# K083200: X-CAL

- Pathway: 510(k) (Traditional)
- Applicant: Streck
- Decided: Feb 3, 2009 after 96 days
- Product code: KRX (Calibrator For Cell Indices)
- Device class: 2
- Regulation: 21 CFR 864.8150
- 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 K840261 (1984). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840261: Cal-Chex, a Hematology Calibrator, Streck Laboratories, Inc. (1984) Summary page 1.

## Most influential descendants
- K120745: XN CAL (2012), 2 descendants of its own
- K141962: XN CAL (2014), 1 descendant of its own
- K120747: XN Cal PF (2012), 1 descendant of its own
- K160585: XN CAL (2016), 0 descendants of its own
- K141955: XN Cal PF (2014), 0 descendants of its own

## Indications for use
X-Cal is used to calibrate and verify calibration of Sysmex hematology analyzers. Refer to product assay sheet.

Source page: https://510kreport.com/device/K083200
Methodology: https://510kreport.com/methodology