Cleared Traditional

K895652 - EBV-EA IFA KIT

K895652 is an FDA 510(k) clearance for EBV-EA IFA KIT, manufactured by Organon Teknika Treyburn. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K895652 · Organon Teknika Treyburn · Microbiology device
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Dec 1989
Decision
89d
Days
Class 1
Risk

K895652 is an FDA 510(k) clearance for the EBV-EA IFA KIT. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Organon Teknika Treyburn (Durham, US). The FDA issued a Cleared decision on December 18, 1989 after a review of 89 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 Organon Teknika Treyburn devices

FDA 510(k) Submission Details - K895652

510(k) Number K895652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1989
Decision Date December 18, 1989
Days to Decision 89 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

LSE Device Classification - Class 1, General Controls

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 49
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K895652.
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
EBV/EA-CHECK TM TEST KIT
K903612 · Diagnostic Technology, Inc. · Oct 1990
FIAX EB VCA-M TEST KIT
K894932 · Whittaker Bioproducts, Inc. · Oct 1989
EB VCA STAT M TEST KIT
K894235 · Whittaker Bioproducts, Inc. · Aug 1989
EPSTEIN-BARR VIRAL CAPSID ANTIGEN IGG #4590
K883870 · Clinical Sciences, Inc. · Jul 1989