Cleared Traditional

K871373 - EBV-CHECK(TM) TEST KIT (IGG)

K871373 is an FDA 510(k) clearance for EBV-CHECK(TM) TEST KIT (IGG), manufactured by Diagnostic Technology, Inc.. The device is a Class 1 Microbiology device with product code GNP cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K871373 · Diagnostic Technology, Inc. · Microbiology device
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Jun 1987
Decision
79d
Days
Class 1
Risk

K871373 is an FDA 510(k) clearance for the EBV-CHECK(TM) TEST KIT (IGG). Classified as Antiserum, Cf, Epstein-barr Virus (product code GNP), Class I - General Controls.

Submitted by Diagnostic Technology, Inc. (Hauppauge, US). The FDA issued a Cleared decision on June 25, 1987 after a review of 79 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

FDA 510(k) Submission Details - K871373

510(k) Number K871373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1987
Decision Date June 25, 1987
Days to Decision 79 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
23d faster than avg
Panel avg: 102d · This submission: 79d
Pathway characteristics
Predicate-based equivalence.

GNP Device Classification - Class 1, General Controls

Product Code GNP Antiserum, Cf, 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 - GNP Antiserum, Cf, Epstein-barr Virus

All 10
Devices cleared under the same product code (GNP) and FDA review panel - the closest regulatory comparables to K871373.
EBV-VCA ANTIBODY (IGG)
K884591 · Hillcrest Biologicals · Jan 1989
EBV-VCA IGG ANTIBODY TEST SYSTEM (FLUORESCENT)
K880883 · Immuno Concepts, Inc. · Aug 1988
EBV-VCA IGG ANTIBODY TEST SYSTEM (ENZYME)
K880885 · Immuno Concepts, Inc. · Aug 1988
EBV/VCA-CHECK(TM) ANTIGEN SLIDES
K863408 · Diagnostic Technology, Inc. · Nov 1986
ANTI-EPSTEIN-BARR VIRUS KIT
K842662 · Amico Lab, Inc. · Dec 1985
AMIZYME-EBV TEST KIT
K842530 · Amico Lab, Inc. · Dec 1985