QBD · Microbial Nucleic Acid Storage And Stabilization Device
Microbiology · 21 CFR 866.2950 · Class 2
Overview
| Product Code | QBD |
|---|---|
| Device Name | Microbial Nucleic Acid Storage And Stabilization Device |
| Regulation | 21 CFR 866.2950 |
| Device Class | Class 2 |
| Review Panel | Microbiology |
Identification
A microbial nucleic acid storage and stabilization device is a device that consists of a container and reagents intended to stabilize microbial nucleic acids in human specimens for subsequent isolation and purification of nucleic acids for further molecular testing. The device is not intended for preserving morphology or viability of microorganisms.
Classification Rationale
Class II (special controls). The special controls for this device are:
Special Controls
The special controls for this device are: (1) The intended use for the 21 CFR 809.10 labeling must include a detailed description of microorganisms and types of human specimens intended to be preserved. (2) The 21 CFR 809.10(b) labeling must include: (i) A detailed device description, including all device components. (ii) Performance characteristics from applicable analytical studies, including but not limited to, nucleic acid stability and microorganism inactivation. (iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing. (iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies. (3) Design verification and validation must include the following: (i) Overall device design including all device components and all control elements incorporated into the analytical validation procedures. (ii) Thorough description of the microorganisms and methodology used in the validation of the device including, but not limited to, extraction platforms and assays used for the detection of preserved nucleic acids. (iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
*Classification.* Class II (special controls). The special controls for this device are:(1) The intended use for the labeling required under § 809.10 of this chapter must include a detailed description of microorganisms and types of human specimens intended to be preserved. (2) The labeling required under § 809.10(b) of this chapter must include the following: (i) A detailed device description, including all device components; (ii) Performance characteristics from applicable analytical studies, including nucleic acid stability and microorganism inactivation; (iii) A limiting statement that erroneous results may occur when the transport device is not compatible with molecular testing; and (iv) A limiting statement that the device has only been validated to preserve the representative microorganisms used in the analytical studies. (3) Design verification and validation must include the following: (i) Overall device design, including all device components and all control elements incorporated into the analytical validation procedures; (ii) Thorough description of the microorganisms and methodology used in the validation of the device including, extraction platforms and assays used for the detection of preserved nucleic acids; and (iii) The limit of detection (LoD) of the molecular test used to establish microorganism nucleic acid stability.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K242820 | Puritan PurSafe Plus Collection and Transport System | Puritan Medical Products, LLC | May 27, 2025 | SESE |
| K240797 | PPH Saliva Collection Kit | Permantis Public Health | Oct 11, 2024 | SESE |
| K222771 | Sample Preservative Fluid | Hangzhou Bioer Technology Co., Ltd. | Jun 26, 2024 | SESE |
| K233324 | Molecular Transport Media - MTM | Alb Luz | Jun 17, 2024 | SESE |
| K221547 | InActiv Blue | Fertipro NV | Jun 11, 2024 | SESE |
| K212878 | Sample preservation solution | Zhejiang Gene Science Co., Ltd. | Apr 8, 2024 | SESE |
| K231013 | DNA/RNA Shield SafeCollect Saliva Collection kit | Zymo Research | Sep 28, 2023 | SESE |
| K221664 | CLEARinse CTS Specimen Collection and Transport System | Aardvark Medical, Inc. | Jul 3, 2023 | SESE |
| K221802 | iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) | Mawi Dna Technologies | Apr 3, 2023 | SESE |
| K223497 | Spectrum Saliva Collection Device | Spectrum Solutions, LLC | Feb 17, 2023 | SESE |
| K220059 | Biosci Inactivated Transport Medium, Biosci ITM | Shenzhen Dakewe Bio-Engineering Co., Ltd. | Jan 19, 2023 | SESE |
| K211675 | Dasky Disposable Sampling Tube (Model name: VSM02) | Ningbo Dasky Life Science Co., Ltd. | Aug 8, 2022 | SESE |
| K212113 | MagXtract Collection Tube | Magbio Genomics, Inc. | Jul 28, 2022 | SESE |
| K210440 | Disposable Sampler Inactivated Transport Media, Nest ITM | Wuxi Nest Biotechnology Co., Ltd. | Sep 20, 2021 | SESE |
| K202641 | DNA/RNA Shield Collection Tube | Zymo Research | Dec 14, 2020 | SESE |
| K201849 | eNAT molecular collection and preservation medium | Copan Italia Spa | Sep 17, 2020 | SESE |
| DEN170029 | PrimeStore MTM | Longhorn Vaccines and Diagnostics, LLC | Mar 19, 2018 | DENG |
Top Applicants
- Zymo Research — 2 clearances
- Aardvark Medical, Inc. — 1 clearance
- Alb Luz — 1 clearance
- Copan Italia Spa — 1 clearance
- Fertipro NV — 1 clearance
