Cleared Traditional

K890639 - RESUBMITTED EBV/IGM-CHECK TEST KIT

K890639 is an FDA 510(k) clearance for RESUBMITTED EBV/IGM-CHECK TEST KIT, manufactured by Diagnostic Technology, Inc.. The device is a Class 1 Microbiology device with product code LJN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

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

FDA 510(k) Submission Details - K890639

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 102d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

LJN Device Classification - Class 1, General Controls

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

All 14
Devices cleared under the same product code (LJN) and FDA review panel - the closest regulatory comparables to K890639.
BARTELS EPSTEIN-BARR VIRUS IGM EIA
K922331 · Baxter Diagnostics, Inc. · Sep 1992
EBV IGM ELISA TEST
K910042 · Gull Laboratories, Inc. · Feb 1991
EBV VCA ANTIBODY (IGM)
K896594 · Hillcrest Biologicals · Jan 1990
EBV-VCA IGM ANTIBODY TEST SYSTEM (ENZYME)
K880884 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGM ANTIBODY TEST SYSTEM (FLUORESCENT)
K880886 · Immuno Concepts, Inc. · Aug 1988
DU PONT VCA-IGM ANTIBODY ELISA KIT
K875204 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1988