(22 days)
The Influenza B Lineage Genotyping Kit contains reagents and controls of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel and is intended for use in real-time RT-PCR (rRT-PCR) assays on an Applied Biosystems (ABI) 7500 Fast Dx Real Time PCR Instrument in conjunction with clinical and epidemiological information:
- For determination of the genetic lineage of human influenza B viruses as B/Victoria or B/Yamagata lineage from viral RNA in upper respiratory tract clinical specimens (including nasopharyngeal swabs [NPS], nasal swabs [NS], throat swabs [TS], nasal aspirates [NA], nasal washes [NW] and dual nasopharyngeal/throat swabs [NPS/TS]) from human patients with signs and symptoms of respiratory infection and/or from viral culture:
- To provide epidemiologic information for surveillance of circulating influenza viruses.
Performance characteristics for influenza B lineage genotyping were established during a season when influenza B/Victoria and B/Yamagata lineages were found in approximately equal proportion.
Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other patient management decisions. Conversely, positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.
All users, analysts, and any person reporting results from use of this device should be trained to perform and interpret the results from this procedure by a competent instructor prior to use. CDC Influenza Division will limit the distribution of this device to only those users who have successfully completed a training course provided by CDC instructors or designees.
The Influenza B Lineage Genotyping Kit contains components of the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel that is used in real-time RT-PCR (rRT-PCR) assays on the ABI 7500 Fast Dx Real-Time PCR Instrument. The Influenza B Lineage Genotyping Kit consists of oligonucleotide primers and dual-labeled hydrolysis (TaqMan®) probes to be used in rRT-PCR for the in vitro qualitative detection and characterization of human influenza viruses from viral RNA in respiratory specimens from patients presenting with influenza-like illness (ILI). The Influenza B Lineage Genotyping Kit is based on technology which is used in many molecular diagnostic assays.
This is an interesting case where the submission is a "New Special 510(k)" for a labeling change only. This means that no new performance studies were conducted, as the technological attributes of the device itself were not altered. The entire submission focuses on establishing substantial equivalence to the predicate device based on this labeling change.
Therefore, the typical acceptance criteria and study data related to device performance in detecting influenza B lineages are not present in this document. Instead, the "acceptance criteria" here implicitly refer to the FDA's acceptance of the labeling changes and the conclusion of substantial equivalence.
Given this, I will answer the questions based on the information available and clarify where specific data (like sample sizes for performance studies) are not applicable or not provided due to the nature of this submission.
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission (K140857) is a "New Special 510(k)" for the CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza B Lineage Genotyping Kit. The submission states that the proposed changes are for labeling purposes only and will not alter the technological attributes of the device. Consequently, no new performance studies were conducted or are presented in this document to demonstrate the device meets new acceptance criteria.
The acceptance criteria implicitly relate to the FDA's evaluation of the labeling changes and whether the modified kit remains substantially equivalent to the predicate device (K132508) based on these changes. The study proving the device meets this "acceptance criteria" is the analysis of substantial equivalence presented.
1. Table of Acceptance Criteria and Reported Device Performance:
Since this submission is for a labeling change only, there are no new quantitative acceptance criteria or device performance metrics reported for the Influenza B Lineage Genotyping Kit that are different from its predicate device. The "performance characteristics" mentioned in the Intended Use refer to those established for the original device (K132508) during a season when both B/Victoria and B/Yamagata lineages were prevalent.
| Acceptance Criteria (Implicit for Labeling Change) | Reported Device Performance (as established for predicate, implied for this device) |
|---|---|
| Maintain substantial equivalence to predicate device (K132508) | Declared substantially equivalent by FDA. |
| Labeling accurately reflects the intended use and technological characteristics of the device | Labeling modified to create a separate Package Insert for the Influenza B Lineage Genotyping Kit, retaining all required information. No new or increased risks identified. |
| No alteration to device's design or technological attributes | Confirmed by the submitter; no changes beyond labeling are proposed. |
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable. As this submission is for a labeling change only, no new test set was used, and no new performance data provenance is provided. The previous performance characteristics were established during a season when influenza B/Victoria and B/Yamagata lineages were approximately equally proportioned, but the specific sample size and geographic origin for that study are not detailed in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. No new test set for performance evaluation was involved in this labeling-only submission.
4. Adjudication Method for the Test Set:
Not applicable. No new test set for performance evaluation was involved in this labeling-only submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done as part of this submission. This submission focuses solely on a labeling change, not on evaluating the device's diagnostic performance or its improvement of human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
The device itself is a real-time RT-PCR diagnostic panel, which is a laboratory test, not an algorithm, and its performance is inherently standalone in the sense that the test provides a result. However, for diagnostic interpretation, the "Intended Use" explicitly states that the kit is used in conjunction with "clinical and epidemiological information," implying that the end result is interpreted by trained personnel. No new standalone performance studies were conducted for this specific 510(k) submission.
7. The Type of Ground Truth Used:
For the original performance characteristics of the predicate device (K132508), the ground truth for influenza B lineage genotyping would have been established through methods outside the scope of this document, typically through confirmatory laboratory methods such as gene sequencing or other validated reference assays. This submission does not provide new ground truth data.
8. The Sample Size for the Training Set:
Not applicable. This submission is for a labeling change only; therefore, no new training set was used or described.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No new training set was used or described in this labeling-only submission.
§ 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.