510(k) · Cleared
Recalled · Class II · 2020Architect Havab-G
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 Jun 28, 2012 as substantially equivalent to K063329 (Abbott Laboratories, 2007) after a 195-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jun 28, 2012
- Review
- 195 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K063329 (2007). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K222850HAVAb IgG IIAbbott Laboratories · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K063329 | Abbott Architect Havab-M | Abbott Laboratories | 2007 | 2 |
| 0 (this device) | K113704 | Architect Havab-G | Abbott Laboratories | 2012 | — |
| +1 | K222850 | HAVAb IgG II | Abbott Laboratories | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K063329 | Abbott Architect Havab-MSummary page 2…ion: 862.1660 Device Classification: I Classification Panel: Microbiology Code: MJY/MJX Legally marketed device to which equivalency is claimed: ARCHITECT HAVAB-M (k063329) FDA Document Numbers of all prior related submissions (regardless of outcome): ARCHITECT HAVAB-G Pre-IDE 100394 Intended Us… | 2007 |
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 |
|---|---|---|---|
| K222850 | HAVAb IgG II | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 9, 2020 | Class II | Z-1728-2020 | Mixed-up of materials/components | An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots. |
| Nov 7, 2019 | Class II | Z-0574-2020 | Material/Component Contamination | Abbott has identified that Calibrator lot 08219BE00 is potentially impacted by an increase in Relative Light Units (RLUs) up to 94%. It has been confirmed that the increase in the calibrator RLU values may cause a decrease in the control… |
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. 2012, 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?
ARCHITECT HAVAB-G. The ARCHITECT HAVAB-G assay is a chemilumninescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the inmnune status of individuals to hepatitis A virus infection. Warning: This assay has not been FDA cleared or approved…
Read the full statement (288 words)
ARCHITECT HAVAB-G.
The ARCHITECT HAVAB-G assay is a chemilumninescent microparticle immunoassay (CMIA) for the qualitative detection of IgG antibody to hepatitis A virus (IgG anti-HAV) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the inmnune status of individuals to hepatitis A virus infection.
Warning: This assay has not been FDA cleared or approved for the screening of blood or plasma donors. This assay cannot be used for the diagnosis of acute HAV infection.
Assay performance characteristics have not been established when the ARCHITECT HAVAB-G assay is used in conjunction with other hepatitis assays.
ARCHITECT HAVAB-G Calibrator:
The ARCHITECT HAVAB-G Calibrator is for the calibration of the ARCHITECT iSystem, when used for the qualitative detection of IgO antibody to hepatitis A virus (IgG anti-HAy) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Calibrator has not been established with any other IgG anti-HAV assays.
HAVAB-G Controls:
The ARCHITECT HAVAB-G Controls are used for monitoring the performance of the ARCHITECT i System, when used for the qualitative detection of JgG antibody to hepatitis A virus (IgG anti-HAy) in human adult and pediatric serum from patients with signs and symptoms or at risk for hepatitis. The ARCHITECT HAVAB-G assay is used to determine the immune status of individuals to hepatitis A virus infection, using the ARCHITECT HAVAB-G Reagent Kit. The performance of the ARCHITECT HAVAB-G Controls have not been established with any other IgG anti-HAV assays
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113704 · printed Nov 3, 2026
Cite this page
510(k) Report. “K113704: Architect Havab-G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K113704
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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