# K110412: Ids-Isys Ifg-I Control Set

- Pathway: 510(k) (Abbreviated)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Mar 16, 2011 after 30 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- 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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The IDS-iSYS IGF-I Controls Set is a quality control material device intended for medical purposes for use in the IDS-iSYS Insulin like Growth Factor-I (IGF-I) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGF-I Assay.

Source page: https://510kreport.com/device/K110412
Methodology: https://510kreport.com/methodology