# K983424: Abbott Archeitect Total B-HCG

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Dec 1, 1998 after 63 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
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AxSYM Total B-hCG: named in the summary without a submission number

## Most influential descendants
- K170317: Alinity i Total ß-hCG Reagent Kit, Alinity i System (2017), 1 descendant of its own
- K063720: Vitros Immunodiagnostic Products Total B-HCG II Reagent Pack, Calibrators, Range Verifiers (2007), 1 descendant of its own
- K233581: VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack (2024), 0 descendants of its own
- 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
- K133002: i-STAT Total beta-hCG Test, i-STAT Total beta-hCG Controls, i-STAT Total beta-hCG Calibration Verification Materials (2015), 0 descendants of its own

## Indications for use
Abbott ARCHITECT™ Total B-hCG is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma on the Abbott ARCHITECT i System for the early detection of pregnancy.

Source page: https://510kreport.com/device/K983424
Methodology: https://510kreport.com/methodology