# K840261: Cal-Chex, a Hematology Calibrator

- Pathway: 510(k) (Traditional)
- Applicant: Streck Laboratories, Inc.
- Decided: Feb 21, 1984 after 47 days
- Product code: KRZ (Calibrator For Hemoglobin And Hematocrit Measurement)
- Device class: 2
- Regulation: 21 CFR 864.8165
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083200: X-CAL (2009), 5 descendants of its own
- 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

## Recalls of this device
- Jun 4, 2025 · Class II · Z-2086-2025: Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.

Source page: https://510kreport.com/device/K840261
Methodology: https://510kreport.com/methodology