FDA product code LBZ: Enzyme Immunoassay, Quinidine
LBZ is the FDA product code for enzyme immunoassay, quinidine. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel. FDA has cleared 27 510(k) submissions under LBZ, from 17 different applicants. The average 510(k) review took 55 days (median 48). FDA has posted 2 recalls for LBZ devices, 2 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Quinidine |
| Device class | Class II |
| Regulation | 21 CFR 862.3320 |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Clinical Toxicology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LBZ clearance
Top LBZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 7 | 1992-08-24 |
| Abbott Laboratories | 3 | 1987-08-13 |
| Roche Diagnostic Systems, Inc. | 2 | 1994-07-06 |
| Innotron of Oregon, Inc. | 2 | 1990-04-12 |
| Seradyn, Inc. | 1 | 2005-12-23 |
12 more applicants have LBZ clearances. See the full list in Caduvo.
Most recent LBZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K052826 | Seradyn, Inc. | QMS QUINIDINE. QMS QUINIDINE CALIBRATORS | 2005-12-23 | 79 |
| K032332 | Roche Diagnostics Corp. | ROCHE ONLINE TDM QUINIDINE | 2004-01-12 | 167 |
| K011605 | Syva Co., Dade Behring, Inc. | EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229 | 2001-06-12 | 19 |
| K964116 | Bayer Corp. | QUINIDINE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) | 1996-12-24 | 70 |
| K964212 | Diagnostic Reagents, Inc. | QUINIDINE ENZYME IMMUNOASSAY | 1996-12-18 | 57 |
Recalls for LBZ devices
2 product recalls in 1 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2026-07-13.
| Year | Recalls |
|---|---|
| 2026 | 2 |
Frequently asked questions
What is FDA product code LBZ?
LBZ is the FDA product code for enzyme immunoassay, quinidine. It is a Class II device, regulated under 21 CFR 862.3320 and reviewed by the Clinical Toxicology panel.
What device class is LBZ?
Class II, regulation 21 CFR 862.3320. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBZ?
Across 27 cleared submissions the average was 55 days from receipt to decision (median 48).
Which companies have the most LBZ clearances?
Syva Co. (7); Abbott Laboratories (3); Roche Diagnostic Systems, Inc. (2); Innotron of Oregon, Inc. (2); Seradyn, Inc. (1).
Have LBZ devices been recalled?
Yes: 2 product recalls across 1 recall events; the most recent began 2026-07-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LBZ
- Run a recall and safety report across every LBZ manufacturer
- Watch product code LBZ 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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