FDA product code PAM: Gram-Positive Bacteria And Their Resistance Markers
PAM is the FDA product code for gram-positive bacteria and their resistance markers. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel. FDA has cleared 6 510(k) submissions under PAM, 2 in the last five years, from 6 different applicants. The average 510(k) review took 183 days (median 206); 216 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 11 recalls for PAM devices, 2 initiated in the last five years.
Definition
A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
Classification
| Field | Value |
|---|---|
| Device name | Gram-Positive Bacteria And Their 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 PAM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 249 |
| 2018 | 1 | 178 |
| 2025 | 1 | 206 |
| 2026 | 1 | 226 |
Compare with all 510(k) review times · Search every PAM clearance
Top PAM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| QIAGEN GmbH | 1 | 2026-08-06 |
| Luminex Corporation | 1 | 2025-06-06 |
| Genmark Diagnostics, Incorporated | 1 | 2018-12-20 |
| Icubate, Inc. | 1 | 2017-08-08 |
| Great Basin Scientific, Inc. | 1 | 2016-03-25 |
1 more applicants have PAM clearances. See the full list in Caduvo.
Most recent PAM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254194 | QIAGEN GmbH | QIAstat-Dx BCID GPF Plus AMR Panel | 2026-08-06 | 226 |
| K243490 | Luminex Corporation | LIAISON PLEX Gram-Positive Blood Culture Assay | 2025-06-06 | 206 |
| K181663 | Genmark Diagnostics, Incorporated | ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel | 2018-12-20 | 178 |
| K163390 | Icubate, Inc. | iC-GPC Assay TM for use on the iC-SystemTM | 2017-08-08 | 249 |
| K152470 | Great Basin Scientific, Inc. | Great Basin Staph ID/R Blood Culture Panel | 2016-03-25 | 207 |
Recalls for PAM devices
11 product recalls in 11 recall events; 2 initiated in the last five years and 2 still open. Most recent: 2024-06-20.
| Year | Recalls |
|---|---|
| 2018 | 3 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 1 |
Frequently asked questions
What is FDA product code PAM?
PAM is the FDA product code for gram-positive bacteria and their resistance markers. It is a Class II device, regulated under 21 CFR 866.3365 and reviewed by the Microbiology panel.
What device class is PAM?
Class II, regulation 21 CFR 866.3365. Typical premarket route: 510(k).
How long does a 510(k) take for product code PAM?
Across 6 cleared submissions the average was 183 days from receipt to decision (median 206).
Which companies have the most PAM clearances?
QIAGEN GmbH (1); Luminex Corporation (1); Genmark Diagnostics, Incorporated (1); Icubate, Inc. (1); Great Basin Scientific, Inc. (1).
Have PAM devices been recalled?
Yes: 11 product recalls across 11 recall events; the most recent began 2024-06-20.
Next steps
- Run an FDA pathway report with predicate devices for product code PAM
- Run a recall and safety report across every PAM manufacturer
- Watch product code PAM 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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