Cleared Traditional

K953316 - SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ...

K953316 is the FDA 510(k) clearance for SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ... by Sa Scientific, Inc.. It is a Class 2 Microbiology device (product code GNB) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K953316 · Sa Scientific, Inc. · Microbiology device
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Aug 1995
Decision
22d
Days
Class 2
Risk

K953316 is an FDA 510(k) clearance for the SAS SHIGELLA DYSENTERIAE GROUP A (1-7) 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 August 4, 1995 after a review of 22 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 K953316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 1995
Decision Date August 04, 1995
Days to Decision 22 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
80d faster than avg
Panel avg: 102d · This submission: 22d
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 K953316.
SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM
K961556 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM
K961558 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM
K961559 · Sa Scientific, Inc. · May 1996
SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM
K953317 · Sa Scientific, Inc. · Aug 1995
SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM
K953318 · Sa Scientific, Inc. · Aug 1995
SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM
K953319 · Sa Scientific, Inc. · Aug 1995