510(k) · Cleared

Cleared

Incstar Cytomegalovirus Igg Elisa Assay

K955361510(k) TraditionalCleared Jul 22, 1996243-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

Incstar Corp. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Cleared on Jul 22, 1996 as substantially equivalent to K915892 (Gull Laboratories, Inc., 1992) after a 243-day review. Its family tree reaches back 1 generation to 1992. 4 later devices descend from it.

Decided: Jul 22, 1996
Review: 243 days
Class: Class II
Product code: LFZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915892 (1992). 4 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK915892 CMV Igg Elisa TestGull Laboratories, Inc. · 1992
This deviceK955361 Incstar Cytomegalovirus Igg Elisa AssayIncstar Corp. · 1996
Descendant · cites it directly · 3 of its ownK040290 Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005
Descendant · 2 generations on · 0 of its ownK162969 LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control SetDiaSorin, Inc. · 2017
Descendant · 2 generations on · 0 of its ownK161526 LIAISON CMV IgM Serum Control SetDiaSorin, Inc. · 2016
Descendant · 2 generations on · 0 of its ownK161522 LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016

Most influential descendants

Showing 4 of 4 · See all

K040290Diasorin Liaison CMV Igm/IggDiasorin S.P.A · 2005 · cites it directly3descendants
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
K161522LIAISON EBV IgM Serum Control SetDiaSorin, Inc. · 2016 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915892	CMV Igg Elisa Test	Gull Laboratories, Inc.	1992	—
0 (this device)	K955361	Incstar Cytomegalovirus Igg Elisa Assay	Incstar Corp.	1996	—
+1	K040290	Diasorin Liaison CMV Igm/Igg	Diasorin S.P.A	2005	—
+2	K162969	LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set	DiaSorin, Inc.	2017	—
+2	K161526	LIAISON CMV IgM Serum Control Set	DiaSorin, Inc.	2016	—
+2	K161522	LIAISON EBV IgM Serum Control Set	DiaSorin, Inc.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2016	2	0
2017	1	0

FIG. 1 — Lineage of K955361, 1992–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), 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 K220911 Elecsys CMV IgGscore 4.8 · 3 generations · no Class I recall
#2 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K915892	CMV Igg Elisa Test Summary page 2 …n present in the reaction solution. SAFETY AND EFFECTIVENESS: The INCSTAR CMV IgG ELISA Kit is substantially equivalent (SE) to the GULL CMV IgG ELISA test, 510(k) No. K915892, which has been cleared by the FDA and is currently in U.S. commercial distribution. In clinical performance studies, 308 serum…	Gull Laboratories, Inc.	1992	—

Also cleared against K915892: 1 other device →

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K040290	Diasorin Liaison CMV Igm/Igg	Diasorin S.P.A	2005	3

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?

Its one ancestor has no recall.
Of its descendants, K040290 (Diasorin S.P.A, 2005) has gone furthest, with 3 descendants of its own.
1 other device also cites its predicate K915892.

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

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

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	0	—	1	7
2008	0	—	0	7
2009	0	—	1	14
2010	0	—	0	3
2011	0	—	0	7
2012	0	—	0	0
2013	0	—	0	1
2014	2	—	0	3
2015	0	—	0	7
2016	0	—	0	14
2017	2	—	0	13
2018	1	—	0	9
2019	0	—	0	10
2020	0	—	0	7
2021	0	—	0	23
2022	2	—	1	11
2023	0	—	0	36
2024	0	—	0	34
2025	0	—	1	53
2026	0	—	0	—

What is it indicated for?

The INCSTAR CMV IgG ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of 1gG antibodies to cytomegalovirus in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the CMV IgG ELISA test is of value in the determination of immunological response to infection with CMV. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of primary infection, reactivated infection, or reinfection with cytomegalovirus.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K955361 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955361: Incstar Cytomegalovirus Igg Elisa Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955361

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026