PTS Panels eGLU™ Test Strips
The FDA summary includes PTS Panels eGLU test strips among the components marketed with the CardioChek Plus and CardioChek Home systems. The filing describes these systems as portable…
The FDA summary includes PTS Panels eGLU test strips among the components marketed with the CardioChek Plus and CardioChek Home systems.
The filing describes these systems as portable analyzer and test-strip systems for in vitro quantitative testing. Its home-system indication specifies glucose among the measured analytes in fingertip capillary whole blood.
Listed Item
PTS Panels eGLU™ test strips are in vitro diagnostic devices used to monitor glucose levels in human whole blood. These test strips must be used in conjunction with a CardioChek® Plus analyzer.
Test-System Context
The filing identifies glucose testing as a Class II test-system category and lists the eGLU strip alongside the CardioChek system product names.
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 | Polymer Technology Systems, United States |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K140068 |
| Record published | 2016-07-22 |
| Record revised | 2022-12-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry.; Storage environment temperature 68 to 86 °F; Storage environment temperature 20 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2728 | 15 | 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 |
|---|---|
| K140068 | 2015-05-22 |
| K071507 | 2007-09-10 |
| K070017 | 2007-01-31 |
| K041750 | 2004-07-23 |
| K014099 | 2001-12-21 |
| K013203 | 2001-11-16 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 | 2020-07-06 |
| Polymer Technology Systems | 510(k) number | 2019-12-02 | Class II | Device Design | One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse cont | 44,448 total | 2020-07-06 |
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 |
|---|---|---|---|---|---|
| 2018-03-14 | Class II | Under Investigation by firm | Potential for loss of activity of the glucose analyte (under-recovery) prior to the full stated shelf life (August 2018) | 2018-09-13 | |
| 2016-03-15 | Class II | Storage | This lot of test strips is showing an under-recovery when tested against a reference method. | 6467 | 2020-06-05 |
| 2013-04-04 | Class II | Under Investigation by firm | Internal investigation demonstrated under-recovery for glucose when tested against a reference method. This could result in a low to moderate health risk. | 7048 total, 3499 in USA | 2014-04-16 |
| 2010-07-06 | Not classified | Other | The test strips appear to under-recover Cholesterol, HDL and glucose. | 5805 | 2011-05-11 |
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.