CueSee® Hypoxic
CueSee Hypoxic is a quality control liquid used to check blood gas analyzers at critically low oxygen partial pressures. It is intended for professional assessment of analyzer performance…
CueSee Hypoxic is a quality control liquid used to check blood gas analyzers at critically low oxygen partial pressures. It is intended for professional assessment of analyzer performance rather than measurement of a patient sample. Each lot has assigned oxygen values for comparison with the instrument’s readings.
The liquid contains purified bovine hemoglobin without red cell membranes. A predetermined mixture of oxygen and nitrogen establishes its oxygen partial pressure, while the hemoglobin provides oxygen buffering similar to fresh whole blood. The solution contains no preservatives or viscosity adjusting additives.
Listed Item
CueSee® Hypoxic is a pre-tonometered bovine hemoglobin (Hb) quality control material for professional use for monitoring blood gas analyzers’ performance of Oxygen partial pressure (pO2).
Ampule Format
The control is supplied in 2.5 millilitre glass ampules at one low oxygen level. Its stated value range is 15 to 25 millimetres of mercury, with the actual assigned range determined for each lot.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Eurotrol B.V., Netherlands |
|---|---|
| FDA product code | JJS |
| Device type | Controls For Blood-Gases, (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K152553 |
| Record published | 2020-10-08 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Packaging | Product box of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CueSee® Hypoxic X-Low | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 16 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 11 |
| Architect | Abbott Laboratories | 7 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Blood Gas and Electrolyte Control | Edan Instruments, Inc. | 3 |
| VKR-7 | Radiometer America, Inc. | 1 |
| Mission Control, Level 1 | Diamond Diagnostics Inc. | 1 |
| Autocheck 3+, Level 1, S7335 | Radiometer Medical APS | 1 |
| Autocheck 3+, Level 4, S7365 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 4 | Radiometer Medical APS | 1 |
| Qualicheck 5+, Level 3 | Radiometer Medical APS | 1 |
| QC Adaptor | Radiometer Medical APS | 1 |
Showing 12 of 45. All products under Controls For Blood-Gases, (Assayed And Unassayed)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152553 | 2016-04-22 |
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.