Cleared Traditional

SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM (K953320) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K953320 · Sa Scientific, Inc. · Microbiology device
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Aug 1995
Decision
22d
Days
Class 2
Risk

K953320 is an FDA 510(k) clearance for the SAS SHIGELLA DYSENTERIAE TYPE 4 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 K953320 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
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.