510(k) Report

510(k) · Cleared

Recalled · 2003

CMV Elisa Test System

K924096510(k) TraditionalCleared Apr 2, 1993232-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

Zeus Scientific, Inc. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Cleared on Apr 2, 1993 after a 232-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 later device descends from it. It has been recalled once.

Decided
Apr 2, 1993
Review
232 days
Class
Class II
Product code
LFZ
Recalls
1
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared1990200020102020
  1. This deviceK924096 CMV Elisa Test SystemZeus Scientific, Inc. · 1993
  2. Descendant · cites it directly · 0 of its ownK093784 Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010

Most influential descendants

Showing 1 of 1 · See all
  • K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K924096CMV Elisa Test SystemZeus Scientific, Inc.1993—
+1K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
FIG. 1 — Lineage of K924096, 1993–2010Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K093784Athena Multi-Lyte Torch Igg Plus Test SystemZeus Scientific, Inc.20100

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 18, 2003Not classifiedZ-1127-03OtherThe Low Positive Standard kit component is losing potency that may result in false positive test results.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K093784 (Zeus Scientific, Inc., 2010) has gone furthest, with 0 descendants 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 Zeus Scientific, Inc.

140 FDA decisions under this applicant name. See the company

  • K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineZeus Scientific, Inc. · 2022
  • K190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemZeus Scientific, Inc. · 2019
  • K191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemZeus Scientific, Inc. · 2019
  • K191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemZeus Scientific, Inc. · 2019
  • P150045Zeus Elisa Parvovirus B19 Igg Test SystemZeus Scientific, Inc. · 20171 recall

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/K924096 · printed Nov 6, 2026

Cite this page

510(k) Report. “K924096: CMV Elisa 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/K924096

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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