Cleared Traditional

CRAG LATERAL FLOW ASSAY (LFA) (K112422) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K112422 · Immuno-Mycologics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.