(31 days)
The Alere™ i Influenza A & B assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection and discrimination of influenza A and B viral RNA in direct nasal or nasopharyngeal swabs eluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the differential diagnosis of influenza A and B viral infections in conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenza C virus.
Negative results do not preciude influenza virus infection and should not be used as the sole basis for diagnosis, treatment or other patient management decisions.
Performance characteristics for influenza A were established during the 2012-2013 and the 2014-2015 influenza seasons when influenza A/H1N1 pandemic were the predominant influenza A viruses in circulation. When other influenza A viruses are emerging, performance characteristics may vary.
If infection with a novel influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions for novel virulent Influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
Alere™ i Strep A is a rapid, instrument-based, molecular in vitro diagnostic test utilizing isothermal nucleic acid amplification technology for the qualitative detection of Streptococcus progeness, Group A Streptococcus bacterial nucleic acid in throat swab specimens obtained from patients with signs and symptoms of pharyngitis. It is intended to aid in the rapid diagnosis of Group A Streptococcus bacterial infections.
All negative test results should be confirmed by bacterial culture because negative results do not preclude infection with Group A Streptococcus and should not be used as the sole basis for treatment.
The Alere™ i RSV assay performed on the Alere™ i Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology for the qualitative detection of respiratory syncytial virus (RSV) virus (RSV) virus (RSV) virus (RSV) virus (RSV) viral RNA in direct nasopharyngeal swabs and nasopharyngeal swabs cluted in viral transport media from patients with signs and symptoms of respiratory infection. It is intended for use as an aid in the diagnosis of RSV in children
Alere™ i Influenza A & B is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal or nasopharyngeal swab specimens eluted in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.
Alere™ i Strep A is a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens.
Alere™ i RSV is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of respiratory syncytial virus (RSV) viral RNA from direct nasopharyngeal swab (NPS) and NPS eluted in viral transport media from patients with signs and symptoms of respiratory infection.
Alere™ i Influenza A & B 2 is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B from nasal swab or nasopharyngeal swabs tested directly or after elution in viral transport media collected from patients presenting with signs and symptoms of respiratory infection.
All Alere™ i assays utilize isothermal nucleic acid amplification technology and are comprised of:
- Sample Receiver single use, disposable containing the elution buffer .
- . Test Base - single use, disposable comprising two sealed reaction tubes, each containing a lyophilized pellet
- Transfer Cartridge sinqle use, disposable for transfer of the eluted sample to the Test Base, and ●
- Alere™ i Instrument repeat use reader .
The reaction tubes in the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 Test Base contain the reaqents required for amplification of the target nucleic acid and an internal control. Alere™ i Influenza A & B utilizes a pair of templates (similar to primers) for the specific amplification of RNA from influenza A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.
The reaction tubes in the Alere™ i Strep A Test Base contain the reagents required for Group A Strep bacterial lysis and the subsequent amplification of the target nucleic acid and an internal control. Alere™ i Strep A utilizes a pair of templates (similar to primers) for the specific amplification of DNA from Group A Strep and a fluorescently labeled molecular beacon designed to specifically identify the amplified nucleic acid target.
The reaction tubes in the Alere™ i RSV Test Base contain the reagents required for amplification of the target nucleic acid and an internal control. Alere™ i RSV utilizes a pair of templates (similar to primers) for the specific amplification of RNA from RSV A and B and a fluorescently labeled molecular beacon designed to specifically identify the amplified RNA targets.
All Alere™ i assays are performed within the confinement of the Test Base, and no other part of the Alere™ i Instrument has contact with the sample during the amplification process. This reduces the risk of instrument contamination and sample carry-over between measurements.
To perform the assay, the Sample Receiver and Test Base are inserted into the Alere™ i Instrument and the elution buffer is automatically heated by the instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, resuspending the Iyophilized pellets contained within the Test Base and initiating bacterial lysis (for Alere™ i Strep A) and target amplification. Heating, mixing and detection by fluorescence is provided by the instrument, with results automatically reported.
Results are displayed by the Alere™ i Instrument and are also stored in an on-board archive and are assigned to a sample ID that has been entered into the Alere™ i Instrument by the operator, and the date/time the test was performed. Data can be retrieved and downloaded by the operator at any time after testing. An external Alere™ Universal Printer can be attached via USB to the Alere™ i Instrument to print test results.
This document describes a Special 510(k) submission for the Alere™ i Instrument and its associated assays (Influenza A & B, Strep A, RSV, and Influenza A & B 2). The purpose of this submission is to address a software modification to the Alere™ i Instrument's algorithm to mitigate issues with false invalid results due to baseline values being lower than allowed, which were incorrectly identified as "Empty Tube Values." The submission states that there have been no changes made to the chemistry of the assays.
The document highlights the substantial equivalence of the modified devices to their legally marketed predicate devices. However, it does not contain specific acceptance criteria or detailed study data to prove the device meets these criteria. Instead, it focuses on comparing the modified devices with their predicates, stating that all parameters (FDA Product Code, Assay Target, Intended Use, Intended Environment for Use, Instrumentation, Sample Type, Viral/Bacterial Target, Technology, Internal Control, Result Interpretation, Assay Result, and Time to Result) are "Same" as the predicate devices.
Given the information provided, it is not possible to complete a table of acceptance criteria and reported device performance, nor can we detail the study that proves the device meets the acceptance criteria, as this specific information is not present in the provided text. The document asserts "substantial equivalence" based on the described software modification and the consistency of other parameters with the predicate devices.
Therefore, the following information can be extracted or derived based on the provided text, with many fields remaining unascertainable:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states that the modified devices are "substantially equivalent" to their predicate devices and lists various parameters which are "Same" as the predicates. No specific numerical acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) are detailed for the modified device or its predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The submission focuses on the software modification and states that no changes were made to the assay chemistry. It does not describe any new clinical studies or test sets with sample sizes for the modified device to demonstrate its performance against new acceptance criteria. It refers to historical performance characteristics for influenza A established during certain influenza seasons for the Alere™ i Influenza A & B and Alere™ i Influenza A & B 2 assays.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. As there is no description of a new clinical study with a test set and ground truth establishment, these details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable. The device is an in vitro diagnostic test for detecting viral/bacterial RNA/DNA, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The device is described as an "instrument-based, molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology" with "automated" result interpretation. This implies a standalone (algorithm only) performance, i.e., without human-in-the-loop performance influencing the assay result. However, specific standalone performance study details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For the original performance characteristics mentioned for the influenza assays, it can be inferred that the ground truth would have been established by a reference method for detecting viral RNA, likely PCR or viral culture, rather than expert consensus or pathology in the context of an IVD. However, the document does not explicitly state the ground truth used for performance characteristics, nor does it detail ground truth for any new studies related to the software modification.
8. The sample size for the training set:
This information is not provided in the document. Since this is a software modification to an existing algorithm for an IVD, it's possible the "training set" concept as used in AI/ML might not directly apply, or details about algorithm development data are not included.
9. How the ground truth for the training set was established:
This information is not provided in the document.
In summary, the provided document is a 510(k) summary for a software modification to existing IVD devices, asserting substantial equivalence to predicates without detailing new clinical studies, acceptance criteria, or performance data for the modified device.
§ 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.