FDA product code LQP: Campylobacter Spp.
LQP is the FDA product code for campylobacter spp.. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel. FDA has cleared 12 510(k) submissions under LQP, from 7 different applicants. The average 510(k) review took 101 days (median 74). FDA has posted 1 recall for LQP devices.
Classification
| Field | Value |
|---|---|
| Device name | Campylobacter Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3110 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for LQP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 111 |
| 2019 | 2 | 20 |
| 2021 | 2 | 235 |
Compare with all 510(k) review times · Search every LQP clearance
Top LQP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Techlab, Inc. | 4 | 2019-06-20 |
| Meridian Bioscience, Inc. | 3 | 2021-12-23 |
| Quidel Corporation | 1 | 2021-11-23 |
| Alexon - Trend, Inc. | 1 | 1998-11-18 |
| Meridian Diagnostics, Inc. | 1 | 1988-04-12 |
2 more applicants have LQP clearances. See the full list in Caduvo.
Most recent LQP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K210976 | Meridian Bioscience, Inc. | Curian Campy | 2021-12-23 | 266 |
| K211342 | Quidel Corporation | Sofia 2 Campylobacter FIA | 2021-11-23 | 204 |
| K191442 | Techlab, Inc. | Campylobacter Chek | 2019-06-20 | 21 |
| K191456 | Techlab, Inc. | Campylobacter Quik Chek | 2019-06-20 | 20 |
| K173219 | Techlab, Inc. | CAMPYLOBACTER CHEK | 2018-01-22 | 111 |
Recalls for LQP devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2002-07-15.
Frequently asked questions
What is FDA product code LQP?
LQP is the FDA product code for campylobacter spp.. It is a Class I device, regulated under 21 CFR 866.3110 and reviewed by the Microbiology panel.
What device class is LQP?
Class I, regulation 21 CFR 866.3110. Typical premarket route: 510(k).
How long does a 510(k) take for product code LQP?
Across 12 cleared submissions the average was 101 days from receipt to decision (median 74).
Which companies have the most LQP clearances?
Techlab, Inc. (4); Meridian Bioscience, Inc. (3); Quidel Corporation (1); Alexon - Trend, Inc. (1); Meridian Diagnostics, Inc. (1).
Have LQP devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2002-07-15.
Next steps
- Run an FDA pathway report with predicate devices for product code LQP
- Run a recall and safety report across every LQP manufacturer
- Watch product code LQP 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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