i-STAT
i-STAT pairs a point-of-care analyzer with disposable test cartridges. Microfabricated electrochemical sensors in each cartridge perform the measurements; the analyzer runs the cartridge…
i-STAT pairs a point-of-care analyzer with disposable test cartridges. Microfabricated electrochemical sensors in each cartridge perform the measurements; the analyzer runs the cartridge tests and reports their results.
The cartridge selected determines the available test or panel, with applications including blood chemistry, blood gases, coagulation and cardiac markers. Trained medical professionals operate the system.
Listed Item
i-STAT 1 Analyzer, Immuno Ready
Result Transfer Options
The i-STAT 1 Wireless variant adds Wi-Fi result transfer to a facility Data Manager, alongside the infrared connection available through accessories. Wireless transmission is optional and occurs separately from measurement: the radio module is unpowered during the measurement cycle. These connection features apply to the wireless configuration.
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) | K103195 |
| Record published | 2016-09-09 |
| Record revised | 2024-02-16 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature 16 to 30 °C; Handling environment temperature -10 to 46 °C; Storage environment humidity up to 90 % RH; Handling environment humidity up to 90 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 03P75-06R | In distribution | |
| 03P75-57 | In distribution | |
| 03P75-89 | In distribution | |
| 03P75-52 | In distribution | |
| 04P75-38 | In distribution | |
| 03P75-53 | In distribution | |
| 03P75-54 | In distribution | |
| 03P75-88 | In distribution | |
| 04P75-32 | In distribution | |
| 03P75-81 | In distribution | |
| 04P75-33 | In distribution | |
| 03P75-85 | In distribution | |
| 03P75-06 | In distribution | |
| 04P75-34 | In distribution | |
| 04P75-40 | In distribution | |
| 04P75-01R | In distribution | |
| 03P75-62 | In distribution | |
| 03P75-83 | In distribution | |
| 04P75-39 | In distribution | |
| 03P75-01 | In distribution | |
| 04J48-20 | In distribution | |
| 03P75-63 | In distribution | |
| 04P75-43 | In distribution | |
| 04P75-01 | In distribution | |
| 03P75-59 | In distribution | |
| 03P75-86 | In distribution | |
| 04P75-35 | In distribution | |
| 04P75-30 | In distribution | |
| 04P75-42 | In distribution | |
| 03P75-87 | In distribution | |
| 04P75-41 | In distribution | |
| 04P75-03 | In distribution | |
| 03P75-50 | In distribution | |
| 03P75-56 | In distribution | |
| 03P75-60 | In distribution | |
| 04P75-44 | In distribution | |
| 03P75-55 | In distribution | |
| 03P75-07 | In distribution | |
| 03P75-82 | In distribution | |
| 03P75-90 | In distribution | |
| 04P75-45 | In distribution | |
| 04P75-36 | In distribution | |
| 03P75-58 | In distribution | |
| 04P75-31 | In distribution | |
| 03P75-51 | In distribution | |
| 04P75-37 | In distribution | |
| 03P75-84 | In distribution | |
| 03P75-61 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| StatSensor/StatStrip | Nova Biomedical Corporation | 6 |
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 Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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 |
| Abbott Point OF Care Inc. | 510(k) number | 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.