510(k) · Cleared
Recalled · 2010Monolisa Anti-Hav Igm Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Oct 29, 2009 as substantially equivalent to K063319 (Bio-Rad Laboratories, 2007) after an 86-day review. Its family tree reaches back 2 generations to 1990. It has been recalled once.
- Decided
- Oct 29, 2009
- Review
- 86 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to P890014 (1990). 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 13.8 · 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 |
|---|---|---|---|
| * | K063319 | Monolisa Anti-Hav Igm EiaSummary page 1…ISATM Anti-HAV IgM EIA used with the EVOLIS TM Automated Microplate System is substantially equivalent to the MONOLISA TM Anti-HAV IgM EIA using the manual method (k063319) 4. Description of the Device: The MONOLISATM Anti-HAV IgM EIA is an enzyme immunoassay (IgM antibody capture format) for… | 2007 |
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 |
|---|---|---|---|---|
| Jul 19, 2010 | Not classified | Z-2201-2011 | Software design | The EVOLIS Assay Protocol Files Software is configured in such a way that may result in a miscalculation of quantitative test results and/or an error in reporting positive/negative sample values. |
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 16.8 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. 2009, 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 MONOLISA TM Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results, in conjunction with other serological or clinical information, may be…
Read the full statement (146 words)
The MONOLISA TM Anti-HAV IgM EIA is an in vitro enzyme immunoassay kit intended for use in the qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human (adult and pediatric) serum or plasma (EDTA, Heparin, Citrate, ACD). This assay is indicated for testing specimens from individuals who have signs and symptoms consistent with acute hepatitis. Assay results, in conjunction with other serological or clinical information, may be used for the laboratory diagnosis of individuals with acute or recent hepatitis A. The MONOLISA TM Anti-HAV IgM EIA is intended for manual use and with the Evolis TM Automated Microplate System in the detection of IgM antibodies to hepatitis A virus.
Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients, and cord blood or neonatal specimens.
Warning: This assay is not intended for screening blood or solid or soft tissue donors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092353 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092353: Monolisa Anti-Hav Igm Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092353
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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