(73 days)
Not Found
No
The summary describes a molecular collection and preservation medium and its performance in preserving viral RNA and inactivating the virus. There is no mention of any computational analysis, algorithms, or learning processes that would indicate the use of AI or ML.
No
The device is described as a collection and preservation medium for diagnostic samples, specifically for stabilizing and inactivating viral RNA, not for treating a disease or condition in a patient.
No
Explanation: This device is a molecular collection and preservation medium intended for the stabilization, transportation, and inactivation of clinical specimens. It preserves nucleic acid integrity for subsequent diagnostic assays but does not perform the diagnostic function itself.
No
The device description clearly outlines physical components: a plastic screw-cap tube, molecular preservation and transport medium, and nylon flocked swabs. These are hardware components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA." This specimen is collected from a patient for the purpose of diagnosis.
- Use with Molecular Assays: It is intended for use with "compatible molecular assays," which are diagnostic tests performed in vitro.
- Device Description: The description mentions its purpose is to "preserve nucleic acid integrity of clinical specimens during transport and storage" for "nucleic acids amplification techniques," which are common methods used in IVD testing for infectious diseases.
- Performance Studies: The document includes performance studies (inactivation, analytical sensitivity, stability) that are typical for demonstrating the suitability of a device used in an IVD workflow.
- Predicate Device: It references a predicate device (PrimeStore™ MTM) which is also a molecular transport medium used in IVD testing.
All these points indicate that the Copan eNAT is a device intended to be used in the collection, preservation, and transport of a human specimen for subsequent in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.
Product codes (comma separated list FDA assigned to the subject device)
QBD
Device Description
The primary purpose of nucleic acids amplification techniques is to screen for a wide range of infectious diseases, so nucleic acid integrity of clinical specimens during transport and storage should be preserved.
eNAT® medium contains a detergent and a protein denaturant to prevent microbial proliferation and to maintains the integrity of the nucleic acids from cells or pathogens collected from patients and inactivates pathogen viability, thus eNAT® is not intended to be used for culture-based techniques.
Copan eNAT® has 3 different configurations:
Ref. 6U072S: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium.
Ref. 6U073S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium and a regular size tip nylon flocked swab for sample collection.
Ref. 6U074S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport and a minitip nylon flocked swab for sample collection.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper respiratory
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:
- Study Type: Inactivation study to verify that Copan eNAT® inactivates Flu A virus as efficiently as the predicate device PrimeStore MTM, following the study design described by Longhorn in the PrimeStore MTM Decision Summary, DEN170029.
- Sample Size: Not explicitly stated, but high concentrations of Flu A in nasal matrix were inoculated in eNAT® using Copan's regular nasal-type FLOQSwabs®.
- Key Results: The results showed > 4.0 log reduction in Flu A titer in 10 seconds.
- Standalone Performance: The viability of the virus was measured after 10 seconds in eNAT® medium by inoculating aliquots onto MDCK (Madin-Darby Canine Kidney) cell lines, incubating for four days and measuring the cytopathic effect (CPE).
Analytical Sensitivity Study:
- Study Type: Analytical sensitivity study to determine the Flu A limit of detection (LoD) obtained by eNAT® in combination with the Cepheid Xpert® Xpress Flu/RSV assay.
- Sample Size: Not explicitly stated for total samples, but 24/24 positive replicates were observed for eNAT® samples at a specific dilution.
- Key Results: eNAT® medium in combination with the Cepheid assay reached the same LoD as UTM (reference device for the assay) and LoD fell within the declared range of TCID 50/ml for Flu A detection (0.75 - 0.006 TCID50/ml in the matrix).
Stability Study:
- Study Type: Stability study designed to demonstrate that RNA from Flu A is preserved and stable in eNAT® medium.
- Sample Size: Not explicitly stated for total samples, but 24/24 positive replicates were observed at time zero, 4 weeks at 2-8°C, and 4 weeks at 25°C.
- Key Results: RNA stability in eNAT® met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at both 2-8°C and 25°C storage. This demonstrates at least equivalent performance of eNAT® with PrimeStore MTM™ in the influenza A RNA stability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Inactivation Study:
- Log reduction in viral load: 4.5 log reduction (Flu A in eNAT®)
Analytical Sensitivity Study:
- N° of positive replicates: 24/24 (at dilution corresponding to 0.180 TCIDs/ml)
- Average PCR Ct obtained: 34.4
- Standard deviation: 0.93
- CV%: 2.7%
Stability Study:
- N° of positive replicates at Time zero: 24/24
- Average of PCR CTs at Time zero: 30.8
- St. Dev at Time zero: 0.40
- CV% at Time zero: 1.3%
- N° of positive replicates at 4 weeks @ 2-8°C: 24/24
- Average of PCR CTs at 4 weeks @ 2-8°C: 30.6
- St. Dev at 4 weeks @ 2-8°C: 0.20
- CV% at 4 weeks @ 2-8°C: 0.6%
- ΔCt 4w-T0 at 4 weeks @ 2-8°C: -0.2
- N° of positive replicates at 4 weeks @ 25°C: 24/24
- Average of PCR CTs at 4 weeks @ 25°C: 30.7
- St. Dev at 4 weeks @ 25°C: 0.28
- CV% at 4 weeks @ 25°C: 0.9%
- ΔCt 4w-T0 at 4 weeks @ 25°C: -0.1
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Copan Italia S.p.A. Elena Simeonato Regulatory Affairs Manager Via F. Perotti 10 Brescia, Brescia 25125 Italy
September 17, 2020
Re: K201849
Trade/Device Name: eNAT molecular collection and preservation medium Regulation Number: 21 CFR 866.2950 Regulation Name: microbial nucleic acid storage and stabilization device Regulatory Class: Class II Product Code: QBD Dated: June 30, 2020 Received: July 6, 2020
Dear Elena Simeonato:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kristian Roth, Ph.D. Chief Bacterial Respiratory and Medical Counter Measures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201849
Device Name
eNAT - molecular collection and preservation medium-
Indications for Use (Describe)
Copan eNAT- molecular collection and preservation medium- is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
5. 510 (K) SUMMARY
I. SUBMITTER
| Applicant Name: | Copan Italia S.p.A. |
|---|---|
| Via F. Perotti 10 | |
| 25125 Brescia, Italy | |
| Contact Person: | Elena Simeonato |
| Via F. Perotti, 10 | |
| Brescia, Italy | |
| Telephone: | +39 030 2687212 |
| Establishment Registration Number: | 3002444944 |
| Date Prepared: | June 30, 2020 |
4
II. DEVICE - CLASSIFICATION
| Proprietary Name | eNAT® - molecular collection and preservation medium |
|---|---|
| Common/Usual Name | eNAT® |
| Device | Transport device for the stabilization of microbial nucleic acids |
| Classification Number | 21 CFR 866. 2950 |
| Product Code | QBD |
| Device Class | Class II |
| Review Panel | Microbiology |
5
III. PREDICATE DEVICE – CLASSIFICATION
| Device Name | PrimeStore™ MTM |
|---|---|
| 510(k) Number | DEN170029 |
| Device | Transport device for the stabilization of microbial |
| nucleic acids | |
| Classification Number | 21 CFR 866. 2950 |
| Product Code | QBD |
| Device Class | Class II |
| Review Panel | Microbiology |
IV. INTENDED USE OF THE DEVICE
Copan eNAT - molecular collection and preservation medium - is intended for the stabilization, transportation and inactivation of an unprocessed upper respiratory clinical specimen suspected of containing influenza A virus RNA. eNAT- molecular collection and preservation medium- is intended for use with compatible molecular assays.
V. DEVICE DESCRIPTION
The primary purpose of nucleic acids amplification techniques is to screen for a wide range of infectious diseases, so nucleic acid integrity of clinical specimens during transport and storage should be preserved.
eNAT® medium contains a detergent and a protein denaturant to prevent microbial proliferation and to maintains the integrity of the nucleic acids from cells or pathogens collected from patients and inactivates pathogen viability, thus eNAT® is not intended to be used for culture-based techniques.
Copan eNAT® has 3 different configurations:
6
Ref. 6U072S: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium.
Ref. 6U073S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport medium and a regular size tip nylon flocked swab for sample collection.
Ref. 6U074S01: a plastic screw-cap tube filled with 2 ml of Molecular Preservation and Transport and a minitip nylon flocked swab for sample collection.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Copan eNAT® Molecular Collection and Preservation Medium is substantially equivalent in intended use and overall function to the commercially distributed device PrimeStore™ Molecular Transport Medium® by Longhorn Vaccines and Diagnostics LLC.
PrimeStore MTM™ by Longhorn Vaccines and Diagnostics LLC consists of a polypropylene tube containing 1 mL or 1.5 mL of a medium.
Copan eNAT® is provided ready to use in a polypropylene tube with a leak-proof screw-cap closure, containing 2mL of medium for the inactivation of influenza A (Flu A) and the stabilization of the Flu A RNA.
eNAT® and PrimeStore MTM™ medium show similar composition including the two active ingredients: guanidine thiocyanate and N-lauroylsarcosine (detergent). These components inactive Flu A. denature and lyse cells. and stabilize Flu A virus RNA.
eNAT® is also supplied in kit format consisting of the media-filled tube with either a regular nylon flocked swab or a minitip nylon flocked swab (Copan FLOQSwabs®), while PrimeStore MTM™ is supplied in tube format only. See Table 1: Side-by-Side Comparison of Copan eNAT® - molecular collection and preservation medium
Table 1: Side-by-Side Comparison of Copan eNAT® and Predicate Device.
7
| Characteristics | Copan eNAT® Molecular Collection
and Preservation Medium | PrimeStore Molecular Transport
Medium® DEN170029 (Longhorn
Vaccines and Diagnostics LLC) |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Collection device
intended use | Copan eNAT® is intended for the
collection, inactivation and transport of
clinical specimens containing influenza A
viruses from the collection site to the
testing laboratory. eNAT® can be
processed and used with compatible
molecular assays the require stabilization
of nucleic acids from influenza A viruses | The PrimeStore MTM (#DEN170029) is
intended for the stabilization, transportation
and inactivation of infectious unprocessed
nasal washes suspected of containing
Influenza A virus RNA and is also intended
for the stabilization, transportation and
inactivation of infectious unprocessed
sputum samples suspected of containing
Mycobacterium tuberculosis DNA from
human samples |
| Indication for use | eNAT® medium is a 'ready to use' system
that allows for the stabilization and safe
transport of clinical samples at ambient
temperature for viral RNA detection | PrimeStore MTM is a self-contained
'ready to use' system that allows for the
stabilization and safe transport of clinical
samples at ambient temperature from the
collection site to the laboratory |
| Specimen Type | Respiratory specimens | Nasal washes and sputum samples |
| Microorganism
nucleic acids
preserved | Influenza A virus | Influenza A virus and Mycobacterium
tuberculosis |
| Specimen stability | eNAT® medium preserves influenza A
RNA for up to 28 days at 2-25°C. | Primestore MTM® medium preserves
influenza A RNA for up to 8 days at 27°C
and 29 days at 4°C. |
| Inactivation tested
on Flu A | >4.0 log reduction in concentration at 10
seconds | Same |
| Container | Tube; plastic, conical bottom, | Same |
| | self-standing with a screw cap | |
| Medium | Tris-EDTA | TRIS |
| Formulation | Guanidine thiocyanate
Detergent
HEPES
Distilled water | EDTA
Guanidine thiocyanate
N-lauroylsarcosine sodium
Antifoam A
TCEP
Sodium citrate
Ethanol
HCl
Water |
| Medium Volume | 2 mL | 1 mL or 1.5 mL |
| Storage
Temperature | 2-25°C | Same |
| Shelf-life | 18 months | 24 months |
8
VII. PERFORMANCE DATA
An inactivation study was conducted to verify that Copan eNAT® inactivates Flu A virus as efficiently as the predicate device PrimeStore MTM following the study design described by Longhorn in the PrimeStore MTM Decision Summary, DEN170029.
High concentrations of Flu A in nasal matrix were inoculated in eNAT® using Copan's regular nasaltype FLOQSwabs®. In particular, the swab was dipped into the infected matrix and used to transfer the sample into eNAT®.
The viability of the virus was measured after 10 seconds in eNAT® medium by inoculating aliquots onto MDCK (Madin-Darby Canine Kidney) cell lines, incubating for four days and measuring the cytopathic effect (CPE).
9
The results for the inactivation study (Table 2) confirmed > 4.0 log reduction in Flu A titer in 10 seconds and demonstrates equivalent performance of eNAT® with PrimeStore MTM™ in the inactivation of influenza A.
| Sample | Viral load after 10s incubation | Log. reduction |
|---|---|---|
| CTRL+ (Flu A only) | 3.16*107 TCID50/ml | n/a |
| Flu A in eNAT® | ≤ 103 TCID50/ml | 4.5 |
Table 2: Summary of influenza A inactivation study results
An analytical sensitivity study was conducted to determine the Flu A limit of detection (LoD) obtained by eNAT® in combination with the Cepheid Xpert® Xpress Flu/RSV assay. eNAT® medium in combination with the Cepheid assay has reached the same LoD than UTM (reference device for the assay) and LoD has fallen within the range of TCID 50/ml declared by the Cepheid assay (0.75 -0.006 TCID50/ml in the matrix) for Flu A detection (Table 3) (Flu A 1 channel results shown).
Table 3: Summary of results obtained at the dilution corresponding to 0.180 TCIDs(/ml (in the matrix) during the Analytical Sensitivity Study using Xpert® Xpress Flu/RSV assay
| N° of positive replicates | eNAT® samples
24/24 |
|---------------------------|------------------------|
| Average PCR Ct obtained | 34.4 |
| Standard deviation | 0.93 |
| CV% | 2.7% |
10
A stability study was designed to demonstrate that RNA from Flu A is preserved and stable in eNAT® medium. The stability of Flu A RNA in eNAT® was tested with the Cepheid Xpert® Xpress Flu/RSV Assay. The results of eNAT® influenza A RNA Stability Study (Table 4) (Flu A 1 channel results shown) confirmed that RNA stability in eNAT® met the acceptance criteria of +/- 3.0 Ct after 4 weeks storage at both 2-8°C and 25°C storage. The stability of RNA from Flu A spiked into nasal wash and stored in Longhorn PrimeStore MTM™ is 29 days at 4°C and 8 days at 27°C. This study demonstrates at least equivalent performance of eNAT® with PrimeStore MTM™ in the influenza A RNA stability.
| eNAT® samples | Results | |
|---|---|---|
| Time zero | N° of positive replicates | 24/24 |
| Average of PCR CTs | 30.8 | |
| St. Dev | 0.40 | |
| CV% | 1.3% | |
| PASS | yes | |
| 4 weeks @ 2-8°C | N° of positive replicates | 24/24 |
| Average of PCR CTs | 30.6 | |
| St. Dev | 0.20 | |
| CV% | 0.6% | |
| ΔCt 4w-T0 | -0.2 | |
| PASS | yes | |
| 4 weeks @ 25°C | N° of positive replicates | 24/24 |
| Average of PCR CTs | 30.7 | |
| St. Dev | 0.28 | |
| CV% | 0.9% | |
| ΔCt 4w-T0 | -0.1 | |
| PASS | yes |
Table 4: Flu A data in eNAT® at time zero and after 4 weeks at 2-8°C and 25°C
11
VIII. CONCLUSIONS
Based on the above, Copan Italia S.p.A. believes that Copan eNAT® is substantially equivalent to the commercially distributed product PrimeStore MTM™ for the stabilization, inactivation and transportation of clinical specimens containing influenza A viruses from the collection site to the testing laboratory. No new issues of safety or effectiveness were found for Copan eNAT®.