Cleared Traditional

RSV OIA (K021172) - FDA 510(k) Clearance

Class I Microbiology device.

K021172 · Thermo Biostar, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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.