Cleared Traditional

K942171 - CMV EARLY ANTIGEN TEST

K942171 is an FDA 510(k) clearance for CMV EARLY ANTIGEN TEST, manufactured by Neogenex. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K942171 · Neogenex · Microbiology device
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Jun 1994
Decision
56d
Days
Class 2
Risk

K942171 is an FDA 510(k) clearance for the CMV EARLY ANTIGEN TEST. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on June 30, 1994 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3175 - 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 Neogenex devices

FDA 510(k) Submission Details - K942171

510(k) Number K942171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1994
Decision Date June 30, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GQI Device Classification - Class 2, Special Controls

Product Code GQI Antiserum, Cf, Cytomegalovirus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GQI Antiserum, Cf, Cytomegalovirus

All 9
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K942171.
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · Gull Laboratories, Inc. · May 1988
ENZYGNOST ANTI-CMV IGG TEST
K863488 · Behring Diagnostics, Inc. · Jul 1987
CMV MICROASSAY
K864420 · Diamedix Corp. · Feb 1987
COR DOT CMV
K853989 · Cordis Corp. · Jun 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · Clinical Sciences, Inc. · Feb 1986
AMIZYME-CMV KIT
K842529 · Amico Lab, Inc. · Dec 1985