Pointe Scientific, Inc.
HDL Cholesterol Standard, for use as a cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol assays used with HDL Cholesterol procedures. Size: 1 x 15…
HDL Cholesterol Standard, for use as a cholesterol standard for standardization or calibration of enzymatic, endpoint cholesterol assays used with HDL Cholesterol procedures. Size: 1 x 15 mL. Concentration: 50 mg/dL
3manufacturers in China registered for this device type
11catalogue numbers in this listing
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) | K891117 |
| Record published | 2016-08-31 |
| Record revised | 2025-10-02 (version 5) |
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 |
|---|---|---|
| H7507-80 | In distribution | |
| 13-H7511-30 | In distribution | |
| H7545-1000 | In distribution | |
| H7511-60 | In distribution | |
| H7545-320 | In distribution | |
| H7545-CAL | In distribution | |
| H7545-40 | In distribution | |
| H7512-STD | In distribution | |
| H7545-80 | In distribution | |
| 13-H7512-STD | In distribution | |
| HH945-240 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Curo L5 | KPI Healthcare, Inc. | 1 |
Showing 12 of 47. All products under Ldl & Vldl Precipitation, Hdl
Recalls Naming This Product
9 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 | 2009-11-10 | Not classified | Process control | The firm initiated the recall due to the presence of visible contamination of the product. | 379 sets | 2011-02-11 |
| Horiba Instruments Incorporated | 510(k) number | 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 |
| 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 |
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.