Cleared Traditional

K792685 - BLASTOMYCES DERMATITIDIS, ANTISERUM (FDA 510(k) Clearance)

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

K792685 · Meridian Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1980
Decision
21d
Days
Class 2
Risk

K792685 is an FDA 510(k) clearance for the BLASTOMYCES DERMATITIDIS, ANTISERUM. Classified as Antiserum, Positive Control, Blastomyces Dermatitidis (product code KFH), Class II - Special Controls.

Submitted by Meridian Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 17, 1980 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3060 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Meridian Diagnostics, Inc. devices

Submission Details

510(k) Number K792685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1979
Decision Date January 17, 1980
Days to Decision 21 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 102d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KFH Antiserum, Positive Control, Blastomyces Dermatitidis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3060
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.