Pointe Scientific
HDL reagent for the quantitative determination high-density lipoprotein cholesterol in human serum or plasma. For in vitro diagnostic use only. 6 x 60ml, 6 x 20ml
3manufacturers in China registered for this device type
1catalogue number
6recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
| Hangzhou Lysun Biotechnology Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 22 |
Record
| Listed by | Horiba Instruments Incorporated, United States |
|---|---|
| FDA product code | LBR |
| Device type | Ldl & Vldl Precipitation, Hdl |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1475 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K992002 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HH945-480 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Synermed® | Infrared Laboratory Systems LLC | 4 |
| LDL-Cholesterol Gen.3 | Roche Diagnostics Gmbh | 3 |
| L-Type HDL-C Reagent 2 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Teco Diagnostics Direct HDL Cholesterol Reagent Kit TC-Matrix | Teco Diagnostics | 2 |
| N-geneous LDL Cholesterol Reagent (R1) | Sekisui Diagnostics, LLC | 2 |
| N-geneous LDL Cholesterol Reagent (R2) | Sekisui Diagnostics, LLC | 2 |
| PTS Panels® HDL Cholesterol Test Strips | Polymer Technology Systems | 2 |
| Teco Diagnostics HDL Cholesterol Reagent Set | Teco Diagnostics | 2 |
| CardioChek | Henry Schein, Inc. | 2 |
| L-Type HDL-C Reagent 1 | Fujifilm Wako Pure Chemical Corporation | 2 |
| Carolina Liquid Chemistries Corp.® CLC720 HDL RGT KIT Product No. ST616 | Carolina Liquid Chemistries | 1 |
Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl
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 |
|---|---|---|---|---|---|---|---|
| Horiba Instruments Incorporated | 510(k) number | 2018-08-10 | Class III | Error in labeling | Vials of the autoHDL/LDL Calibrator were shipped without a vial label. | 22 | 2019-12-04 |
| Horiba Instruments Incorporated | 510(k) number | 2015-03-13 | Class III | Nonconforming Material/Component | Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance. | H7545-R1, 8.75 L; 12-H7545-162, 4 kits; H7545-1000, 3 kits; | 2015-10-29 |
| Horiba Instruments Incorporated | 510(k) number | 2009-01-29 | Not classified | Nonconforming Material/Component | The R1 reagent has microbial contamination. | 497 kits, 93L | 2010-10-20 |
| Horiba Instruments Incorporated | 510(k) number | 2009-01-29 | Not classified | Nonconforming Material/Component | The R1 reagent has microbial contamination. | 717 kits, 164L | 2010-10-20 |
| Stanbio Laboratory | 510(k) number | 2006-09-18 | Not classified | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | 47 test kits. | 2007-06-06 |
| Stanbio Laboratory | 510(k) number | 2006-09-18 | Not classified | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | 05276CE: 78 test kits; 05312CE: 6 test kits; 05299CE: 10 tes | 2007-06-06 |
| Stanbio Laboratory | 510(k) number | 2006-09-18 | Not classified | Other | Unexpected changes in QC and proficiency results due to QC and proficiency material matrix. | 9 test kits. | 2007-06-06 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-11-10 | Not classified | Process control | The firm initiated the recall due to the presence of visible contamination of the product. | 237 sets plus 9L | 2011-02-11 |
| 2009-11-10 | Not classified | Process control | The firm initiated the recall due to the presence of visible contamination of the product. | 379 sets | 2011-02-11 |
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.