Cleared Traditional

K961541 - SAS SHIGELLA BOYDII TYPE 8 ANTISERUM

K961541 is the FDA 510(k) clearance for SAS SHIGELLA BOYDII TYPE 8 ANTISERUM by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code GNB) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K961541 · Sa Scientific, Inc. · Microbiology device
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May 1996
Decision
28d
Days
Class 2
Risk

K961541 is an FDA 510(k) clearance for the SAS SHIGELLA BOYDII TYPE 8 ANTISERUM. Classified as Antisera, All Types, Shigella Spp. (product code GNB), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on May 20, 1996 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3660 - 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 K961541 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date May 20, 1996
Days to Decision 28 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
74d faster than avg
Panel avg: 102d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GNB Antisera, All Types, Shigella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3660
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 - GNB Antisera, All Types, Shigella Spp.

All 39
Devices cleared under the same product code (GNB) and FDA review panel - the closest regulatory comparables to K961541.
SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM
K961538 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM
K961539 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA SONNEI GROUP D ANTISERUM
K961540 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM
K961542 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA BOYDII TYPE 9 ANTISERUM
K961543 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM
K961546 · Sa Scientific, Inc. · May 1996