LIAISON PLEX Gram-Positive Blood Culture Assay
FDA 510(k) clearance K243490 · decided 2025-06-06
Clearance details
- K-number
- K243490
- Device name
- LIAISON PLEX Gram-Positive Blood Culture Assay
- Applicant
- Luminex Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-11-12
- Decision date
- 2025-06-06
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- PAM
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Luminex Corporation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QIAstat-Dx BCID GPF Plus AMR Panel (K254194) | QIAGEN GmbH | 2026-08-06 |
| ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel (K181663) | Genmark Diagnostics, Incorporated | 2018-12-20 |
| iC-GPC Assay TM for use on the iC-SystemTM (K163390) | Icubate, Inc. | 2017-08-08 |
| Great Basin Staph ID/R Blood Culture Panel (K152470) | Great Basin Scientific, Inc. | 2016-03-25 |
| VERIGENE GRAM-POSITIVE BLOOD CULTURE (GC-GP) NUCLEIC ACID TEST (K122514) | Nanosphere, Inc. | 2012-09-19 |
| VERIGENE GRAM POSITIVE BLOOD CULTURE NUCLEIC ACID TEST (BC-GP) (DEN120014) | Nanosphere, Inc. | 2012-06-26 |
Recalls involving this device
No recalls on record reference this clearance.