(386 days)
K/DEN number is not in the text, but there is a Reference Device(s) section with the value "Not Found".
No
The summary describes a collection tube and lysis buffer for stabilizing and transporting biological samples, with no mention of AI or ML technology for analysis or processing.
No.
This device is designed for the collection, transport, and stabilization of samples for diagnostic testing (specifically for SARS-CoV-2 RNA), not for treating a disease or improving health.
No
This device is a collection tube intended for the stabilization, transportation, and direct lysis of samples for subsequent use with molecular diagnostic devices. It does not perform the diagnostic analysis itself.
No
The device description clearly states it is a "sterile plastic, 5 ml cryogenic collection tube pre-filled with 1.2 mL of proprietary stabilization/lysis buffer". This is a physical device with a chemical component, not software.
Based on the provided information, the MagXtract Collection Tube is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "stabilization, transportation, and direct lysis of infectious unprocessed nasopharyngeal samples suspected of containing SARS-COV-2 virus RNA." It also states that specimens collected and stored in the tube are "suitable for use with legally marketed molecular diagnostic devices." This clearly indicates its role in the pre-analytical phase of a diagnostic test.
- Device Description: The description reinforces its function in the collection, transportation, direct lysis, and stabilization of RNA from samples suspected of containing SARS-COV-2. It highlights its role in preparing the sample for downstream molecular analysis.
- Performance Studies: The performance studies described (Limit of Detection and Specimen Stability) are typical studies conducted for IVD devices to demonstrate their analytical performance and suitability for diagnostic use.
- Predicate Device: The mention of a predicate device (DEN170029; PrimeStore MTM) is a strong indicator that this device is being compared to a previously cleared IVD device.
While the document doesn't explicitly state "IVD," the intended use, device description, and performance studies align perfectly with the definition and characteristics of an In Vitro Diagnostic device. It is a component used in the process of performing a diagnostic test outside of the body.
N/A
Intended Use / 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℃) or ambient temperatures (20-25℃). Specimens collected and stored in a MagXtract collection tube are suitable for use with legally marketed molecular diagnostic devices.
Product codes
QBD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 1x10^1 TCID50/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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
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,
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
2
Indications for Use
510(k) Number (if known) K212113
Device Name MagXtract Collection Tube
Indications for Use (Describe)
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.
| 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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3
510(k) Summary
| 1. 510(k) Submitter: | MagBio Genomics, Inc.
944 Clopper Road
Gaithersburg, MD 20878
Phone: 301-302-0144
Email: 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, PhD
Brij Strategic Consultations, LLC
20271 Goldenrod Lane, Suite 2020
Germantown, MD 20876
Phone: 240-750-4893
Email: mkumar@fdamap.com | | |
| 5. Device Classification: | Trade name:
Common name:
Device:
Regulation:
Class:
Product Code: | MagXtract Collection Tube
Specimen Collection Tube
Collection Tube
870.2950
2
QBD | |
| 6. Predicate 1: | Applicant:
Device:
510(k) Number: | Longhorn Vaccines and Diagnostics,
PrimeStore MTM
DEN170029 | |
- 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
4
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.
-
- 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 & Predicate | ||
| Device(s): | Device: K212113 | Predicate: DEN170029 |
| Device Trade Name | ||
| General Device | ||
| Characteristic Similarities | ||
| Intended Use/Indications | ||
| For Use | The MagXtract collection tube | |
| 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. | PrimeStore MTM is intended | |
| for the stabilization, | ||
| transportation and | ||
| inactivation of infectious | ||
| unprocessed nasal washes | ||
| suspected of containing | ||
| Influenza A virus RNA. | ||
| PrimeStore MTM is also | ||
| intended for the | ||
| stabilization, transportation | ||
| and inactivation of | ||
| infectious unprocessed | ||
| sputum samples suspected | ||
| of containing | ||
| Mycobacterium tuberculosis | ||
| DNA from human samples. | ||
| Inactivation test | Inactivates virus | same |
| General Device | ||
| Characteristic Differences | ||
| Specimen stability | MagXtract collection tube | |
| preserves SARS-CoV-2 RNA for | ||
| up to 5 days at 2-4°C and 20- | ||
| 25°C | PrimeStore MTM medium | |
| preserves influenza A RNA | ||
| for up to 8 days at 27°C and | ||
| 29 days at 4°C | ||
| Specimen Type | Nasopharyngeal swab | |
| suspected of containing SARS- | ||
| CoV-2. | Nasal wash suspected of | |
| containing Influenza A virus. | ||
| Sputum samples suspected | ||
| of containing MTB. |
Comparison To Predicate... As shown in Table 5, MagXtract PrimeStore MTM.
2
5
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.