Cleared Traditional

Applied Biosystems? TaqPath? COVID-19 Diagnostic PCR Kit

K233453 · Life Technologies Corporation · Microbiology

Jul 2024

Decision

264d

Days

Class 2

Risk

About This 510(k) Submission

K233453 is an FDA 510(k) clearance for the Applied Biosystems? TaqPath? COVID-19 Diagnostic PCR Kit, a Respiratory Specimen Nucleic Acid Sars-cov-2 Test (Class II — Special Controls, product code QQX), submitted by Life Technologies Corporation (Pleasanton,, US). The FDA issued a Cleared decision on July 10, 2024, 264 days after receiving the submission on October 20, 2023. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3981.

Submission Details

510(k) Number	K233453 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2023
Decision Date	July 10, 2024
Days to Decision	264 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.