Cleared Traditional

K971349 - BIOSIGN STREP A - DIRECT STREP A ANTIGE...

K971349 is an FDA 510(k) clearance for BIOSIGN STREP A - DIRECT STREP A ANTIGE..., manufactured by Princeton BioMeditech Corp.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K971349 · Princeton BioMeditech Corp. · Microbiology device
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Jul 1997
Decision
88d
Days
Class 1
Risk

K971349 is an FDA 510(k) clearance for the BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 7, 1997 after a review of 88 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K971349

510(k) Number K971349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1997
Decision Date July 07, 1997
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
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 34
Devices cleared under the same product code (GTY) and FDA review panel - the closest regulatory comparables to K971349.
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BIOSTREP A-DIRECT STREP A ANTIGEN TEST
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QUICKVUE IN-LINE ONE-STEP STREP A CONTROL SWABS (POSITIVE & NEGATIVE SWAB SPECIMENS)
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BIOSTARS STREP A OIA -- MODIFICATION
K922765 · Biosearch Medical Products, Inc. · Aug 1992
ABBOTT STREP A CONTROLS
K922490 · Abbott Laboratories · Jul 1992