Cleared Traditional

STREP A OIA MAX (K962060) - FDA 510(k) Clearance

Class I Microbiology device.

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

Submission Details

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.

Device Classification

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 104
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K962060.
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K971522 · Abbott Laboratories · Mar 1998
ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC)
K952819 · Abbott Laboratories · Jan 1996
DIRECTIGEN 1-2-3 GROUP A STREP TEST
K951542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1995
ABBOTT TEST PACK STREP A TEST
K945571 · Abbott Laboratories · Aug 1995
TESTPACK PLUS STREP A
K922345 · Abbott Laboratories · Jul 1992
BBL STREP GROUPING KIT
K920565 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1992