Cleared Traditional

K894262 - RUBELLA ANTIGEN AND CONTROL ANTIGEN

K894262 is an FDA 510(k) clearance for RUBELLA ANTIGEN AND CONTROL ANTIGEN, manufactured by Microbix Biosystems, Inc.. The device is a Class 2 Microbiology device with product code GON cleared through the Traditional 510(k) pathway after a 117-day FDA review.

K894262 · Microbix Biosystems, Inc. · Microbiology device
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Oct 1989
Decision
117d
Days
Class 2
Risk

K894262 is an FDA 510(k) clearance for the RUBELLA ANTIGEN AND CONTROL ANTIGEN. Classified as Antigen, Cf (including Cf Control), Rubella (product code GON), Class II - Special Controls.

Submitted by Microbix Biosystems, Inc. (Flemington, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3510 - 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 Microbix Biosystems, Inc. devices

FDA 510(k) Submission Details - K894262

510(k) Number K894262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 1989
Decision Date October 16, 1989
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 102d · This submission: 117d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GON Device Classification - Class 2, Special Controls

Product Code GON Antigen, Cf (including Cf Control), Rubella
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3510
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.