Cleared Traditional

K963084 - OPUS CMV TEST SYSTEM-MODIFICATION

K963084 is the FDA 510(k) clearance for OPUS CMV TEST SYSTEM-MODIFICATION by Behring Diagnostics, Inc.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K963084 · Behring Diagnostics, Inc. · Microbiology device
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Oct 1996
Decision
62d
Days
Class 2
Risk

K963084 is an FDA 510(k) clearance for the OPUS CMV TEST SYSTEM-MODIFICATION. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 9, 1996 after a review of 62 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Behring Diagnostics, Inc. devices

Submission Details

510(k) Number K963084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1996
Decision Date October 09, 1996
Days to Decision 62 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
40d faster than avg
Panel avg: 102d · This submission: 62d
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 K963084.
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997
HEMAGEN CMV IGG KIT
K944438 · Hemagen Diagnostics, Inc. · Feb 1997
INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530
K960434 · Incstar Corp. · Oct 1996
AXSYM CMV IGG ANTIBODY ASSAY
K953943 · Abbott Laboratories · Sep 1996
INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY
K955360 · Incstar Corp. · Jul 1996
INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY
K955361 · Incstar Corp. · Jul 1996