Architect
ICT Urine Calibrator
2manufacturers in China registered for this device type
3catalogue numbers in this listing
4510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Abbott Laboratories, United States |
|---|---|
| FDA product code | CEM |
| Device type | Electrode, Ion Specific, Potassium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1600 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-06-06 |
| Record revised | 2023-09-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2021-03-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2P32-11 | In distribution | |
| 1J72-20 | In distribution | |
| 1E47-02 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nova | Nova Biomedical Corporation | 8 |
| Stat Profile | Nova Biomedical Corporation | 7 |
| Potassium electrode | Roche Diagnostics Gmbh | 4 |
| Potassium Electrode | Diamond Diagnostics Inc. | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 2 |
| I.S.E. K | Randox Laboratories Limited | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Potassium Electrode | Medica Corp. | 2 |
| Na/K Solution Pack | Medica Corp. | 2 |
| Selectra | VitalScientific B.V. | 2 |
| FlexLab | Inpeco SA | 1 |
Showing 12 of 93. All products under Electrode, Ion Specific, Potassium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K093318 | 2010-02-19 |
| K993083 | 1999-10-05 |
| K884566 | 1988-12-02 |
| K850950 | 1985-08-12 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-04-02 | Class II | Software Design Change | In the case of an AQM clot detection error a portion of the distilled water from the Aliquoter Module hydraulic circuit may be dispensed into the Primary Tube leading to sample dilution, which could lead to incorrect results. | 11 | 2021-04-28 |
| 2014-07-22 | Class II | Process control | ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem. | 11,215 units | 2015-07-21 |
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.