Cleared Traditional

K091489 - CLEARVIEW ADVANCED STREP A , MODEL 737-430

K091489 is an FDA 510(k) clearance for CLEARVIEW ADVANCED STREP A, manufactured by Binax, Inc.. The device is a Class 1 Microbiology device with product code GTY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K091489 · Binax, Inc. · Microbiology device
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Sep 2009
Decision
107d
Days
Class 1
Risk

K091489 is an FDA 510(k) clearance for the CLEARVIEW ADVANCED STREP A , MODEL 737-430. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Binax, Inc. (Scarborough, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 107 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 Binax, Inc. devices

FDA 510(k) Submission Details - K091489

510(k) Number K091489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2009
Decision Date September 04, 2009
Days to Decision 107 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d slower than avg
Panel avg: 102d · This submission: 107d
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
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