Cleared Traditional

K790672 - ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU

K790672 is an FDA 510(k) clearance for ASPERGILLUS FUMIGATUS, manufactured by Diagnostica, Inc.. The device is a Class 1 Microbiology device with product code JWT cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K790672 · Diagnostica, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1979
Decision
55d
Days
Class 1
Risk

K790672 is an FDA 510(k) clearance for the ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU. Classified as Antigen, Cf, Aspergillus Spp. (product code JWT), Class I - General Controls.

Submitted by Diagnostica, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 31, 1979 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3040 - 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.

FDA 510(k) Submission Details - K790672

510(k) Number K790672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1979
Decision Date May 31, 1979
Days to Decision 55 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 102d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

JWT Device Classification - Class 1, General Controls

Product Code JWT Antigen, Cf, Aspergillus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JWT Antigen, Cf, Aspergillus Spp.

Devices cleared under the same product code (JWT) and FDA review panel - the closest regulatory comparables to K790672.
REAGENTS FOR SERODIAGNOSIS OF ASPERGILL
K812740 · Nolan Biological Laboratories, Inc. · Oct 1981
ASPERGILLUS SP, COMPLEMENT FIXATION
K792700 · Meridian Diagnostics, Inc. · Jan 1980
ASPERGILLUS MYCELIAL ANTIGEN #CF10024X
K791387 · Immuno-Mycologics, Inc. · Aug 1979
ASPERGILLUS MYCELIAL ANTIGEN
K760830 · I M, Inc. · Nov 1976
K790672 · ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU
Download PDF Diagnostica, Inc.