Cleared Traditional

K202755 - Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack

K202755 is an FDA 510(k) clearance for Simplexa Congenital CMV Direct and Simp..., manufactured by Diasorin Molecular, LLC. The device is a Class 2 Microbiology device with product code QDZ cleared through the Traditional 510(k) pathway after a 775-day FDA review.

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

FDA 510(k) Submission Details - K202755

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.

QDZ Device Classification - Class 2, Special Controls

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.