Cleared Traditional

Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086)

K241580 · Abbott Molecular · Microbiology

Dec 2024

Decision

186d

Days

Class 2

Risk

About This 510(k) Submission

K241580 is an FDA 510(k) clearance for the Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-086), a Respiratory Specimen Nucleic Acid Sars-cov-2 Test (Class II — Special Controls, product code QQX), submitted by Abbott Molecular (Des Plaines, US). The FDA issued a Cleared decision on December 6, 2024, 186 days after receiving the submission on June 3, 2024. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K241580 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 03, 2024
Decision Date	December 06, 2024
Days to Decision	186 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

Device Classification

Product Code	QQX — Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3981
Definition	A Device To Detect And Identify Nucleic Acid Targets In Respiratory Specimens From Sars-cov-2 That Cause Covid-19 Is An In Vitro Diagnostic Device Intended For The Detection And Identification Of Sars-cov-2 Nucleic Acid Targets In Human Clinical Respiratory Specimens From Patients Suspected Of Covid-19 Based On Signs And Symptoms Of Respiratory Infections By Their Healthcare Providers. The Device Is Intended To Aid In The Diagnosis Of Covid-19 In Conjunction With Other Clinical, Epidemiologic, And Laboratory Data Or Other Risk Factors.