Cleared Traditional

K915493 - PREMIER COCCIDIOIDES

K915493 is an FDA 510(k) clearance for PREMIER COCCIDIOIDES, manufactured by Meridian Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code MIY cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K915493 · Meridian Diagnostics, Inc. · Microbiology device
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Jul 1992
Decision
214d
Days
Class 2
Risk

K915493 is an FDA 510(k) clearance for the PREMIER COCCIDIOIDES. Classified as Enzyme Linked Immunosorbent Assay, Coccidioides Immitis (product code MIY), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 10, 1992 after a review of 214 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3135 - 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 - K915493

510(k) Number K915493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1991
Decision Date July 10, 1992
Days to Decision 214 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d slower than avg
Panel avg: 102d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MIY Device Classification - Class 2, Special Controls

Product Code MIY Enzyme Linked Immunosorbent Assay, Coccidioides Immitis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3135
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.