Cleared Traditional

K861363 - ENZYGNOST ANTI-CMV IGM TEST

K861363 is an FDA 510(k) clearance for ENZYGNOST ANTI-CMV IGM TEST, manufactured by Behring Diagnostics, Inc.. The device is a Class 2 Microbiology device with product code LKQ cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K861363 · Behring Diagnostics, Inc. · Microbiology device
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Jul 1986
Decision
102d
Days
Class 2
Risk

K861363 is an FDA 510(k) clearance for the ENZYGNOST ANTI-CMV IGM TEST. Classified as Antibody Igm,if, Cytomegalovirus Virus (product code LKQ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (La Jolla, US). The FDA issued a Cleared decision on July 21, 1986 after a review of 102 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 Behring Diagnostics, Inc. devices

FDA 510(k) Submission Details - K861363

510(k) Number K861363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1986
Decision Date July 21, 1986
Days to Decision 102 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
At panel average
Panel avg: 102d · This submission: 102d
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 15
Devices cleared under the same product code (LKQ) and FDA review panel - the closest regulatory comparables to K861363.
IGM CMV CLIN-ELISA(TM) TEST SYSTEM NUMBER: 5530
K872942 · Clinical Sciences, Inc. · Jan 1988
CMV IGM MICROASSAY
K871832 · Diamedix Corp. · Aug 1987
FIAX(R) TEST KIT CYTOMEGALOVIRUS M ANTIBODIES
K863798 · Whittaker Bioproducts, Inc. · Apr 1987
CORDIA CMV-M
K853889 · Cordis Corp. · Apr 1986
CYTOMEGELISA M TEST KIT
K854839 · Whittaker Bioproducts, Inc. · Feb 1986
CMV IGM TEST
K831711 · Gull Laboratories, Inc. · Oct 1983