FDA product code LBT: Electrophoresis, Cholesterol Via Esterase-Oxidase, Hdl
LBT is the FDA product code for electrophoresis, 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 8 510(k) submissions under LBT, from 4 different applicants. The average 510(k) review took 90 days (median 66).
Classification
| Field | Value |
|---|---|
| Device name | Electrophoresis, 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 LBT clearance
Top LBT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Helena Laboratories | 4 | 1990-11-09 |
| Morax | 2 | 1999-06-18 |
| Roche Diagnostics Corp. | 1 | 2000-08-04 |
| Gelman Sciences, Inc. | 1 | 1979-06-15 |
Most recent LBT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K000568 | Roche Diagnostics Corp. | HDL CHOLESTEROL PLUS | 2000-08-04 | 164 |
| K990250 | Morax | HYDRAGEL LDL/HDL CHOL DIRECT KIT-P.N. 4005, HYDRAGEL 7 LDL/HDL CHOL DIRECT KIT-P.N. 4103, HYDRAGEL LDL/HDL CHOL DIRECT 0 | 1999-06-18 | 143 |
| K972015 | Morax | HYDRAGEL 7,15,30, CHOL-HDL KIT | 1997-10-27 | 150 |
| K904035 | Helena Laboratories | REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM | 1990-11-09 | 70 |
| K894366 | Helena Laboratories | REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 | 1989-08-31 | 48 |
Recalls for LBT devices
openFDA lists no recalls for product code LBT.
Frequently asked questions
What is FDA product code LBT?
LBT is the FDA product code for electrophoresis, 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 LBT?
Class I, regulation 21 CFR 862.1475. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LBT?
Across 8 cleared submissions the average was 90 days from receipt to decision (median 66).
Which companies have the most LBT clearances?
Helena Laboratories (4); Morax (2); Roche Diagnostics Corp. (1); Gelman Sciences, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBT
- Run a recall and safety report across every LBT manufacturer
- Watch product code LBT 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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