# K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Oct 23, 2017 after 264 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K983212 (1998). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983424: Abbott Archeitect Total B-HCG, Abbott Laboratories (1998) Summary page 5.
- K983212: Abbott Architect Testosterone, Abbott Laboratories (1998) Summary page 5.

## Most influential descendants
- K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (2023), 0 descendants of its own

## Recalls of this device
- Nov 13, 2025 · Class II · Z-0961-2026: Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the A
- Nov 24, 2022 · Class III · Z-0958-2023: Reaction vessels may contain a potential contaminant that could affect their optical performance.
- Nov 21, 2018 · Class II · Z-0666-2019: Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it ma

## Indications for use
The Alinity i Total β-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (β-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer. The Alinity i System is a fully automated immunoassay analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology. CMIA technology is used to determine the presence of antigens, antibodies, and analyte in samples.

Source page: https://510kreport.com/device/K170317
Methodology: https://510kreport.com/methodology