510(k) Report

510(k) · Cleared

Recalled · Class II · 2022

Seraquest CMV Igm

K982485510(k) TraditionalCleared Jan 13, 1999180-day reviewClass II21 CFR 866.3175Recalls 2

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

Quest Intl., Inc. · LFZ Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus

Cleared on Jan 13, 1999 after a 180-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 2 times.

Decided
Jan 13, 1999
Review
180 days
Class
Class II
Product code
LFZ
Recalls
2
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K982485Source: FDA 510(k) database · 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), the FDA 510(k) statement (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. #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’s file for it is a 510(k) statement, which names no predicate.

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 19, 2022Class IIZ-0342-2023Nonconforming Material/ComponentDue to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
Sep 28, 2010Not classifiedZ-0837-2012StorageQuest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.

No ancestor or descendant has a Class I recall.

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—

What is it indicated for?

1. For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection.

2. A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection.

3. Useful for the above indications, with specimens obtained from women of childbearing age.

4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

More from Quest Intl., Inc.

25 FDA decisions under this applicant name. See the company

  • K091260Seraquest Ebv EA-D Igg TestQuest Intl., Inc. · 2009
  • K033915Modification to Seraquest EB Vca IggQuest Intl., Inc. · 2004
  • K033780Modification to Seraquest Vca IgmQuest Intl., Inc. · 2004
  • K023593Seraquest Anti-Thyroid Peroxidase (Tpo)Quest Intl., Inc. · 2003
  • K023592Seraquest Anti-ThyroglobulinQuest Intl., Inc. · 2003

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/K982485 · printed Nov 6, 2026

Cite this page

510(k) Report. “K982485: Seraquest CMV Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982485

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026