Cleared Traditional

K791897 - BACTO-HATTS

K791897 is an FDA 510(k) clearance for BACTO-HATTS, manufactured by Difco Laboratories, Inc.. The device is a Class 2 Microbiology device with product code GMT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K791897 · Difco Laboratories, Inc. · Microbiology device
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Nov 1979
Decision
49d
Days
Class 2
Risk

K791897 is an FDA 510(k) clearance for the BACTO-HATTS. Classified as Antigens, Ha, Treponema Pallidum (product code GMT), Class II - Special Controls.

Submitted by Difco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - 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 Difco Laboratories, Inc. devices

FDA 510(k) Submission Details - K791897

510(k) Number K791897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date November 13, 1979
Days to Decision 49 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
53d faster than avg
Panel avg: 102d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GMT Device Classification - Class 2, Special Controls

Product Code GMT Antigens, Ha, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
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.

Regulatory Peers - GMT Antigens, Ha, Treponema Pallidum

All 7
Devices cleared under the same product code (GMT) and FDA review panel - the closest regulatory comparables to K791897.
MODIFIED PK TP CONTROL
K911266 · Olympus Corp. · May 1991
CELLOGNOST SYPHILIS H
K896410 · Behring Diagnostics, Inc. · May 1990
OLYMPUS PK(TM) TP
K893124 · Fujirebio Diagnostics,Inc. · Nov 1989
AGGLUTINOTEST-SYPHILIS
K791457 · Volu Sol Medical Industries · Sep 1979
REAGENT, VDRL
K760098 · Gamma Biologicals, Inc. · Aug 1976