i-STAT G Cartridge
The i-STAT G Cartridge measures glucose in arterial, venous or capillary whole blood when used with the i-STAT 1 analyzer. It is a prescription in vitro diagnostic test for trained medical…
The i-STAT G Cartridge measures glucose in arterial, venous or capillary whole blood when used with the i-STAT 1 analyzer. It is a prescription in vitro diagnostic test for trained medical professionals in point-of-care or clinical laboratory settings.
The single-use cartridge contains glucose sensors, a calibrant pouch, sample entry well, fluid channels and a waste chamber. Once a blood sample is loaded and the cartridge is inserted, the analyzer moves fluid across the sensors and generates a quantitative glucose result.
Measurement Principle
Glucose oxidase activity produces hydrogen peroxide, which is measured amperometrically. The cartridge uses a 65-microliter sample and performs its fluid movements internally, with the analyzer providing the measurement readout.
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 | Abbott Point OF Care Inc., United States |
|---|---|
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K223755 |
| Record published | 2024-04-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 03P83-26 | 25 | 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 |
| 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 |
Showing 12 of 215. All products under Glucose Oxidase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K223755 | 2023-09-11 |
| K223710 | 2023-07-28 |
| K210958 | 2021-08-13 |
| K183678 | 2020-02-07 |
| K163271 | 2017-04-10 |
| K103195 | 2011-02-08 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-09-20 | Not classified | Other | i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component. | 06F16-02- 1295: 210000 – 1076; 210001 – 447; 210002 – 5339; | 2013-01-28 |
| 2010-09-20 | Not classified | Other | i-STAT Analyzers batteries may overheat due to a circuitry failure, resulting in the analyzer becoming uncomfortably hot in the area of the battery component. | 04J48-01 – 56; 215000 – 695. | 2013-01-28 |
| 2010-08-20 | Not classified | Device Design | Reliability issues associated with broken connection pins within the downloader that mate with the pins from the analyzer. | 277 | 2012-07-25 |
| 2009-11-06 | Not classified | Component design/selection | Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse. | 6432 printers (1208 have already been returned and repaired | 2011-09-14 |
| 2009-09-09 | Not classified | Labeling mix-ups | The storage temperature on the label on the side of the i-Stat Portable Clinical Analyzer shipping box does not match product specification. | 3,918 analyzers | 2014-12-08 |
| 2009-04-22 | Not classified | Nonconforming Material/Component | It appears that the rechargeable battery pack is overheating with or without the presence of smoke. | 2552 | 2010-02-25 |
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.