Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

K221834 · Centers for Disease Control and Prevention · PBK · Jun 24, 2022 · Microbiology

Device Facts

• Record ID: K221834
• Device Name: Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set
• Applicant: Centers for Disease Control and Prevention
• Product Code: PBK · Microbiology
• Decision Date: Jun 24, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.3315
• Device Class: Class 2

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 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 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.

Device Story

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set; in vitro diagnostic device; utilizes real-time PCR technology for detection of non-variola orthopoxvirus nucleic acids; intended for use by laboratory professionals; modification involves updated extraction procedures and assay labeling; output provides qualitative detection of viral genetic material; assists clinicians in diagnosis of orthopoxvirus infections.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design control activities, risk analysis, and verification of modifications to extraction procedures and labeling.

Technological Characteristics

Real-time PCR primer and probe set. Principle: Nucleic acid amplification and fluorescent probe detection. Requires real-time PCR instrumentation and associated software. Intended for use in CDC-designated laboratories.

Indications for Use

Indicated for the detection of non-variola orthopoxviruses using nucleic acid-based reagents.

Regulatory Classification

Identification

In vitro qualitative detection of non-variola Orthopoxvirus nucleic acids extracted from human specimens or viral culture.

Predicate Devices

• Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set (K221834)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K221834

B Applicant

Centers For Disease Control And Prevention

C Proprietary and Established Names

Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PBK | Class II | 21 CFR 866.3315 - Nucleic Acid Based Reagents For Detection Of Non-Variola Orthopoxviruses | MI - Microbiology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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3. A description of the device **MODIFICATION(S)**, including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the **FUNDAMENTAL SCIENTIFIC TECHNOLOGY** of the modified device has not changed. This change was for modifications to an extraction procedure and modifications to assay labeling regarding test distribution.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared device.

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