Cleared Traditional

K212147 - Simplexa COVID-19 Direct (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212147 · Diasorin Molecular, LLC · Microbiology device
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Sep 2022
Decision
431d
Days
Class 2
Risk

K212147 is an FDA 510(k) clearance for the Simplexa COVID-19 Direct. Classified as Respiratory Specimen Nucleic Acid Sars-cov-2 Test (product code QQX), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on September 13, 2022 after a review of 431 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Diasorin Molecular, LLC devices

Submission Details

510(k) Number K212147 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2021
Decision Date September 13, 2022
Days to Decision 431 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
329d slower than avg
Panel avg: 102d · This submission: 431d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K212147.
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