510(k) · Cleared
ClearedAnti-Hav
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Professional Diagnostics · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Oct 5, 2010 as substantially equivalent to P780012 (Abbott Laboratories, 1979) after a 187-day review. Its family tree reaches back 1 generation to 1979. 3 later devices descend from it.
- Decided
- Oct 5, 2010
- Review
- 187 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P780012 (1979). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backP780012 HAVABAbbott Laboratories · 1979 · Recalled
- This deviceK100903 Anti-HavRoche Professional Diagnostics · 2010
- Descendant · cites it directly · 2 of its ownK190428 Elecsys Anti-HAV IIRoche Diagnostics · 2019
- Descendant · 2 generations on · 0 of its ownK242492 Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem…Techno-Path Manufacturing, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK243846 Access anti-HAVBeckman Coulter, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K190428Elecsys Anti-HAV IIRoche Diagnostics · 2019 · cites it directly2descendants
- K242492Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G (SR102MG)…Techno-Path Manufacturing, Ltd. · 2025 · 2 generations on0descendants
- K243846Access anti-HAVBeckman Coulter, Inc. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P780012 | HAVAB | Abbott Laboratories | 1979 | 1 |
| 0 (this device) | K100903 | Anti-Hav | Roche Professional Diagnostics | 2010 | — |
| +1 | K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019 | — |
| +2 | K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G… | Techno-Path Manufacturing, Ltd. | 2025 | — |
| +2 | K243846 | Access anti-HAV | Beckman Coulter, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 2 | 0 |
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 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 |
|---|---|---|---|
| * | P780012 | HAVABSummary page 3…)ruthenium(II)-complex (Ru(bpy)) 3 2+ J. Substantial Equivalence Information: 1. Predicate device name(s): Abbott AxSym HAVAB® 2.0 2. Predicate Numbers (s): P780012/S009 3. Comparison with predicate: Similarities Anti-HAV Immunoassay Comparison Feature Elecsys Anti-HAV… | 1979 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190428 | Elecsys Anti-HAV II | 2019 | 2 |
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?
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. 2010, 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?
The Roche Elecsys Anti-HAV immunoassay is used for the in vitro qualitative detection of total antibodies (IgM and IgG) to hepatitis A virus in human serum and plasma (K2-EDTA). The assay is intended for use as an aid in the laboratory diagnosis of past or acute/recent hepatitis A infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus…
Read the full statement (184 words)
The Roche Elecsys Anti-HAV immunoassay is used for the in vitro qualitative detection of total antibodies (IgM and IgG) to hepatitis A virus in human serum and plasma (K2-EDTA). The assay is intended for use as an aid in the laboratory diagnosis of past or acute/recent hepatitis A infection.
Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis A infection, or used as an aid to determine the presence of antibody response to HAV in vaccine recipients.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Anti-HAV is used for the quality control of the Elecsys Anti-HAV immunoassay on the Elecsys and cobas e immunoassay analyzers.
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 users are responsible for establishing their own assay performance characteristics in these populations.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K100903 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100903: Anti-Hav.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100903
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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