Cleared Traditional

FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (K853540) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853540 · Idt, A Division of Whittaker M.A. Bioproducts · Microbiology device
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Feb 1986
Decision
165d
Days
Class 2
Risk

K853540 is an FDA 510(k) clearance for the FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY. Classified as Antiserum, Cf, Varicella-zoster (product code GQX), Class II - Special Controls.

Submitted by Idt, A Division of Whittaker M.A. Bioproducts (San Jose, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 165 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3900 - 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 K853540 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1985
Decision Date February 04, 1986
Days to Decision 165 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 102d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GQX Antiserum, Cf, Varicella-zoster
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3900
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.