Cleared Traditional

K974244 - IMMUNODOT MONO-M TEST

K974244 is an FDA 510(k) clearance for IMMUNODOT MONO-M TEST, manufactured by Genbio. The device is a Class 1 Microbiology device with product code LSE cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K974244 · Genbio · Microbiology device
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Sep 1998
Decision
314d
Days
Class 1
Risk

K974244 is an FDA 510(k) clearance for the IMMUNODOT MONO-M TEST. Classified as Epstein-barr Virus, Other (product code LSE), Class I - General Controls.

Submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on September 22, 1998 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Genbio devices

FDA 510(k) Submission Details - K974244

510(k) Number K974244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1997
Decision Date September 22, 1998
Days to Decision 314 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 102d · This submission: 314d
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 46
Devices cleared under the same product code (LSE) and FDA review panel - the closest regulatory comparables to K974244.
EA-D IGM ELISA TEST SYSTEM
K982350 · Columbia Bioscience, Inc. · Nov 1998
VCA IGM ELISA TEST SYSTEM
K982352 · Columbia Bioscience, Inc. · Nov 1998
IMMUNODOT MONO-G TEST
K974226 · Genbio · Sep 1998
ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA
K981120 · Zeus Scientific, Inc. · Aug 1998
IMMUNOWELL EBV VCA IGG TEST
K973940 · Genbio · Aug 1998
VCA IGM ELISA TEST SYSTEM
K980596 · Clark Laboratories, Inc. · Jul 1998