# K111650: Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys...

- Pathway: 510(k) (Abbreviated)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: Sep 6, 2011 after 85 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.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices 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.

## Most influential descendants
- K161082: IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers (2016), 0 descendants of its own
- K142994: IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers (2015), 0 descendants of its own
- K143324: IDS-iSYS CTX-I Calibration Verifiers (2015), 0 descendants of its own

## Indications for use
The IDS-iSYS CTX-I (CrossLaps) Control Set is intended for medical purposes for use in the IDS-iSYS CTX-I (Crosslaps) Assay on the IDS-iSYS Multi-Discipline Automated Analyser to monitor the accuracy and quality of the IDS-iSYS CTX-I (Crosslaps) Assay. The IDS-iSYS 25-Hydroxy Vitamin D Calibration Verifiers are intended for use in the quantitative verification of calibration and assay range of the IDS-iSYS 25-Hydroxy Vitamin D Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer. The IDS-iSYS CTX-I,(CrossLaps) Calibration Verifier is a device intended for medical purposes for use in the quantitative verification of calibration and assay range of the IDS-iSYS CTX-I (CrossLaps®) Assay when performed on the IDS-iSYS Multi-Discipline Automated Analyzer.

Source page: https://510kreport.com/device/K111650
Methodology: https://510kreport.com/methodology