Cleared Traditional

K023270 - SAS STREPALERT

K023270 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 16-day FDA review.

K023270 · Sa Scientific, Inc. · Microbiology device
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Oct 2002
Decision
16d
Days
Class 1
Risk

K023270 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 October 17, 2002 after a review of 16 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 K023270 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2002
Decision Date October 17, 2002
Days to Decision 16 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
86d faster than avg
Panel avg: 102d · This submission: 16d
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 K023270.
INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC
K051638 · Unipath , Ltd. · Dec 2005
STATUS FIRST STREP A
K040708 · Princeton BioMeditech Corp. · Nov 2004
ACON STREP A RAPID TEST DEVICE
K031784 · ACON Laboratories, Inc. · Jul 2003
SAS STREPALERT
K013379 · Sa Scientific, Inc. · Dec 2001
QUICKVUE DIPSTICK STREP A
K011097 · Quidel Corp. · May 2001
SAS STREP A TEST
K993456 · Sa Scientific, Inc. · Mar 2000