# K251249: Tru Hematology Test

- Pathway: 510(k) (Traditional)
- Applicant: Truvian Sciences, Inc.
- Decided: Jan 16, 2026 after 268 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K040073 (2004). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190898: Sight OLO, Sight Diagnostics, Ltd. (2019) Summary page 5.

## Indications for use
The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to classify and enumerate WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph#, Lymph%, Neut#, Neut%, Other WBC#, and Other WBC% in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings. The Tru Hematology Test (part of the TruWellness Panel™) is intended for use in adults 18 years of age or older. It is not intended for use in diagnosing or monitoring critical disease states such as oncology.

Source page: https://510kreport.com/device/K251249
Methodology: https://510kreport.com/methodology