Disposable Sampler Inactivated Transport Media, Nest ITM

Q: What is the product code of K210440?

The FDA product code is QBD – Microbial Nucleic Acid Storage And Stabilization Device, a Class II (moderate risk) device regulated under 21 CFR 866.2950.

FDA 510(k) K210440 · Wuxi Nest Biotechnology Co., Ltd.

Substantially Equivalent

510(k) numberK210440

Submission

Device name: Disposable Sampler Inactivated Transport Media, Nest ITM
Applicant: Wuxi Nest Biotechnology Co., Ltd.
Wuxi, CN
Received: February 12, 2021
Decision date: September 20, 2021
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: QBD – Microbial Nucleic Acid Storage And Stabilization Device
Device class: Class II (moderate risk)
Regulation: 21 CFR 866.2950
Specialty: Microbiology

Molecular transport media is a device intended for the stabilization and transportation of nucleic acids from unprocessed human samples suspected of containing infectious material.

Other 510(k)s with product code QBD

510(k)	Device	Applicant	Decision
K242820	Puritan PurSafe Plus Collection and Transport SystemQBD · Traditional	Puritan Medical Products, LLC	05/27/2025SE
K240797	PPH Saliva Collection KitQBD · Traditional	Permantis Public Health	10/11/2024SE
K222771	Sample Preservative FluidQBD · Traditional	Hangzhou Bioer Technology Co., Ltd.	06/26/2024SE
K233324	Molecular Transport Media - MTMQBD · Traditional	Alb Luz	06/17/2024SE
K221547	InActiv BlueQBD · Traditional	Fertipro NV	06/11/2024SE
K212878	Sample preservation solutionQBD · Traditional	Zhejiang Gene Science Co., Ltd.	04/08/2024SE
K231013	DNA/RNA Shield SafeCollect Saliva Collection kitQBD · Traditional	Zymo Research	09/28/2023SE
K221664	CLEARinse CTS Specimen Collection and Transport SystemQBD · Traditional	Aardvark Medical, Inc.	07/03/2023SE
K221802	iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)QBD · Traditional	Mawi Dna Technologies	04/03/2023SE
K223497	Spectrum Saliva Collection DeviceQBD · Traditional	Spectrum Solutions, LLC	02/17/2023SE

510(k)	Device	Decision
K240961	Disposable Pen Injector AssemblyFMF · Traditional	08/15/2024SE
K240774	Pen InjectorFMF · Traditional	06/18/2024SE
K211256	Disposable Sampler Viral Transport MediaJSM · Traditional	05/20/2022SE

Questions and answers

When was Disposable Sampler Inactivated Transport Media, Nest ITM cleared by the FDA?

Disposable Sampler Inactivated Transport Media, Nest ITM (K210440) received a 510(k) decision of Substantially Equivalent on September 20, 2021, 220 days after the submission was received.

What is the product code of K210440?

The FDA product code is QBD – Microbial Nucleic Acid Storage And Stabilization Device, a Class II (moderate risk) device regulated under 21 CFR 866.2950.