Cleared Traditional

K913693 - ENZYGNOST ANTI-CMV/IGM

K913693 is the FDA 510(k) clearance for ENZYGNOST ANTI-CMV/IGM by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K913693 · Behring Diagnostics, Inc. · Microbiology device
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Feb 1992
Decision
192d
Days
Class 2
Risk

K913693 is an FDA 510(k) clearance for the ENZYGNOST(R) ANTI-CMV/IGM. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Somerville, US). The FDA issued a Cleared decision on February 27, 1992 after a review of 192 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 Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K913693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date February 27, 1992
Days to Decision 192 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 102d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LFZ Enzyme Linked Immunoabsorbent Assay, 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 - LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

All 42
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K913693.
CMV ELISA TEST SYSTEM
K924096 · Zeus Scientific, Inc. · Apr 1993
VIDAS CMV IGG ASSAY
K920661 · Vitek Systems, Inc. · Feb 1993
ENZYGNOST(R) ANTI-CMV IGG
K913910 · Behring Diagnostics, Inc. · Apr 1992
CMV IGG ELISA TEST
K915892 · Gull Laboratories, Inc. · Feb 1992
ENZYGNOST ANTI-CMV/IGG + IGM
K901485 · Behring Diagnostics, Inc. · May 1991
CMV IGM ELISA TEST
K903807 · Gull Laboratories, Inc. · Dec 1990