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Copan Universal Transport Medium (UTM-RT) System is intended for the collection and transport of clinical specimen containing viruses, chlamydiae, mycoplasma or ureaplasma from the to the testing laboratory. UTM-RT can be processed using standard clinical laboratory operating procedures for viral, chlamydial, mycoplasma and ureaplasma culture.

UTM-RT is intended for the stabilization and transportation of an unprocessed upper respiratory clinical specimen suspected of containing respiratory viruses' nucleic acids. UTM-RT is intended for use with compatible molecular assays.

Copan Universal Transport Medium (UTM-RT®) System is composed of a tube with 3mL of UTM-RT® transport medium, which may be supplied in bulk or as a kit with a sterile specimen collection flocked swab. UTM-RT® medium is designed to maintain viability of viruses, chlamydiae, mycoplasma or ureaplasma during transport from the collection site to the testing laboratory for subsequent culture and to maintain the integrity of respiratory viruses' nucleic acids for testing with a compatible molecular assay.

The provided text is for a 510(k) premarket notification for a medical device called "Copan Universal Transport Medium (UTM-RT) System". This type of document describes the device, its intended use, and comparative performance data against a predicate device to demonstrate substantial equivalence, rather than a clinical trial or study in the traditional sense involving human readers or sophisticated AI algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/machine learning device is not fully applicable here. This document focuses on the stability and preservation of viral nucleic acids in a transport medium.

However, I can extract the relevant "acceptance criteria" and "study" details as they pertain to the chemical and biological stability performance of the transport medium, which is the device in question.

Here's the breakdown of the information as it relates to the device's performance in preserving viral nucleic acids:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The performance and stability study was conducted using specific "sets" of UTM-RT® lots.
  • Lot Ages: Lots within one-to-four months of manufacture ("Freshly produced (new)"), lots approximately a year after manufacture ("Middle-Aged"), and lots aged beyond 18 months ("Old/Expired").
  • Lot Age Ranges: New (0.8–4.2 months), Middle-aged (11.1-13.5 months), Old/Expired (18.7-22.7 months).
  • Test Setup: For each UTM-RT® lot and ATCC strain of representative respiratory viruses (Influenza A, Influenza B, Respiratory Syncytial virus), 5 replicates were tested at each time point.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a premarket notification for a CE-marked device originating from Italy, the studies were likely conducted by the manufacturer. It appears to be a prospective experimental study conducted in a lab setting rather than real-world clinical data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This information is not applicable to this type of device and study. The "ground truth" for this study is not established by human experts in the sense of image interpretation or diagnostic performance. Instead, it's based on objective molecular assay results (Ct values) indicating viral nucleic acid presence and stability.

4. Adjudication Method for the Test Set

• Not applicable. This is not a study requiring human adjudication. The results are quantitative (Ct values) and objectively measured by the Xpert® Xpress CoV-2/Flu/RSV plus assay.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is not relevant for this device, which is a transport medium, not an AI or imaging diagnostic device that human readers interact with.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a transport medium. The "performance" is its ability to preserve nucleic acids, measured by a molecular assay, not an algorithm's standalone diagnostic capability.

7. The Type of Ground Truth Used

• The "ground truth" for the performance and stability study was established by molecular assay results (Ct values) from a reference molecular diagnostic test (Xpert® Xpress CoV-2/Flu/RSV plus assay) on known ATCC strains of viruses. This acts as an objective measure of the integrity and concentration of viral nucleic acids, which is the performance characteristic being evaluated.

8. The Sample Size for the Training Set

• Not applicable. This document describes the validation of a physical transport medium, not an AI/machine learning model that would require a "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable, as there is no "training set" for this device.

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The Cepheid Xpert Flu/RSV XC Assay is an automated, multiplex real-time, reverse transcriptase polymerase chain reaction (RT-PCR) assay intended for the in vitro qualitative detection and differentiation of influenza B, and respiratory syncytial virus (RSV) viral RNA. The Xpert Flu/RSV XC Assay uses nasopharyngeal swab and nasal aspirate/wash specimens collected from patients with signs and symptoms of respiratory infection. The Xpert Flu/RSV XC Assay is intended as an aid in the diagnosis of influenza and respiratory syncytial virus infections in conjunction with clinical and epidemiological risk factors.

Negative results do not preclude influenza virus or respiratory syncytial virus infection and should not be used as the sole basis for treatment or other patient management decisions.

Performance characteristics for influenza A were established during the 2013-2014 influenza season. When other novel 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.

The Xpert Flu/RSV XC Assay is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of influenza A. influenza B, and respiratory syncytial virus (RSV). The assay is performed on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx systems and GeneXpert Infinity Systems). The GeneXpert Instrument System platform automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in simple or complex samples using real-time PCR and reverse transcriptase PCR (RT-PCR) assays. The systems require the use of singleuse disposable cartridges (the Xpert Flu/RSV XC cartridges) that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized.

The Xpert Flu/RSV XC Assay includes reagents for the detection and differentiation of influenza A, influenza B, and RSV viral RNA directly from nasopharyngeal (NP) swab and nasal aspirate/wash (NA/W) specimens collected from patients with signs and symptoms of respiratory infection. A Sample Processing Control (SPC) and a Probe Check Control (PCC) are also included in the cartridge. The SPC is present to control for adequate processing of the target viruses and to monitor the presence of inhibitors in the PCR reaction. The Probe Check Control (PCC) verifies reagent rehydration, PCR tube filling in the cartridge, probe integrity and dye stability.

The single-use, multi-chambered fluidic cartridges are designed to complete sample preparation and real-time RT-PCR for detection and differentiation of influenza A, influenza B and RSV viral RNA in approximately 60 minutes or less. The GeneXpert Instrument Systems, comprised of the GeneXpert Dx Systems and the GeneXpert Infinity Systems, have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), an ultrasonic horn for lysing cells or spores, and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection.

Specimens are collected following the user's institution standard procedures for collecting NA/W specimens and NP swab specimens for influenza and RSV testing. The ancillary Cepheid Xpert Nasopharyngeal Sample Collection Kit (Cepheid catalog #SWAB/B-100) or Cepheid's Sample Collection Kit (Cepheid catalog #NASL-100N-100) are required but not provided for use with the assay. Both kits contain the identical viral transport medium and sterile nylon flocked swab. The NA/W specimen or the NP swab specimen is placed into the Xpert viral transport medium and sent to the GeneXpert® testing area for processing. When stored in the transport medium, the NA/W specimen or NP swab specimen is stable for up to 24 hours at 2-30 ℃ or up to seven days at 2-8 ℃. When ready to test the specimen, the user briefly mixes the specimen by inverting the tube five times, transfers the eluted material to the sample chamber in the top of the disposable fluidic cartridge. The user initiates a test from the system user interface and places the cartridge into the GeneXpert instrument platform, which performs hands-off real-time, multiplex polymerase chain reaction (PCR) for detection of RNA. The results are automatically generated at the end of the process in a report that can be viewed and printed.

Here's an analysis of the provided text, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the clinical performance in terms of specific PPA/NPA thresholds that had to be met for clearance. It presents the performance of the device and claims substantial equivalence to predicate devices. However, we can infer the desired performance from the presented data and the implicit expectation for a diagnostic assay to perform well. The analytical studies (LoD, specificity, inclusivity) demonstrate performance against well-defined criteria.

Inferred Clinical Acceptance Criteria (Based on Comparator Performance and FDA Clearance): The device's performance (PPA and NPA) should be demonstrably similar to or better than previously cleared predicate devices, with high positive and negative agreement. While no explicit thresholds like "PPA > X%" are stated for clinical studies, the demonstration of high agreement values and the claim of "substantially equivalent" implies these levels were considered acceptable by the FDA.

2. Sample Sizes and Data Provenance

• Test Set (Clinical Comparison Study):

  • NA/W Specimens: 657 total (581 fresh, prospectively collected; 76 frozen, archived).
  • NP Swab Specimens: 593 total (190 fresh, prospectively collected; 403 frozen, archived).
  • Data Provenance: United States (six institutions), conducted during the 2013-2014 influenza season. Both retrospective (frozen, archived specimens) and prospective (fresh, prospectively collected) data were used.

• Reproducibility Study Test Set (a subset of samples with varying concentrations): 10 specimens (dilution panel) * 1 time/day * 10 days * 2 operators * 3 sites = 600 total qualitative results.

• Instrument System Precision Study Test Set (a subset of samples with varying concentrations): 10 specimens (dilution panel) * 2 times/day * 12 days * 2 operators * 2 instrument systems = 960 total qualitative results.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not specify the number of experts or their qualifications for establishing the ground truth during the clinical comparison study. It states that the Xpert Flu/RSV XC Assay performance was compared to a "FDA-cleared comparator assay." This implies the comparator assay's results were considered the ground truth, rather than independent expert adjudication.

4. Adjudication Method for the Test Set

• The primary method for establishing the ground truth for the clinical comparison study was comparison against an FDA-cleared comparator assay.
• Discordant results between the Xpert Flu/RSV XC Assay and the comparator assay were further analyzed by sequencing using primers different from those used in the Xpert Flu/RSV XC Assay. This serves as an adjudication method to determine the "true" status of discordant samples.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. This study evaluates the device's standalone performance compared to a predicate device, not the improvement in human reader performance with AI assistance. The device is a fully automated diagnostic assay, not an AI-assisted diagnostic tool requiring human interpretation.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The entire clinical comparison study (NA/W and NP Swab specimens) evaluates the performance of the Xpert Flu/RSV XC Assay algorithm only (as it is a fully automated system) compared to a predicate FDA-cleared assay. The results in Tables 5-12 and 5-13 represent this standalone performance.

7. Type of Ground Truth Used

• For Analytical Studies (LoD, specificity, inclusivity): Known concentrations of cultured viral, bacterial, and yeast strains (measured in TCID50/mL or CFU/mL). For avian influenza A, purified viral RNA was used due to biosafety regulations.
• For Clinical Comparison Studies: Results from an FDA-cleared comparator assay, with bi-directional sequencing for discordant results. This is a form of expert reference method.

8. Sample Size for the Training Set

The document does not specify a training set size or how the device was developed. As this is an in vitro diagnostic (IVD) assay based on RT-PCR, it relies on precisely designed primers and probes, rather than machine learning models that require explicit training sets in the same way an AI device would. The "development" process would involve iterative design and testing of these components based on known viral genetic sequences, rather than a quantifiable "training set" in the context of AI/ML.

9. How Ground Truth for the Training Set was Established

As noted above, a distinct "training set" in the AI/ML sense is not described. The ground truth for the design of the assay's primers and probes would be based on known genetic sequences of influenza A, influenza B, and RSV from public databases and clinical isolates, ensuring broad reactivity and specificity. This is intrinsic to the design of nucleic acid amplification tests.

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