Cleared Traditional

K993456 - SAS STREP A TEST

K993456 is an FDA 510(k) clearance for SAS STREP A TEST, manufactured by Sa Scientific, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K993456 · Sa Scientific, Inc. · Microbiology device
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Mar 2000
Decision
146d
Days
Class 1
Risk

K993456 is an FDA 510(k) clearance for the SAS STREP A TEST. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on March 7, 2000 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K993456

510(k) Number K993456 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date March 07, 2000
Days to Decision 146 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
44d slower than avg
Panel avg: 102d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

GTY Device Classification - Class 1, General Controls

Product Code GTY Antigens, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTY Antigens, All Groups, Streptococcus Spp.

All 37
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K993456.
SAS STREPALERT
K023270 · Sa Scientific, Inc. · Oct 2002
SAS STREPALERT
K013379 · Sa Scientific, Inc. · Dec 2001
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp. · May 2001
OSOM ULTRA STREP A TEST, MODEL 147
K992658 · Wyntek Diagnostics, Inc. · Jan 2000
STREP B OIA
K991828 · Biostar, Inc. · Aug 1999
UNI-GOLD STREP A TEST KIT
K982373 · Trinity Biotech, Plc · Feb 1999