Cleared Traditional

K202755 - Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack (FDA 510(k) Clearance)

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

K202755 · Diasorin Molecular, LLC · Microbiology device
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Nov 2022
Decision
775d
Days
Class 2
Risk

K202755 is an FDA 510(k) clearance for the Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack. Classified as Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection (product code QDZ), Class II - Special Controls.

Submitted by Diasorin Molecular, LLC (Cypress, US). The FDA issued a Cleared decision on November 5, 2022 after a review of 775 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3181 - 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 K202755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2020
Decision Date November 05, 2022
Days to Decision 775 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
673d slower than avg
Panel avg: 102d · This submission: 775d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QDZ Qualitative Cytomegalovirus Nucleic Acid-based Detection Device For Congenital Cytomegalovirus Infection
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3181
Definition The Device Is A Qualitative, In Vitro Diagnostic Test For The Direct Detection Of Cytomegalovirus (cmv) Dna In Saliva From Newborn Babies.
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.