# K935673: Axsym Total B-HCG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Jun 21, 1994 after 207 days
- Product code: JHI (Visual, Pregnancy Hcg, Prescription Use)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Apr 10, 2007 · Not classified · Z-1067-2007: 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 s
- Apr 10, 2007 · Not classified · Z-1068-2007: 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 s
- Apr 10, 2007 · Not classified · Z-1069-2007: 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 s
- Apr 10, 2007 · Not classified · Z-1070-2007: 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 s
- Mar 24, 2005 · Not classified · Z-0893-05: 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 show
- Aug 24, 2004 · Not classified · Z-0006-05: Assay may give elevated patients results.
- Jul 7, 2004 · Not classified · Z-1436-04: Complaints have been received for AxSYM Total B-hCG Reagents lots 17202Q100, 17556Q100 and 17387Q100 failing calibrations.

Source page: https://510kreport.com/device/K935673
Methodology: https://510kreport.com/methodology