Cleared Traditional

K132066 - INFLAMMA DRY (FDA 510(k) Clearance)

Class I Chemistry device.

K132066 · Rapid Pathogen Screening, Inc. · Chemistry device
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Nov 2013
Decision
141d
Days
Class 1
Risk

K132066 is an FDA 510(k) clearance for the INFLAMMA DRY. Classified as Mmp-9 Test System (product code PFQ), Class I - General Controls.

Submitted by Rapid Pathogen Screening, Inc. (Sarasota, US). The FDA issued a Cleared decision on November 21, 2013 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1540 - 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 Rapid Pathogen Screening, Inc. devices

Submission Details

510(k) Number K132066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2013
Decision Date November 21, 2013
Days to Decision 141 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 88d · This submission: 141d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code PFQ Mmp-9 Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1540
Definition A Visual, Qualitative Immunoassay For The In Vitro Detection Of Elevated Levels Of The Mmp-9 Protein In Tear Fluid From Patients Suspected Of Having Dry Eye.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.