Cleared Traditional

K915700 - PERMIER HISTOPLASMA (FDA 510(k) Clearance)

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

K915700 · Meridian Diagnostics, Inc. · Microbiology device
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Jul 1992
Decision
220d
Days
Class 2
Risk

K915700 is an FDA 510(k) clearance for the PERMIER HISTOPLASMA. Classified as Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum (product code MIZ), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on July 30, 1992 after a review of 220 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3320 - 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 K915700 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1991
Decision Date July 30, 1992
Days to Decision 220 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
118d slower than avg
Panel avg: 102d · This submission: 220d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MIZ Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3320
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.