TRUEtrack
HealthWise Pharmacy TRUEtrack Blood Glucose Meter - Free Meter Only
8manufacturers in China registered for this device type
12catalogue numbers in this listing
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 | Trividia Health, Inc., United States |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K032657 |
| Record published | 2016-09-20 |
| Record revised | 2022-05-09 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 40 to 86 °F |
| Packaging | Case of 24, box, box of 2, case of 12, case of 6, case of 360 |
| Distribution end date | 2018-01-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TRUEtrack BLOOD GLUCOSE MONITORING SYSTEM | In distribution | ||
| TRUEtrack PRE-PACK | In distribution | ||
| TRUEtrack 25 Blood Glucose Test Strips | 25 | In distribution | |
| TRUEtrack 10 Blood Glucose Test Strips | 10 | In distribution | |
| TRUEtrack 50 Blood Glucose Test Strips | 50 | In distribution | |
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack PRE-PACK | Withdrawn | ||
| TRUEtrack Blood Glucose Meter – Free Meter Only | Withdrawn |
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 |
| 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 |
| StatSensor/StatStrip | Nova Biomedical Corporation | 6 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Trividia Health, Inc. | 510(k) number | 2016-06-28 | Class II | Nonconforming Material/Component | Product gives incorrect low blood glucose levels. | 5,527,921 In total =4,621,639 strips & 393,808 kits domestic | |
| Trividia Health, Inc. | 510(k) number | 2013-10-02 | Class II | Software design (manufacturing process) | Manufactured with an incorrect factory set unit of measure. | 105 | 2016-01-28 |
| Trividia Health, Inc. | 510(k) number | 2013-02-25 | Class II | Environmental control | Meter kit outer boxes containing 10 ct. test strips state incorrect storage temperature range. | 1,627 Kits | 2013-07-08 |
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.