Cleared Traditional

K853989 - COR DOT CMV

K853989 is an FDA 510(k) clearance for COR DOT CMV, manufactured by Cordis Corp.. The device is a Class 2 Microbiology device with product code GQI cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K853989 · Cordis Corp. · Microbiology device
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Jun 1986
Decision
259d
Days
Class 2
Risk

K853989 is an FDA 510(k) clearance for the COR DOT CMV. Classified as Antiserum, Cf, Cytomegalovirus (product code GQI), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on June 13, 1986 after a review of 259 days - an extended review 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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K853989

510(k) Number K853989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date June 13, 1986
Days to Decision 259 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
157d slower than avg
Panel avg: 102d · This submission: 259d
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 8
Devices cleared under the same product code (GQI) and FDA review panel - the closest regulatory comparables to K853989.
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
CYTOMEGALOVIRUS (CMV) ELISA TEST SYS. CAT. NO:4530
K854666 · Clinical Sciences, Inc. · Feb 1986
AMIZYME-CMV KIT
K842529 · Amico Lab, Inc. · Dec 1985
ANTI-CYTOMEGALOVIRUS KIT
K842661 · Amico Lab, Inc. · Dec 1985