510(k) · Cleared
ClearedHAVAb IgG II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · LOL Hepatitis A Test (Antibody And Igm Antibody)
Cleared on Aug 10, 2023 as substantially equivalent to K113704 (Abbott Laboratories, 2012) after a 323-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Aug 10, 2023
- Review
- 323 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 13.8 · 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 |
|---|---|---|---|
| * | K113704 | Architect Havab-GSummary page 5…l material for clinical microbiology assays Governing Regulation: 21 CFR § 866.3920 Code: QCH IV. Predicate Device Abbott Laboratories: ARCHITECT HAVAB-G (-K113704) V. Description of Device Reagents The kit configuration of the HAVAb IgG II reagent kit is described below.… | 2012 |
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 16 years and passes through 1 company; a new generation was cleared every 11.1 years on median.
- 2 of the 2 ancestors have 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. 2023, 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 HAVAb IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric (4 through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, dipotassium EDTA, and tripotassium EDTA tubes) from patients with signs and symptoms or at risk for…
Read the full statement (145 words)
The HAVAb IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric (4 through 21 years) serum (collected in serum and serum separator tubes) and plasma (collected in sodium heparin, lithium heparin, lithium heparin separator, dipotassium EDTA, and tripotassium EDTA tubes) from patients with signs and symptoms or at risk for hepatitis A on the Alinity i system.
The HAVAb IgG II assay is used to determine the immune status of individuals to hepatitis A virus (HAV) infection.
Warning: This assay has not been cleared for use in screening blood, plasma, or tissue donors. This assay cannot be used for the diagnosis of acute HAV infection.
Assay performance characteristics have not been established when the HAVAb IgG II assay is used in conjunction with other hepatitis assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222850: HAVAb IgG II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222850
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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