Cleared Traditional

K860493 - CYTOTECH CMV IGG EIA

K860493 is an FDA 510(k) clearance for CYTOTECH CMV IGG EIA, manufactured by Cytotech, Inc.. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K860493 · Cytotech, Inc. · Microbiology device
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May 1986
Decision
99d
Days
Class 2
Risk

K860493 is an FDA 510(k) clearance for the CYTOTECH CMV IGG EIA. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Cytotech, Inc. (San Diego, US). The FDA issued a Cleared decision on May 20, 1986 after a review of 99 days - within the typical 510(k) review window.

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. 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 Cytotech, Inc. devices

FDA 510(k) Submission Details - K860493

510(k) Number K860493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 1986
Decision Date May 20, 1986
Days to Decision 99 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d faster than avg
Panel avg: 102d · This submission: 99d
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 12
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K860493.
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
CYTOMEGALOVIRUS IGG EIA TEST KIT
K843189 · Labsystems, Inc. · Jan 1986
AMIZYME-CMV KIT
K842529 · Amico Lab, Inc. · Dec 1985