PEO · Class II · 21 CFR 866.3365

FDA Product Code PEO: Fungal Organisms, Nucleic Acid-based Assay

A Qualitative Multiplexed In Vitro Diagnostic Device To Detect And Identify Fungal Organisms In Positive Blood Cultures.

Leading manufacturers include Luminex Corporation.

2
Total
2
Cleared
88d
Avg days
2018
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 90d avg (recent)

FDA 510(k) Cleared Fungal Organisms, Nucleic Acid-based Assay Devices (Product Code PEO)

2 devices
1–2 of 2
Cleared Jun 04, 2024
LIAISON PLEX Yeast Blood Culture Assay
K240627
Luminex Corporation
Microbiology · 90d

About Product Code PEO - Regulatory Context

510(k) Submission Activity

2 total 510(k) submissions under product code PEO since 2018, with 2 receiving FDA clearance (average review time: 88 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for PEO submissions have been consistent, averaging 90 days recently vs 85 days historically.

PEO devices are reviewed by the Microbiology panel. Browse all Microbiology devices →