Cleared Traditional

K021172 - RSV OIA

K021172 is an FDA 510(k) clearance for RSV OIA, manufactured by Thermo Biostar, Inc.. The device is a Class 1 Microbiology device with product code GOG cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K021172 · Thermo Biostar, Inc. · Microbiology device
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Sep 2002
Decision
154d
Days
Class 1
Risk

K021172 is an FDA 510(k) clearance for the RSV OIA. Classified as Antisera, Cf, Poliovirus 1-3 (product code GOG), Class I - General Controls.

Submitted by Thermo Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on September 13, 2002 after a review of 154 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3405 - 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 Thermo Biostar, Inc. devices

FDA 510(k) Submission Details - K021172

510(k) Number K021172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2002
Decision Date September 13, 2002
Days to Decision 154 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
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

GOG Device Classification - Class 1, General Controls

Product Code GOG Antisera, Cf, Poliovirus 1-3
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3405
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.