Cleared Traditional

K882023 - FIAX TEST KIT FOR EB-VCA-G ANTIBODY

K882023 is the FDA 510(k) clearance for FIAX TEST KIT FOR EB-VCA-G ANTIBODY by Whittaker Bioproducts, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K882023 · Whittaker Bioproducts, Inc. · Microbiology device
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Aug 1988
Decision
78d
Days
Class 1
Risk

K882023 is an FDA 510(k) clearance for the FIAX TEST KIT FOR EB-VCA-G ANTIBODY. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Whittaker Bioproducts, Inc. (Walkersville, US). The FDA issued a Cleared decision on August 3, 1988 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3235 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Whittaker Bioproducts, Inc. devices

Submission Details

510(k) Number K882023 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1988
Decision Date August 03, 1988
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 102d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LSE Epstein-barr Virus, Other
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3235
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.

Regulatory Peers - LSE Epstein-barr Virus, Other

All 24
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K882023.
FLUORECENT EBV-EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912488 · Immuno Concepts, Inc. · Jul 1991
COLORZYME EBV EARLY ANTIGEN IGG ANTIBODY TEST SYS
K912489 · Immuno Concepts, Inc. · Jul 1991
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · Zeus Scientific, Inc. · Dec 1988
EBV-EA TEST
K872617 · Gull Laboratories, Inc. · Jan 1988