Cleared Traditional

K993456 - SAS STREP A TEST

K993456 is the FDA 510(k) clearance for SAS STREP A TEST by Sa Scientific, Inc.. It is a Class 1 Microbiology device (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

Submission Details

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.

Device Classification

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 24
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
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · Princeton BioMeditech Corp. · Nov 1998
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST
K971349 · Princeton BioMeditech Corp. · Jul 1997
QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
K945080 · Quidel Corp. · Feb 1995