FDA product code LBR: Ldl & Vldl Precipitation, Hdl
LBR is the FDA product code for ldl & vldl precipitation, hdl. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel. FDA has cleared 66 510(k) submissions under LBR, from 52 different applicants. The average 510(k) review took 71 days (median 58). FDA has posted 11 recalls for LBR devices.
Classification
| Field | Value |
|---|---|
| Device name | Ldl & Vldl Precipitation, 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 LBR clearance
Top LBR applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Pointe Scientific, Inc., | 3 | 1999-08-05 |
| Genzyme Corp. | 3 | 1997-06-18 |
| Merchant House Scientific | 3 | 1994-09-06 |
| Ortho-Clinical Diagnostics, Inc. | 2 | 2001-08-30 |
| Diagnostic Chemicals , Ltd. | 2 | 1998-04-27 |
47 more applicants have LBR clearances. See the full list in Caduvo.
Most recent LBR clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K143691 | Roche Diagnostics Operations (Rdo) | LDLC3 LDL-Cholesterol Gen.3 | 2015-01-28 | 35 |
| K072523 | General Atomics | DIAZYME LDL-CHOLESTEROL REAGENT, CALIBRATOR AND CONTROLS | 2008-01-22 | 137 |
| K050823 | Teco Diagnostics | DIRECT HDL CHOLESTEROL AND DIRECT HDL/LDL CALIBRATOR | 2005-07-26 | 117 |
| K023784 | Hemagen Diagnostics, Inc. | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | 2002-12-24 | 42 |
| K012593 | Ortho-Clinical Diagnostics, Inc. | VITROS CHEMISTRY PRODUCTS MAGNETIC HDL-CHOLESTEROL REAGENT, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2 | 2001-08-30 | 20 |
Recalls for LBR devices
11 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-10.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code LBR?
LBR is the FDA product code for ldl & vldl precipitation, hdl. It is a Class I device, regulated under 21 CFR 862.1475 and reviewed by the Clinical Chemistry panel.
What device class is LBR?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LBR?
Across 66 cleared submissions the average was 71 days from receipt to decision (median 58).
Which companies have the most LBR clearances?
Pointe Scientific, Inc., (3); Genzyme Corp. (3); Merchant House Scientific (3); Ortho-Clinical Diagnostics, Inc. (2); Diagnostic Chemicals , Ltd. (2).
Have LBR devices been recalled?
Yes: 11 product recalls across 7 recall events; the most recent began 2018-08-10.
Next steps
- Run an FDA pathway report with predicate devices for product code LBR
- Run a recall and safety report across every LBR manufacturer
- Watch product code LBR 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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