Cleared Traditional

K111363 - PPX REAGENT

K111363 is the FDA 510(k) clearance for PPX REAGENT by Medica Corp.. It is a Class 2 Chemistry device (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

Submission Details

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
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.

Device Classification

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 14
Devices cleared under the same product code (JXN) and FDA review panel - the closest regulatory comparables to K111363.
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ONLINE DAT PROPOXYPHENE PLUS
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PROPOXYPHENE
K013100 · Abbott Laboratories · Mar 2002
SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL
K993981 · Syva Co. · Feb 2000
MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
K983700 · Roche Diagnostic Systems, Inc. · Dec 1998