Cleared Traditional

K112422 - CRAG LATERAL FLOW ASSAY (LFA)

K112422 is the FDA 510(k) clearance for CRAG LATERAL FLOW ASSAY (LFA) by Immuno-Mycologics, Inc.. It is a Class 2 Microbiology device (product code GMD) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K112422 · Immuno-Mycologics, Inc. · Microbiology device
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Mar 2012
Decision
218d
Days
Class 2
Risk

K112422 is an FDA 510(k) clearance for the CRAG LATERAL FLOW ASSAY (LFA). Classified as Antisera, Latex Agglutination, Cryptococcus Neoformans (product code GMD), Class II - Special Controls.

Submitted by Immuno-Mycologics, Inc. (Norman, US). The FDA issued a Cleared decision on March 28, 2012 after a review of 218 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3165 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immuno-Mycologics, Inc. devices

Submission Details

510(k) Number K112422 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2011
Decision Date March 28, 2012
Days to Decision 218 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 102d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMD Antisera, Latex Agglutination, Cryptococcus Neoformans
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3165
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 Microbiology devices follow this clearance model.

Regulatory Peers - GMD Antisera, Latex Agglutination, Cryptococcus Neoformans

Devices cleared under the same product code (GMD) and FDA review panel - the closest regulatory comparables to K112422.
CRYPTO-LEX SYSTEM
K930418 · Trinity Laboratories, Inc. · Feb 1994
(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE
K894845 · Meridian Diagnostics, Inc. · Sep 1989
CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX
K792693 · Meridian Diagnostics, Inc. · Jan 1980
CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM
K780526 · I M, Inc. · Apr 1978