Cleared Traditional

K962060 - STREP A OIA MAX

K962060 is an FDA 510(k) clearance for STREP A OIA MAX, manufactured by Biostar, Inc.. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K962060 · Biostar, Inc. · Microbiology device
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Jul 1997
Decision
421d
Days
Class 1
Risk

K962060 is an FDA 510(k) clearance for the STREP A OIA MAX. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on July 23, 1997 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Biostar, Inc. devices

FDA 510(k) Submission Details - K962060

510(k) Number K962060 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1996
Decision Date July 23, 1997
Days to Decision 421 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
319d slower than avg
Panel avg: 102d · This submission: 421d
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 87
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