510(k) Report

510(k) · Cleared

Cleared

CMV Igg Elisa Test

K915892510(k) TraditionalCleared Feb 14, 199252-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

Gull Laboratories, Inc. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Cleared on Feb 14, 1992 after a 52-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
Feb 14, 1992
Review
52 days
Class
Class II
Product code
LFZ
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 2 descendants cleared2005: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared1990200020102020
  1. This deviceK915892 CMV Igg Elisa TestGull Laboratories, Inc. · 1992
  2. Descendant · cites it directly · 4 of its ownK955361 Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp. · 1996
  3. Descendant · 2 generations on · 3 of its ownK040290 Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005
  4. Descendant · 3 generations on · 0 of its ownK162969 LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017
  5. Descendant · 3 generations on · 0 of its ownK161526 LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016
  6. Descendant · 3 generations on · 0 of its ownK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

1996: 22005: 12016: 22017: 1
1996high 2 (1996) · low 0 (1997)2026

Most influential descendants

Showing 5 of 6 · See all
  • K955361Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp. · 1996 · cites it directly4descendants
  • K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005 · 2 generations on3descendants
  • K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017 · 3 generations on0descendants
  • K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016 · 3 generations on0descendants
  • K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915892CMV Igg Elisa TestGull Laboratories, Inc.1992—
+1K955361Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp.1996—
+2K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A2005—
+3K162969LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc.2017—
+3K161526LIAISON CMV IgM Serum Control SetDiaSorin, Inc.2016—
+3K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
200510
201620
201710
FIG. 1 — Lineage of K915892, 1992–2017Source: 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 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? (6)

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

NumberDeviceApplicantDecidedDescendants
K955361Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp.19964
K955360Incstar Cytomegalovirus Igg Fast Elisa AssayIncstar Corp.19960

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, K955361 (Incstar Corp., 1996) has gone furthest, with 4 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 Gull Laboratories, Inc.

57 FDA decisions under this applicant name. See the company

  • K983541HSV 1+2 Igg Elisa TestGull Laboratories, Inc. · 1999
  • K971857Mumps Igg Elisa TestyGull Laboratories, Inc. · 1997
  • K962343Toxo Igg Elisa TestGull Laboratories, Inc. · 1997
  • K935730Ebna Igg Elisa TestGull Laboratories, Inc. · 1995
  • K940093Ebv-EA (D) Igg Elisa TestGull Laboratories, Inc. · 1995

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/K915892 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915892: CMV Igg Elisa Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915892

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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