The MagXtract Collection Tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.

Device Description

The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2. The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory. The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.

AI/ML Overview

The information provided does not describe an AI medical device. The document is a 510(k) premarket notification for a medical device called the "MagXtract Collection Tube," which is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-CoV-2 virus RNA.

Therefore, the requested information about acceptance criteria for an AI device, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance cannot be extracted from this document as it pertains to a different type of medical device.

However, I can extract the acceptance criteria and study information that is present in the document for the MagXtract Collection Tube:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Limit of Detection (LoD): To accurately detect SARS-CoV-2.	LoD of 1x10$^1$ TCID$_{50}$/ml for SARS-COV-2 (when used with TaqPath COVID-19 Combo Kit).
Specimen Stability: SARS-CoV-2 RNA to be preserved and stabilized over time.	SARS-CoV-2 RNA was stabilized and preserved, meeting the acceptance criteria of +/- 3.0 Ct after 5 days of storage at refrigeration (2-8°C) and room temperature (20-25°C).

2. Sample size used for the test set and the data provenance:

Limit of Detection Study: The document states that "The viral culture lysate of SARS-COV-2 was spiked into MagXtract collection tube containing Magbio CTL Medium with nasopharyngeal swab matrix." No specific number of samples (test set size) is provided. The data provenance is not explicitly stated as 'country of origin' or 'retro/prospective', but implies laboratory-based spiked samples.
Specimen Stability Study: "The stability study used nasopharyngeal matrix in transport media and SARS-CoV-2 viral lysate spiked at the limit of detection." No specific number of samples (test set size) is provided. The data provenance implies laboratory-based spiked samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the studies described are analytical performance studies (LoD, stability) involving viral lysates and molecular detection, not clinical studies requiring expert ground truth for interpretation of medical images or other clinical data. The "ground truth" here is the known concentration of spiked virus.

4. Adjudication method for the test set:

Not applicable for analytical performance studies involving known spiked concentrations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI medical device.

7. The type of ground truth used:

Limit of Detection Study: Known concentration of SARS-CoV-2 viral culture lysate spiked into the collection tubes.
Specimen Stability Study: Known concentration of SARS-CoV-2 viral lysate spiked at the limit of detection.

8. The sample size for the training set:

Not applicable. This is not an AI medical device, and the described studies are analytical performance validation, not machine learning model training.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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MagBio Genomics, Inc. % Mukesh Kumar CEO Brij Strategic Consultations, LLC 20271 Goldenrod Lane, Suite 2020 Germantown, Maryland 20876

July 28, 2022

Re: K212113

Trade/Device Name: MagXtract Collection Tube Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: July 5, 2021 Received: July 7, 2021

Dear Mukesh Kumar:

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

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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,

Kristian Roth, Ph.D. Deputy Director Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K212113

Device Name MagXtract Collection Tube

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

1. 510(k) Submitter:	MagBio Genomics, Inc.944 Clopper RoadGaithersburg, MD 20878Phone: 301-302-0144Email: m.mlalazi@magbiogenomics.com
2. Company Contact:	Mothomang Mlalazi-Oyinloye Ph.D.Associate Scientific Director
3. Date of Submission:	May 15, 2021
4. US Agent:	Mukesh Kumar, PhDBrij Strategic Consultations, LLC20271 Goldenrod Lane, Suite 2020Germantown, MD 20876Phone: 240-750-4893Email: mkumar@fdamap.com
5. Device Classification:	Trade name:Common name:Device:Regulation:Class:Product Code:	MagXtract Collection TubeSpecimen Collection TubeCollection Tube870.29502QBD
6. Predicate 1:	Applicant:Device:510(k) Number:	Longhorn Vaccines and Diagnostics,PrimeStore MTMDEN170029

Device Description. The MagXtract collection tube is intended for the collection, transportation, direct lysis, and stabilization of RNA from unprocessed nasopharyngeal swab samples suspected of containing SARS-COV-2.

LLC

The MagXtract collection tube stores and transports specimens in a closed tube. Proper specimen collection and transport are essential in molecular testing and obtaining accurate test results. MagXtract collection tube allows for the stabilization and transportation of nasopharyngeal swab samples at ambient temperature from the collection site to the processing laboratory.

The MagXtract collection tube consists of a sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer (MagBio CTL Medium). MagBio

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CTL Medium is intended to disrupt/lyse cells and stabilize SARS-COV-2. The preserved and stabilized RNA maintains its integrity for downstream molecular based detection/analysis. MagXtract collection tube may be used in conjunction with a swab or as a tube alone.

1. Indications For Use. The MagXtract collection tube is intended for the stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA. These devices can be used for collection transport and storage of specimens at refrigerated (2-8°C) or ambient temperatures (20-25°C). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.

Table 5 - Comparison Table
Device & PredicateDevice(s):	Device: K212113	Predicate: DEN170029
Device Trade Name
General DeviceCharacteristic Similarities
Intended Use/IndicationsFor Use	The MagXtract collection tubecollection tube is intended forthe stabilization, transportation,and direct lysis of infectiousunprocessed nasopharyngealsamples suspected of containingSARS-COV-2 virus RNA. Thesedevices can be used forcollection transport and storageof specimens at refrigerated (2-8°C) or ambient temperatures(20-25°C). Specimens collectedand stored in a MagXtractcollection tube are suitable foruse with legally marketedmolecular diagnostic devices.	PrimeStore MTM is intendedfor the stabilization,transportation andinactivation of infectiousunprocessed nasal washessuspected of containingInfluenza A virus RNA.PrimeStore MTM is alsointended for thestabilization, transportationand inactivation ofinfectious unprocessedsputum samples suspectedof containingMycobacterium tuberculosisDNA from human samples.
Inactivation test	Inactivates virus	same
General DeviceCharacteristic Differences
Specimen stability	MagXtract collection tubepreserves SARS-CoV-2 RNA forup to 5 days at 2-4°C and 20-25°C	PrimeStore MTM mediumpreserves influenza A RNAfor up to 8 days at 27°C and29 days at 4°C
Specimen Type	Nasopharyngeal swabsuspected of containing SARS-CoV-2.	Nasal wash suspected ofcontaining Influenza A virus.Sputum samples suspectedof containing MTB.

Comparison To Predicate... As shown in Table 5, MagXtract PrimeStore MTM.

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9. Performance data:

Limit of detection

An analytical sensitivity study was conducted to determine the SARS-CoV-2 Limit of Detection (LoD) obtained using MagXtract collection tubes in combination with TagPath COVID-19 Combo Kit (detection of SARS-COV-2).

The viral culture lysate of SARS-COV-2 was spiked into MagXtract collection tube containing Magbio CTL Medium with nasopharyngeal swab matrix. RNA was captured from MagXtract Collection Tube using MagBio Genomics paramagnetic beads on KingFisher Flex Purification system.

RNA extracts from Kingfisher Flex system were amplified using SARS-CoV-2 RT-PCR Kit (TaqPath COVID-19 Combo Kit). MagXtract collection tube had LoD of 1x101 TCIDso/ml for SARS-COV-2.

Specimen Stability

A stability study was undertaken to demonstrate that SARS-CoV-2 is preserved and stabilized in the MagXtract Collection Tube. The stability study used nasopharyngeal matrix in transport media and SARS-CoV-2 viral lysate spiked at the limit of detection. The samples were then extracted using the KingFisher Flex Purification system and amplified using the TaqPath COVID-19 Combo Kit. The results of the SARS-CoV-2 RNA stability study confirmed that RNA was stabilized and preserved in MagXtract Collection Tube met the acceptance criteria of +/- 3.0 Ct after 5 days of storage at refrigeration and room temperature.

10. Substantial Equivalence:

Based on the above information, MagXtract Collection Tube is substantially equivalent to FDA cleared predicates (PrimeStore MTM (DEN170029) for the LoD, the stabilization/recovery of samples containing SARS-CoV-2. MagXtract collection tube successfully followed the pathway to substantial equivalence in the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications" (July 2014). The steps are summarized below:

The predicate is legally marketed.
. The subject and predicate devices have the same intended use (and indications).
Technological differences between the subject and primary predicate were evaluated; none of the differences raised different issues of safety and effectiveness.
The following methods for evaluation of the effects of different characteristics on safety and effectiveness were deemed acceptable—stability, limit of detection.
Data from these tests demonstrated equivalence and support the indications for use.

Regulation Number and Section

§ 866.2950 Microbial nucleic acid storage and stabilization device.

(a)
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.(b)
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.