TRUEtrack
LEADER TRUEtrack Blood Glucose Meter – FREE METER ONLY – CANNOT SUBMIT FOR REIMBURSEMENT
12manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jilin (1). 3 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 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
| Guangdong Transtek Medical Electronics Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 11 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Sejoy Biomedical Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 5 |
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
| Human Metabolomics Institute, Inc. | Shenzhen | Guangdong | Manufacturer | 4 |
| Changsha Sinocare Inc. | Changsha | Hunan | Manufacturer | 2 |
Record
| Listed by | Trividia Health, Inc., United States |
|---|---|
| FDA product code | JJX |
| Device type | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K032657 |
| Record published | 2016-12-22 |
| Record revised | 2021-11-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Storage | Storage environment temperature 36 to 86 °F |
| Packaging | Case of 12 |
| Distribution end date | 2017-11-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TRUEtrack Blood Glucose Monitoring System | In distribution | |
| TRUEtrack Blood Glucose Meter FREE METER ONLY | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 55 |
| Validate | LGC Clinical Diagnostics, Inc. | 37 |
| Architect | Abbott Laboratories | 24 |
| Architect | Abbott Medical | 23 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 22 |
| Architect | Abbott Ireland | 18 |
| Liquichek | Bio-Rad Laboratories Inc. | 17 |
| Alinity | Abbott Medical | 17 |
| Alinity | Abbott Ireland | 15 |
| Fora | Fora Care Inc. | 15 |
| Pregnancy-Skreen | Biochemical Diagnostics, Inc. | 14 |
| Accurun® | LGC Clinical Diagnostics, Inc. | 14 |
Showing 12 of 907. All products under Single (Specified) Analyte Controls (Assayed And Unassayed)
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 |
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.