Cleared Traditional

K914022 - SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS

K914022 is an FDA 510(k) clearance for SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI..., manufactured by Pharmacia Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LFY cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K914022 · Pharmacia Diagnostics, Inc. · Microbiology device
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Jan 1992
Decision
140d
Days
Class 2
Risk

K914022 is an FDA 510(k) clearance for the SERIOLOGICAL TEST KIT/IGM ANTIBODY VARI-ZOST VIRUS. Classified as Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (product code LFY), Class II - Special Controls.

Submitted by Pharmacia Diagnostics, Inc. (Columbia, US). The FDA issued a Cleared decision on January 27, 1992 after a review of 140 days - within the typical 510(k) review window.

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 Pharmacia Diagnostics, Inc. devices

FDA 510(k) Submission Details - K914022

510(k) Number K914022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1991
Decision Date January 27, 1992
Days to Decision 140 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 102d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFY Device Classification - Class 2, Special Controls

Product Code LFY Enzyme Linked Immunoabsorbent Assay, 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.

Regulatory Peers - LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

All 14
Devices cleared under the same product code (LFY) and FDA review panel - the closest regulatory comparables to K914022.
VARICELISA, MODIFICATION
K943843 · Biowhittaker Molecular Applications, Inc. · Mar 1996
VZV IGG ELISA TEST
K941046 · Gull Laboratories, Inc. · Aug 1995
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM
K923122 · Biomerieux Vitek, Inc. · Oct 1992
VARICELLA ZOSTER IGG CLIN-ELISA TEST KIT
K900688 · Clinical Sciences, Inc. · May 1990
VZV MICROASSAY
K890642 · Diamedix Corp. · May 1989