FDA product code PEN: Gram-Negative Bacteria And Associated Resistance Markers
PEN is the FDA product code for gram-negative bacteria and associated resistance markers. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel. FDA has cleared 11 510(k) submissions under PEN, 3 in the last five years, from 6 different applicants. The average 510(k) review took 108 days (median 90); 108 days on average over the last three years. FDA has posted 20 recalls for PEN devices, 6 initiated in the last five years.
Definition
A qualitative multiplexed in vitro diagnostic device to detect and identify gram-negative bacteria and resistance markers in positive blood cultures.
Classification
| Field | Value |
|---|---|
| Device name | Gram-Negative Bacteria And Associated Resistance Markers |
| Device class | Class II |
| Regulation | 21 CFR 866.3365 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for PEN
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 1 | 29 |
| 2019 | 2 | 167 |
| 2020 | 1 | 90 |
| 2022 | 1 | 209 |
| 2024 | 1 | 14 |
| 2025 | 1 | 203 |
Compare with all 510(k) review times · Search every PEN clearance
Top PEN applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biofire Diagnostics, LLC | 5 | 2024-12-20 |
| Genmark Diagnostics, Incorporated | 2 | 2022-04-27 |
| Luminex Corporation | 1 | 2025-04-18 |
| Icubate, Inc. | 1 | 2019-06-28 |
| Nanosphere, Inc. | 1 | 2014-01-08 |
1 more applicants have PEN clearances. See the full list in Caduvo.
Most recent PEN clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K243013 | Luminex Corporation | LIAISON PLEX Gram-Negative Blood Culture Assay | 2025-04-18 | 203 |
| K243759 | Biofire Diagnostics, LLC | BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) | 2024-12-20 | 14 |
| K213236 | Genmark Diagnostics, Incorporated | ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel | 2022-04-27 | 209 |
| K193519 | Biofire Diagnostics, LLC | BioFire Blood Culture Identification 2 (BCID2) Panel | 2020-03-18 | 90 |
| K190341 | Icubate, Inc. | iC-GN iC-Cassette for use on the iC-System | 2019-06-28 | 134 |
Recalls for PEN devices
20 product recalls in 18 recall events; 6 initiated in the last five years and 4 still open. Most recent: 2025-04-16.
| Year | Recalls |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 4 |
| 2021 | 5 |
| 2023 | 2 |
| 2024 | 2 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code PEN?
PEN is the FDA product code for gram-negative bacteria and associated resistance markers. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel.
What device class is PEN?
Class II, regulation 21 CFR 866.3365. Typical premarket route: 510(k).
How long does a 510(k) take for product code PEN?
Across 11 cleared submissions the average was 108 days from receipt to decision (median 90).
Which companies have the most PEN clearances?
Biofire Diagnostics, LLC (5); Genmark Diagnostics, Incorporated (2); Luminex Corporation (1); Icubate, Inc. (1); Nanosphere, Inc. (1).
Have PEN devices been recalled?
Yes: 20 product recalls across 18 recall events; the most recent began 2025-04-16.
Next steps
- Run an FDA pathway report with predicate devices for product code PEN
- Run a recall and safety report across every PEN manufacturer
- Watch product code PEN 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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