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

Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection

21 CFR 866.3230 / Microbiology
FDA source (opens on fda.gov)

QXA is the FDA product code for Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection, a class II device type, regulated under 21 CFR 866.3230. FDA's definition for this code 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 measurement, or both of one or more non-microbial analytes in human clinical specimens...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QXA
Device name
Lateral Flow Immunochromatography Assay For Host Biomarkers Of Respiratory Infection
FDA definition
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 measurement, or both of one or more non-microbial analytes in human clinical specimens to aid in the assessment, identification, or both of a localized microbial infection when used in conjunction with clinical signs and symptoms and other clinical and laboratory findings.
Regulation
21 CFR 866.3230
Device class
Class II
Review panel
Microbiology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QXA

By decision year
2 clearances under product code QXA with a decision year between 2023 and 2026, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QXA by decision year
YearClearances
20231
20261

Applicants with the most clearances

Product code QXA
Applicants holding the most 510(k) clearances under product code QXA
ApplicantClearances
Lumos Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code