Tyson Bio HS100 Blood Glucose Monitoring System
The Tyson Bio HS100 Blood Glucose Monitoring System measures glucose in fresh capillary whole blood for home self testing by a person with diabetes. Samples can come from a fingertip, palm…
The Tyson Bio HS100 Blood Glucose Monitoring System measures glucose in fresh capillary whole blood for home self testing by a person with diabetes. Samples can come from a fingertip, palm or forearm; palm and forearm testing is limited to times when glucose is not changing rapidly.
The meter works with Tyson Bio 50H test strips and control solutions. Its electrochemical biosensor uses glucose dehydrogenase and measures an electrical current associated with the glucose reaction. A test uses 0.7 microliters of blood.
Use Scope
The system is for one patient and must not be shared. It is intended to monitor diabetes control rather than diagnose or screen for diabetes, and it is not for neonatal use. The meter stores up to 500 results with their dates and times.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 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 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | Tyson Bioresearch, Inc., Taiwan |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K182046 |
| Record published | 2023-01-16 |
| Record revised | 2023-09-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 72, pack of 165 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HS100 | In distribution | |
| HS100 | In distribution | |
| HS100 | In distribution | |
| HS100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182046 | 2018-11-30 |
| K182047 | 2018-11-29 |
| K170079 | 2017-10-06 |
| K123087 | 2013-06-18 |
| K112916 | 2012-08-21 |
| K101543 | 2011-08-30 |
| K090629 | 2009-06-04 |
| K081726 | 2008-08-26 |
| K072854 | 2008-06-30 |
| K073492 | 2008-04-08 |
| K072441 | 2008-03-25 |
| K062829 | 2006-10-10 |
| K052818 | 2006-06-16 |
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.