# K122141: Ids-Isys Igf-I Calibration Verifiers

- Pathway: 510(k) (Abbreviated)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Aug 7, 2012 after 19 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
Longest line of descent: 6 generations back to K001015 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103221: Elecys HGH Calset, Elecsys HGH Calcheck 5, Roche Diagnostics (2010) Summary page 1.

## Indications for use
The IDS-iSYS IGF-I Calibration Verifier is a device intended for verification of calibration of the IDS-iSYS IGF-I Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Source page: https://510kreport.com/device/K122141
Methodology: https://510kreport.com/methodology