Cleared Traditional

K922332 - BARTELS EPSTEIN-BARR VIRUS IGG EIA

K922332 is the FDA 510(k) clearance for BARTELS EPSTEIN-BARR VIRUS IGG EIA by Baxter Diagnostics, Inc.. It is a Class 1 Microbiology device (product code LSE) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K922332 · Baxter Diagnostics, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1992
Decision
112d
Days
Class 1
Risk

K922332 is an FDA 510(k) clearance for the BARTELS EPSTEIN-BARR VIRUS IGG EIA. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Baxter Diagnostics, Inc. (Bellevue, US). The FDA issued a Cleared decision on September 2, 1992 after a review of 112 days - within the typical 510(k) review window.

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: 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 Baxter Diagnostics, Inc. devices

Submission Details

510(k) Number K922332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1992
Decision Date September 02, 1992
Days to Decision 112 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 102d · This submission: 112d
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 23
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K922332.
INCSTAR EPSTEIN-BARR VIRAL CAPSID ANTIGEN (VCA) IGG ELISA KIT
K946159 · Incstar Corp. · Jun 1995
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc. · Nov 1993
EPSTEIN-BARR VIR EARLY ANTI DIFF IGG CLIN-ELISA
K921628 · Incstar Corp. · Sep 1992
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