(34 days)
Not Found
No
The device description and performance studies focus on standard RT-PCR technology and analytical methods, with no mention of AI or ML algorithms for data analysis or interpretation.
No
Explanation: The device is an in vitro diagnostic test for the qualitative detection of hMPV; diagnostics are not considered therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the Pro hMPV™+ Assay is "an in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid" and that 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 indicates its purpose is to aid in diagnosing a medical condition.
No
The device is an in vitro diagnostic test that involves physical reagents, sample processing, and a hardware instrument (Cepheid SmartCycler® II) for nucleic acid amplification and detection. While software is likely involved in the instrument's operation and data analysis, the core of the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The Pro hMPV™+ Assay is a Real-Time PCR (RT-PCR) in vitro diagnostic test for the qualitative detection of human Metapneumovirus (hMPV) nucleic acid..."
This statement directly identifies the device as an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 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 hMPVnucleic 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.
Product codes
OEM
Device Description
The Pro hMPV+ Assay enables detection 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.
An Internal Control (IC) 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 easyMAGTM 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 and target-specific oligonucleotide probes. The primers are complementary to highly conserved regions of genetic sequences for these respiratory viruses. The probes are dual-labeled with a reporter dye attached to the 51-end and a quencher dye attached to the 3'-end (see table below).
Analyte: human Metapneumovirus, Gene Targeted: Nucleocapsid, Probe Fluorophore: FAM, Absorbance Peak: 495 nm, Emission Peak: 520 nm, Instrument Channel: FAM
Analyte: Internal Control, Gene Targeted: NA, Probe Fluorophore: Quasar 670, Absorbance Peak: 647nm, Emission Peak: 667nm, 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. 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
One hundred eighty-three retrospective nasopharyngeal swab samples collected during 2011 – 2012 at two sites (Milwaukee, WI and Chicago, IL) were used for this study. hMPV positive and negative NP swab samples were selected for inclusion based on previous site-specific molecular test results. One sample was not used in the final analysis as it was Unresolved upon initial and repeat testing with both the original and reformulated ProhMPV+ Assays.
"True" hMPV positives were considered as any sample that tested positive for hMPV by the original Pro hMPV+ Assay. "True" hMPV negatives were considered as any sample that tested negative for hMPV by the original Pro hMPV+ Assay. Discrepant analysis for samples where the reformulated Pro hMPV+ Assay and the original Pro hMPV+ results were in disagreement was performed using RT-PCR with hMPV specific primers targeting the hMPV phosphoprotein gene followed by bi-directional genetic sequencing.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Comparison Study: The Pro hMPV+ Assay's supermix was reformulated and performance characteristics were established by comparing the reformulated assay to the original Pro hMPV+ Assay.
Sample size: 182 (183 initial samples, one was unresolved).
Results (New Pro hMPV+ Assay vs. Current Pro hMPV+ Assay):
Positive: 43 positive in both; 2 positive in new, negative in current.
Negative: 0 negative in new, positive in current; 137 negative in both.
Percent Positive Agreement: 100% (91.80%-100%) 95% CI.
Percent Negative Agreement: 98.6% (94.91%-99.61%) 95% CI.
Two samples tested positive for hMPV by bi-directional sequencing.
Select Analytic Studies:
Limit of Detection: Determined using quantified (TCIDs) mL) cultures of two hMPV (subtype B2) strains serially diluted in nasopharyngeal clinical matrix. Each viral strain was processed using the bioMérieux NucliSENS EasyMAG system for extraction and the SmartCycler II Instrument for RT-PCR.
LoD was identical to the original Pro hMPV+ Assay for hMPV strain A2 and 0.5 log lower for hMPV strain B2.
hMPV subtype A2: LoD Concentration (Original Pro hMPV+): $10^2$ TCID50/mL, LoD Concentration (Reformulated Pro hMPV+): $10^2$ TCID50/mL
hMPV subtype B2: LoD Concentration (Original Pro hMPV+): $10^1$ TCID50/mL, LoD Concentration (Reformulated Pro hMPV+): $10^{0.5}$ TCID50/mL
Positive Control Effectiveness:
The Pro hMPV+ Control (PC) is a non-infectious in vitro transcribed RNA of the hMPV viral sequence targeted by the New Pro hMPV+ Assay. Its purpose is to test for procedural errors. The New Pro hMPV+ Assay uses the PC at a higher concentration than Current Pro hMPV. "Defective" RT-PCR master mixes were prepared and tested to assess the PC's ability to detect global errors, using 20 replicates of the New Pro hMPV+ Control for each defective mix. A Negative Control (NC) was included. For each defective mix, none of the hMPV PC replicates were detected, indicating the New PC was effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percent Positive Agreement 100% (91.80%-100%) 95% CI
Percent Negative Agreement 98.6% (94.91%-99.61%) 95% CI
Predicate Device(s)
K082688, K112490, K063765, K081483, K091667
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
12/23/2012
Attachment D 510(k) SUMMARY
Modification of Prodesse Pro hMPV+ Assay
JAN 1 6 2013
INTRODUCTION: According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis of substantial equivalence.
SUBMITTED BY:
Gen-Probe Prodesse, Inc. 20925 Crossroads Circle Waukesha. WI 53186
Phone: 262-953-8415 Fax: 262-446-0600
Contact: Karen Harrington, PhD Date Submitted: 12/10/2012
NAME AND CLASSIFICATION OF DEVICE
Trade Name: ProhMPV+ Assay Regulation Number: 21 CFR 866.3980 Product Code: OEM Classification Name: Nucleic acid amplification assay for human metapneumovirus RNA
PREDICATE DEVICE
- K082688, Gen-Probe Prodesse Pro hMPV+ Assay .
- K112490, Quidel Molecular hMPV Assay .
- K063765, K081483, K091667 Luminex ID-Tag RVP Assay .
INTENDED USE
The 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 hMPVnucleic 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.
PRODUCT DESCRIPTION
The Pro hMPV+ Assay enables detection human Metapneumovirus and Internal Control nucleic acid. Nasopharyngeal swab specimens are collected from patients with signs and symptoms of a respiratory
Gen-Probe Prodesse, Inc.
1
infection using a polyester, rayon or nylon tipped swab and placed into viral transport medium.
An Internal Control (IC) 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 easyMAGTM 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 and target-specific oligonucleotide probes. The primers are complementary to highly conserved regions of genetic sequences for these respiratory viruses. The probes are dual-labeled with a reporter dye attached to the 51-end and a quencher dye attached to the 3'-end (see table below).
| Analyte | Gene
Targeted | Probe
Fluorophore | Absorbance
Peak | Emission
Peak | Instrument
Channel |
|--------------------------|------------------|----------------------|--------------------|------------------|-----------------------|
| human
Metapneumovirus | Nucleocapsid | FAM | 495 nm | 520 nm | FAM |
| Internal Control | NA | Quasar 670 | 647nm | 667nm | 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. 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.
SUBSTANTIAL EQUIVALENCE
The Pro hMPV+ Assay is substantially equivalent to the Pro hMPV+ Assay (K082688), Quidel Molecular hMPV Assay (K112490) and the Luminex RVP Assay (K063765, K081483, and K091667). All were determined to be class II devices.
The following table compares the Pro hMPV+ Assay to the previously cleared Pro hMPV+ Assay (K082688), Quidel Molecular hMPV Assay (K112490) and the Luminex RVP Assay (K063765, K081483, and K091667).
| | New Device
New Pro hMPV+ Assay | Predicate Devices
Current Pro hMPV+ Assay | Luminex RVP |
|--------------|-----------------------------------|----------------------------------------------|---------------------------|
| Features | | | |
| 510(k) | TBD | K082688 | K063765, K081483, K091667 |
| Regulation | 866.3980 | 866.3980 | 866.3980 |
| Product Code | OEM | OEM | OCC, OEM, OEP |
| Device Class | Class II | Class II | Class II |
| Intended Use | For the in vitro | For the in vitro | Direct and differential |
Gen-Probe Prodesse, Inc.
2
| New Device | Predicate Devices | ||
|---|---|---|---|
| Features | New Pro hMPV+ Assay | Current Pro hMPV+ Assay | Luminex RVP |
| qualitative detection of human metapneumovirus nucleic acids. | qualitative detection of human metapneumovirus nucleic acids. | qualitative detection of human metapneumovirus, influenza types A and B, RSV types A and B, Parainfluenza types 1, 2 and 3, Adenovirus, and Rhinovirus viral nucleic acids. | |
| Technology/ Detection | Real Time RT-PCR Detection | Real Time RT-PCR Detection | RT-PCR Detection: |
| Amplified products are coupled to microspheres and detected using spectrofluorometric analysis. | |||
| Specimen Types | NP swabs | NP swabs | NP swabs |
| Nucleic Acid Isolation | Roche MagNA Pure LC System and bioMérieux NucliSENS easyMAG | Roche MagNA Pure LC System and bioMérieux NucliSENS easyMAG | NucliSENS®miniMAG extraction Kit (bioMérieux) QIAamp®MiniElute® Virus Spin Kit (Qiagen) |
| Instrument /Assay Platform | Cepheid SmartCycler II System | Cepheid SmartCycler II System | Luminex 100 or 200 |
| Assay Controls | hMPV positive RNA transcript control and an Internal RNA control provided | hMPV positive RNA transcript control and an Internal RNA control provided | Bacteriophage lambda positive control and E. coli MS2 phage Internal Control – ancillary reagents not provided |
| Element | New Device: Pro hMPV+
Assay | Predicate: Current Pro hMPV+
Assay (K082688) |
|---------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------|
| Assay Cutoff Cycle for hMPV detection | 35 | 40 |
| hMPV Positive RNA Control | Provided "at use"
concentration for RT-PCR
(no dilution prior to RT-
PCR required). | Dilute 1:10 prior to use for RT-
PCR |
Clinical Comparison Study
The Pro hMPV+ Assay's supermix was reformulated and performance characteristics were established by comparing the reformulated assay to the original Pro hMPV+ Assay. One hundred eighty-three retrospective nasopharyngeal swab samples collected during 2011 – 2012 at two sites (Milwaukee, WI and Chicago, IL) were used for this study. hMPV positive and negative NP swab samples were selected for inclusion based on previous site-specific molecular test results. One sample was not used in the final analysis as it was Unresolved upon initial and repeat testing with both the original and reformulated
3
ProhMPV+ Assays.
"True" hMPV positives were considered as any sample that tested positive for hMPV by the original Pro hMPV+ Assay. "True" hMPV negatives were considered as any sample that tested negative for hMPV by the original Pro hMPV+ Assay. Discrepant analysis for samples where the reformulated Pro hMPV+ Assay and the original Pro hMPV+ results were in disagreement was performed using RT-PCR with hMPV specific primers targeting the hMPV phosphoprotein gene followed by bi-directional genetic sequencing.
hMPV Comparison Results
| New Pro hMPV+ Assay | Current Pro hMPV+
Assay | | | Comments |
|---------------------|----------------------------|----------|-------|------------------------------------------------------------|
| | Positive | Negative | Total | |
| Positive | 43 | 2* | 45 | Percent Positive Agreement 100%
(91.80%-100%) 95% CI |
| Negative | 0 | 137 | 137 | Percent Negative Agreement 98.6%
(94.91%-99.61%) 95% CI |
| Total | 43 | 139 | 182 | |
- Two samples tested positive for hMPV by bi-directional sequencing.
Select Analytic Studies
Limit of Detection
The analytical sensitivity (limit of detection or LoD) of the Pro hMPV+ Assay was determined using quantified (TCIDs) mL) cultures of two hMPV (subtype B2) strains serially diluted in nasopharyngeal clinical matrix. Each viral strain was processed using the bioMérieux NucliSENS EasyMAG system for extraction and the SmartCycler II Instrument for RT-PCR. The LoD was identical to the original Pro hMPV+ Assay for hMPV strain A2 and 0.5 log lower for hMPV strain B2.
| Viral Strain | LoD Concentration
(Original Pro hMPV+) | LoD Concentration
(Reformulated Pro hMPV+) |
|-----------------|-------------------------------------------|-----------------------------------------------|
| hMPV subtype A2 | $10^2$ TCID50/mL | $10^2$ TCID50/mL |
| hMPV subtype B2 | $10^1$ TCID50/mL | $10^{0.5}$ TCID50/mL |
Positive Control Effectiveness
The Pro hMPV+ Control (PC) is a non-infectious in vitro transcribed RNA of the hMPV viral sequence targeted by the New Pro hMPV+ Assay. Its purpose is to test for procedural errors (absence of reagent, instrument failure, etc.) that may result in failure of the assay to detect hMPV. The New Pro hMPV+ Assay uses the PC at a higher concentration than Current Pro hMPV. "Defective" RT-PCR master mixes (e.g. no reverse transcriptase, no Taq polymerase, decreased hMPV primer concentration) were prepared and tested to assess the PC's ability to detect global errors. Each defective mix was tested using 20 replicates of the New Pro hMPV+ Control. A Negative Control (NC) consisting of Internal Control (IC) in viral transport media was included in each run. For each defective mix, none of the hMPV PC replicates were detected and thus, the New PC was considered effective.
4
CONCLUSION:
The results of the clinical study indicate that the New Pro hMPV+ Assay is sensitive and specific as compared to the Current Pro hMPV+ Assay (K082688). Furthermore, analytical studies support substantial equivalence to the predicate device, the current Pro hMPV+ Assay (K082688).
Gen-Probe Prodesse, Inc.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized representation of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
JAN 1 6 2013
Gen-Probe Prodesse, Inc. C/O Karen Harrington, PhD 20925 Crossroads Cir. Waukesha, WI, 53186
Re: K123838
Trade/Device Name: Pro hMPV™+ Assay Regulation Number: 21 CFR 866.3980 Regulation Name: Respiratory viral panel multiplex nucleic acid assay Regulatory Class: Class II Product Code: OEM Dated: December, 12, 2012 Received: December 17, 2012
Dear Dr. Harrington:
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.
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 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.
6
Page 2 - Karen Harrington
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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
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/cdrh/industry/support/index.html.
Sincerely yours,
Uwe Scherf for
Sally A. 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
7
Indication for Use
510(k) Number (if known): K
Device Name: Pro hMPV+ Assay
Indication 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 CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Vaursa Feldbh
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K 12 38 38