510(k) · Cleared
ClearedElecsys Anti-HAV IgM
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 Apr 7, 2026 as substantially equivalent to K251995 (Beckman Coulter, Inc., 2026) after a 90-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Apr 7, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K063329 (2007). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K251995 | Access anti-HAV IgM Cleared while this submission was under review Summary page 7…e of assay in pediatric populations. The technological characteristics of the Elecsys Anti-HAV IgM are compared to the identified predicate device, Access anti-HAV IgM (K251995) in Table 1. Table 1: Similarities and Differences between the Elecsys Anti-HAV IgM and the Access anti-HAV IgM (… | 2026 |
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 19 years and passes through 3 companies; a new generation was cleared every 18.8 years on median.
- 1 of the 2 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. 2026, 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 IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired…
Read the full statement (116 words)
Immunoassay for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) from adult and pediatric (2 through 21 years of age) patients with signs and symptoms of hepatitis or persons who may be at risk for hepatitis A infection. The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus (HAV) infection. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HAV.
The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260048 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260048: Elecsys Anti-HAV IgM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260048
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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