Cleared Traditional

K001767 - DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM

K001767 is the FDA 510(k) clearance for DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM by Diamedix Corp.. It is a Class 2 Microbiology device (product code LJO) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K001767 · Diamedix Corp. · Microbiology device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
56d
Days
Class 2
Risk

K001767 is an FDA 510(k) clearance for the DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM. Classified as Antigen, Iha, Cytomegalovirus (product code LJO), Class II - Special Controls.

Submitted by Diamedix Corp. (Miami, US). The FDA issued a Cleared decision on August 7, 2000 after a review of 56 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 Diamedix Corp. devices

Submission Details

510(k) Number K001767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2000
Decision Date August 07, 2000
Days to Decision 56 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
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJO Antigen, Iha, 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 - LJO Antigen, Iha, Cytomegalovirus

Devices cleared under the same product code (LJO) and FDA review panel - the closest regulatory comparables to K001767.
Capture-CMV
K203612 · Immucor, Inc. · Mar 2021
Capture-CMV
K183571 · Immucor, Inc. · Feb 2019
CMVGEN
K974456 · Instrumentation Laboratory CO · May 1998
ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY
K951851 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1996
CMV LATEX AGGLUTINATION TEST KIT
K841520 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1984