(203 days)
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.
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.
The provided text describes the performance evaluation of the PPH Saliva Collection Kit, a device for the non-invasive collection, inactivation, and stabilization of viral nucleic acids for in vitro diagnostic testing of saliva samples, specifically for SARS-CoV-2.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf-life Stability | Not explicitly stated (implied maintenance of physical characteristics, pH, color, volume loss, and functional performance over time) | 9 months at room temperature (15-30°C) with no observed volume loss, significant pH change, or color change. |
| Physical stability (appearance) | Clear liquid without precipitation, no observed volume loss. | |
| Color stability | No color change. | |
| pH stability | No significant change in buffer pH. | |
| Limit of Detection (LoD) | Detection of SARS-CoV-2 with >95% accuracy | N1 Target: 0.25 copies/µL with 100% (20/20) detection. |
| N2 Target: 0.25 copies/µL with 95% (19/20) detection. | ||
| Sample Stability | Samples stable for up to 7 days at ambient temperature (20-25°C) | Largest Ct difference observed was 0.40 at 8 days. Test results fall within established acceptance criteria, indicating stability for up to 7 days. |
| Inactivation | No detectable virus (zero positive plaques) after 4 days growth following exposure to PPH Saliva Collection Kit buffer | SARS-CoV-2 inactivation after 90 seconds of exposure to PPH Saliva Collection Kit buffer, with no PFUs obtained after 60 seconds and onward. |
| Cytotoxicity | Buffer not toxic to a cell monolayer at a certain dilution ratio | Concentration of 1:5,000 PPH Saliva Collection Kit buffer determined not to have a cytopathic effect on Vero E6 cells. |
2. Sample Size Used for the Test Set and Data Provenance
- Limit of Detection (LoD) Study:
- Preliminary LoD: 3 replicates for each serial dilution.
- Confirmatory LoD: 20 replicates for each of the four concentrations tested.
- Sample Stability Study:
- Low positive samples: 20 samples per device lot for 3 lots, totaling 60 low positive samples.
- Negative samples: 10 samples per device lot for 3 lots, totaling 30 negative samples.
- Inactivation Assay: 6 replicates for each time point.
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. It describes laboratory studies conducted to evaluate the device's performance characteristics.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth for the test set. The ground truth for LoD, sample stability, and inactivation studies appears to be based on laboratory measurements (e.g., SARS-CoV-2 spiked into saliva, PCR results, plaque assays).
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (e.g., 2+1, 3+1) as there is no mention of human readers or experts establishing ground truth through consensus. The ground truth is established through laboratory analyses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The PPH Saliva Collection Kit is a collection and stabilization device, not an AI-assisted diagnostic tool for human interpretation.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The PPH Saliva Collection Kit is a physical device for sample collection and stabilization, not a software algorithm or an AI-based system. Its performance is evaluated through its ability to stabilize and inactivate viral nucleic acids, which are then processed by legally marketed molecular diagnostic devices.
7. The Type of Ground Truth Used
The ground truth for the performance studies was:
- Limit of Detection: Known concentrations of SARS-CoV-2 (inactivated and spiked) in saliva, detected via rRT-PCR.
- Sample Stability: Known concentrations of inactivated SARS-CoV-2 spiked into saliva, with stability assessed by rRT-PCR over time.
- Inactivation: Known concentrations of live SARS-CoV-2, with inactivation assessed by plaque assay (detection of live virus).
8. The Sample Size for the Training Set
The document does not mention a "training set" as it pertains to AI/machine learning. The studies described are performance validation studies for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/machine learning model, this question is not applicable.
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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
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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)
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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 salivasamples |
| Address: | Spectrum Solutions12248 S. Lone Peak Parkway, #106Draper, UT 64020www.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 CollectionDevice |
| General Device Characteristic Similarities | ||
| Intended Use/Indications for Use | The PPH Saliva Collection Kit isdesigned for use in the non-invasivecollection, inactivation, andstabilization of viral nucleic acids forin vitro diagnostic testing of salivasamples. The device is intended toinactivate and stabilize humanclinical saliva samples from thecollection site to the laboratory atroom temperature. The device isintended to be used by a health careprovider for the collection of salivasamples suspected of containingSARS-CoV-2. | The Spectrum Solutions SalivaCollection Device is designed for usein the non-invasive collection,inactivation, and stabilization of viralnucleic acids for in vitro diagnostictesting of saliva samples. The deviceis intended to inactivate and stabilizehuman clinical saliva samples fromthe collection site to the laboratory atroom temperature. The saliva sampleis stabilized and suitable for use withlegally marketed molecular diagnosticdevices. The device is intended to beused by a health care provider forsamples suspected of containingSARS-CoV-2. |
| Analyte | RNA from SARS-CoV-2 | Same |
| Transport Media | Disrupt/lyses lipid membranes,inactivates enzymes, and stabilizesnucleic 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 FunnelCap - 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 <40 were considered positive for SARS-CoV-2. Results from the preliminary LoD study are summarized in Table 1 below.
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| Copies/µL | N1 Detection Rate | N1 Mean Ct | N2 Detection Rate | N2 Mean Ct |
|---|---|---|---|---|
| 8 | 3/3 | 31.03 | 3/3 | 30.92 |
| 4 | 3/3 | 32.13 | 3/3 | 31.97 |
| 2 | 3/3 | 33.06 | 3/3 | 32.62 |
| 1 | 3/3 | 34.37 | 3/3 | 33.90 |
| 0.5 | 3/3 | 35.23 | 3/3 | 35.20 |
| 0.25 | 3/3 | 37.85 | 2/3 | - |
| 0.125 | 3/3 | 39.53 | 2/3 | - |
| 0.06125 | 2/3 | - | 1/3 | - |
| 0 | 0/3 | - | 0/3 | - |
Table 1. Preliminary LoD Estimation Results
The estimated LoD based on the preliminary results was identified as 0.125 copies/ul.
To further confirm this preliminary LoD assessment, four concentrations of SARS-CoV-2 (0, 0.0625, 0.125, and 0.25 copies/pl) in saliva were evaluated in 20 replicates using the PPH Saliva Collection Kit. Results from the LoD confirmation study are summarized in Table 2 below.
| Copies/µL | N1 Detection Rate | N1 Mean Ct | N2 Detection Rate | N2 Mean Ct |
|---|---|---|---|---|
| 0.25 | 20/20 | 35.99 | 19/20 | 37.57 |
| 0.125 | 17/20 | - | 4/20 | - |
| 0.06125 | 18/20 | - | 5/20 | - |
| 0 | 0/20 | - | - | - |
Table 2. Confirmatory LoD Study Results
In summary, the results of the LoD study indicate an LoD of 0.25 copies/ul with observed detection of 100% (20/20) for the N1 target and 95% (19/20) for N2 replicate.
1. Sample Stability:
A real-time sample stability study was conducted to evaluate the stability of samples containing SARS-CoV-2 when stored for up to 8 days at ambient temperature (20-25°C). Inactivated SARS-CoV-2 (Zeptometrix, Cat # NATSARS(COV2)-ST, 1.21x106 copies/ μl) was used to prepare contrived samples including 20 low positive samples (2X LoD) and 10 negative samples for each device lot. Briefly, saliva matrix and SARS-CoV-2 were combined at a ratio of 1:1 and then added to each collection tube containing 300 µl of PPH Saliva Collection Kit buffer.
Sample stability was assessed at baseline (day 0), day 7, and day 8 after being placed in PPH Saliva Collection Kit buffer and stored at ambient temperature (20-25°C). The difference in Ct over this time course is less than 1. The largest change in Ct observed was 0.40 at 8 days.
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These test results fall within the established acceptance criteria and indicate that samples are stable in the PPH Saliva Collection Kits inactivating media for up to 7 days. Results for sample stability testing is shown in Table 3 below.
| Samples Evaluated | Mean Ct & SD | Day 0 | Day 7 | Day 8 |
|---|---|---|---|---|
| Low positive (60 samples) | N1 Mean Ct | 35.9 | 36.14 | 36.2 7 |
| SD | 0.43 | 0.5 | 0.523 | |
| Low positive (60 samples) | N2 Mean Ct | 35.49 | 35.63 | 35.7 |
| SD | 0.4 | 0.47 | 0.4 | |
| Negative (30 samples) | - | - | - | - |
Table 3. Sample Stability Study Results
Sterilization: The PPH Saliva Collection Kits are not sold as sterile nor are they intended to be sterilized by the user. These vials are single use devices that do not require cleaning or sterilization by the operator.
Inactivation
An inactivation study was conducted to verify that the PPH Saliva Collection device inactivates SARS-CoV-2 as efficiently as the predicate device.
Cytotoxicity: A cytotoxicity study was performed to determine at what dilution ratio the PPH Saliva Collection Kit buffer would not be toxic to a cell monolayer.
To determine the cytotoxic effect of the buffer on test cells, Vero E6 cells that were seeded at a concentration of 2500 cells/well in each well of a 96 well plate were exposed to serially diluted PPH Saliva Collection Kit buffer prepared in Vero E6 DMEM culture medium. Viability of the test cells was assessed using the CellTiterGlo assay (Promega #G7570) after 4 days of exposure and normalized to untreated cells. After the incubation period, concentration of 1:5,000 PPH Saliva Collection Kit buffer was determined not to have a cytopathic effect to the host cells. For the next step, the PPH Saliva Collection Kit buffer was diluted to 1:5,000 with DMEM media to perform the subsequent Inactivation Assay.
Inactivation Assay:
Viral inactivation was assessed using a stock of SARS-CoV-2 (USA WA1/2020) at 5.65x10° PFU/ml. To determine the amount of contact time required for viral inactivation of SARS-CoV-2 with PPH Saliva Collection Kit buffer, the samples were prepared as follows:
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-
- Mixed virus stock with saliva at a 1:1 ratio.
-
- Mixed virus and saliva with PPH Saliva Collection Kit buffer at a 1:1 ratio.
-
- Incubated for 15, 30, 45, 60, 90, 120, 180, or 240 seconds.
- Diluted virus, saliva and buffer to 1:5,000 PPH Saliva Collection Kit buffer with DMEM media, a concentration previously determined not to be cytotoxic.
100 µl of each sample containing ~ 113 PFU of SARS-CoV-2 was added to a 96-well plate confluent with Vero E6 cells after media was removed. Six replicates were plated for each time point. The controls included and plated in triplicates were media only, Saliva and PPH Saliva Collection Kit buffer (no virus), and Virus only. No PFUs were obtained after 60, 90, 120, 180 and 240 seconds of exposure of the cells to the media in the PPH Saliva Collection Kit buffer. Acceptance criteria were met for no detectable virus (zero positive plaques) after 4 days growth.
These study results support SARS-CoV-2 inactivation after 90 seconds of exposure to PPH Saliva Collection Kit buffer.
Overall Summary of Nonclinical and Clinical Studies
The non-clinical and clinical performance data demonstrate that PPH Saliva Collection Kit is as safe, as effective, and performs as well as or better than the predicate device.
§ 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.