Cleared Traditional

K863488 - ENZYGNOST ANTI-CMV IGG TEST

K863488 is an FDA 510(k) clearance for ENZYGNOST ANTI-CMV IGG TEST, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K863488 · Behring Diagnostics, Inc. · Microbiology device
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Jul 1987
Decision
314d
Days
Class 2
Risk

K863488 is an FDA 510(k) clearance for the ENZYGNOST ANTI-CMV IGG TEST. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on July 20, 1987 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 866.3175 - 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: 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K863488

510(k) Number K863488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1986
Decision Date July 20, 1987
Days to Decision 314 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
212d slower than avg
Panel avg: 102d · This submission: 314d
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 11
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K863488.
CMV EARLY ANTIGEN TEST
K942171 · Neogenex · Jun 1994
DETECTADOT SYSTEM 2000 CMV IGG TEST
K875159 · Gull Laboratories, Inc. · May 1988
CMV MICROASSAY
K864420 · Diamedix Corp. · Feb 1987
CYTOMEGALOVIRUS IGG EIA TEST KIT
K862705 · Labsystems, Inc. · Oct 1986
COR DOT CMV
K853989 · Cordis Corp. · Jun 1986
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · Clinical Sciences, Inc. · Feb 1986