510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K182690Substantially Equivalent

ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel

Genmark Diagnostics, Incorporated, Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K182690 is the FDA 510(k) clearance record for ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel, a class II device, cleared for Genmark Diagnostics, Incorporated on under FDA product code PEO (Fungal Organisms, Nucleic Acid-Based Assay). FDA's definition for product code PEO reads: "A qualitative multiplexed in vitro diagnostic device to detect and identify fungal organisms in positive blood cultures". FDA records list 7 510(k) clearances for Genmark Diagnostics, Incorporated, from to . As of , FDA records show no recalls naming K182690.

Clearance record

Decision date
Received
(85 days to decision)
Product code
PEO Fungal Organisms, Nucleic Acid-Based Assay
Regulation
21 CFR 866.3365
Device class
Class II
Review panel
Microbiology
Applicant
Genmark Diagnostics, Incorporated 5964 La Pl. Ct., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PEO

Trailing 12 months

FDA records hold no clearances under product code PEO in the trailing twelve months.

FDA records show no clearances under product code PEO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PEO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260