510(k) · Cleared
Recalled · Class II · 2019Anti-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 Jun 22, 2010 as substantially equivalent to P790019 (Abbott Laboratories, 1980) after a 181-day review. Its family tree reaches back 1 generation to 1980. It has been recalled 2 times.
- Decided
- Jun 22, 2010
- Review
- 181 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to P790019 (1980). No later device cites it as a predicate yet.
- Root · 1 generation backP790019 Havab-M Diagnostic KitAbbott Laboratories · 1980 · Recalled
- This deviceK093955 Anti-Hav IgmRoche Diagnostics · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P790019 | Havab-M Diagnostic Kit | Abbott Laboratories | 1980 | 1 |
| 0 (this device) | K093955 | Anti-Hav Igm | Roche Diagnostics | 2010 | — |
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 13.8 · 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 |
|---|---|---|---|
| * | P790019 | Havab-M Diagnostic KitSummary page 1…(Assayed and Unassayed) Product Code: LOL, JJX Predicate Device: Abbott Axsym HAVAB-M 2.0 Assay (P790019/SOlI 1) DEVICE DESCRIPTION: intended Use: The Roche Elecsys Anti-HAV 1gM immunoassay is used for the in vitro qualitative detec… | 1980 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 28, 2019 | Class II | Z-0669-2020 | Employee error | Current software version of the Anti-HAV IgM APP-file (version 06.05-101) downloaded an erroneous Border Area setting, (1.0 1.00) instead of (0.90 1.10). |
| Dec 17, 2018 | Class II | Z-0784-2019 | Software Design Change | Potential for erroneous result messages for the Anti-HAV IgM assay when run on the cobas e 602 module. Discrepant result reporting may result. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 1 other device also cites its predicate P790019.
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 IgM imnmunoassay is used for the in vitro qualitative detection of 1gM antibodies to hepatitis A virus (anti-HAV 1gM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection. Assay results, in conjunction with other laboratory results and clinical information, may be…
Read the full statement (138 words)
The Roche Elecsys Anti-HAV IgM imnmunoassay is used for the in vitro qualitative detection of 1gM antibodies to hepatitis A virus (anti-HAV 1gM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus 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 and symptoms of hepatitis and in persons at risk for hepatitis A infection.
The clectrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HIAV 1gM immunoassay on the Elecsys and coals e immunoassay analyzers.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093955 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093955: Anti-Hav Igm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093955
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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