Cleared Traditional

K853889 - CORDIA CMV-M

K853889 is an FDA 510(k) clearance for CORDIA CMV-M, manufactured by Cordis Corp.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K853889 · Cordis Corp. · Microbiology device
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Apr 1986
Decision
214d
Days
Class 2
Risk

K853889 is an FDA 510(k) clearance for the CORDIA CMV-M. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on April 21, 1986 after a review of 214 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 - K853889

510(k) Number K853889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1985
Decision Date April 21, 1986
Days to Decision 214 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
112d slower than avg
Panel avg: 102d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKQ Device Classification - Class 2, Special Controls

Product Code LKQ Antibody Igm,if, Cytomegalovirus Virus
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 - LKQ Antibody Igm,if, Cytomegalovirus Virus

All 14
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K853889.
CMV IGM MICROASSAY
K871832 · Diamedix Corp. · Aug 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
K863798 · Whittaker Bioproducts, Inc. · Apr 1987
ENZYGNOST ANTI-CMV IGM TEST
K861363 · Behring Diagnostics, Inc. · Jul 1986
CYTOMEGELISA M TEST KIT
K854839 · Whittaker Bioproducts, Inc. · Feb 1986
CMV IGM TEST
K831711 · Gull Laboratories, Inc. · Oct 1983