CardioChek Plus Home Self-Test Analyzer
The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home…
The CardioChek® Plus Home Self-Test analyzer is intended for self-testing in lay users. It is intended to be used by a single person and should not be shared. The CardioChek® Plus Home Self-Test analyzer is for in vitro diagnostic use to test whole blood from the fingertip. The specific analyte measured is determined by the type of test strip chosen.
Who Else Makes It
Concentrated in Zhejiang (4), Shandong (1), Guangxi (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 BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Biobase Biodustry(Shandong)Co., Ltd. | Jinan | Shandong | Manufacturer | 70 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
| Eaglenos Sciences, Inc. | Nanjing | Jiangsu | Manufacturer | 4 |
| Medicalsystem Biotechnology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 1 |
Record
| Listed by | Polymer Technology Systems, United States |
|---|---|
| FDA product code | CHH |
| Device type | Enzymatic Esterase–Oxidase, Cholesterol |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1175 |
| Establishment | Complaint-file establishment, Manufacturer |
| Record published | 2022-04-11 |
| Record revised | 2023-10-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 10 to 40 °C; Storage environment humidity 20 to 80 % RH; Storage environment temperature 50 to 104 °F; Special storage condition: Keep away from sunlight.; Special storage condition: Keep dry. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4750 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fora | Fora Care Inc. | 8 |
| Synermed® | Infrared Laboratory Systems LLC | 7 |
| JAS Diagnostics | Drew Scientific, Ltd. | 7 |
| Standard™ LipidoCare Lipid Test Strip – Lipid Profile | SD Biosensor, Inc. | 4 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 4 |
| Biobase | Biobase Biodustry(Shandong)Co., Ltd. | 4 |
| Carolina Liquid Chemistries Corp.® Cholesterol Reagent KIT BL211 | Carolina Liquid Chemistries | 4 |
| Cholesterol Gen.2 | Roche Diagnostics Gmbh | 3 |
| AU | Beckman Coulter, Inc. | 3 |
| Pointe Scientific, Inc. Cholesterol | Horiba Instruments Incorporated | 3 |
| Cholestech LDX™ | Alere San Diego, Inc. | 3 |
| Pointe Scientific Cholesterol (Liquid) | Horiba Instruments Incorporated | 3 |
Showing 12 of 77. All products under Enzymatic Esterase–Oxidase, Cholesterol
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151545 | 2016-12-22 |
| K071593 | 2007-10-15 |
| K023558 | 2002-11-15 |
| K022898 | 2002-09-24 |
| K013173 | 2001-10-22 |
| K990688 | 1999-06-24 |
| K981493 | 1998-07-22 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 1,887 vials US; 2,728 vials OUS | 2020-07-08 |
| 2019-06-07 | Class III | Under Investigation by firm | The MEMo chips provided with lot P901 may be mislabeled, the MEMo Chip may display Q901 on the analyzer LCD screen, instead of P901 | 559 vials | 2020-07-08 |
| 2019-01-16 | Class II | Device Design | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being displayed. | 67643 total | 2020-06-24 |
| 2019-01-16 | Class II | Device Design | Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bu | 67643 total | 2020-06-24 |
| 2009-06-05 | Not classified | Nonconforming Material/Component | Exhibits under-recovery of all analytes. | Not available. | 2010-10-20 |
| 2009-04-02 | Not classified | Process control | The memory chip was coded with incorrect product information. | 486 vials | 2010-10-20 |
| 2009-02-20 | Not classified | Process control | Extended expiration date; the product expired on February 12, 2009 but was labeled with a April 4, 2009 expiration date. | 3,748 vials | 2010-10-20 |
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.