# K161082: IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

- Pathway: 510(k) (Traditional)
- Applicant: Immunodiagnostic Systems, Ltd.
- Decided: May 17, 2016 after 29 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 K111650 (2011). 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)
- K111650: Ids-Isys CTX-1 (Crosslaps) Calibration Verifiers, Ids-Isys 25 Hydroxy Vitamin D Calibration Verifiers, and Ids-Isys..., Immunodiagnostic Systems, Ltd. (2011) Summary page 5.

## Indications for use
The IDS-iSYS 17-OH Progesterone Control Set is for in vitto diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System. The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System.

Source page: https://510kreport.com/device/K161082
Methodology: https://510kreport.com/methodology