# K230852: HemosIL Chromogenic Factor IX

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory Company
- Decided: Dec 13, 2023 after 260 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K893524 (1989). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031829: Hemosil Factor IX Deficient Plasma, Instrumentation Laboratory CO (2003) Summary page 4.

## Indications for use
HemosIL Chromogenic Factor IX is an automated assay for the photometric, quantitative determination of factor IX activity in 3.2% citrated plasma on the ACL TOP® Family and ACL TOP Family 50 Series in the laboratory setting by a healthcare professional. HemosIL Chromogenic Factor IX is indicated for use on patients when identifying factor IX deficiency or measuring factor IX activity from patients on replacement therapy. For adult population only. For prescription use only.

Source page: https://510kreport.com/device/K230852
Methodology: https://510kreport.com/methodology