Cleared Traditional

K915493 - PREMIER COCCIDIOIDES (FDA 510(k) Clearance)

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

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

Submission Details

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
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.

Device Classification

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.