(203 days)
Not Found
No
The device is a collection kit for saliva samples and does not involve any data processing or analysis that would utilize AI/ML. The summary focuses on the physical components, collection process, and sample stability/inactivation properties.
No
Explanation: This device is for collecting and stabilizing saliva samples for in vitro diagnostic testing, not for treating any condition or disease.
No
This device is a collection device intended to inactivate and stabilize viral nucleic acids in saliva samples for in vitro diagnostic testing. It does not perform the diagnostic testing itself; rather, it prepares the sample for use with other legally marketed molecular diagnostic devices.
No
The device description explicitly lists physical components (plastic bulb pipette, paper cup, plastic tube with buffer) and describes their function in collecting and stabilizing saliva samples. This indicates a hardware component is central to the device's operation.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "in vitro diagnostic testing of saliva samples." It's designed to prepare a sample for subsequent diagnostic testing.
- Device Description: The description reinforces its purpose in "in vitro diagnostic testing of saliva samples."
- Function: The device's function is to collect, inactivate, and stabilize viral nucleic acids in saliva samples, making them suitable for use with "legally marketed molecular diagnostic devices." This preparation step is crucial for the diagnostic process.
While the device itself doesn't perform the diagnostic test, it is an essential component in the overall in vitro diagnostic workflow by preparing the sample for analysis.
N/A
Intended Use / Indications for Use
The PPH Saliva Collection Kit is designed for use in the non-invasivation, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
Product codes
OBD
Device Description
The PPH Saliva Collection Device contains a plastic bulb pipette, paper cup, plastic tube with PPH Saliva collection buffer (0.3 ml). This collection device designed for the collection of human saliva samples. It is designed for use in the non-invasive collection, inactivation of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature.
Sample collection is conducted by first collecting saliva into the provided paper cup, uncapping the tube containing inactivating media, using the bulb pipet to transfer saliva into the tube, replacing the cap, and mixing the saliva with the PPH Saliva collection buffer by inverting the caped tube 5-10 times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care provider / collection site to the laboratory
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)
Shelf life: A real-time stability study was conducted. Time points evaluated were T = 0, 1, 3, 6, 9, and 12 months. Physical stability (appearance), color, volume loss, and pH stability were evaluated. The shelf life was established as nine (9) months at room temperature (15-30°C).
Detection Limit (LoD) Study:
- Preliminary LoD: Three replicates of several serial dilutions of saliva spiked with SARS-CoV-2 and collected in the PPH Saliva Collection device were evaluated. Ct values
§ 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.
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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.
October 11, 2024
Permantis Public Health Robert Darnell President PO Box 941 New York, NY 10021
Re: K240797
Trade/Device Name: PPH Saliva Collection Kit Regulation Number: 21 CFR 866.2950 Regulation Name: Microbial Nucleic Acid Storage And Stabilization Device Regulatory Class: Class II Product Code: OBD Dated: March 22, 2024 Received: March 22, 2024
Dear Robert Darnell:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Digitally signed by Bryan M. Bryan M. Grabias -S Grabias -S Date: 2024.10.11
09:22:36 -04'00'
Bryan Grabias, Ph.D. Acting Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240797
Device Name
Permantis Public Health (PPH) Saliva Collection Kit
Indications for Use (Describe)
The PPH Saliva Collection Kit is designed for use in the non-invasivation, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
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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FORM FDA 3881 (8/23)
5
510(k) Summary
PPH Saliva Collection Kit For In vitro Diagnostic Use
Submitter's information:
Robert B. Darnell, MD, PhD Permantis Public Health P.O. Box 941 New York, NY 10021 Telephone: 917-946-1890 Date Summary Prepared: March 22, 2024
Name of Device:
| Trade Name: | PPH Saliva Collection Kit |
|---|---|
| Common Name: | Saliva Collection Device |
| Classification Name: | Microbial nucleic acid storage and stabilization device |
| Classification Number: | Class II, 21 CFR 866.2950 |
| Product Code: | QBD |
Predicate Device:
| Trade Name: | Spectrum Saliva Collection Device |
|---|---|
| Common name: | SDNA 1000 |
| Classification Name: | Microbial nucleic acid storage and stabilization device |
| Classification Number: | Class II, 21 CFR 866.2950 |
| Product Code: | QBD |
| Description: | A self-sample collection device designed for the collection of human saliva |
| samples | |
| Address: | Spectrum Solutions |
| 12248 S. Lone Peak Parkway, #106 | |
| Draper, UT 64020 | |
| www.spectrumsolution.com |
Description of the device:
The PPH Saliva Collection Device contains a plastic bulb pipette, paper cup, plastic tube with PPH Saliva collection buffer (0.3 ml). This collection device designed for the collection of human saliva samples. It is designed for use in the non-invasive collection, inactivation of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature.
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Sample collection is conducted by first collecting saliva into the provided paper cup, uncapping the tube containing inactivating media, using the bulb pipet to transfer saliva into the tube, replacing the cap, and mixing the saliva with the PPH Saliva collection buffer by inverting the caped tube 5-10 times.
Performance of the device has been validated to support the claims of specimen stability for 7 days at ambient temperature (20-25°C) , see section limit of detection, stability, viral inactivation.
Intended Use:
The PPH Saliva Collection Kit is designed for use in the non-invasive collection, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples. The device is intended to inactivate and stabilize human clinical saliva samples from the collection site to the laboratory at room temperature. The device is intended to be used by a health care provider for the collection of saliva samples suspected of containing SARS-CoV-2. The saliva sample is stabilized and suitable for use with legally marketed molecular diagnostic devices.
Technologic characteristics:
The proposed device shares the same technological characteristics found in the predicate device and other cleared saliva collection devices on the market.
| Feature | Device K240797 | Predicate: K223497 |
|---|---|---|
| Device Trade Name | PPH Saliva Collection Device | Spectrum Solutions Saliva Collection |
| Device | ||
| General Device Characteristic Similarities | ||
| Intended Use/ | ||
| Indications for Use | The PPH Saliva Collection Kit is | |
| designed for use in the non-invasive | ||
| collection, inactivation, and | ||
| stabilization of viral nucleic acids for | ||
| in vitro diagnostic testing of saliva | ||
| samples. The device is intended to | ||
| inactivate and stabilize human | ||
| clinical saliva samples from the | ||
| collection site to the laboratory at | ||
| room temperature. The device is | ||
| intended to be used by a health care | ||
| provider for the collection of saliva | ||
| samples suspected of containing | ||
| SARS-CoV-2. | The Spectrum Solutions Saliva | |
| Collection Device is designed for use | ||
| in the non-invasive collection, | ||
| inactivation, and stabilization of viral | ||
| nucleic acids for in vitro diagnostic | ||
| testing of saliva samples. The device | ||
| is intended to inactivate and stabilize | ||
| human clinical saliva samples from | ||
| the collection site to the laboratory at | ||
| room temperature. The saliva sample | ||
| is stabilized and suitable for use with | ||
| legally marketed molecular diagnostic | ||
| devices. The device is intended to be | ||
| used by a health care provider for | ||
| samples suspected of containing | ||
| SARS-CoV-2. | ||
| Analyte | RNA from SARS-CoV-2 | Same |
| Transport Media | Disrupt/lyses lipid membranes, | |
| inactivates enzymes, and stabilizes | ||
| nucleic acids | Same |
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| Material | Medical-grade polypropylene | Same |
|---|---|---|
| Sterility | Non-Sterile | Same |
| General Device Characteristic Differences | ||
| Physical container | Plastic polypropylene collection tube | Tube – Polypropylene Funnel |
| Cap - Polypropylene & HDPE | ||
| Buffer | PPH Saliva Collection Kit buffer | Spectrum's Nucleic Acid Stabilization Solution |
| Specimen Stability | 7 days at ambient temperature (20-25°C) | SARS-CoV-2 for 28 days at 20-25°C |
| Shelf life | 9 months at room temperature (15-30 °C) | 24 months at room temperature (15-30°C) |
The PPH Saliva Collection Kit is substantially equivalent to the legally marketed predicate device. The PPH Saliva Collection Kit has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device. Performance data demonstrates that the PPH Saliva Collection Kit is as safe and effective.
Performance Data: Non-Clinical
Shelf life: The shelf life for the PPH Saliva Collection Kit is nine (9) months at room temperature (15-30°C) after the date of manufacture. The shelf-life stability of the PPH Saliva Collection Kit was established in a real-time stability study that evaluated several time points (T = 0, 1, 3, 6, 9, and 12 months) for both temperature extremes. In this study, shelf-life stability also included evaluation of physical stability (appearance), color, volume loss, and pH stability during the period of storage. At each time point, the appearance of the product was inspected visually as a clear liquid without precipitation and with no observed volume loss, change in buffer pH, or color change when stored under the specified storage conditions.
Detection Limit
A limit of detection (LoD) study was conducted to determine the lowest concentration that contains measurable nucleic acids that can be repeatedly detected in samples collected in the PPH Saliva Collection Kit with greater than 95% accuracy. RNA extraction was performed using magnetic bead purification on a Thermo Fisher Apex Purification system. Viral RNA was subsequently amplified using Triplex CII-SARS-CoV-2 rRT-PCR for SARS-CoV-2 detection assay (RUCGL.SCV2.2 assay). The primers and probes used in this assay allow simultaneous measurements of SARS-CoV-2 nucleocapsid RNA (N1 and/or N2), and human Ribonuclease P (RP) transcripts. RT-gPCR was performed with RP primers as positive control to detect the human RNase P gene.
A preliminary LoD was established by evaluating three replicates of several serial dilutions of saliva spiked with SARS-CoV-2 and collected in the PPH Saliva Collection device. These samples were evaluated on the RUCGL.SCV2.2 assay for SARS-CoV-2 detection. Ct values