Cleared Traditional

Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)

K212778 · Abbott Molecular, Inc. · Microbiology
Jul 2022
Decision
317d
Days
Class 2
Risk

About This 510(k) Submission

K212778 is an FDA 510(k) clearance for the Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075), a Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna (Class II — Special Controls, product code QLX), submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on July 15, 2022, 317 days after receiving the submission on September 1, 2021. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3183.

Submission Details

510(k) Number K212778 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2021
Decision Date July 15, 2022
Days to Decision 317 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code QLX — Nucleic Acid Amplification Test For The Quantitation Of Epstein-barr Virus (ebv) Dna
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3183
Definition A Quantitative Viral Nucleic Acid Test For Transplant Patient Management Is Identified As A Device Intended For Prescription Use In The Detection Of Viral Pathogens By Measurement Of Viral Deoxyribonucleic Acid (dna) Or Ribonucleic Acid (rna) Using Specified Specimen Processing, Amplification, And Detection Instrumentation. The Test Is Intended For Use As An Aid In The Management Of Transplant Patients With Active Viral Infection Or At Risk For Developing Viral Infections. The Test Results Are Intended To Be Interpreted By Qualified Healthcare Professionals In Conjunction With Other Relevant Clinical And Laboratory Findings.