Cleared Traditional

K981163 - DIAMEDIX IS-CMV IGG TEST SYSTEM

K981163 is the FDA 510(k) clearance for DIAMEDIX IS-CMV IGG TEST SYSTEM by Diamedix Corp.. It is a Class 2 Microbiology device (product code LFZ) cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K981163 · Diamedix Corp. · Microbiology device
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Sep 1998
Decision
174d
Days
Class 2
Risk

K981163 is an FDA 510(k) clearance for the DIAMEDIX IS-CMV IGG TEST SYSTEM. Classified as Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (product code LFZ), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on September 21, 1998 after a review of 174 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 Diamedix Corp. devices

Submission Details

510(k) Number K981163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1998
Decision Date September 21, 1998
Days to Decision 174 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
72d slower than avg
Panel avg: 102d · This submission: 174d
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 40
Devices cleared under the same product code (LFZ) and FDA review panel - the closest regulatory comparables to K981163.
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K984139 · Zeus Scientific, Inc. · Jan 1999
THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE
K983803 · Zeus Scientific, Inc. · Dec 1998
MODIFICATION TO COPALIS CMV TOTAL ANTIBODY ASSAY
K982027 · DiaSorin, Inc. · Nov 1998
QUANTA LITE CMV IGG ELISA
K971335 · Inova Diagnostics, Inc. · Dec 1997
ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION)
K954301 · Abbott Laboratories · Mar 1997
HEMAGEN CMV IGG KIT
K944438 · Hemagen Diagnostics, Inc. · Feb 1997