Cleared Traditional

Alinity m BKV

K241921 · Abbott Molecular, Inc. · Microbiology
Mar 2025
Decision
266d
Days
Class 2
Risk

About This 510(k) Submission

K241921 is an FDA 510(k) clearance for the Alinity m BKV, a Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna (Class II — Special Controls, product code QMI), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on March 24, 2025, 266 days after receiving the submission on July 1, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3183.

Submission Details

510(k) Number K241921 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2024
Decision Date March 24, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QMI — Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bk) Dna
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3183
Definition An In Vitro Nucleic Acid Amplification Test For The Quantitation Of Bk Virus (bkv) Dna In Human Samples Intended For Use As An Aid In The Management Of Bkv In Transplant Patients. In Patients Undergoing Monitoring Of Bkv, Serial Dna Measurements Can Be Used To Indicate The Need For Potential Treatment Changes And To Assess Viral Response To Treatment. Test Results Are Intended To Be Read And Analyzed By A Qualified Licensed Healthcare Professional In Conjunction With Clinical Signs And Symptoms And Relevant Laboratory Findings. Test Results Must Not Be The Sole Basis For Patient Management Decisions.