PAM
7 FDA 510(k) clearances · Product code
206 daysmedian time to decision
249 days90th percentile
7clearances measured
FDA profile
- Official device name
- Gram-Positive Bacteria And Their Resistance Markers
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3365
- Medical specialty
- Microbiology
- FDA definition
- A qualitive multiplexed in vitro diagnostic device to detect and identify Gram positive bacteria and resistant markers in positive blood cultures.
- Adverse events (MAUDE)
- 2023: 106 · 2024: 422 · 2025: 77
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 | + Add |
| LIAISON PLEX Gram-Positive Blood Culture Assay (K243490) | Luminex Corporation | 2025-06-06 | + Add |
| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 | + Add |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 | + Add |
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 | + Add |
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 | + Add |
| VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (DEN120014) | Nanosphere, Inc. | 2012-06-26 |
Track PAM automatically
Every clearance here is in the API, with alerts when new ones post.