Accutrend Plus Meter Kit
2 catalogue numbers from 05346754160, listed by Roche Diagnostics Gmbh, Germany, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
2catalogue numbers in this listing
3510(k) clearances naming this product code
20recalls 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 | Roche Diagnostics Gmbh, Germany |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K051376 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-10 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -25 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05346754160 | In distribution | |
| 07769202001 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K014139 | 2002-03-21 |
| K001907 | 2000-09-05 |
| K000365 | 2000-02-23 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that the test strip may be damaged or test was not performed correctly | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives a strip error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error and the manual only instructs the use | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives a strip error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error and the manual only instructs the us | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a strip error. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2006-06-22 | Not classified | Other | The meter gives an error message that can “actually” mean either a problem with the strip or a blood glucose too low to measure, but the meter error message only reports that there is a bad strip. | 55,189 meters (for all Recalls Z-1354-1371-06) | 2008-04-07 |
| 2005-12-09 | Not classified | Other | Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2. | 2006-04-10 | |
| 2005-12-09 | Not classified | Other | Potential for hemoglobin derivatives which are outside of the quality control (QC) limits to not engage the auto lock out feature of the system for 02Hb, COHb, HHb, MetHb or SO2. | 2006-04-10 | |
| 2005-05-18 | Not classified | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been pre | 2006-02-26 | |
| 2005-05-18 | Not classified | Other | The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been pre | 2006-02-26 | |
| 2005-04-18 | Not classified | Other | If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using ‘C’ cell batteri | 2006-03-07 | |
| 2005-04-18 | Not classified | Other | If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using ‘C’ cell batteri | 2006-03-07 | |
| 2005-04-18 | Not classified | Other | If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using ‘C’ cell batteri | 2006-03-07 |
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.