Cleared Traditional

FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067) - FDA 510(k) Clearance

Class I Microbiology device.

K853067 · Idt, A Division of Whittaker M.A. Bioproducts · Microbiology device
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Oct 1985
Decision
92d
Days
Class 1
Risk

K853067 is an FDA 510(k) clearance for the FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT. Classified as Antiserum, Fluorescent, Rubeola (product code GRE), Class I - General Controls.

Submitted by Idt, A Division of Whittaker M.A. Bioproducts (San Jose, US). The FDA issued a Cleared decision on October 22, 1985 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3520 - 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 Idt, A Division of Whittaker M.A. Bioproducts devices

Submission Details

510(k) Number K853067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1985
Decision Date October 22, 1985
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GRE Antiserum, Fluorescent, Rubeola
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3520
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.