PTS Panels® Cholesterol Test Strips
PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek®…
PTS Panels® Cholesterol test strips are in vitro diagnostic devices used to monitor cholesterol levels in human whole blood. These test strips must be used in conjunction with a CardioChek® brand analyzer.
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 |
| 510(k) | K981493 |
| Record published | 2016-07-15 |
| Record revised | 2023-07-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep away from sunlight Keep dry; Storage environment temperature 68 to 86 °F; Storage environment temperature 20 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1711 | 25 | In distribution | |
| 1790 | 3 | 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 Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Polymer Technology Systems | 510(k) number | 2009-04-02 | Not classified | Process control | The memory chip was coded with incorrect product information. | 486 vials | 2010-10-20 |
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 |
| 2009-02-20 | 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.