510(k) Report

510(k) · Cleared

Cleared

Diamedix IS-CMV Igm Capture Test System

K001767510(k) TraditionalCleared Aug 7, 200056-day reviewClass II21 CFR 866.3175

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Diamedix Corp. · LJO Antigen, Iha, Cytomegalovirus

Cleared on Aug 7, 2000 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.

Decided
Aug 7, 2000
Review
56 days
Class
Class II
Product code
LJO
Recalls
None
Predicates
0

6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2014: 1 descendant cleared2005: 1 descendant cleared2016: 2 descendants cleared2017: 2 descendants cleared200020052010201520202025
  1. This deviceK001767 Diamedix IS-CMV Igm Capture Test SystemDiamedix Corp. · 2000
  2. Descendant · cites it directly · 3 of its ownK040290 Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005
  3. Descendant · cites it directly · 1 of its ownK142133 Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014
  4. Descendant · 2 generations on · 0 of its ownK163569 Elecsys CMV IgMRoche Diagnostics · 2017 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK162969 LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017
  6. Descendant · 2 generations on · 0 of its ownK161526 LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12014: 12016: 22017: 2
2005high 2 (2016) · low 0 (2006)2026

Most influential descendants

Showing 5 of 6 · See all
  • K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005 · cites it directly3descendants
  • K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics · 2014 · cites it directly1descendant
  • K163569Elecsys CMV IgMRoche Diagnostics · 2017 · 2 generations on0descendants
  • K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017 · 2 generations on0descendants
  • K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001767Diamedix IS-CMV Igm Capture Test SystemDiamedix Corp.2000—
+1K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A2005—
+1K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics2014—
+2K163569Elecsys CMV IgMRoche Diagnostics20172
+2K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.2017—
+2K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
201410
201620
201720
FIG. 1 — Lineage of K001767, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LJO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LJO device

  1. #1 K203612 Capture-CMVscore 1.3 · 2 generations · no Class I recall
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (6)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A20053
K142133Elecys CMV Igm Immunoassay; Elecys Precicontrol CMV IgmRoche Diagnostics20141

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K040290 (Diasorin S.P.A, 2005) has gone furthest, with 3 descendants of its own.

How does its category compare?

All LJO devices

LJO Antigen, Iha, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJO

1in 2021

2019: 12021: 1
2007high 1 (2019) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJO

Too few LJO 510(k)s in any year since 2007 to give a median.

Recalls per year · LJO

No recall names LJO since 2007.

Adverse event reports per year · LJO

1in 2018

2011: 22016: 12018: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code LJO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—02
20120—00
20130—00
20140—00
20150—00
20160—01
20170—00
20180—01
20191—00
20200—00
20211—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Diamedix Corp.

68 FDA decisions under this applicant name. See the company

  • K093101MAGO 4SDiamedix Corp. · 2011
  • K021394Diamedix IS-Rheumatoid Factor Test SystemDiamedix Corp. · 2002
  • K013956Diamedix IS-Anti-B2 Glycoprotein I ScreenDiamedix Corp. · 2002
  • K013628Diamedix IS-Anti-B2 Glycoprotein I Igg/Igm Test SystemDiamedix Corp. · 2001
  • K012449Diamedix IS-Anti-Cardiolipin Igg/Igm Test SystemDiamedix Corp. · 2001

Recent decisions in LJO

The LJO category page

  • K203612Capture-CMVImmucor, Inc. · 2021
  • K183571Capture-CMVImmucor, Inc. · 2019
  • K974901Hybrid Capture System CMV Dna AssayDigene Corp. · 1998
  • K974456CmvgenInstrumentation Laboratory CO · 1998
  • K951851Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence AssayE.I. Dupont DE Nemours & Co., Inc. · 1996

https://510kreport.com/device/K001767 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001767: Diamedix IS-CMV Igm Capture Test System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001767

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026