# K190898: Sight OLO

- Pathway: 510(k) (Traditional)
- Applicant: Sight Diagnostics, Ltd.
- Decided: Nov 1, 2019 after 210 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K040073 (2004). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112605: Sysmex XN-Series, Sysmex America, Inc. (2012) Summary page 4.

## Most influential descendants
- K251249: Tru Hematology Test (2026), 0 descendants of its own
- K211840: Sight OLO (2022), 0 descendants of its own

## Recalls of this device
- May 13, 2024 · Class II · Z-2173-2024: One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot pe
- Jun 14, 2022 · Class II · Z-1469-2022: The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the is
- Jan 20, 2022 · Class II · Z-0963-2022: In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3
- Mar 17, 2021 · Class II · Z-2517-2021: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

## Indications for use
The Sight OLO is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening capillary or venous whole blood samples collected in K2EDTA blood collection tubes, or fingertip samples collected using the Sight OLO test kit micro-capillary tubes. When used with the Sight OLO cartridge, the Sight OLO enumerates the following CBC parameters in whole blood: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EOS%/#, and BASO%/#. The Sight OLO is indicated for use in clinical laboratories to identify and classify one or more of the formed elements of blood in children 3 months and above, adolescents and adults.

Source page: https://510kreport.com/device/K190898
Methodology: https://510kreport.com/methodology