FDA product code LIE: Reagent/Device, Inoculum Calibration
LIE is the FDA product code for reagent/device, inoculum calibration. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel. FDA has cleared 7 510(k) submissions under LIE, 1 in the last five years, from 7 different applicants. The average 510(k) review took 127 days (median 91). FDA has posted 2 recalls for LIE devices.
Classification
| Field | Value |
|---|---|
| Device name | Reagent/Device, Inoculum Calibration |
| Device class | Class II |
| Regulation | 21 CFR 866.1640 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LIE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2023 | 1 | 317 |
Compare with all 510(k) review times · Search every LIE clearance
Top LIE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Beckman Coulter, Inc. | 1 | 2023-04-05 |
| Trek Diagnostic Systems | 1 | 2011-06-22 |
| Trek Diagnostic Systems, Ltd. | 1 | 2011-04-27 |
| Radiometer America, Inc. | 1 | 1994-03-29 |
| Scientific Device Laboratory, Inc. | 1 | 1991-06-10 |
2 more applicants have LIE clearances. See the full list in Caduvo.
Most recent LIE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K221493 | Beckman Coulter, Inc. | MicroScan Prompt Inoculation System-D | 2023-04-05 | 317 |
| K103456 | Trek Diagnostic Systems | THE SENSITITRE AIM | 2011-06-22 | 210 |
| K110331 | Trek Diagnostic Systems, Ltd. | SENSITITRE AIM (TM) | 2011-04-27 | 83 |
| K935566 | Radiometer America, Inc. | SENSI-CAL AMCO AEPA-1 | 1994-03-29 | 131 |
| K911059 | Scientific Device Laboratory, Inc. | TURBIDOMETRIC STANDARD | 1991-06-10 | 91 |
Recalls for LIE devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2019-12-13.
| Year | Recalls |
|---|---|
| 2019 | 1 |
Frequently asked questions
What is FDA product code LIE?
LIE is the FDA product code for reagent/device, inoculum calibration. It is a Class II device, regulated under 21 CFR 866.1640 and reviewed by the Microbiology panel.
What device class is LIE?
Class II, regulation 21 CFR 866.1640. Typical premarket route: 510(k).
How long does a 510(k) take for product code LIE?
Across 7 cleared submissions the average was 127 days from receipt to decision (median 91).
Which companies have the most LIE clearances?
Beckman Coulter, Inc. (1); Trek Diagnostic Systems (1); Trek Diagnostic Systems, Ltd. (1); Radiometer America, Inc. (1); Scientific Device Laboratory, Inc. (1).
Have LIE devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2019-12-13.
Next steps
- Run an FDA pathway report with predicate devices for product code LIE
- Run a recall and safety report across every LIE manufacturer
- Watch product code LIE 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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