(1 days)
Not Found
No
The device description and intended use focus on a PCR-based assay for detecting viral DNA, with no mention of AI or ML technologies.
No
Explanation: This device is an in vitro diagnostic (IVD) test intended for the qualitative presumptive detection of non-variola Orthopoxvirus DNA. It is used to identify a pathogen rather than to directly treat or prevent a disease.
Yes
The intended use states that the device is for "in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA" and that "Results of this assay are for the identification of non-variola Orthopoxvirus DNA." It further specifies that "These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection." These phrases clearly indicate its role in diagnosis.
No
The device is a primer and probe set for a PCR assay, which are chemical reagents and not software.
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 device is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA. "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Specimen Type: The assay is performed on human specimens (pustular rash specimens and viral cell culture lysates), which are typical inputs for IVD tests.
- Purpose: The purpose is to detect a specific analyte (non-variola Orthopoxvirus DNA) to aid in the diagnosis of Orthopoxvirus infection. This aligns with the definition of an IVD, which is used to examine specimens from the human body to provide information for diagnostic purposes.
The other sections of the document further support this classification by describing a laboratory-based test performed on biological samples.
N/A
Intended Use / Indications for Use
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and ectromelia viruses at varying concentrations. This assay does not differentiate vaccinia virus or monkeypox virus from other orthopoxviruses detected by this assay and does not detect variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash IIIness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not prection virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention designated laboratories.
Product codes (comma separated list FDA assigned to the subject device)
PBK
Device Description
Unchanged from original submission (K221658).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human pustular or vesicular rash specimens
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory Response Network (LRN) reference laboratory.
Centers for Disease Control and Prevention designated laboratories.
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)
Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.
The limit of detection for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set was determined through an analytical sensitivity study.
Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.
Inquiries regarding clinical performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.
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.
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221658)
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
N/A
0
Image /page/0/Picture/0 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Centers For Disease Control And Prevention Julie Villanueva Laboratory Preparedness and Response Branch Chief 1600 Clifton Road, NE, MS: H24-11 Atlanta, Georgia 30329
June 24, 2022
Re: K221834
Trade/Device Name: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Regulation Number: 21 CFR 866.3315 Regulation Name: Nucleic Acid Based Reagents For Detection Of Non-Variola Orthopoxviruses Regulatory Class: Class II Product Code: PBK Dated: June 23, 2022 Received: June 23, 2022
Dear Julie Villanueva:
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
1
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 (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,
Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221834
Device Name
Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
Indications for Use (Describe)
The Non-variola Orthopoxvirus Real-ime PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including vaccinia, cowpox, monkeypox and ectromelia viruses at varying concentrations. This assay does not differentiate vaccinia virus or monkeypox virus from other orthopoxviruses detected by this assay and does not detect variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash IIIness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not prection virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention designated laboratories.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Centers for Disease Control and Prevention Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Special 510(k)
510(k) Summary 15.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Assigned 510(k)
| number: | TBD |
|---|---|
| Submitted by: | Centers for Disease Control and Prevention |
| 1600 Clifton Road NE | |
| Atlanta, GA 30329 | |
| Contact Person: | Julie Villanueva, PhD |
| Laboratory Preparedness and Response Branch Chief | |
| Division of Preparedness and Emerging Infections | |
| National Center for Emerging and Zoonotic Infectious | |
| Diseases | |
| Centers for Disease Control and Prevention | |
| (Registration number: 1050190) | |
| 1600 Clifton Road, NE, MS H24-11 | |
| Atlanta, GA 30329 | |
| (404) 639-3851 (office) | |
| Jfv3@cdc.gov | |
| Date prepared: | June 23, 2022 |
| Device trade name: | Non-variola Orthopoxvirus Real-time PCR |
| Primer and Probe Set | |
| Classification name and | |
| regulation (if applicable): | 21 CFR 866.3315 |
| Predicate device(s): | Non-variola Orthopoxvirus Real-time PCR |
| Primer and Probe Set (K221658) |
Background
Variola virus, a member of the Orthopoxvirus genus, is the causative agent of smallpox and was certified eradicated in 1980 by the World Health Organization. At that time, smallpox vaccinations were ceased worldwide as a result. However, in recent years, concerns over the potential use of Variola virus as a biological weapon led the United States to resume smallpox vaccinations on a limited basis. Since the smallpox vaccine contains live Vaccinia virus, it is possible for vaccine recipients and/or their close contacts to develop adverse reactions to the vaccine including the emergence of pustules on the skin.
The Laboratory Response Network (LRN) is part of a national bioterrorism preparedness initiative created to ensure an effective laboratory response to biological threats by helping to improve the nation's public health laboratory infrastructure. Member laboratories must meet specific membership requirements and pass rigorous proficiency tests demonstrating their ability to accurately identify agents of concern. One of the major goals is the development and validation of rapid and specific assays for detection of
4
Centers for Disease Control and Prevention Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set Special 510(k)
biothreat agents and emerging infectious diseases. Accordingly, scientists at the Centers for Disease Control and Prevention have developed several realtime PCR based assays to detect non-variola Orthopoxvirus and other potential biothreat agents in an effort to meet the need for rapid detection.
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set was developed for use in conjunction with clinical observations and other tests as described in the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash Illness Testing Protocol in the United States. The assay is designed to aid in the identification of the causative aqent of a pustular or vesicular rash illness and to help rule out the presence of Variola virus in patients presenting with pustular rash illness.
This assay detects most commonly known human pathogenic Orthopoxyiruses (e.q., Vaccinia, Cowpox, and Monkeypox viruses) but does not detect Variola virus, the causative agent of smallpox. Vaccinia virus infection in the United States usually occurs in conjunction with smallpox vaccination or contact with a smallpox vaccine recipient. Monkeypox and Cowpox viruses are endemic to locations outside the United States, with the exception of the 2003 monkeypox outbreak associated with prairie dogs, which became infected due to imported African rodents.
As of June 21, 2022, LRN laboratories and the CDC have detected 141 (82 confirmed monkevpox virus. 59 confirmed orthopoxvirus) across 21 jurisdictions and 1 out of country resident. One additional case in Florida was diagnosed in the United Kingdom (U.K.) and is counted among U.K. cases. As case counts continue to rise in the United States and in 40 other countries where monkeypox is not endemic, there is an urgent need to prepare for larger scale diagnostic testing for orthopoxviruses. The use of the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set in CDC designated laboratories has introduced the need for product labeling that removes the LRN logo and LRN specific language. The following table outlines the similarities and differences between the two devices.
Device Description
Unchanged from original submission (K221658).
Intended Use
The Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set is intended for the in vitro qualitative presumptive detection of non-variola Orthopoxvirus DNA extracted from human pustular or vesicular rash specimens and viral cell culture lysates submitted to a Laboratory Response Network (LRN) reference laboratory. The assay detects non-variola Orthopoxvirus DNA, including Vaccinia, Cowpox, Monkeypox and Ectromelia viruses at varying concentrations. This assay does not differentiate Vaccinia virus or Monkeypox virus from other Orthopoxviruses detected by this assay and does not detect Variola virus. Refer to the CDC algorithm, Acute, Generalized Vesicular or Pustular Rash Illness Testing Protocol in the United States for recommended testing and evaluation algorithms for patients presenting with acute, generalized pustular or vesicular rash illness.
Results of this assay are for the presumptive identification of non-variola Orthopoxvirus DNA. These results must be used in conjunction with other
5
diagnostic assays and clinical observations to diagnose Orthopoxvirus infection. The assay should only be used to test specimens with low/moderate risk of smallpox. If a high risk of smallpox exists, viral culture should not be attempted. Negative results obtained with this device do not preclude Variola virus infection and should not be used as the sole basis for treatment or other patient management decisions.
Use is limited to Centers for Disease Control and Prevention designated laboratories.
Device Comparison
The following table summarizes the similarities and differences between the cleared assay and the new submission for this device.
| | New Submission | Original Submission
(K221658) |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Non-variola Orthopoxvirus
Real-time PCR Primer and
Probe Set | Non-variola Orthopoxvirus
Real-time PCR Primer and
Probe Set (K221658) |
| Intended Use | The Non-variola
Orthopoxvirus Real-time
PCR Primer and Probe Set
is intended for the in vitro
qualitative presumptive
detection of non-variola
Orthopoxvirus DNA
extracted from human
pustular or vesicular rash
specimens and viral cell
culture lysates submitted
to a Laboratory Response
Network (LRN) reference
laboratory. The assay
detects non-variola
Orthopoxvirus DNA,
including vaccinia,
cowpox, monkeypox and
ectromelia viruses at
varying concentrations.
This assay does not
differentiate vaccinia virus
or monkeypox virus from
other orthopoxviruses
detected by this assay
and does not detect
variola virus. Refer to the
CDC algorithm, Acute,
Generalized Vesicular or
Pustular Rash Illness
Testing Protocol in the | The Non-variola
Orthopoxvirus Real-time
PCR Primer and Probe Set
is intended for the in vitro
qualitative presumptive
detection of non-variola
Orthopoxvirus DNA
extracted from human
pustular or vesicular rash
specimens and viral cell
culture lysates submitted
to a Laboratory Response
Network (LRN) reference
laboratory. The assay
detects non-variola
Orthopoxvirus DNA,
including vaccinia, cowpox,
monkeypox and ectromelia
viruses at varying
concentrations. This assay
does not differentiate
vaccinia virus or
monkeypox virus from
other orthopoxviruses
detected by this assay and
does not detect variola
virus. Refer to the CDC
algorithm, Acute,
Generalized Vesicular or
Pustular Rash Illness
Testing Protocol in the |
| | United States for
recommended testing and
evaluation algorithms for
patients presenting with
acute, generalized
pustular or vesicular rash
illness.
Results of this assay are
for the identification of
non-variola Orthopoxvirus
DNA. These results must
be used in conjunction
with other diagnostic
assays and clinical
observations to diagnose
Orthopoxvirus
infection. The assay
should only be used to
test specimens with
low/moderate risk of
smallpox. If a high risk of
smallpox exists, viral
culture should not be
attempted. Negative
results obtained with this
device do not preclude
Variola virus infection and
should not be used as the
sole basis for treatment
or other patient
management decisions. | United States for
recommended testing and
evaluation algorithms for
patients presenting with
acute, generalized pustular
or vesicular rash illness.
Results of this assay are
for the identification of
non-variola Orthopoxvirus
DNA. These results must
be used in conjunction
with other diagnostic
assays and clinical
observations to diagnose
Orthopoxvirus
infection. The assay
should only be used to test
specimens with
low/moderate risk of
smallpox. If a high risk of
smallpox exists, viral
culture should not be
attempted. Negative
results obtained with this
device do not preclude
Variola virus infection and
should not be used as the
sole basis for treatment or
other patient management
decisions. |
| | Use is limited to
Centers for Disease
Control and Prevention
designated
laboratories. | Use is limited to
Laboratory Response
Network (LRN)
designated
laboratories. |
| Principle of
Operation | Unchanged | Nucleic acid amplification
and fluorescent probe
detection |
| Sample Types | Unchanged | • Vesicle fluid, skin, crust,
"roof"
• Dry or wet swab of
lesion (dry swab is
preferred)
• Touch prep (slide) of
lesion
• Fresh biopsy of pustule
or vesicle (no formalin)
• Viral cell culture lysates |
| Instrumentation
and Software | Unchanged | • Real-time PCR
instrumentation and
software |
6
7
Establishment of Performance Characteristics
Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.
Analytical Limit of Detection (LoD)
The limit of detection for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set was determined through an analytical sensitivity study.
Analytical Sensitivity and Specificity
Inquiries regarding performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.
Clinical Performance
Inquiries regarding clinical performance characteristics for the Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set should be directed to the Centers for Disease Control and Prevention.