Cleared Traditional

EBV/EA-CHECK TM TEST KIT (K903612) - FDA 510(k) Clearance

Class I Microbiology device.

K903612 · Diagnostic Technology, Inc. · Microbiology device
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Oct 1990
Decision
68d
Days
Class 1
Risk

K903612 is an FDA 510(k) clearance for the EBV/EA-CHECK TM TEST KIT. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on October 16, 1990 after a review of 68 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 Diagnostic Technology, Inc. devices

Submission Details

510(k) Number K903612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1990
Decision Date October 16, 1990
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 102d · This submission: 68d
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 7
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K903612.
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · Zeus Scientific, Inc. · Aug 1998
EBV-VCA IGM ELISA TEST STSTEM
K944449 · Zeus Scientific, Inc. · Sep 1995
ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS
K931443 · Ortho Diagnostic Systems, Inc. · Nov 1993
EPSTEIN-BARR VIRUS EARLY ANTIGEN (EA) ANTIBODY TES
K882447 · Zeus Scientific, Inc. · Dec 1988