Not Cleared Direct

DEN200070 - Simple 2 Test (FDA 510(k) Clearance)

Class II Microbiology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200070 · Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) · Microbiology device
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Nov 2023
Decision
1094d
Days
Class 2
Risk

DEN200070 is an FDA 510(k) submission (not cleared) for the Simple 2 Test. Classified as System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home (product code QYA), Class II - Special Controls.

Submitted by Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) (Dun Laoghaire, IE). The FDA issued a Not Cleared (DENG) decision on November 15, 2023 after a review of 1094 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3385 - the FDA microbiology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 1094 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.) devices

Submission Details

510(k) Number DEN200070 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received November 16, 2020
Decision Date November 15, 2023
Days to Decision 1094 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
992d slower than avg
Panel avg: 102d · This submission: 1094d
Pathway characteristics

Device Classification

Product Code QYA System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3385
Definition This Device Is An In Vitro Diagnostic System Intended For Self-collecting Specimens In Home Settings Or Similar Environments And Testing In A Clinical Laboratory For Detection Of Nucleic Acids From Non-viral Microorganism(s) Causing Sexually Transmitted Infections. The Device Is Intended To Aid In The Diagnosis Of Sexually Transmitted Infections. The Device Is Intended For Prescription Use Or Over-the-counter Use.
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 - QYA System For Detection Of Nucleic Acid From Non-viral Microorganism(s) Causing Stis Using Specimens Collected At Home

Devices cleared under the same product code (QYA) and FDA review panel - the closest regulatory comparables to DEN200070.
simpli-COLLECT STI Test
K243410 · Abbott Molecular · Jan 2025