510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260787Substantially Equivalent

FebriDx Bacterial/Non-bacterial Assay

Lumos Diagnostics, Inc., Carlsbad CA / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260787 is the FDA 510(k) clearance record for FebriDx Bacterial/Non-bacterial Assay, a class II device, cleared for Lumos Diagnostics, Inc. on under FDA product code QXA (Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection). FDA's definition for product code QXA reads: "A device to detect and measure non-microbial analytes to aid in the detection and identification of localized human infections is identified as an in vitro device intended for the detection and qualitative measurement, quantitative...". FDA records list 2 510(k) clearances for Lumos Diagnostics, Inc., from to . As of , FDA records show no recalls naming K260787.

Clearance record

Decision date
Received
(14 days to decision)
Product code
QXA Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
Regulation
21 CFR 866.3230
Device class
Class II
Review panel
Microbiology
Applicant
Lumos Diagnostics, Inc. 2724 Loker Ave. W., Carlsbad CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXA

Trailing 12 months
1 clearance under product code QXA in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QXA, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260