(286 days)
No reference devices were used in this submission.
No
The document describes a sample collection device and media, focusing on stabilization and inactivation of specimens. There is no mention of AI, ML, or any computational analysis of data. The performance studies are related to the physical and chemical properties of the media and its ability to preserve the sample for downstream molecular testing.
No
The device is intended for the collection, transport, and storage of specimens for molecular diagnostic tests, not for treating or diagnosing a disease.
No
The device is a collection media and extraction device intended for stabilizing, inactivating, collecting, transporting, and storing human specimens. It prepares specimens for use with "legally marketed molecular diagnostic tests," but it is not itself a diagnostic test.
No
The device description clearly outlines a physical collection tube with a stabilizing buffer and insert, indicating it is a hardware device for specimen collection and transport, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is for the "stabilization and inactivation of upper respiratory and saliva human specimens suspected of containing SARS-CoV-2." It also mentions that specimens collected in the device are "suitable for use with legally marketed molecular diagnostic tests." This clearly indicates that the device is intended to be used in the process of diagnosing a disease (SARS-CoV-2) by analyzing a specimen taken from the human body.
- Device Description: The description details a collection tube pre-filled with a stabilizing buffer designed to prepare a human specimen for downstream diagnostic testing.
- Performance Studies: The performance studies described, such as Limit of Detection and Precision/Reproducibility, are typical analytical performance studies conducted for IVD devices to demonstrate their suitability for use in diagnostic workflows.
- Predicate Device: The predicate device listed (K202641; DNA/RNA Shield Collection Tube) is also a sample collection device intended for use with diagnostic tests, further supporting the classification of this device as an IVD.
In summary, the device is designed to collect, stabilize, and prepare human specimens for use with diagnostic tests, which is the core function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
OBD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory and saliva human specimens
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)
- Inactivation study: demonstrated inactivation of the SARS-CoV-2 virus.
- Limit of Detection study: An analytical sensitivity study was conducted to determine the Limit of Detection of SARS-CoV-2 collected in iSWAB™-Respiratory Tract Sample Collection Media-Extraction Less in combination with the BGI Real-Time Fluorescent RT-PCR Kit for Detecting SARS-CoV-2.
- Specimen Stability study: A stability study was conducted to demonstrate that SARS-CoV-2 is stabilized long-term at ambient temperature in iSWAB™-RC-EL.
- Precision/Reproducibility studies: Two reproducibility studies were conducted to evaluate Lot-Lot reproducibility, Day-Day, and Operator-Operator Reproducibility. The results of this study demonstrated lot-lot reproducibility.
- Compatibility study: Samples collected with iSWAB™- RC-EL (no RNA extraction steps required) are directly compatible with the CDC 2019-Novel Coronavirus (2019-nCoV) RT-PCR Diagnostic Panel (with TaqPath 1-Step Multiplex Master Mix, the BGI Real-Time Fluorescent RT-PCR Kit, Bio- Rad's Reliance SARS-CoV-2 RT-PCR Assay, the PRIME CovidDetect RT-LAMP-based assay, and the UCSD RT-LAMP and LFIA test for the detection of SARS-CoV-2. Compatibility is not limited to these assays.
- 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.
- No animal studies were required.
- No human clinical performance testing was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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
1
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
2
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)
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 suith legally marketed molecular diagnostic tests.
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:
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.
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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 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. | The DNA/RNA Shield™ collection tube is | |
| intended for the stabilization and | ||
| inactivation of upper and lower | ||
| respiratory human specimens suspected | ||
| of containing SARS-CoV- 2. | ||
| These devices can be used for collection | ||
| transport and storage of specimens at | ||
| ambient temperatures (20- 25°C). | ||
| Specimens collected and stored in a | ||
| DNA/RNA Shield™ collection tube are | ||
| suitable for use with legally marketed | ||
| molecular diagnostic tests. | ||
| Inactivation | SARS-CoV-2 inactivation | SARS-CoV-2 inactivation |
| Storage | SARS-CoV-2: 28 days for nasal | |
| specimens 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 Saliva | |
| Specimens for SARS-CoV-2 | ||
| Sample Processing | ||
| Steps | RNA extraction optional | Requires RNA extraction before use |
| Device Specs | 12X50 mm Screwcap vial, with patented | |
| insert, pre-filled with iSWAB™- | ||
| Respiratory Tract Sample Collection | ||
| Media-Extraction Less stabilizing buffer | ||
| (800µL) | 12X80 mm Screwcap vial pre-filled with | |
| DNA/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 to | |
| demonstrate inactivation of the SARS- | ||
| CoV-2 virus. | An inactivation study was conducted to | |
| verify that DNA/RNA Shield inactivates | ||
| SARS-CoV-2 virus. | ||
| Limit of Detection | An analytical sensitivity study was | |
| conducted to determine the Limit of | ||
| Detection of SARS-CoV-2 collected in | ||
| iSWAB™-Respiratory Tract Sample | ||
| Collection Media-Extraction Less in | ||
| combination with the BGI Real-Time | ||
| Fluorescent RT-PCR Kit for Detecting | ||
| SARS-CoV-2. | An analytical sensitivity study was | |
| conducted to determine the SARS-CoV-2 | ||
| Limit of Detection (LoD) obtained by | ||
| DNA/RNA Shield in combination with the | ||
| Quick SARS-CoV-2 rRT-PCR Kit. | ||
| Specimen Stability | A stability study was conducted to | |
| demonstrate that SARS-CoV-2 is | ||
| stabilized long-term at ambient | ||
| temperature in iSWAB™-RC-EL. | A stability study was designed to | |
| demonstrate that SARS-CoV-2 RNA from | ||
| sputum and oral swab was preserved and | ||
| stabilized in DNA/RNA Shield media. | ||
| Precision/ Reproducibility | Two reproducibility studies were | |
| conducted to evaluate: |
- Lot-Lot reproducibility,
- Day-Day, and
- Operator-Operator Reproducibility.
The results of this study demonstrated
lot-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 CDC
2019-Novel Coronavirus (2019-nCoV)
RT-PCR Diagnostic Panel (with
TaqPath 1-Step Multiplex Master Mix,
the BGI Real-Time Fluorescent RT-
PCR Kit, Bio- Rad's Reliance SARS-
CoV-2 RT-PCR Assay, the PRIME
CovidDetect RT-LAMP-based assay,
and the UCSD RT-LAMP and LFIA test
for the detection of SARS-CoV-2.
Compatibility is not limited to these
assays. | 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.