Cleared Traditional

NEGATIVE CONTROL SERUM FOR CF RO ID (K791385) - FDA 510(k) Clearance

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

K791385 · Immuno-Mycologics, Inc. · Microbiology device
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Aug 1979
Decision
36d
Days
Class 2
Risk

K791385 is an FDA 510(k) clearance for the NEGATIVE CONTROL SERUM FOR CF RO ID. Classified as Antiserum, Positive And Negative Febrile Antigen Control Serum (product code GSN), Class II - Special Controls.

Submitted by Immuno-Mycologics, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3085 - 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 Immuno-Mycologics, Inc. devices

Submission Details

510(k) Number K791385 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1979
Decision Date August 16, 1979
Days to Decision 36 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 102d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GSN Antiserum, Positive And Negative Febrile Antigen Control Serum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3085
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.