(29 days)
Not Found
No
The description details a standard RT-PCR assay for detecting viral nucleic acid. There is no mention of AI or ML being used for data analysis, interpretation, or any other part of the process. The analysis relies on fluorescent signal detection and thresholding, which is a standard method in PCR.
No
This device is an in vitro diagnostic test designed to detect human Metapneumovirus (hMPV) qualitatively from patient specimens, which aids in diagnosis rather than providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "in vitro diagnostic test" and "aids in the diagnosis of human respiratory hMPV infection".
No
The device is an in vitro diagnostic test that involves physical specimens, reagents, and laboratory instruments (MagNA Pure LC Instrument, NucliSENS® easyMAG™ System, Cepheid SmartCycler® II instrument) for nucleic acid isolation, purification, and amplification. While software is likely involved in controlling these instruments and analyzing the results, the core of the device is a physical assay kit and associated hardware, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the Prodesse® Pro hMPV®+ Assay is an "in vitro diagnostic test".
- Purpose: The test is designed for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid in patient specimens (nasopharyngeal swabs) to aid in the diagnosis of hMPV infection. This is a classic function of an in vitro diagnostic device, which is used to examine specimens from the human body to provide information for diagnosis, treatment, or prevention of disease.
- Methodology: The device uses Real-Time PCR (RT-PCR) to detect nucleic acid, which is a common laboratory technique performed outside of the body (in vitro).
The description clearly aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Prodesse® Pro hMPV + Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This Assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four genetic sublineages of hMPV.
Negative results do not prectude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Product codes (comma separated list FDA assigned to the subject device)
OEM, OOI
Device Description
The Pro hMPV+ Assay enables detection of human Metapneumovirus and internal control nucleic acid. Nasopharyngeal swab specimens are collected from patients with signs and symptoms of a respiratory infection using a polyester, rayon or nylon tipped swab and placed into viral transport medium.
A Universal Internal Control (UIC) is added to each sample prior to nucleic acid isolation to monitor for inhibitors present in the specimens. The isolation and purification of the nucleic acids is performed using either a MagNA Pure LC Instrument (Roche) and the MagNA Pure Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS® easyMAG™ System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
The purified nucleic acids are added to Pro hMPV+ Supermix along with enzymes included in the Pro hMPV+ Assay Kit. The Pro hMPV+ Supermix contains oligonucleotide primers complementary to a highly conserved region of the Nucleocapsid gene of hMPV and a targetspecific oligonucleotide probe dual-labeled with a reporter dye attached to the 5'-end and a quencher dve attached to nucleotide #7 from the 5 end. (see table below).
Analyte: Human Metapneumovirus; Gene Targeted: Nucleocapsid; Probe Fluorophore: FAM; AbsorbancePeak: 495 nm; EmissionPeak: 520 nm; Instrument Channel: FAM
Analyte: Universal Internal Control; Gene Targeted: NA; Probe Fluorophore: Quasar 670; AbsorbancePeak: 647 nm; EmissionPeak: 667 nm; Instrument Channel: Cy5
Reverse transcription of the RNA in the sample into complementary DNA (cDNA) and subsequent amplification of DNA is performed in a Cepheid SmartCycler® II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The Pro hMPV+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the SmartCyclerII instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasopharyngeal swab (NP) 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)
Verification and validation studies performed demonstrated that all clinical and analytical performance/functionality remains unchanged from the previous device.
The UIC did not affect the ability of the Pro hMPV+ Assay to detect target organisms at the limit of detection as evinced by the results of Analytical Sensitivity, IC Interference, Extractor Equivalency, and Sample Stability studies. Additionally, the results of a retrospective clinical comparison study demonstrated the modified Pro hMPV+ Assay with UIC continues to meet the performance claims for the current Pro hMPV+ Assay.
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.
0
Page 1 of 3 8/13/2013
510(k) SUMMARY
CONTACT
Emily Ziegler Scientist I Gen-Probe Prodesse, Inc. 20925 Crossroads Circle Waukesha, W153186
AUG 1 4 2013
NAME OF DEVICE
| Trade Name: | |
|---|---|
| Regulation Number: | |
| Product Code: | |
| Classification Name: |
Prodesse® Pro hMPV®+ Assay 21 CFR 866.3980 OEM, OOI Nucleic acid amplification assay for detection of human metapneumovirus
PREDICATE DEVICE
K123838, Pro hMPVTM+ Assay
INTENDED USE
The Prodesse® Pro hMPV + Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This Assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four genetic sublineages of hMPV.
Negative results do not prectude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
PRODUCT DESCRIPTION
The Pro hMPV+ Assay enables detection of human Metapneumovirus and internal control nucleic acid. Nasopharyngeal swab specimens are collected from patients with signs and symptoms of a respiratory infection using a polyester, rayon or nylon tipped swab and placed into viral transport medium.
A Universal Internal Control (UIC) is added to each sample prior to nucleic acid isolation to monitor for inhibitors present in the specimens. The isolation and purification of the nucleic acids is performed using either a MagNA Pure LC Instrument (Roche) and the MagNA Pure
Confidential to Gen-Probe Prodesse, Inc.
1
Total Nucleic Acid Isolation Kit (Roche) or a NucliSENS® easyMAG™ System (bioMérieux) and the Automated Magnetic Extraction Reagents (bioMérieux).
The purified nucleic acids are added to Pro hMPV+ Supermix along with enzymes included in the Pro hMPV+ Assay Kit. The Pro hMPV+ Supermix contains oligonucleotide primers complementary to a highly conserved region of the Nucleocapsid gene of hMPV and a targetspecific oligonucleotide probe dual-labeled with a reporter dye attached to the 5'-end and a quencher dve attached to nucleotide #7 from the 5 end. (see table below).
| Analyte | Gene
Targeted | Probe
Fluorophore | AbsorbancePeak | EmissionPeak | Instrument
Channel |
|-------------------------------|------------------|----------------------|----------------|--------------|-----------------------|
| Human
Metapneumovirus | Nucleocapsid | FAM | 495 nm | 520 nm | FAM |
| Universal Internal
Control | NA | Quasar 670 | 647 nm | 667 nm | Cy5 |
Reverse transcription of the RNA in the sample into complementary DNA (cDNA) and subsequent amplification of DNA is performed in a Cepheid SmartCycler® II instrument. In this process, the probe anneals specifically to the template followed by primer extension and amplification. The Pro hMPV+ Assay is based on Taqman chemistry, which utilizes the 5' - 3' exonuclease activity of the Taq polymerase to cleave the probe thus separating the reporter dye from the quencher. This generates an increase in fluorescent signal upon excitation from a light source. With each cycle, additional reporter dye molecules are cleaved from their respective probes, further increasing fluorescent signal. The amount of fluorescence at any given cycle is dependent on the amount of amplification products present at that time. Fluorescent intensity is monitored during each PCR cycle by the SmartCyclerII instrument.
DEVICE COMPARISON
The modified Pro hMPV+ Assay differs from the current kit in the following ways: Outsourcing of control stock manufacturing leading to a change in control vector; Universal Internal Control, consisting of an RNA in vitro transcript and a DNA plasmid, incorporated into the kit.
The labeling was updated accordingly to incorporate the modifications listed above.
SUBSTANTIAL EQUIVALENCE
-
- The Intended Use and Warnings or Precautions of the modified device as described in the labeling have not changed.
-
- The modifications detailed in the table below had not had any effect or caused any changes to the fundamental scientific technology of the device.
| Modification | Potential Impact of Modification | Verification/Validation Result |
|---|---|---|
| Outsourcing of controls | ||
| leading to minor changes in | ||
| sequence | Modification of the internal | |
| control may affect the ability of | ||
| the device to detect the target | The UIC did not affect the ability of | |
| the Pro hMPV+ Assay to detect | ||
| target organisms at the limit of |
Confidential to Gen-Probe Prodesse, Inc.
2
| Modification | Potential Impact of
Modification | Verification/Validation Result |
|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Incorporation of a Universal
Internal Control, containing
both RNA and DNA
internal control sequences. | organisms. Additionally, it may
change the clinical performance
of the Pro hMPV+ Assay. | detection as evinced by the results
of Analytical Sensitivity, IC
Interference, Extractor Equivalency,
and Sample Stability studies.
Additionally, the results of a
retrospective clinical comparison
study demonstrated the modified
Pro hMPV+ Assay with UIC
continues to meet the performance
claims for the current Pro hMPV+
Assay. |
-
- Verification and validation studies performed demonstrated that all clinical and analytical performance/functionality remains unchanged from the previous device.
-
- The appropriate Design Control activities were performed;
- a. A Risk Analysis was performed and did not raise any new concerns of safety and efficacy associated with the modifications.
- b. A declaration of conformity with design controls has been submitted.
The modified Pro hMPV+ Assay is substantially equivalent to the current legally marketed device, Pro hMPV+ Assay.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 14th, 2013
Emily Ziegler Scientist I Gen-Probe Prodesse, Inc. 20925 Crossroads Circle Waukesha. WI 53186
Re: K132200
Trade/Device Name: Prodesse® Pro hMPV®+ Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Virus Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OEM, OOI Dated: July 15, 2013 Received: July 16, 2013
Dear Ms. Ziegler:
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. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Emily Ziegler
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Sally 생ộjvat -S
Sally Hojvat, M.Sc., Ph.D. Director, Division of Microbiology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indication for Use
510(k) Number (if known): K132200 Device Name: Prodesse® Pro hMPV®+ Assay
Indications for Use:
The Prodesse® Pro hMPV®+ Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid isolated and purified from nasopharyngeal swab (NP) specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This Assay targets a highly conserved region of the Nucleocapsid gene of hMPV. The detection of hMPV nucleic acid from symptomatic patients aids in the diagnosis of human respiratory hMPV infection if used in conjunction with other clinical and laboratory findings. This test is not intended to differentiate the four genetic sub-lineages of hMPV.
Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other management decisions.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Tamara V퀘eldblyum -S 2013.08.14 08:33:06 -04'00'