510(k) · Cleared
Recalled · 2011Abbott Architect Havab-M
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 Apr 16, 2007 after a 164-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 16, 2007
- Review
- 164 days
- Class
- Class II
- Product code
- LOL
- Recalls
- 2
- Predicates
- 1
4 later devices descend from it, 2 citing it directly.
- This deviceK063329 Abbott Architect Havab-MAbbott Laboratories · 2007
- Descendant · cites it directly · 1 of its ownK251995 Access anti-HAV IgMBeckman Coulter, Inc. · 2026
- Descendant · cites it directly · 1 of its ownK113704 Architect Havab-GAbbott Laboratories · 2012 · Recalled
- Descendant · 2 generations on · 0 of its ownK260048 Elecsys Anti-HAV IgMRoche Diagnostics · 2026
- Descendant · 2 generations on · 0 of its ownK222850 HAVAb IgG IIAbbott Laboratories · 2023
Most influential descendants
Showing 4 of 4 · See all- K251995Access anti-HAV IgMBeckman Coulter, Inc. · 2026 · cites it directly1descendant
- K113704Architect Havab-GAbbott Laboratories · 2012 · cites it directly1descendant
- K260048Elecsys Anti-HAV IgMRoche Diagnostics · 2026 · 2 generations on0descendants
- K222850HAVAb IgG IIAbbott Laboratories · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K063329 | Abbott Architect Havab-M | Abbott Laboratories | 2007 | — |
| +1 | K251995 | Access anti-HAV IgM | Beckman Coulter, Inc. | 2026 | — |
| +1 | K113704 | Architect Havab-G | Abbott Laboratories | 2012 | 2 |
| +2 | K260048 | Elecsys Anti-HAV IgM | Roche Diagnostics | 2026 | — |
| +2 | K222850 | HAVAb IgG II | Abbott Laboratories | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 2 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | P790012 | ABBOTT AxSYM® HAVAB®-M 2.0 assay Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…AV) Classification Number: 21 CFR §866.3310 Predicate Device: ABBOTT AxSYM® HAVAB®-M 2.0 assay. PMA Number: P790012/S011 Decision Date: February 2, 2004 Device reclassified from… |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 20, 2011 | Not classified | Z-2413-2011 | Nonconforming Material/Component | The HAVAB-M reagent lot has reduced specificity and may cause an increase in false grayzone and/or false reactive results. |
| Dec 30, 2009 | Not classified | Z-1596-2010 | Pending | There is a potential to generate a false grayzone or reactive HAVAB-M result when the ARCHITECT AUSAB assay precedes the ARCHITECT HAVAB-M assay. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K251995 (Beckman Coulter, Inc., 2026) has gone furthest, with 1 descendant of its own.
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 ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in…
Read the full statement (265 words)
The ARCHITECT HAVAB-M assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) in human adult and pediatric serum and plasma (dipotassium EDTA, lithium heparin, and sodium heparin) and neonatal serum. A test for IgM anti-HAV is indicated for testing of specimens from individuals who have signs and symptoms consistent with acute hepatitis. Test results are used in conjunction with other laboratory results and clinical information as an aid in the diagnosis of acute or recent hepatitis A viral infection.
Warning: Not intended for use in screening blood, plasma, or tissue donors. The effectiveness of ARCHITECT HAVAB-M for use in screening blood, plasma, or tissue donors has not been established.
Assay performance characteristics have not been established when the ARCHITECT HAVAB-M assay is used in conjunction with other manufacturers' assays for specific hepatitis markers. Users are responsible for establishing their own performance characteristics.
ARCHITECT HAVAB-M Calibrator:
The ARCHITECT HAVAB-M Calibrator is used to calibrate the ARCHITECT i System when the system is used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Calibrator has not been established with any other IgM anti-HAV assays.
ARCHITECT HAVAB-M Controls:
The ARCHITECT HAVAB-M Controls are used for monitoring the performance of the ARCHITECT i System when used for the qualitative detection of IgM antibody to hepatitis A virus (IgM anti-HAV) using the ARCHITECT HAVAB-M Reagent Kit. The performance of the ARCHITECT HAVAB-M Controls has not been established with any other IgM anti-HAV assays.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063329 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063329: Abbott Architect Havab-M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063329
Report an extraction error
Are you the manufacturer?
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