# K150132: IMMULITE IGF Control Module, IMMULITE Gastrin Control Module

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics
- Decided: Apr 13, 2015 after 82 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: 1 generation back to K955440 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955440: Immulite SHBG (Modification), Diagnostic Products Corp. (1995) Summary page 4.

## Indications for use
IMMULITE® IGF Control Module is an assayed, bi-level control intended for use with IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGF-I, and IMMULITE/IMMULITE 1000 and IMMULITE 2000 IGFBP-3 assays. It is intended as an aid in monitoring day-to-day assay performance. IMMULITE Gastrin Control Module is an assayed, bi-level control intended for use with the IMMULITE/IMMULITE 1000 and IMMULITE 2000 Gastrin assay. It is intended as an aid in monitoring day-to-day assay performance.

Source page: https://510kreport.com/device/K150132
Methodology: https://510kreport.com/methodology