Cleared Traditional

K233453 - Applied Biosystems TaqPath COVID-19 Dia...

K233453 is an FDA 510(k) clearance for Applied Biosystems TaqPath COVID-19 Dia..., manufactured by Life Technologies Corporation. The device is a Class 2 Microbiology device with product code QQX cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K233453 · Life Technologies Corporation · Microbiology device
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Jul 2024
Decision
264d
Days
Class 2
Risk

K233453 is an FDA 510(k) clearance for the Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit. Classified as Respiratory Specimen Nucleic Acid Sars-cov-2 Test (product code QQX), Class II - Special Controls.

Submitted by Life Technologies Corporation (Pleasanton,, US). The FDA issued a Cleared decision on July 10, 2024 after a review of 264 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3981 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Life Technologies Corporation devices

FDA 510(k) Submission Details - K233453

510(k) Number K233453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
162d slower than avg
Panel avg: 102d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QQX Device Classification - Class 2, Special Controls

Product Code QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - QQX Respiratory Specimen Nucleic Acid Sars-cov-2 Test

All 10
Devices cleared under the same product code (QQX) and FDA review panel - the closest regulatory comparables to K233453.
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