Cleared Traditional

K013379 - SAS STREPALERT

K013379 is the FDA 510(k) clearance for SAS STREPALERT by Sa Scientific, Inc.. It is a Class 1 Microbiology device (product code GTY) cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K013379 · Sa Scientific, Inc. · Microbiology device
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Dec 2001
Decision
61d
Days
Class 1
Risk

K013379 is an FDA 510(k) clearance for the SAS STREPALERT. 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 December 12, 2001 after a review of 61 days - a notably fast clearance cycle.

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: 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 K013379 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2001
Decision Date December 12, 2001
Days to Decision 61 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
41d faster than avg
Panel avg: 102d · This submission: 61d
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 K013379.
STATUS FIRST STREP A
K040708 · Princeton BioMeditech Corp. · Nov 2004
ACON STREP A RAPID TEST DEVICE
K031784 · ACON Laboratories, Inc. · Jul 2003
SAS STREPALERT
K023270 · Sa Scientific, Inc. · Oct 2002
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp. · May 2001
SAS STREP A TEST
K993456 · Sa Scientific, Inc. · Mar 2000
BIOSTREP A-DIRECT STREP A ANTIGEN TEST
K983386 · Princeton BioMeditech Corp. · Nov 1998