Not Cleared Direct

DEN170029 - PrimeStore MTM (FDA 510(k) Clearance)

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

DEN170029 · Longhorn Vaccines and Diagnostics, LLC · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2018
Decision
299d
Days
Class 2
Risk

DEN170029 is an FDA 510(k) submission (not cleared) for the PrimeStore MTM. Classified as Microbial Nucleic Acid Storage And Stabilization Device (product code QBD), Class II - Special Controls.

Submitted by Longhorn Vaccines and Diagnostics, LLC (Bethesda, US). The FDA issued a Not Cleared (DENG) decision on March 19, 2018 after a review of 299 days.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2950 - 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. Elevated predicate reliance profile. With 299 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 Longhorn Vaccines and Diagnostics, LLC devices

Submission Details

510(k) Number DEN170029 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 24, 2017
Decision Date March 19, 2018
Days to Decision 299 days
Submission Type Direct
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 102d · This submission: 299d
Pathway characteristics

Device Classification

Product Code QBD Microbial Nucleic Acid Storage And Stabilization Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.2950
Definition Molecular Transport Media Is A Device Intended For The Stabilization And Transportation Of Nucleic Acids From Unprocessed Human Samples Suspected Of Containing Infectious Material.
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 - QBD Microbial Nucleic Acid Storage And Stabilization Device

All 16
Devices cleared under the same product code (QBD) and FDA review panel - the closest regulatory comparables to DEN170029.
Puritan PurSafe Plus Collection and Transport System
K242820 · Puritan Medical Products, LLC · May 2025
PPH Saliva Collection Kit
K240797 · Permantis Public Health · Oct 2024
Sample Preservative Fluid
K222771 · Hangzhou Bioer Technology Co., Ltd. · Jun 2024
Molecular Transport Media - MTM
K233324 · Alb Luz · Jun 2024
InActiv Blue
K221547 · Fertipro NV · Jun 2024
Sample preservation solution
K212878 · Zhejiang Gene Science Co., Ltd. · Apr 2024