# K111938: Ids-Isys Igfbp-3 Control Set, Ids-Isys Human Growth Hormone (HGH) Calibration Verifiers, and Ids-Isys Igfbp-3 Cal...

- Pathway: 510(k) (Abbreviated)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Feb 14, 2012 after 221 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 IGFBP-3 Control Set is intended for medical purposes for use in the IDS-iSYS IGjFBP-3 Assay on the IDS-iSYS Multi -Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS IGFBP-3 Assay. The IDS-iSYS IGFBP-3 Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS IGFBP-3 Assay when performed on the LDS-iSYS Multi-Discipline Automated Analyzer. The IDS-ISYS hGH Calibration Verifier is a device intended for medical purposes for use iii the quantitative verification of calibration of the hGH Assay (IDS-iSYS bhll) when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Source page: https://510kreport.com/device/K111938
Methodology: https://510kreport.com/methodology