Cleared Traditional

K981163 - DIAMEDIX IS-CMV IGG TEST SYSTEM

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

K981163 · Diamedix Corp. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K981163

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.

LFZ Device Classification - Class 2, Special Controls

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 50
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