Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a collection and transport system for biological specimens and does not involve any data processing or analysis that would utilize AI/ML.

Therapeutic

No.
The device is described as a collection and transport system intended for diagnostic techniques, not for treating or preventing diseases.

Diagnostic

No

Explanation: The device is a collection and transport system intended to preserve clinical specimens for subsequent diagnostic/identification techniques in a laboratory. It is not itself performing the diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components: a sterile nylon-flocked collection swab, a plastic shaft, a vial with Viral Transport Medium (VTM), and a sealable biohazard bag. This indicates it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that the system is "intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques." It also specifies its use for "upper respiratory viral diagnostic assays." This clearly indicates its role in the diagnostic process.
Device Description: The description details components used for collecting and transporting biological specimens for laboratory analysis.
Performance Studies: The document describes performance studies evaluating the device's ability to preserve viral viability and nucleic acids for downstream diagnostic testing (culture-based and amplification-based studies).
Intended User/Care Setting: The intended user is the "laboratory," which is where in vitro diagnostic testing is performed.

All these factors align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

Product codes

JSM, LIO

Device Description

The Merit Cultura™ Collection and Transport System contains a sterile nylon-flocked collection swab with a plastic shaft, a vial with 3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag. Prior to use, vials should be stored at 2-8°C and 23-25°C. After collection, the transport tube containing the specimen can be stored for up to 120 hours at 2-8°C and 23-25°C.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Upper respiratory (implied by "upper respiratory viral diagnostic assays").

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Laboratory for standard diagnostic/identification techniques.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Culture-Based Studies:

Performance of the Cultura Collection and Transport System was evaluated for virus viability using commercial strains of Influenza A, Influenza B, RSV, and Rhinovirus.
600 µL of organism suspension was used to inoculate the Cultura VTM in quadruplicate and stored for 0, 48 hrs., 72 hrs., and 120 hrs. at 2-8°C and at controlled room temperature (23-25°C).
At each timepoint, an aliquot of the Cultura VTM and orqanism suspension was inoculated into the appropriate host cell line.
All the cultures were processed using the standard laboratory culture technique.
Organism viability was determined by the Reed-Muench method calculation of TCID50.

Amplification-Based Studies:

Performance of the Cultura Collection and Transport System was evaluated by Real-Time PCR amplification studies using 12 unique, SARS-CoV-2 positive clinical specimens.
Testing has been performed in triplicate to show the suitability of the Cultura VTM for the preservation of nucleic acids (RNA and DNA) for down-stream nucleic acid extraction and molecular testing when VTM and collection samples are stored per the instructions provided.
Nucleic acid was detected using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel (catalog No. 2019-nCoVEUA-01).
The rRT-PCR enzyme used in the master mix was the Thermofisher TagPath™ 1-Step RT-qPCR Master Mix (catalog No. A15299).
RNA was extracted using the Qiagen QlAcube using the QlAmp Viral RNA Mini Kit (catalog No. 52906) per the manufacturer's instructions.
Samples were run on the Applied Biosystems 7500 Fast Dx PCR System with SDS version 1.4 software (catalog No. 4406985).
T=0 hours. T=72 hours, T=120 hours, and T=240 hours samples were stored in temperature-controlled environments of 2-8°C and 20-25°C.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Culture-Based Studies:

Study Type: Virus viability evaluation
Sample Size: Not explicitly stated as a single number (e.g., n=X), but 600 µL of organism suspension was inoculated in quadruplicate for 4 viruses at 4 timepoints and 2 temperatures.
Key Results: Merit Cultura™ Collection and Transport System preserved the samples of all the organisms tested (RSV, Influenza A, Influenza B, Rhinovirus) for up to 120 hours at both controlled room temperature and refrigerated. Viral recovery results at T0 and T120 hours at 2-8°C and 23-25°C showed "Present" for all tested organisms.

Amplification-Based Studies:

Study Type: Real-Time PCR amplification
Sample Size: 12 unique, SARS-CoV-2 positive clinical specimens, tested in triplicate.
Key Results: Results show 100% concordance of the qualitative result (Ct

Regulation Number and Section

§ 866.2390 Transport culture medium.

(a)
Identification. A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.(b)
Classification. Class I (general controls).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 3, 2021

Merit Medical Systems, Inc. Alex Bohorquez Regulatory Affairs Specialist II 1600 West Merit Parkway South Jordan, Utah 84095

Re: K201674

Trade/Device Name: Cultura Collection and Transport System Regulation Number: 21 CFR 866.2390 Regulation Name: Transport Culture Medium Regulatory Class: Class I, reserved Product Code: JSM,LIO Dated: January 12, 2021 Received: January 13, 2021

Dear Alex Bohorquez:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ribhi Shawar, Ph.D. (ABMM) Chief General Bacteriology and Antimicrobial Susceptibility Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K201674

Device Name

Merit Cultura™ Collection and Transport System

Indications for Use (Describe)

The Merit Cultura™ Collection and Transport System is intended for collection and transport of clinical specimens to the laboratory for standard diagnostic/identification techniques. The Merit Cultura™ Collection and Transport System is a culture-based media that can be used for upper respiratory viral diagnostic assays including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

| Sponsor | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
801-208-4685
Alex Bohorquez
27 July 2020
1721504 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Merit Cultura™ Collection and Transport
System
Specimen Collection and Transport System
Transport Culture Medium Devices
Class I
JSM, LIO
866.2390
Microbiology |
| Predicate Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product code:
21 CFR §:
Premarket Notification:
Manufacturer: | Puritan Universal Transport Medium (UTM-
RT) Collection and Transport System
Specimen Collection and Transport System
Transport Culture Medium Devices
Class I
JSM, LIO
866.2390
K113249
Puritan Medical Products LLC |
| Device
Description | The Merit Cultura™ Collection and Transport System contains a
sterile nylon-flocked collection swab with a plastic shaft, a vial with
3.0mL of Viral Transport Medium (VTM) and a sealable biohazard bag.
Prior to use, vials should be stored at 2-8°C and 23-25°C. After
collection, the transport tube containing the specimen can be stored
for up to 120 hours at 2-8°C and 23-25°C. | |
| Indications for
Use | The Merit Cultura™ Collection and Transport System is intended for
collection and transport of clinical specimens to the laboratory for
standard diagnostic/identification techniques. The Merit Cultura™
Collection and Transport System is a culture-based media that can be
used for upper respiratory viral diagnostic assays including Severe | |

4

Predicate

Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Rhinovirus.

The subject and predicate devices are based on the following same technological elements:

Provide a device for the collection of patient specimens .
. Provide a transport media to preserve specimen in transit to the testing laboratory

		Subject Device	Predicate Device
	Intended Use	The Merit Cultura™ Collection and Transport
System is intended for
collection and transport
of clinical specimens to
the laboratory for
standard
diagnostic/identification
techniques. The Merit
Cultura™ Collection and
Transport System is a
culture-based media that
can be used for upper
respiratory viral
diagnostic assays
including Severe Acute
Respiratory Syndrome
Coronavirus 2 (SARS-
CoV-2), Influenza A,
Influenza B, Respiratory
Syncytial Virus (RSV),
and Rhinovirus.	Puritan UTM-RT
Collection and
Transport System is
intended for the
collection and
transport of clinical
samples containing
viruses, chlamydiae,
mycoplasmas or
ureaplasmas from
the collection site to
the testing laboratory.
The specimen
transported in the
Puritan UTM-RT can
be used in the
laboratory to perform
viral, chlamydial,
mycoplasmal and
ureaplasmal culture.
Comparison to
Predicate Device	Device Similarities
	Storage Temp.	2-8°C and 23-25°C	Same
	List of
Ingredients	Hanks Balanced Salt
Solution enriched with
proteins and sugars with
a neutral pH and pH
indicator.	Same
	Tube Material	Plastic	Same
	Single Use
Device	Yes	Same
	Sterile Device	Yes	Same
	Device Differences
	Storage Time	Specimen should be
processed within 120
hours	Specimen should be
processed within 48
hours
	Shelf Life	12 months	15 months

5

| Samples
Transported to
Perform | Assays to detect viruses | Assays to detect
viruses, chlamydiae,
mycoplasmas, or
ureaplasmas |
|--------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------|
| List of
Ingredients | FBS as protein
stabilizer D-glucose as sugar | BSA as protein
stabilizer Sucrose as sugar Gelatin Glutamic acid HEPES |
| Swab Material | Flocked Nylon Fiber Tip
with Breaking Point | Flocked Nylon
Fiber Tip with
Breaking Point Polyester tipped
with breaking
point |

Performance Testing:

Culture-Based Studies

Performance of the Cultura Collection and Transport System was evaluated for virus viability using commercial strains of Influenza A, Influenza B, RSV, and Rhinovirus. 600 µL of organism suspension was used to inoculate the Cultura VTM in quadruplicate and stored for 0, 48 hrs., 72 hrs., and 120 hrs. at 2-8°C and at controlled room temperature (23-25°C). At each timepoint, an aliquot of the Cultura VTM and orqanism suspension was inoculated into the appropriate host cell line. All the cultures were processed using the standard laboratory culture technique. Organism viability was determined by the Reed-Muench method calculation of TCID50.

Performance Data

Merit Cultura™ Collection and Transport System preserved the samples of all the organisms tested for up to 120 hours at both controlled room temperature and refrigerated. The organisms evaluated and the results obtained are given in Table 1 below. The table below represents the titer of virus inoculated at T-0. The word "present" confirms the viability of the virus.

Table 1. Viral recovery results for viruses at T0 and T120 hours at 2-8°C and 23-25°C.

Organism	ATCC#	Host Cell lines	ATCC#	Virus recovered at T-0 (TCID50)	T-0 Hour		T-120 Hours
					2-8°C	23-25°C	2-8°C	23-25°C
RSV	VR-26	Hep-2	CCL-23	101.5	Present	Present	Present	Present
Influenza A Virus	VR-1496-TC	MDCK	CCL-34	101	Present	Present	Present	Present
Influenza B Virus	VR-284	MDCK	CCL-34	101.5	Present	Present	Present	Present
Rhinovirus	VR-1535	H1- Hela	CRL-1958	101.5	Present	Present	Present	Present

Amplification-Based Studies

Performance of the Cultura Collection and Transport System was

6

evaluated by Real-Time PCR amplification studies using 12 unique, SARS-CoV-2 positive clinical specimens. Testing has been performed in triplicate to show the suitability of the Cultura VTM for the preservation of nucleic acids (RNA and DNA) for down-stream nucleic acid extraction and molecular testing when VTM and collection samples are stored per the instructions provided.

Nucleic acid was detected using the CDC 2019-Novel Coronavirus Real-Time RT-PCR Diagnostic Panel (catalog No. 2019-nCoVEUA-01). The rRT-PCR enzyme used in the master mix was the Thermofisher TagPath™ 1-Step RT-qPCR Master Mix (catalog No. A15299). RNA was extracted using the Qiagen QlAcube using the QlAmp Viral RNA Mini Kit (catalog No. 52906) per the manufacturer's instructions. Samples were run on the Applied Biosystems 7500 Fast Dx PCR System with SDS version 1.4 software (catalog No. 4406985). T=0 hours. T=72 hours, T=120 hours, and T=240 hours samples were stored in temperature-controlled environments of 2-8°C and 20-25°C.

Results show 100% concordance of the qualitative result (Ct