Cleared Traditional

CMV ELISA TEST SYSTEM (K891081) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K891081 · Zeus Scientific, Inc. · Microbiology device
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Jun 1989
Decision
93d
Days
Class 2
Risk

K891081 is an FDA 510(k) clearance for the CMV ELISA TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on June 2, 1989 after a review of 93 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 Zeus Scientific, Inc. devices

Submission Details

510(k) Number K891081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date June 02, 1989
Days to Decision 93 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
9d faster than avg
Panel avg: 102d · This submission: 93d
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 24
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K891081.
IMX CMV IGM ANTIBODY ASSAY
K900473 · Abbott Laboratories · Jul 1990
IMX CMV IGG ANTIBODY ASSAY
K900474 · Abbott Laboratories · Jul 1990
CMV IGM ELISA TEST SYSTEM
K896355 · Zeus Scientific, Inc. · Feb 1990
ENZYGNOST + ANTI-CMV IGG TEST
K852478 · Behring Diagnostics, Inc. · Sep 1985
YBBOTT CMV TOTAL AB EIA
K832221 · Abbott Laboratories · Oct 1983
CORDIA CMV
K823123 · Cordis Corp. · Dec 1982