510(k) · Cleared
ClearedMonolisa Anti-Hav Igm Eia
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on May 3, 2007 as substantially equivalent to P890014 (DiaSorin, Inc., 1990) after a 182-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.
- Decided
- May 3, 2007
- Review
- 182 days
- Class
- Class II
- Product code
- LOL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to P890014 (1990). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K092353Monolisa Anti-Hav Igm EiaBio-Rad Laboratories, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P890014 | HA-Igmk and Eti-HA-Igmk | DiaSorin, Inc. | 1990 | 1 |
| 0 (this device) | K063319 | Monolisa Anti-Hav Igm Eia | Bio-Rad Laboratories | 2007 | — |
| +1 | K092353 | Monolisa Anti-Hav Igm Eia | Bio-Rad Laboratories, Inc. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 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 13.8 · 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 |
|---|---|---|---|
| * | P890014 | HA-Igmk and Eti-HA-IgmkSummary page 2…ology and Microbiology Devices REGULATION NUMBER: 21 CFR 866.3310 LEGALLY MARKETED EQUIVALENT (SE) DEVICE DiaSorin ETI-HA-IGMK PLUS PMA Number P890014 Decision Date 12/14/2005 DEVICE DESCRIPTION The MONOLISA TM Anti-HAV IgM EIA is an enzyme immunoassay (IgM antibody capture… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092353 | Monolisa Anti-Hav Igm Eia | 2009 | 0 |
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. 2007, 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 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 (116 words)
The MONOLISA 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.
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/K063319 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063319: Monolisa Anti-Hav Igm Eia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063319
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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