510(k) · Cleared
Recalled · 2007Axsym Total B-HCG
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · JHI Visual, Pregnancy Hcg, Prescription Use
Cleared on Jun 21, 1994 after a 207-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 7 times.
- Decided
- Jun 21, 1994
- Review
- 207 days
- Class
- Class II
- Product code
- JHI
- Recalls
- 7
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JHI? 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 JHI device
- #1 K262299 Instant-View® hCG Combo II Cassette Testscore 12.7 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Apr 10, 2007 | Not classified | Z-1067-2007 | Other | An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background… |
| Apr 10, 2007 | Not classified | Z-1068-2007 | Other | An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background… |
| Apr 10, 2007 | Not classified | Z-1069-2007 | Other | An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background… |
| Apr 10, 2007 | Not classified | Z-1070-2007 | Other | An increase in background counts elevates the results of low level samples up to approximately 6mIU/mL. This is not enough to shift a negative result to positive on an undiluted sample. If low level samples are diluted then the background… |
| Mar 24, 2005 | Not classified | Z-0893-05 | Other | Abbott Diagnostics is investigation a recent increase in customer complaints for AxSYM calibration error code 1048 and controls out of range when using AxSYM Total B-hCG reagent lots. Testing has shown that protein aggregates are present… |
| Aug 24, 2004 | Not classified | Z-0006-05 | Other | Assay may give elevated patients results. |
| Jul 7, 2004 | Not classified | Z-1436-04 | Other | Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All JHI devicesJHI Visual, Pregnancy Hcg, Prescription Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JHI
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · JHI
101in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JHI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JHI
265in 2025
MAUDE reports naming product code JHI, 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 | 4 | 101 | 6 | 245 |
| 2008 | 0 | — | 8 | 29 |
| 2009 | 0 | — | 1 | 106 |
| 2010 | 1 | — | 2 | 143 |
| 2011 | 0 | — | 1 | 138 |
| 2012 | 2 | — | 0 | 219 |
| 2013 | 2 | — | 0 | 185 |
| 2014 | 2 | — | 0 | 112 |
| 2015 | 0 | — | 0 | 134 |
| 2016 | 1 | — | 0 | 143 |
| 2017 | 1 | — | 0 | 113 |
| 2018 | 1 | — | 0 | 132 |
| 2019 | 0 | — | 0 | 571 |
| 2020 | 0 | — | 0 | 114 |
| 2021 | 0 | — | 0 | 158 |
| 2022 | 1 | — | 0 | 126 |
| 2023 | 0 | — | 6 | 147 |
| 2024 | 1 | — | 1 | 256 |
| 2025 | 0 | — | 0 | 265 |
| 2026 | 1 | — | 4 | — |
https://510kreport.com/device/K935673 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935673: Axsym Total B-HCG.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935673
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026