Cleared Traditional

IMMUNO. IDENTIFICATION OF H. CAPSULATUM (K802130) - FDA 510(k) Clearance

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

K802130 · Nolan Biological Laboratories, Inc. · Microbiology device
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Sep 1980
Decision
53d
Days
Class 2
Risk

K802130 is an FDA 510(k) clearance for the IMMUNO. IDENTIFICATION OF H. CAPSULATUM. Classified as Antigens, Histoplasma Capsulatum, All (product code GMJ), Class II - Special Controls.

Submitted by Nolan Biological Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1980 after a review of 53 days - a notably fast clearance 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: 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 Nolan Biological Laboratories, Inc. devices

Submission Details

510(k) Number K802130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1980
Decision Date September 26, 1980
Days to Decision 53 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 102d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GMJ Antigens, Histoplasma Capsulatum, All
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.