Ready Sensor™ Gold Calcium Sensor
Ready Sensor™ Calcium Biosensor. An in vitro diagnostic device for use on the RapidLab® 1200 series instruments
8manufacturers in China registered for this device type
1catalogue number
4recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Yuwen E-Commerce Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 19 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K031560 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight; Storage environment temperature 4 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10315219 | 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| i-STAT | Abbott Point OF Care Inc. | 48 |
| YSI Incorporated | YSI Incorporated | 34 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 28 |
| Stat Profile | Nova Biomedical Corporation | 17 |
| Fora | Fora Care Inc. | 13 |
| TRUEtrack | Trividia Health, Inc. | 12 |
| JAS Diagnostics | Drew Scientific, Ltd. | 11 |
| StatStrip | Nova Biomedical Corporation | 9 |
| Gluc-PAP | Randox Laboratories Limited | 8 |
| Nova Primary | Nova Biomedical Corporation | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| Prodigy No Coding Blood Glucose Test Strips | Prodigy Diabetes Care, LLC | 7 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 138 | 2020-06-23 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2018-07-16 | Class II | Device Design | Therapeutic levels (1mg/mL and 2mg/mL) of Hydroxocobalamin may interfere with tHb and some of the CO-Ox fractions that are reported on the RAPIDPoint and RAPIDLab Blood Gas systems indicated. This may cause lower than expected values for ca | 2357 | 2020-06-23 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2017-04-10 | Class II | Software design | Potential Patient Demographic Error with Blank Patient ID Field | 159 units | 2019-08-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 144 units | 2020-07-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2016-08-11 | Class II | Software design | There is a potential for the first and/or last name of one patient to be printed with Patient ID and result data from a different patient, even though those fields have been turned Off for the system | 197 units | 2020-07-16 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2015-05-06 | Class II | Software design | D50 and D51 Diagnostic error codes are not functional. | 122 devices | 2017-08-02 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 179 units | 2015-04-01 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2012-09-17 | Class II | Software Manufacturing/Software Deployment | RAPIDPoint 400 Series, RAPIDPoint 500, or RAPIDLab 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample | 274 units | 2015-04-01 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-04-04 | Not classified | Software design | Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm data management system. | Domestic – 124 units, Foreign-364 units (all systems) | 2012-07-30 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-04-04 | Not classified | Software design | Invalid CO-oximeter values; Bayer HealthCare determined that under very specific conditions, the RapidLab 1245 or RapidLab 1265 systems may report invalid CO-oximeter values to an LIS, Rapidlink, or Rapidcomm data management system. | Domestic – 124 units, Foreign-364 units (all systems) | 2012-07-30 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-01-20 | Not classified | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1. | 2012-05-02 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-01-20 | Not classified | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1. | 2012-05-02 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-01-20 | Not classified | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1. | 2012-05-02 | |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2006-01-20 | Not classified | Other | When stored data is recalled from memory, the results do not agree with the original results. Software anomaly: a calculation error occurs when using the correlation adjustment feature on the RapidLab 1200 Systems with software versions 1. | 2012-05-02 |
Recalls
3 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 |
|---|---|---|---|---|---|
| 2020-08-28 | Class II | Process control | Sporadically inconsistent discrepant (low bias) glucose results on card lot 01-20095-10. Potential exists for a delay in diagnosis of hyperglycemia or unnecessary treatment for hypoglycemia. | 463 boxes (50 test cards/box ) | 2021-09-09 |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2015-05-06 | Class II | Software design | D50 and D51 diagnostic error codes are not functional. | 2713 devices | 2017-08-02 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P990026 | 2002-02-04 | CYGNUS GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER | Animas Corp. |
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.