AU
LDL-Cholesterol
2manufacturers in China registered for this device type
4catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Shijiazhuang Hipro Biotechnology Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 22 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | LBS |
| Device type | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K040471 |
| Record published | 2016-09-24 |
| Record revised | 2024-10-28 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6296 | In distribution | |
| OSR6295 | In distribution | |
| OSR6196 | In distribution | |
| OSR6195 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| JAS Diagnostics | Drew Scientific, Ltd. | 6 |
| Direct HDL-Cholesterol (HDL) | Randox Laboratories Limited | 4 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| HDL-Cholesterol Gen.4 | Roche Diagnostics Gmbh | 4 |
| Direct HDL Cholesterol LiquiColor® | Stanbio Laboratory, L.P. | 3 |
| Ultra N-geneous HDL Cholesterol Reagent | Sekisui Diagnostics, LLC | 2 |
| Advia® Chemistry D-HDL Direct HDL Cholesterol Reagents | Siemens Healthcare Diagnostics Inc | 2 |
| Vitros | Ortho-Clinical Diagnostics, Inc. | 2 |
| Alinity | Abbott Medical | 2 |
| ox-LDL Elisa | Immundiagnostik, Inc. | 2 |
| ACE | Alfa Wassermann | 2 |
| HDL Ultra Cholesterol | Sekisui Diagnostics, LLC | 2 |
Showing 12 of 30. All products under Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100010 | 2010-05-14 |
| K042195 | 2004-09-16 |
| K040767 | 2004-06-07 |
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 |
|---|---|---|---|---|---|---|
| Beckman Coulter Ireland Inc | 510(k) number | 2025-12-08 | Class II | Device Design | Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up t | 34,451 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2017-04-03 | Class II | Under Investigation by firm | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results. | 91,996 units total (51,027 units in US) | 2018-05-31 |
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.