510(k) · Cleared
ClearedADVIA Centaur HAV IgM Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Oct 13, 2016 as substantially equivalent to K060770 (Ortho-Clinical Diagnostics, Inc., 2006) after an 87-day review. Its family tree reaches back 2 generations to 1980.
- Decided
- Oct 13, 2016
- Review
- 87 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P790019 (1980). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backP790019 Havab-M Diagnostic KitAbbott Laboratories · 1980 · Recalled
- 1 generation backK060770 Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack…Ortho-Clinical Diagnostics, Inc. · 2006
- This deviceK161964 ADVIA Centaur HAV IgM AssaySiemens Healthcare Diagnostics, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P790019 | Havab-M Diagnostic Kit | Abbott Laboratories | 1980 | 1 |
| −1 | K060770 | Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
| 0 (this device) | K161964 | ADVIA Centaur HAV IgM Assay | Siemens Healthcare Diagnostics, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
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 K251995 Access anti-HAV IgMscore 13.7 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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 | Decided |
|---|---|---|---|
| * | K060770 | Vitros Immunodiagnostic Products Anti-Hav Igm-Reagent Pack, Calibrator, and ControlsSummary page 4…. Predicate Device: The ADVIA® Centaur HAV IgM Assay is substantially equivalent to the VITROS Immunodiagnostic Products Anti-HAV IgM Reagent Pack cleared under 510(k): k060770 H. Device Description: The ADVIA Centaur HAV IgM reagent kit contains the following: ReadyPack® primary reagent pack… | 2006 |
| † | K081716 | Advia Centaur Havm Assay | 2008 |
| † | P040018 | Advia Centaur Hav Igm Ready Pack Reagents, Advia Centaur Hav Igm Quality Control Materials | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 36 years and passes through 3 companies; a new generation was cleared every 26.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LOL devicesLOL Hepatitis A Test (Antibody And Igm Antibody): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · LOL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LOL
108in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LOL
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LOL
19in 2025
MAUDE reports naming product code LOL, 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 | 3 | 182 | 2 | 2 |
| 2008 | 3 | 108 | 1 | 13 |
| 2009 | 2 | — | 1 | 24 |
| 2010 | 2 | — | 0 | 53 |
| 2011 | 1 | — | 1 | 353 |
| 2012 | 1 | — | 0 | 42 |
| 2013 | 0 | — | 0 | 49 |
| 2014 | 2 | — | 0 | 19 |
| 2015 | 0 | — | 0 | 29 |
| 2016 | 2 | — | 0 | 36 |
| 2017 | 0 | — | 0 | 26 |
| 2018 | 0 | — | 1 | 61 |
| 2019 | 1 | — | 2 | 51 |
| 2020 | 1 | — | 0 | 104 |
| 2021 | 1 | — | 0 | 12 |
| 2022 | 1 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 21 |
| 2025 | 1 | — | 0 | 19 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems: The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is intended for use as an aid in…
Read the full statement (216 words)
ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems:
The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
ADVIA Centaur CP system:
The ADVIA Centaur® HAV IgM (aHAVM) assay is an in vitro diagnostic immunoassay for the qualitative determination of IgM response to the hepatitis A virus (HAV) in human pediatric (2 through 21 years) and adult serum or plasma (potassium EDTA, lithium or sodium heparinized) using the ADVIA Centaur CP system. This assay is intended for use as an aid in the diagnosis of acute or recent infection (usually 6 months or less) with hepatitis A virus.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, cord blood, or patients less than 2 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161964: ADVIA Centaur HAV IgM Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161964
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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