Sight OLO
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components…
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion.
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| VTech Communications Ltd | Dongguan | Guangdong | Contract manufacturer | 5 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Onechipdx Biotech (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Specification developer | 2 |
Record
| Listed by | S.D. Sight Diagnostics, Ltd., Israel |
|---|---|
| FDA product code | GKZ |
| Device type | Counter, Differential Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 864.5220 |
| 510(k) | K190898 |
| Record published | 2020-02-09 |
| Record revised | 2024-11-14 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2024-09-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OLO-U1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QBC Diagnostics | Drucker Diagnostics, LLC | 41 |
| Cell-DYN | Abbott Laboratories | 19 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 17 |
| Simultest | Becton, Dickinson AND Company | 10 |
| BD FACSCanto™ | Becton, Dickinson AND Company | 10 |
| FACSCanto | Becton, Dickinson AND Company | 7 |
| BD Multitest | Becton, Dickinson AND Company | 6 |
| Coulter AcT | Beckman Coulter, Inc. | 6 |
| BD™ Multi-Check | Becton, Dickinson AND Company | 6 |
| BD Tritest | Becton, Dickinson AND Company | 6 |
| Coulter LH | Beckman Coulter, Inc. | 5 |
| HemoScreen | Pixcell Medical Inc. | 5 |
Showing 12 of 245. All products under Counter, Differential Cell
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211840 | 2022-05-09 |
Recalls Naming This Product
4 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Sight Diagnostics, Ltd. | 510(k) number | 2024-05-13 | Class II | Process control | 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 performing outside of the device specifica | 7,450 units (2,800 US, 4,650 OUS) | |
| Sight Diagnostics, Ltd. | 510(k) number | 2022-06-14 | Class II | Software Design Change | 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 issue, results may incorrectly appear to b | 72 US; 292 OUS | |
| Sight Diagnostics, Ltd. | 510(k) number | 2022-01-20 | Class II | Software design | 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 and all earlier versions, which can pot | 322 units: U.S 109 Foreign 213 | |
| Sight Diagnostics, Ltd. | 510(k) number | 2021-03-17 | Class II | Labeling Change Control | Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator’s Manual and the OLO software | 114 units | 2022-06-08 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.