d
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 Chemistry 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 K111363.
Wondfo Propoxyphene Urine Test
K152495 · Guangzhou Wondfo Biotech Co., Ltd. · Nov 2015
ONLINE DAT PROPOXYPHENE PLUS
K043303 · Roche Diagnostics Corp. · Mar 2005
ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICE
K040445 · ACON Laboratories, Inc. · May 2004
'RAPID ONE' - PROPOXYPHENE TEST
K030835 · American Bio Medica Corp. · May 2003
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