510(k) Report

510(k) · Cleared

Recalled · 2004

Vidas CMV Igg Assay

K920661510(k) TraditionalCleared Feb 12, 1993365-day reviewClass II21 CFR 866.3175Recalls 1

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

Vitek Systems, Inc. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Cleared on Feb 12, 1993 after a 365-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.

Decided
Feb 12, 1993
Review
365 days
Class
Class II
Product code
LFZ
Recalls
1
Predicates
0

4 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2018: 1 descendant cleared2009: 1 descendant cleared2022: 1 descendant cleared2012: 1 descendant cleared1990200020102020
  1. This deviceK920661 Vidas CMV Igg AssayVitek Systems, Inc. · 1993
  2. Descendant · cites it directly · 1 of its ownK181213 ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc. · 2018
  3. Descendant · cites it directly · 1 of its ownK080008 Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc. · 2009
  4. Descendant · cites it directly · 0 of its ownK220949 Architect CMV IgGAbbott Laboratories · 2022
  5. Descendant · 2 generations on · 0 of its ownK120572 Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012

Most influential descendants

Showing 4 of 4 · See all
  • K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc. · 2018 · cites it directly1descendant
  • K080008Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc. · 2009 · cites it directly1descendant
  • K220949Architect CMV IgGAbbott Laboratories · 2022 · cites it directly0descendants
  • K120572Bioplex 2200 Torc IggBio-Rad Laboratories, Inc. · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K920661Vidas CMV Igg AssayVitek Systems, Inc.1993—
+1K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.2018—
+1K080008Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc.2009—
+1K220949Architect CMV IgGAbbott Laboratories2022—
+2K120572Bioplex 2200 Torc IggBio-Rad Laboratories, Inc.2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201210
201810
202210
FIG. 1 — Lineage of K920661, 1993–2022Source: 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 LFZ? 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 LFZ device

  1. #1 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
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? (4)

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

NumberDeviceApplicantDecidedDescendants
K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc.20181
K080008Bioplex 2200 System Torc Igg Kit, Calibrator Set and Control SetBio-Rad Laboratories, Inc.20091
K220949Architect CMV IgGAbbott Laboratories20220

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 9, 2004Not classifiedZ-1047-04OtherThe product may give false positive results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K181213 (Siemens Healthcare Diagnostics, Inc., 2018) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LFZ devices

LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LFZ

2in 2022

2014: 22017: 22018: 12022: 2
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LFZ

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

Recalls per year · LFZ

1in 2025

2007: 12009: 12022: 12025: 1
2007high 1 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LFZ

53in 2025

2007: 72008: 72009: 142010: 32011: 72013: 12014: 32015: 72016: 142017: 132018: 92019: 102020: 72021: 232022: 112023: 362024: 342025: 53
2007high 53 (2025) · low 0 (2012)2025

MAUDE reports naming product code LFZ, 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—17
20080—07
20090—114
20100—03
20110—07
20120—00
20130—01
20142—03
20150—07
20160—014
20172—013
20181—09
20190—010
20200—07
20210—023
20222—111
20230—036
20240—034
20250—153
20260—0—

More from Vitek Systems, Inc.

39 FDA decisions under this applicant name. See the company

  • K921302Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 1992
  • K921176Vitek Immunodiagnostic Assay SystemVitek Systems, Inc. · 19921 recall
  • K920952Vitek Immunodiag Assay Syst (Vidas) Ferritine AssayVitek Systems, Inc. · 1992
  • K915884Vidas Chlamydia Assay, ModificationVitek Systems, Inc. · 19921 recall
  • K905211Vidas Clostridium Difficile Toxin a (Cda) AssayVitek Systems, Inc. · 1991

Recent decisions in LFZ

The LFZ category page

  • K220949Architect CMV IgGAbbott Laboratories · 2022
  • K220911Elecsys CMV IgGRoche Diagnostics · 2022
  • K181213ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality ControlSiemens Healthcare Diagnostics, Inc. · 2018
  • K163569Elecsys CMV IgMRoche Diagnostics · 20172 recalls
  • K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017

https://510kreport.com/device/K920661 · printed Nov 5, 2026

Cite this page

510(k) Report. “K920661: Vidas CMV Igg Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K920661

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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