FDA product code LCM: Enzyme Immunoassay, Phencyclidine
LCM is the FDA product code for enzyme immunoassay, phencyclidine. It is a Unclassified device, reviewed by the Clinical Toxicology panel. FDA has cleared 88 510(k) submissions under LCM, 1 in the last five years, from 51 different applicants. The average 510(k) review took 97 days (median 70). FDA has posted 1 recall for LCM devices.
Classification
| Field | Value |
|---|---|
| Device name | Enzyme Immunoassay, Phencyclidine |
| Device class | Unclassified |
| Review panel | TX — Clinical Toxicology |
| Medical specialty | Unknown |
| Premarket route | 510(k) |
510(k) clearances per year for LCM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 141 |
| 2019 | 1 | 269 |
| 2021 | 1 | 144 |
| 2022 | 1 | 214 |
Compare with all 510(k) review times · Search every LCM clearance
Top LCM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Syva Co. | 10 | 2000-01-27 |
| Abbott Laboratories | 5 | 2002-03-13 |
| Roche Diagnostics Corp. | 4 | 2005-01-10 |
| Phamatech | 4 | 2004-09-10 |
| Roche Diagnostic Systems, Inc. | 4 | 1996-12-13 |
46 more applicants have LCM clearances. See the full list in Caduvo.
Most recent LCM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K212952 | Psychemedics Corporation | Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair | 2022-04-18 | 214 |
| K203489 | Immunalysis Corporation | SEFRIA PCP Oral Fluid Enzyme Immunoassay | 2021-04-20 | 144 |
| K181135 | Immunalysis Corporation | Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay | 2019-01-24 | 269 |
| K163220 | Siemens Healthcare Diagnostics, Inc. | Atellica CH Phencyclidine (Pcp) | 2017-04-06 | 141 |
| K152176 | Immunalysis Corporation | Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators | 2015-09-04 | 31 |
Recalls for LCM devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2005-05-31.
Frequently asked questions
What is FDA product code LCM?
LCM is the FDA product code for enzyme immunoassay, phencyclidine. It is a Unclassified device, reviewed by the Clinical Toxicology panel.
What device class is LCM?
Unclassified. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCM?
Across 88 cleared submissions the average was 97 days from receipt to decision (median 70).
Which companies have the most LCM clearances?
Syva Co. (10); Abbott Laboratories (5); Roche Diagnostics Corp. (4); Phamatech (4); Roche Diagnostic Systems, Inc. (4).
Have LCM devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2005-05-31.
Next steps
- Run an FDA pathway report with predicate devices for product code LCM
- Run a recall and safety report across every LCM manufacturer
- Watch product code LCM 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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