(33 days)
Not Found
No
The device description details a standard Real Time PCR assay for detecting viral DNA. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function within the device or its associated software. The analysis relies on fluorescent signal detection from the PCR reaction.
No.
The device is an in vitro diagnostic test intended for qualitative detection of human Adenovirus (HAdV) DNA to aid in diagnosis, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section states that the device is an "in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA" and is "intended for use to aid in the diagnosis of HAdV infections in humans."
No
The device is an in vitro diagnostic test that involves physical reagents, instruments (MagNA Pure LC, NucliSENS easyMAG, Cepheid SmartCycler II), and the processing of biological specimens. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Prodesse® ProAdeno®+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens..."
This statement clearly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Prodesse® ProAdeno®+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This test is intended for use to aid in the diagnosis of HAdV infections in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, serotypes 1-51.
Negative results do not preclude HAdV infection and should not be used as the sole basis for treatment or other patient management decisions.
Product codes (comma separated list FDA assigned to the subject device)
OCC, OOI
Device Description
The ProAdeno+ Assay enables detection of human adenovirus 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 ProAdeno+ Supermix included in the ProAdeno+ Assay Kit. The ProAdeno+ Supermix contains oligonucleotide primers, target-specific oligonucleotide probes and a Taq DNA polymerase. The primers are complementary to highly conserved regions of the HAdV hexon gene. The probes are dual-labeled with a reporter dye attached to the 5-end and a quencher dye attached to the 3'-end (see table below).
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 ProAdeno+ Assay is based on Tagman 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 SmartCycler II instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal (NP) 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)
The modified UIC did not affect the ability of the ProAdeno+ 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 ProAdeno+ Assay with UIC continues to meet the performance claims for the current ProAdeno+ Assay.
A Positive Control Effectiveness Study demonstrated the positive control's continued ability to monitor for global assay failures at the increased testing concentration.
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
K13215-9
Gen-Probe Prodesse, Inc. Prodesse® ProAdeno®+ Assay Special 510(k) Submission Page 1 of 3 7/11/2013
510(k) SUMMARY
CONTACT
B
Emily Ziegler Scientist I Gen-Probe Prodesse, Inc. 20925 Crossroads Circle Waukesha, WI 53186
AUG 14 2013
PREDICATE DEVICE
K102952, ProAdeno™+ Assay
NAME OF DEVICE
Trade Name: Regulation Number: Product Code: Classification Name: Prodesse® ProAdeno®+ Assay 21 CFR 866.3980 OCC, OOI Nucleic acid amplification assay for detection of human adenovirus
INTENDED USE
The Prodesse® ProAdeno®+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This test is intended for use to aid in the diagnosis of HAdV infections in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, serotypes 1-51.
Negative results do not preclude HAdV infection and should not be used as the sole basis for treatment or other patient management decisions.
PRODUCT DESCRIPTION
The ProAdeno+ Assay enables detection of human adenovirus 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).
Confidential to Gen-Probe Prodesse, Inc.
1
ಕ
i
The purified nucleic acids are added to ProAdeno+ Supermix included in the ProAdeno+ Assay Kit. The ProAdeno+ Supermix contains oligonucleotide primers, target-specific oligonucleotide probes and a Taq DNA polymerase. The primers are complementary to highly conserved regions of the HAdV hexon gene. The probes are dual-labeled with a reporter dye attached to the 5-end and a quencher dye attached to the 3'-end (see table below).
| Analyte | Gene
Targeted | Probe
Fluorophore | AbsorbancePeak | EmissionPeak | Instrument
Channel |
|-------------------------------|------------------|----------------------|----------------|--------------|-----------------------|
| Adenovirus | hexon | FAM | 495 nm | 520 nm | FAM |
| Universal Internal
Control | NA | Quasar 670 | 647 nm | 667 nm | Cy5 |
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 ProAdeno+ Assay is based on Tagman 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 SmartCycler II instrument.
DEVICE COMPARISON
The modified ProAdeno+ Assay differs from the current kit in the following ways:
- . Outsourcing of internal control stock manufacturing leads to changes in the internal control;
- . The 1:10 dilution step of the positive control performed by customers has been removed.
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 modified UIC did not affect the
ability of the ProAdeno+ Assay to
detect target organisms at the limit |
2
4
| Modification | Potential Impact of
Modification | Verification/Validation Result |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | organisms. Additionally, it may
change the clinical performance
of the ProAdeno+ Assay. | 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
ProAdeno+ Assay with UIC
continues to meet the performance
claims for the current ProAdeno+
Assay. |
| Modified positive controls
provided "at use" "
concentration, no dilution is
necessary. | Changes in the testing
concentration may affect the
performance of the positive
control in terms of stability or
ability to detect global assay
failures. | A Positive Control Effectiveness
Study demonstrated the positive
control's continued ability to
monitor for global assay failures at
the increased testing concentration. |
-
- 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 ProAdeno+ Assay is substantially equivalent to the current legally marketed device, ProAdeno+ Assay.
3
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
August 14th, 2013
Emily Ziegler Scientist I Gen-Probe Prodesse, Inc. 20925 Crossroads Circle Waukesha. WI 53186
Re: K132159
Trade/Device Name: Prodesse® ProAdeno®+ Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory Virus Panel Multiplex Nucleic Acid Assay Regulatory Class: Class II Product Code: OCC, OOI Dated: July 11, 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 mav 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 (QS) 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 A Hojivat -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
Gen-Probe Prodesse, Inc. Prodesse® ProAdeno®+ Assay Special 510(k) Submission
Indication for Use
510(k) Number (if known): K132159 Device Name: Prodesse® ProAdeno®+ Assay
Indications for Use:
The Prodesse® ProAdeno®+ Assay is a multiplex Real Time PCR in vitro diagnostic test for the qualitative detection of human Adenovirus (HAdV) DNA isolated and purified from nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of acute respiratory infection. This test is intended for use to aid in the diagnosis of HAdV infections in humans in conjunction with other clinical and laboratory findings. The test detects, but does not differentiate, serotypes 1-51.
Negative results do not preclude HAdV infection and should not be used as the sole basis for treatment or other patient 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 V. Feldblýum -S 2013.08.14 08:31:19 -04'00'