Cleared Traditional

K891542 - EBNA-CHECK(TM) TEST KIT

K891542 is an FDA 510(k) clearance for EBNA-CHECK(TM) TEST KIT, manufactured by Diagnostic Technology, Inc.. The device is a Class 1 Microbiology device with product code LLM cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K891542 · Diagnostic Technology, Inc. · Microbiology device
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Jun 1989
Decision
95d
Days
Class 1
Risk

K891542 is an FDA 510(k) clearance for the EBNA-CHECK(TM) TEST KIT. Classified as Test, Antigen, Nuclear, Epstein-barr Virus (product code LLM), 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 95 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 - K891542

510(k) Number K891542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date June 20, 1989
Days to Decision 95 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
7d faster than avg
Panel avg: 102d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

LLM Device Classification - Class 1, General Controls

Product Code LLM Test, Antigen, Nuclear, 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 - LLM Test, Antigen, Nuclear, Epstein-barr Virus

All 17
Devices cleared under the same product code (LLM) and FDA review panel - the closest regulatory comparables to K891542.
EPSTEIN-BARR VIRUS EBNA-IGG ANTIBODY ELISA TEST
K911569 · Ortho Diagnostic Systems, Inc. · Jun 1991
EBNA ANTIBODY TEST SYSTEM (IMMUNOFLUORESCENT ANTI)
K895708 · Immuno Concepts, Inc. · Dec 1989
EBNA ANTIBODY TEST SYSTEM (IMMUNOENZYME ANTIBODY)
K895707 · Immuno Concepts, Inc. · Dec 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGG CATA. #4550
K883600 · Clinical Sciences, Inc. · May 1989
EPSTEIN-BARR VIRUS (EBNA-1) IGM CATA. #5550
K883601 · Clinical Sciences, Inc. · May 1989
EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN ANTIBODY TEST
K882440 · Zeus Scientific, Inc. · Dec 1988