Clinitek Status®+ Analyzer
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest®…
The CLINITEK Status+ Urine Chemistry Analyzer is a portable, easy to use analyzer. It is designed to read only Siemens Healthcare Diagnostics Reagent Strips for Urinalysis and Clinitest® hCG tests. This analyzer is intended for the measurement of the following inurine: Albumin, Bibilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
4manufacturers in China registered for this device type
1catalogue number
2510(k) clearances naming this product code
16recalls on this code
Who Else Makes It
Concentrated in Zhejiang (1), Guangxi (1), Chongqing (1). 2 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 Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Chong Qing Teco Huayi Pharm. Co. | Shapingba Dist. | Chongqing | Contract manufacturer | 18 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | JFY |
| Device type | Enzymatic Method, Creatinine |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1225 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K091216 |
| Record published | 2016-09-24 |
| Record revised | 2021-11-19 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Storage | Special storage condition: Max 95% RH at 45’c; Handling environment temperature -20 to 60 °C; Storage environment temperature 5 to 40 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10379675 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Creatinine Plus | Roche Diagnostics Gmbh | 3 |
| Teco Diagnostics | Teco Diagnostics | 3 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 3 |
| Creatinine plus ver2 | Roche Diagnostics Gmbh | 3 |
| Architect | Abbott Laboratories | 2 |
| CR Cartridge | LifeHealth, LLC | 2 |
| Alinity | Abbott Laboratories | 2 |
| Creatinine LiquiColor® | Stanbio Laboratory, L.P. | 2 |
| Pointe Scientific, Inc. Creatinine Enzymatic | Horiba Instruments Incorporated | 2 |
| Automatic Urine Analyzer | Urit Medical Electronic Co., Ltd. | 2 |
| Creatinine plus ver.2 | Roche Diagnostics Gmbh | 1 |
| Dimension® Flex® reagent cartridge Ezcr | Siemens Healthcare Diagnostics Inc | 1 |
Showing 12 of 40. All products under Enzymatic Method, Creatinine
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K212223 | 2021-11-24 |
| K090330 | 2009-05-22 |
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 |
|---|---|---|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2014-09-19 | Class II | Process control | The external power supply for the Clintek Status analyzer, which is provided separately, is damaged. It can result in an electric shock to the User. | approx. 4200 | 2015-07-20 |
| Siemens Healthcare Diagnostics Inc | 510(k) number | 2013-02-26 | Class III | Reprocessing Controls | Device with Sample Interference Notes (SIN) enabled not cleared for US marketing. | 1 unit | 2014-05-06 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 1006 | 2021-09-20 |
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 8261 | 2021-09-20 |
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 23,824 | 2021-09-20 |
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 1488 | 2021-09-20 |
| 2019-12-18 | Class II | Under Investigation by firm | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology. | 1,015 units | 2020-06-25 |
| 2019-12-18 | Class II | Under Investigation by firm | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology. | 11,725 units | 2020-06-25 |
| 2019-12-18 | Class II | Under Investigation by firm | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology. | 824 units | 2020-06-25 |
| 2019-12-18 | Class II | Under Investigation by firm | There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology. | 2,198 units | 2020-06-25 |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2016-03-17 | Class II | Device Design | Siemens Healthcare Diagnostics has become aware of N-Acetylcysteine (NAC) and Metamizole (Dipyrone) interference with Trinder and Trinder-like reaction assays. Siemens has confirmed that falsely depressed results may occur on samples drawn | 137422 units total | 2017-09-25 |
| 2015-07-15 | Class II | Device Design | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depressed results up to – 12.7% and -22% respectively, for a creatinine concentration of 1.5 mg/dL when hemolysis exceeds 200 mg/dL and 300 mg/dL res | Total number Dimension Vista – 32,165, Dimension – 238,634 | 2017-03-24 |
| 2010-06-10 | Not classified | Device Design | Results may be falsely depressed up to 0.4 mg/dL or falsely elevated up to 0.6 mg/dL across the assay range. | 1,399 | 2013-12-19 |
| 2010-06-10 | Not classified | Device Design | Patient results may be falsely depressed or falsely elevated across the assay range. | 860 | 2013-03-19 |
| 2010-02-12 | Not classified | Nonconforming Material/Component | The ECREA test results may be falsely elevated or depressed. | 324 | 2010-10-13 |
| 2008-09-29 | Not classified | Component design/selection | Reagent may exhibit unflagged inaccurate patient sample results. | 12,773 cartons | 2009-03-27 |
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.