510(k) Report

510(k) · Cleared

Cleared

Liaison Hav Igm Assay, Liaison Control Hav Igm

K082050510(k) TraditionalCleared Nov 3, 2008108-day reviewClass II21 CFR 866.3310

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

DiaSorin, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)

Cleared on Nov 3, 2008 as substantially equivalent to P890014 (DiaSorin, Inc., 1990) after a 108-day review. Its family tree reaches back 1 generation to 1990. 3 later devices descend from it.

Decided
Nov 3, 2008
Review
108 days
Class
Class II
Product code
LOL
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to P890014 (1990). 3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2014: 1 descendant cleared2026: 1 descendant clearedP890014 · HA-Igmk and Eti-HA-Igmk · DiaSorin, Inc. · 1990 · recalled1990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant P890014 · HA-Igmk and Eti-HA-Igmk · DiaSorin, Inc. · 1990 · recalled0
  1. Root · 1 generation backP890014 HA-Igmk and Eti-HA-IgmkDiaSorin, Inc. · 1990 · Recalled
  2. This deviceK082050 Liaison Hav Igm Assay, Liaison Control Hav IgmDiaSorin, Inc. · 2008
  3. Descendant · cites it directly · 2 of its ownK103529 Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011
  4. Descendant · 2 generations on · 1 of its ownK141116 Liaison XL AnalyzerDiaSorin, Inc. · 2014
  5. Descendant · 3 generations on · 0 of its ownK260770 LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026

Most influential descendants

Showing 3 of 3 · See all
  • K103529Liaison XL Analyzer Model 10050DiaSorin, Inc. · 2011 · cites it directly2descendants
  • K141116Liaison XL AnalyzerDiaSorin, Inc. · 2014 · 2 generations on1descendant
  • K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1P890014HA-Igmk and Eti-HA-IgmkDiaSorin, Inc.19901
0 (this device)K082050Liaison Hav Igm Assay, Liaison Control Hav IgmDiaSorin, Inc.2008—
+1K103529Liaison XL Analyzer Model 10050DiaSorin, Inc.2011—
+2K141116Liaison XL AnalyzerDiaSorin, Inc.2014—
+3K260770LIAISON Murex HBsAg Qual; LIAISON XL; LIAISON diluteXDiaSorin, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
202610
FIG. 1 — Lineage of K082050, 1990–2026Source: 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), 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 LOL? 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 LOL device

  1. #1 K251995 Access anti-HAV IgMscore 13.8 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 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.

TypeNumberDeviceApplicantDecidedRecalls
*P890014HA-Igmk and Eti-HA-Igmk
Summary page 1
…LOL PREDICATE DEVICES DiaSorin Inc. ETI-HA-IGMK Plus Kit (PMA #P890014/S002) DEVICE DESCRIPTION: INTENDED USE: The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended f…
DiaSorin, Inc.19901

Also cleared against P890014: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K103529Liaison XL Analyzer Model 10050DiaSorin, Inc.20112

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 a recall.
  • Of its descendants, K103529 (DiaSorin, Inc., 2011) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate P890014.

How does its category compare?

All LOL devices

LOL Hepatitis A Test (Antibody And Igm Antibody): FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LOL

1in 2025

2007: 32008: 32009: 22010: 22011: 12012: 12014: 22016: 22019: 12020: 12021: 12022: 12023: 12025: 12026 (partial year): 2
2007high 3 (2007) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LOL

108in 2008

2007: 182 days median2008: 108 days median
2007high 182 (2007) · low 108 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LOL

2in 2019

2007: 22008: 12009: 12011: 12018: 12019: 2
2007high 2 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LOL

19in 2025

2007: 22008: 132009: 242010: 532011: 3532012: 422013: 492014: 192015: 292016: 362017: 262018: 612019: 512020: 1042021: 122022: 172023: 362024: 212025: 19
2007high 353 (2011) · low 2 (2007)2025

MAUDE reports naming product code LOL, 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
2007318222
20083108113
20092—124
20102—053
20111—1353
20121—042
20130—049
20142—019
20150—029
20162—036
20170—026
20180—161
20191—251
20201—0104
20211—012
20221—017
20231—036
20240—021
20251—019
20262—0—

What is it indicated for?

The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory…

Read the full statement (143 words)

The LIAISON® HAV IgM assay is an in vitro chemiluminescent immunoassay intended for the qualitative detection of IgM antibodies to hepatitis A virus (IgM anti-HAV) in human serum and sodium heparin plasma using the LIAISON® Analyzer. Assay results, in conjunction with other serological and clinical information, may be used for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis as an aid in the laboratory diagnosis of acute or recent HAV infection.

This assay is not intended for screening blood or solid or soft tissue donors. Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. The user is responsible for establishing their own assay performance characteristics in these populations.

The LIAISON® Control HAV IgM (negative and reactive) is intended for use as assayed quality control samples to monitor the performance of the LIAISON® HAV IgM assay.

Indications for use as stated in the FDA summary.

Also cleared against P890014

2 other devices cite the same predicate.

  • K160650LIAISON HAV IgM, LIAISON Control HAV IgMDiaSorin, Inc. · 2016
  • K063319Monolisa Anti-Hav Igm EiaBio-Rad Laboratories · 2007

More from DiaSorin, Inc.

444 FDA decisions under this applicant name. See the company

  • P180047/S046LIAISON® QuantiFERON®-TB Gold Plus II.DiaSorin, Inc. · 2026
  • P180047/S045LIAISON QuantiFERON-TB Gold III; LIAISON Control QuantiFERON-TB Gold III; LIAISON QuantiFERON-TB Gold Plus…DiaSorin, Inc. · 2026
  • P180047/S043LIAISON QuantiFERON-TB Gold Plus; LIAISON XL Control QuantiFERON-TB Gold Plus; LIAISON QuantiFERON-TB Gold…DiaSorin, Inc. · 2026
  • P220034/S010LIAISON Biotrin Parvovirus B19 IgG Plus; LIAISON Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026
  • P220034/S011LIAISON® Biotrin Parvovirus B19 IgG Plus, LIAISON® Biotrin Control Parvovirus B19 IgG PlusDiaSorin, Inc. · 2026

Recent decisions in LOL

The LOL category page

  • K260048Elecsys Anti-HAV IgMRoche Diagnostics · 2026
  • K251995Access anti-HAV IgMBeckman Coulter, Inc. · 2026
  • K243846Access anti-HAVBeckman Coulter, Inc. · 2025
  • K222850HAVAb IgG IIAbbott Laboratories · 2023
  • K223403LIAISON Anti-HAV; LIAISON XSDiaSorin, Inc. · 2022

https://510kreport.com/device/K082050 · printed Nov 5, 2026

Cite this page

510(k) Report. “K082050: Liaison Hav Igm Assay, Liaison Control Hav Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082050

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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