i-STAT
I-Stat Alinity Instrument (Model 500)
2manufacturers in China registered for this device type
9catalogue numbers in this listing
3510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Abbott Point OF Care Inc., United States |
|---|---|
| FDA product code | JGS |
| Device type | Electrode, Ion Specific, Sodium |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1665 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K153357 |
| Record published | 2021-10-12 |
| Record revised | 2023-09-11 (version 5) |
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, serial number |
| Storage | Storage environment temperature -10 to 50 °C |
| Packaging | Case of 25 |
| Distribution end date | 2023-08-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02R60-01 | In distribution | |
| 09P31-25 | In distribution | |
| 02R60-81 | In distribution | |
| 02R60-80 | In distribution | |
| 02R60-82 | In distribution | |
| 03P83-25 | In distribution | |
| 03P80-25 | In distribution | |
| 03P81-25 | Withdrawn | |
| 03P82-25 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stat Profile | Nova Biomedical Corporation | 13 |
| AU | Beckman Coulter, Inc. | 8 |
| GEM Premier ChemSTAT PAK Na+,K+,Ca++,Cl-, Glu, Crea, BUN, tCO2, Hct, Lac,pH,pCO2 | Instrumentation Laboratory SPA | 8 |
| Nova | Nova Biomedical Corporation | 6 |
| Phoenix Diagnostics, Inc. | Phoenix Diagnostics, Inc. | 5 |
| Sodium Electrode | Roche Diagnostics Gmbh | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Architect | Abbott Laboratories | 3 |
| Synermed® | Infrared Laboratory Systems LLC | 3 |
| Sodium Electrode | Diamond Diagnostics Inc. | 3 |
| Phoenix Diagnostics | Phoenix Diagnostics, Inc. | 2 |
| Sodium Electrode | Medica Corp. | 2 |
Showing 12 of 88. All products under Electrode, Ion Specific, Sodium
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230275 | 2023-10-27 |
| K183688 | 2020-02-07 |
| K153357 | 2016-07-08 |
Recalls Naming This Product
7 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 | 2011-02-15 | Not classified | Other | i-STAT CHEM 8+ cartridge may generate false results for sodium, chloride and hematocrit. | 6575 cartirdges | 2012-07-10 |
| Abbott Point OF Care Inc. | 510(k) number | 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certian lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 | |
| Abbott Point OF Care Inc. | 510(k) number | 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 | |
| Abbott Point OF Care Inc. | 510(k) number | 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 | |
| Abbott Point OF Care Inc. | 510(k) number | 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 | |
| Abbott Point OF Care Inc. | 510(k) number | 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 | |
| Abbott Point OF Care Inc. | 510(k) number | 2006-05-24 | Not classified | Other | Erroneous sodium and/or ionized calcium readings with a patient sample could be obtained | 59775 cartridges | 2007-08-15 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-01-15 | Class II | No Marketing Application | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well | 9,049,725 | 2021-03-02 |
| 2007-10-18 | Not classified | Packaging change control | Difficult to Close — Certain lots of i-STAT cartridges are difficult to close, will not close or do not stay closed. | 2008-07-18 |
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.