Cleared Traditional

BIOSTAR OIA SHIGATOX (K061889) - FDA 510(k) Clearance

Class I Microbiology device.

K061889 · Inverness Medical-Biostar, Inc. · Microbiology device
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Dec 2006
Decision
162d
Days
Class 1
Risk

K061889 is an FDA 510(k) clearance for the BIOSTAR OIA SHIGATOX. Classified as Antigens, All Types, Escherichia Coli (product code GMZ), Class I - General Controls.

Submitted by Inverness Medical-Biostar, Inc. (Louisville, US). The FDA issued a Cleared decision on December 12, 2006 after a review of 162 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3255 - 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 Inverness Medical-Biostar, Inc. devices

Submission Details

510(k) Number K061889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date December 12, 2006
Days to Decision 162 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 102d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GMZ Antigens, All Types, Escherichia Coli
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3255
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.