(29 days)
Not Found
No
The summary describes a standard RT-PCR assay for detecting viral RNA. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on target-specific primers and fluorescent probes, not algorithmic learning.
No
This device is an in vitro diagnostic test intended to aid in the differential diagnosis of RSV and hMPV infections, not to treat them.
Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans."
No
The device is an in vitro diagnostic test that involves the detection of viral nucleic acids from patient samples using automated extraction platforms and RT-PCR instruments. This clearly involves hardware components and chemical reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans..."
- Nature of the Test: The device performs a Real-Time PCR (RT-PCR) assay on biological specimens (nasal and nasopharyngeal swabs) to detect and identify specific viral RNA. This is a classic example of an in vitro diagnostic test, which is performed on samples taken from the human body to provide information about a person's health.
- Purpose of the Test: The test is intended to aid in diagnosis, which is a key function of IVDs.
Therefore, based on the provided information, the Lyra RSV + hMPV Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
The Lyra RSV + hMPV Assay can be performed using ether the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.
Product codes (comma separated list FDA assigned to the subject device)
OEM, OCC
Device Description
The Lyra RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® or NucliSENS® EMAG® automated extraction platform. A multiplex RT-PCR reaction is then performed in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II, the Applied Biosystems 7500 Fast DX, or the Life Technologies QuantStudio" Dx. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal and nasopharyngeal swab 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)
Non-clinical and clinical verification and validation activities conducted with the Lyra RSV+hMPV Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. All verification activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness. Evidence is demonstrated through the following studies:
- Limit of Detection Equivalency Study
- Clinical Equivalence Study
These studies demonstrated equivalent performance of the Lyra RSV+hMPV Assay to the predicate product K131813.
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.
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
§ 866.3980 Respiratory viral panel multiplex nucleic acid assay.
(a)
Identification. A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The detection and identification of a specific viral nucleic acid from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection when used in conjunction with other clinical and laboratory findings. The device is intended for detection and identification of a combination of the following viruses:(1) Influenza A and Influenza B;
(2) Influenza A subtype H1 and Influenza A subtype H3;
(3) Respiratory Syncytial Virus subtype A and Respiratory Syncytial Virus subtype B;
(4) Parainfluenza 1, Parainfluenza 2, and Parainfluenza 3 virus;
(5) Human Metapneumovirus;
(6) Rhinovirus; and
(7) Adenovirus.
(b)
Classification. Class II (special controls). The special controls are:(1) FDA's guidance document entitled “Class II Special Controls Guidance Document: Respiratory Viral Panel Multiplex Nucleic Acid Assay;”
(2) For a device that detects and identifies Human Metapneumovirus, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Human Metapneumovirus (hMPV) Using Nucleic Acid Assays;” and
(3) For a device that detects and differentiates Influenza A subtype H1 and subtype H3, FDA's guidance document entitled “Class II Special Controls Guidance Document: Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays.” See § 866.1(e) for the availability of these guidance documents.
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Date: March 10, 2023
Image /page/0/Picture/1 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
Quidel Corporation Selena Liu Senior Regulatory Specialist 10165 McKellar Court San Diego, California 92121
Re: K230349
Trade/Device Name: Lyra RSV + hMPV Assay Regulation Number: 21 CFR 21 CFR 866.3980 Regulation Name: Respiratory Viral Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OEM, OCC Dated: February 8, 2023 Received: February 9, 2023
Dear Selena Liu:
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
1
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 (OS) 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,
Joseph Briggs -S
Joseph Briggs, Ph.D. Deputy Branch Chief Viral Respiratory and HPV 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) K230349
Device Name Lyra RSV + hMPV Assay
Indications for Use (Describe)
The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in humans in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four genetic sub-lineages of hMPV.
Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
The Lyra RSV + hMPV Assay can be performed using ether the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.
| 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) |
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3
510(K) SUMMARY
Submitter
Quidel Corporation 10165 McKellar Court San Diego, CA 92121 Telephone: (800) 874-1517
Submission Contact
Selena Liu Senior Regulatory Specialist (619) 818-6642 Selena.liu@quidel.com
Date Prepared
Feb 08, 2023
Proprietary and Established Names Lyra RSV + hMPV Assay
Common Name Lyra RSV + hMPV Assay
Classification
| Product Code | Classification | Regulatory Section | Description |
|---|---|---|---|
| OEM, OCC | II | 21 CFR 866.3980 | Respiratory Viral panel multiplex nucleic |
| acid assay |
Panel
Microbiology
Predicate Device K131813
Device Description
The Lyra RSV + hMPV Assay detects viral nucleic acids that have been extracted from a patient sample using the NucliSENS® easyMAG® or NucliSENS® EMAG® automated extraction platform. A multiplex RT-PCR reaction is then performed in a single tube generating amplicons for each of the target viruses present in the sample. This reaction is performed utilizing either the Cepheid SmartCycler® II, the Applied Biosystems 7500 Fast DX, or the Life Technologies QuantStudio" Dx. Identification of RSV and hMPV and the PRC occurs by the use of target-specific primers and fluorescent-labeled probes that hybridize to conserved regions in the genomes of RSV and hMPV and the PRC.
Intended Use
The Lyra RSV + hMPV Assay is a multiplex Real-Time PCR (RT-PCR) assay for the qualitative detection and identification of respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) ribonucleic acid (RNA) extracted from nasal and nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection. This in vitro diagnostic test is intended to aid in the differential diagnosis of RSV and hMPV infections in conjunction with clinical and epidemiological risk factors. This test is not intended to differentiate the two subtypes of RSV or the four
4
genetic sub-lineages of hMPV.
Negative results do not preclude RSV infection and/or hMPV infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Conversely, positive results do not rule-out bacterial infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection.
The Lyra RSV + hMPV Assay can be performed using either the Life Technologies QuantStudio Dx RT-PCR Instrument, the Applied Biosystems 7500 Fast Dx RT-PCR Instrument, or the Cepheid SmartCycler II System.
Comparison with Predicate
The Lyra RSV+hMPV Assay was modified to include a validated nucleic acid extraction platform, BioMerieux NucliSENS EMAG. The predicate device was cleared under K131813 for use with the BioMerieus NucliSENS easyMAG extraction platform. The purpose of the change is to allow customers to continue to use Lyra RSV+hMPV Assay after easyMAG is discontinued.
A comparison of the similarities and differences between the devices is provided in the following table.
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Image /page/5/Picture/0 description: The image shows the logo for Quidel. The logo consists of a square with a smaller square cut out of the bottom right corner. The larger square is filled with a gradient of colors, ranging from red to yellow to green to blue. Below the square is the word "QUIDEL" in a sans-serif font.
| Features | Predicate Device / Unmodified Device
Quidel RSV+hMPV Assay (K131813) | Modified Device
Lyra RSV + hMPV
Assay |
|------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| Intended Use | The Quidel Molecular RSV + hMPV Assay is a
multiplex Real-Time PCR (RT-PCR) assay for the
qualitative detection and identification of respiratory
syncytial virus (RSV) and human metapneumovirus
(hMPV) ribonucleic acid (RNA) extracted from nasal
and nasopharyngeal swab specimens from patients with
signs and symptoms of respiratory infection. This in
vitro diagnostic test is intended to aid in the differential
diagnosis of RSV and hMPV infections in humans in
conjunction with clinical and epidemiological risk
factors. This test is not intended to differentiate the two
subtypes of RSV or the four genetic sub-lineages of
hMPV.
Negative results do not preclude RSV infection and/or
hMPV infection and should not be used as the sole
basis for diagnosis, treatment or other patient
management decisions.
Conversely, positive results do not rule-out bacterial
infection or co-infection with other viruses. The agent
detected may not be the definite cause of disease. The
use of additional laboratory testing and clinical
presentation must be considered in order to obtain the
final diagnosis of respiratory viral infection.
The Quidel Molecular RSV + hMPV Assay can be
performed using either the Life Technologies
QuantStudio Dx RT-PCR Instrument, the Applied
Biosystems 7500 Fast Dx RT-PCR Instrument, or the
Cepheid SmartCycler II System. | Same* |
| Test Principle | Multiplex RT-PCR | Same |
| Detection Method | Multiplex assay using different reporter dyes for
each target | Same |
| Assay Result | Qualitative | Same |
| Analyte | RSV and hMPV | Same |
| Specimen Type | Nasal swab and nasopharyngeal swab | Same |
| Extraction Method | BioMerieux NucliSENS easyMAG | BioMerieux NucliSENS
easyMAG and EMAG |
| Quality Control | Process Control (PRC) | Same |
| *The predicate device name was changed from Quidel Molecular RSV + hMPV Assay to Lyra RSV +
hMPV Assay in CR210354. | | |
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Summary of Performance Data
Non-clinical and clinical verification and validation activities conducted with the Lyra RSV+hMPV Assay demonstrate that the modified device met predetermined acceptance criteria, supporting equivalency of the modified device to the cleared device. All verification activities were performed in accordance with relevant standards, established plans, protocols, and Design Control procedures. Testing verified all acceptance criteria were met. Verification of the changes did not raise any new items of safety and effectiveness. Evidence is demonstrated through the following studies:
- Limit of Detection Equivalency Study ●
- . Clinical Equivalence Study
Conclusion
These studies demonstrated equivalent performance of the Lyra RSV+hMPV Assay to the predicate product K131813.