# K230790: Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: May 19, 2023 after 58 days
- Product code: DHA (System, Test, Human Chorionic Gonadotropin)
- Device class: 2
- Regulation: 21 CFR 862.1155
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K872494 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System, Abbott Laboratories (2017) Summary page 6.
- K170316: Alinity C Glucose Reagent Kit, Alinity C System, Abbott Laboratories (2017) Summary page 6.
- K170320: Alinity c ICT Sample Diluent, Abbott Laboratories (2017) Summary page 6.

## Indications for use
The Alinity ci-series is intended for in vitro diagnostic use only. The Alinity ci-series is a System comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation. The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids. The Alinity i System is a fully automated 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 analytes in samples. The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine on the Alinity c analyzer. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis. The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. 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.

Source page: https://510kreport.com/device/K230790
Methodology: https://510kreport.com/methodology