Cleared Traditional

RESUBMITTED EBV/IGM-CHECK TEST KIT (K890639) - FDA 510(k) Clearance

Class I Microbiology device.

K890639 · Diagnostic Technology, Inc. · Microbiology device
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Jun 1989
Decision
132d
Days
Class 1
Risk

K890639 is an FDA 510(k) clearance for the RESUBMITTED EBV/IGM-CHECK TEST KIT. Classified as Antibody Igm, If, Epstein-barr Virus (product code LJN), Class I - General Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 132 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 Diagnostic Technology, Inc. devices

Submission Details

510(k) Number K890639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 1989
Decision Date June 20, 1989
Days to Decision 132 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LJN Antibody Igm, If, Epstein-barr Virus
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 - LJN Antibody Igm, If, Epstein-barr Virus

Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K890639.
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
ORTHO*EPSTEIN-BARR VIRUS VCA-IGM ANTIBODY ELISA
K930020 · Ortho Diagnostic Systems, Inc. · Jul 1993
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1988
ORTHO MONOLERT* RAPID ELISA TEST FOR INFECT. MONO.
K872541 · Ortho Diagnostic Systems, Inc. · May 1988
EBV-VCA-IGM IFA TEST SYSTEM
K833014 · Zeus Scientific, Inc. · Dec 1983