FDA product code LCI: Automated Radioimmunoassay Systems, For Clinical Use
LCI is the FDA product code for automated radioimmunoassay systems, for clinical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel. FDA has cleared 3 510(k) submissions under LCI, from 3 different applicants. The average 510(k) review took 52 days (median 32). FDA has posted 1 recall for LCI devices.
Classification
| Field | Value |
|---|---|
| Device name | Automated Radioimmunoassay Systems, For Clinical Use |
| Device class | Class I |
| Regulation | 21 CFR 862.2050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LCI clearance
Top LCI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| DiaSorin, Inc. | 1 | 1998-11-16 |
| Union Carbide Corp. | 1 | 1980-05-28 |
| Beckman Instruments, Inc. | 1 | 1978-09-01 |
Most recent LCI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983617 | DiaSorin, Inc. | 25-HYDROXYVITAMIN D 125I RIA KIT | 1998-11-16 | 32 |
| K801037 | Union Carbide Corp. | CENTRIA SYSTEM 2 AUTOMATED METHOD/RIA | 1980-05-28 | 26 |
| K780886 | Beckman Instruments, Inc. | SYSTEM 6000 AUTOMATED RIA ANALYZER | 1978-09-01 | 98 |
Recalls for LCI devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2004-06-30.
Frequently asked questions
What is FDA product code LCI?
LCI is the FDA product code for automated radioimmunoassay systems, for clinical use. It is a Class I device, regulated under 21 CFR 862.2050 and reviewed by the Clinical Chemistry panel.
What device class is LCI?
Class I, regulation 21 CFR 862.2050. Typical premarket route: 510(k).
How long does a 510(k) take for product code LCI?
Across 3 cleared submissions the average was 52 days from receipt to decision (median 32).
Which companies have the most LCI clearances?
DiaSorin, Inc. (1); Union Carbide Corp. (1); Beckman Instruments, Inc. (1).
Have LCI devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2004-06-30.
Next steps
- Run an FDA pathway report with predicate devices for product code LCI
- Run a recall and safety report across every LCI manufacturer
- Watch product code LCI 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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