Cleared Traditional

K962296 - STREPTOLEX-STAT

K962296 is an FDA 510(k) clearance for STREPTOLEX-STAT, manufactured by Unipath , Ltd.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K962296 · Unipath , Ltd. · Microbiology device
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Dec 1996
Decision
187d
Days
Class 1
Risk

K962296 is an FDA 510(k) clearance for the STREPTOLEX-STAT. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Unipath , Ltd. (Beverly, US). The FDA issued a Cleared decision on December 16, 1996 after a review of 187 days - an extended review 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: 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 Unipath , Ltd. devices

FDA 510(k) Submission Details - K962296

510(k) Number K962296 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1996
Decision Date December 16, 1996
Days to Decision 187 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
85d slower than avg
Panel avg: 102d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, 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 - GTZ Antisera, All Groups, Streptococcus Spp.

All 89
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