510(k) · Cleared
ClearedElecsys Anti-HAV II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Aug 13, 2019 as substantially equivalent to K100903 (Roche Professional Diagnostics, 2010) after a 172-day review. Its family tree reaches back 2 generations to 1979. 2 later devices descend from it.
- Decided
- Aug 13, 2019
- Review
- 172 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to P780012 (1979). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backP780012 HAVABAbbott Laboratories · 1979 · Recalled
- 1 generation backK100903 Anti-HavRoche Professional Diagnostics · 2010
- This deviceK190428 Elecsys Anti-HAV IIRoche Diagnostics · 2019
- Descendant · cites it directly · 0 of its ownK242492 Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem…Techno-Path Manufacturing, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK243846 Access anti-HAVBeckman Coulter, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P780012 | HAVAB | Abbott Laboratories | 1979 | 1 |
| −1 | K100903 | Anti-Hav | Roche Professional Diagnostics | 2010 | — |
| 0 (this device) | K190428 | Elecsys Anti-HAV II | Roche Diagnostics | 2019 | — |
| +1 | K242492 | Multichem ID-G (09339892190); Multichem ID-G (SR102G); Multichem ID-G… | Techno-Path Manufacturing, Ltd. | 2025 | — |
| +1 | K243846 | Access anti-HAV | Beckman Coulter, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K100903 | Anti-HavSummary page 5…t Codes, 1. LOL, 21 CFR §866.3310 Regulation Numbers 2. QCH, 21 CFR §866.3920, Quality Control Predicate Devices Elecsys Anti-HAV (K100903) For the Elecsys Anti-HAV II, the establishment registration number for Roche… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 40 years and passes through 3 companies; a new generation was cleared every 31.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K242492 (Techno-Path Manufacturing, Ltd., 2025) has gone furthest, with 0 descendants of its own.
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. 2019, 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?
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li-heparin, potassium EDTA, Na-citrate, Na-heparin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of…
Read the full statement (148 words)
Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li-heparin, potassium EDTA, Na-citrate, Na-heparin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on the cobas e immunoassay analyzers.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.
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/K190428 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190428: Elecsys Anti-HAV II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190428
Report an extraction error
Are you the manufacturer?
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