Gluc-PAP
A glucose test system is a device intended for the quantitative in vitro determination of Glucose concentration in serum, plasma and urine
8manufacturers in China registered for this device type
8catalogue numbers in this listing
2510(k) clearances naming this product code
3recalls 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 | Randox Laboratories Limited, United Kingdom |
|---|---|
| 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 |
| 510(k) | K003346 |
| Record published | 2016-09-16 |
| Record revised | 2021-06-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The working reagent is stable for 3 months at +2 to +8°C or 5 days at +15 to +25°C.; Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GL364 | In distribution | |
| GL3981 | In distribution | |
| GL366 | In distribution | |
| GL2623 | In distribution | |
| GL2614 | In distribution | |
| GL1021 | In distribution | |
| GL3815 | In distribution | |
| GL7952 | 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 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K024014 | 2003-12-04 |
| K003346 | 2001-03-15 |
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 |
|---|---|---|---|---|
| 2023-09-06 | Class II | Under Investigation by firm | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when inco | 5 units |
| 2023-09-06 | Class II | Under Investigation by firm | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when inco | 13 units |
| 2023-09-06 | Class II | Under Investigation by firm | RX Parameter rerun settings (Sample Volume Low/High), and Dilutions used for Auto reruns, not meeting sample re-run conditions when samples are above or below assay range and may result i issues with the re-run feature conditions when inco | O units |
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.