FDA product code LBS: Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
LBS is the FDA product code for ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 80 510(k) submissions under LBS, from 59 different applicants. The average 510(k) review took 84 days (median 66). FDA has posted 9 recalls for LBS devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl |
| Device class | Class I |
| Regulation | 21 CFR 862.1475 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LBS clearance
Top LBS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Abbott Laboratories | 4 | 2005-08-25 |
| Beckman Instruments, Inc. | 4 | 1993-10-14 |
| Randox Laboratories, Ltd. | 3 | 2016-01-08 |
| Beckman Coulter, Inc. | 3 | 2010-05-14 |
| Genzyme Corp. | 3 | 2002-07-25 |
54 more applicants have LBS clearances. See the full list in Caduvo.
Most recent LBS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K162593 | Roche Diagnostics Operations (Rdo) | HDL-Cholesterol Gen.4 | 2016-10-19 | 33 |
| K153435 | Randox Laboratories, Ltd. | Direct HDL Cholesterol (HDL) | 2016-01-08 | 42 |
| K132711 | Carolina Liquid Chemistries Corp. | CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT | 2014-05-08 | 252 |
| K120609 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS DHDL SLIDES | 2012-09-07 | 191 |
| K111516 | Liposcience, Inc. | NMR LIPOPROFILE (R) TEST AND NMR PROFILER | 2011-09-27 | 118 |
Recalls for LBS devices
9 product recalls in 8 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-12-08.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code LBS?
LBS is the FDA product code for ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is LBS?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LBS?
Across 80 cleared submissions the average was 84 days from receipt to decision (median 66).
Which companies have the most LBS clearances?
Abbott Laboratories (4); Beckman Instruments, Inc. (4); Randox Laboratories, Ltd. (3); Beckman Coulter, Inc. (3); Genzyme Corp. (3).
Have LBS devices been recalled?
Yes: 9 product recalls across 8 recall events; the most recent began 2025-12-08.
Next steps
- Run an FDA pathway report with predicate devices for product code LBS
- Run a recall and safety report across every LBS manufacturer
- Watch product code LBS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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