The iSWAB-Respiratory Tract Sample Collection Media-Extraction device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.

Device Description

The iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB™ -RC-EL) collection device consists of a collection tube that is pre-filled with 800 µL of the iSWAB™-RC-EL nontoxic, stabilizing buffer and fitted with a proprietary insert. The insert is designed to optimize the release of specimens collected with swabs into the stabilizing buffer, creating a minimal footprint and allowing for swab-free transport of specimens. The iSWAB™-RC-EL collection device eliminates the costly and timeconsuming RNA isolation step from diagnostic workflows.

AI/ML Overview

The provided text describes the Mawi DNA Technologies iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) device, a microbial nucleic acid storage and stabilization device. However, this document does not describe the acceptance criteria of a device or a study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The provided text pertains to a sample collection and stabilization device for SARS-CoV-2, which is a physical diagnostic device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (e.g., ground truth, MRMC study, training set, human-in-the-loop performance) are not applicable to the information contained in this document.

The document discusses performance data related to:

Sterilization & Shelf-life Testing: Stability studies for bacterial/fungal growth, appearance, pH, voltage resistance, and density over time.
Biocompatibility Testing: Not applicable as it's an IVD with no patient contact.
Electrical safety and electromagnetic compatibility (EMC): Not applicable as it's a passive device.
Software Verification and Validation Testing: Not applicable as it's a passive device.
Mechanical and acoustic Testing: Not applicable.
Animal Study: Not required.
Human Clinical Performance Testing: Not required.

The performance data that was provided and could be interpreted as "proving the device meets acceptance criteria" for a sample collection device includes:

Inactivation Study: Demonstrated inactivation of the SARS-CoV-2 virus.
Limit of Detection (LoD): An analytical sensitivity study to determine the LoD of SARS-CoV-2 collected using the iSWAB-RC-EL in combination with a specific RT-PCR kit.
Specimen Stability: A study demonstrating stabilization of SARS-CoV-2 at ambient temperature for specified durations (e.g., 28 days for nasal, 33 days for saliva at 15-30°C).
Precision/Reproducibility: Studies conducted for lot-lot, day-day, and operator-operator reproducibility.
Compatibility: Demonstrated compatibility with various legally marketed molecular diagnostic tests (e.g., CDC 2019-nCoV RT-PCR Diagnostic Panel, BGI Real-Time Fluorescent RT-PCR Kit).

Since the requested information pertains to an AI/ML device and the provided document is about a physical sample collection device, it is not possible to fully answer the prompt's specific questions.

However, I can extract information relevant to the performance studies conducted for this specific medical device (iSWAB-RC-EL), even though it does not fit the AI/ML context:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" values for each test, but rather describes that the tests were performed and implies successful outcomes for substantial equivalence. I will infer the performance reported based on the study descriptions.

Performance Characteristic	Acceptance Criteria (Inferred from study description)	Reported Device Performance
SARS-CoV-2 Inactivation	Demonstrated inactivation of SARS-CoV-2.	Inactivation study conducted and results supported.
Limit of Detection (LoD)	Determined LoD in combination with a specific RT-PCR kit sufficient for molecular diagnostic use.	Determined LoD of SARS-CoV-2 in iSWAB-RC-EL in combination with the BGI Real-Time Fluorescent RT-PCR Kit.
Specimen Stability (Ambient)	SARS-CoV-2 stabilized for specific durations at ambient temperature.	SARS-CoV-2 stabilized for 28 days (nasal) and 33 days (saliva) at 15-30°C.
Precision/Reproducibility	Demonstrated acceptable lot-lot, day-day, and operator-operator reproducibility.	Two reproducibility studies conducted; results demonstrated lot-lot reproducibility. (Day-Day and Operator-Operator results are implied but not explicitly detailed).
Compatibility	Compatible with legally marketed molecular diagnostic tests.	Compatible with CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR Diagnostic Panel, BGI Real-Time Fluorescent RT-PCR Kit, Bio-Rad's Reliance SARS-CoV-2 RT-PCR Assay, PRIME CovidDetect RT-LAMP-based assay, and UCSD RT-LAMP and LFIA test.
Shelf-Life	Stable for a specified duration after manufacture.	15 months shelf-life established through Realtime and Accelerated stability on 3 lots checked for bacterial/fungal growth, appearance, pH, voltage resistance, and density.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for the LoD, inactivation, stability, or reproducibility studies. It only mentions "3 lots" for shelf-life testing.
Data provenance for the performance studies is not explicitly stated (e.g., country of origin, retrospective/prospective). It refers to internal studies conducted by the submitter (Mawi DNA Technologies).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable to this type of device. Ground truth as typically defined for AI/ML models (e.g., expert consensus on image reads, pathology reports) is not relevant for a sample collection and stabilization device. The "truth" here is determined by laboratory assays (e.g., viral load detection, stability measurements, inactivation efficacy assays).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable to this type of device. Adjudication methods are typically used for reconciling disagreements among human readers/experts in diagnostic evaluations for AI/ML studies.

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 a physical sample collection device, not an AI/ML diagnostic software, and therefore MRMC studies with human readers are not relevant.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by analytical laboratory measurements using reference methods and controls to demonstrate:
- Viral inactivation efficacy (e.g., cell culture assays, qPCR to confirm no viable virus).
- Stability of nucleic acids over time (e.g., RT-PCR cycle threshold (Ct) values over incubation periods).
- Limit of Detection (e.g., serial dilutions of viral RNA analyzed by RT-PCR).
- Reproducibility of measurements (e.g., statistical analysis of results across different lots, days, operators).

8. The sample size for the training set

Not applicable. This classification is for AI/ML model development. This device does not involve a training set.

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

Not applicable. No training set is involved for this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is 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.

April 3, 2023

Mawi DNA Technologies Bassam El-Fahmawi President 26203 Production Avenue, Suite 3 Hayward, California 94545

Re: K221802

Trade/Device Name: iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage And Stabilization Device Regulatory Class: Class II Product Code: OBD Dated: June 20, 2022 Received: June 21, 2022

Dear Bassam El-Fahmawi:

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

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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 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 medical devices and radiation-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,

Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221802

Device Name iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL)

Indications for Use (Describe)

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)

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510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

SUBMITTER -

Mawi DNA Technologies LLC 2603 26203 Production Avenue, Suite 3 Hayward, CA 94545 USA Tel:+1.510.256.5186 Fax:+1.510.576.2948

Contact Person: Dr. Bassam El-Fahmawi, PhD Date Prepared: June 17, 2022

II. DEVICE

Device Trade Name:	(iSWABTM-RC-EL)
	iSWABTM-Respiratory Tract Sample Collection Media-Extraction Less
Classification Name:	Microbial Nucleic Acid Storage and Stabilization Device
Regulation:	21 CFR §866.2950
Regulatory Class:	Class II
Device Panel:	Microbiology
Product Classification Code:	QBD

For invitro diagnostic use only: Rx only

lll. PREDICATE DEVICE

Predicate Manufacturer:	Zymo Research
Predicate Trade Name:	DNA/RNA Shield Collection Tube
Predicate 510(k):	K202641

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

General Description:

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V. INDICATIONS FOR USE

The iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device is intended for the stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2. This device can be used for the collection, transport, and storage of specimens at ambient temperature. Specimens collected in the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less collection device are suitable for use with legally marketed molecular diagnostic tests.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

Feature	Subject Device	Predicate Device (K202641)
Indications for Use	The iSWAB-Respiratory Tract SampleCollection Media-Extraction Lesscollection device is intended for thestabilization and inactivation of upperrespiratory and saliva human specimenssuspected of containing SARS-CoV-2.This device can be used for thecollection, transport, and storage ofspecimens at ambient temperature.Specimens collected in the iSWAB-Respiratory Tract Sample CollectionMedia-Extraction Less collectiondevice are suitable for use with legallymarketed molecular diagnostic tests.	The DNA/RNA Shield™ collection tube isintended for the stabilization andinactivation of upper and lowerrespiratory human specimens suspectedof containing SARS-CoV- 2.These devices can be used for collectiontransport and storage of specimens atambient temperatures (20- 25°C).Specimens collected and stored in aDNA/RNA Shield™ collection tube aresuitable for use with legally marketedmolecular diagnostic tests.
Inactivation	SARS-CoV-2 inactivation	SARS-CoV-2 inactivation
Storage	SARS-CoV-2: 28 days for nasalspecimens and 33 days for saliva at 15-30°C	SARS-CoV-2 RNA: 28 Days at 20-25°C
Sample source	Human respiratory	Human respiratory
Sample Stability at 2-4ºC	No 2-4ºC claim	No 2-4ºC claim
Analyte	RNA from SARS-CoV-2	RNA from SARS-CoV-2
Specimen Type	Nasal and Saliva Specimens for SARS-CoV-2	Lower, Upper Respiratory and SalivaSpecimens for SARS-CoV-2
Sample ProcessingSteps	RNA extraction optional	Requires RNA extraction before use
Device Specs	12X50 mm Screwcap vial, with patentedinsert, pre-filled with iSWAB™-Respiratory Tract Sample CollectionMedia-Extraction Less stabilizing buffer(800µL)	12X80 mm Screwcap vial pre-filled withDNA/RNA Shield (1 mL or 2 mL)
Shelf-Life	15 months	24 months
Test	Subject Device	Predicate Device [K202641]
Inactivation	An inactivation study was conducted todemonstrate inactivation of the SARS-CoV-2 virus.	An inactivation study was conducted toverify that DNA/RNA Shield inactivatesSARS-CoV-2 virus.
Limit of Detection	An analytical sensitivity study wasconducted to determine the Limit ofDetection of SARS-CoV-2 collected iniSWAB™-Respiratory Tract SampleCollection Media-Extraction Less incombination with the BGI Real-TimeFluorescent RT-PCR Kit for DetectingSARS-CoV-2.	An analytical sensitivity study wasconducted to determine the SARS-CoV-2Limit of Detection (LoD) obtained byDNA/RNA Shield in combination with theQuick SARS-CoV-2 rRT-PCR Kit.
Specimen Stability	A stability study was conducted todemonstrate that SARS-CoV-2 isstabilized long-term at ambienttemperature in iSWAB™-RC-EL.	A stability study was designed todemonstrate that SARS-CoV-2 RNA fromsputum and oral swab was preserved andstabilized in DNA/RNA Shield media.
Precision/ Reproducibility	Two reproducibility studies wereconducted to evaluate:- Lot-Lot reproducibility,- Day-Day, and- Operator-Operator Reproducibility.The results of this study demonstratedlot-lot reproducibility.	N/A - not available in Decision Summary
Compatibility	Samples collected with iSWAB™- RC-EL (no RNA extraction steps required)are directly compatible with the CDC2019-Novel Coronavirus (2019-nCoV)RT-PCR Diagnostic Panel (withTaqPath 1-Step Multiplex Master Mix,the BGI Real-Time Fluorescent RT-PCR Kit, Bio- Rad's Reliance SARS-CoV-2 RT-PCR Assay, the PRIMECovidDetect RT-LAMP-based assay,and the UCSD RT-LAMP and LFIA testfor the detection of SARS-CoV-2.Compatibility is not limited to theseassays.	N/A - Not available in Decision Summary

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

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Sterilization & Shelf-life Testing

This device is non-sterile.

The shelf life for the iSWAB-Respiratory Tract Sample Collection Media-Extraction Less Collection tube with media is 15 months after the date of manufacture. The iSWAB-Respiratory Tract Sample Collection Media-Extraction Less Collection tube with media was performed using Realtime and Accelerated stability on a total of 3 lots. Stability looked for bacterial and fungal growth in the media along with properties of the media, appearance, pH, voltage resistance and density.

Biocompatibility Testing

Not Applicable -IVD, no patient contact

Electrical safety and electromagnetic compatibility (EMC)

Not Applicable (Passive Device)

Software Verification and Validation Testing

Not Applicable (Passive Device)

Mechanical and acoustic Testing

Not Applicable

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Human Clinical Performance Testing

Clinical testing was not required to demonstrate the safety and effectiveness of the device.

VIII. CONCLUSIONS

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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.