Cleared Traditional

K952131 - SAS FEBRILE ANTIGEN SET

K952131 is the FDA 510(k) clearance for SAS FEBRILE ANTIGEN SET by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code GSO) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K952131 · Sa Scientific, Inc. · Microbiology device
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Jul 1995
Decision
70d
Days
Class 2
Risk

K952131 is an FDA 510(k) clearance for the SAS FEBRILE ANTIGEN SET. Classified as Antigens (febrile), Agglutination, Brucella Spp. (product code GSO), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 17, 1995 after a review of 70 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 Sa Scientific, Inc. devices

Submission Details

510(k) Number K952131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date July 17, 1995
Days to Decision 70 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 102d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GSO Antigens (febrile), Agglutination, Brucella Spp.
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.

Regulatory Peers - GSO Antigens (febrile), Agglutination, Brucella Spp.

All 8
Devices cleared under the same product code (GSO) and FDA review panel - the closest regulatory comparables to K952131.
SAS BRUCELLA SUIS ANTIGEN
K952139 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H D ANTIGEN
K952135 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H B ANTIGEN
K952136 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H A ANTIGEN
K952137 · Sa Scientific, Inc. · Jul 1995
SAS BRUCELLA MELTIENSIS ANTIGEN
K952140 · Sa Scientific, Inc. · Jul 1995
SAS BRUCELLA ABORTUS ANTIGEN
K952147 · Sa Scientific, Inc. · Jul 1995