# K203270: IMMULITE/IMMULITE® 1000 Cortisol

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Products, Ltd.
- Decided: Jan 15, 2021 after 71 days
- Product code: CGR (Radioimmunoassay, Cortisol)
- Device class: 2
- Regulation: 21 CFR 862.1205
- 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 K931409 (1993). 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)
- K931409: Immulite Cortisol, Diagnostic Products Corp. (1993) Summary page 4.

## Indications for use
For in vitro diagnostic use with the IMMULITE® and IMMULITE 1000 Analyzers — for the quantitative measurement of cortisol (hydrocortisone, Compound F) in serum, as an aid in the clinical assessment of adrenal status.

Source page: https://510kreport.com/device/K203270
Methodology: https://510kreport.com/methodology