Cleared Traditional

K904393 - PREMIER-CRYPTOCOCCAL ANTIGEN

K904393 is an FDA 510(k) clearance for PREMIER-CRYPTOCOCCAL ANTIGEN, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code MDU cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K904393 · Meridian Diagnostics, Inc. · Microbiology device
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Jan 1991
Decision
122d
Days
Class 2
Risk

K904393 is an FDA 510(k) clearance for the PREMIER-CRYPTOCOCCAL ANTIGEN. Classified as Antigen, Elisa, Cryptococcus (product code MDU), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on January 25, 1991 after a review of 122 days - within the typical 510(k) review window.

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 Meridian Diagnostics, Inc. devices

FDA 510(k) Submission Details - K904393

510(k) Number K904393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1990
Decision Date January 25, 1991
Days to Decision 122 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 102d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MDU Device Classification - Class 2, Special Controls

Product Code MDU Antigen, Elisa, Cryptococcus
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.