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510(k) Data Aggregation
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cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic
The cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System (cobas® Influenza A/B) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus and Influenza B virus RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of Influenza A and Influenza B in humans and is not intended to detect Influenza C.
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.
Performance characteristics for Influenza A were established when Influenza A/H1 and A/H3 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 BSL3+ facility is available to receive and culture specimens.
The cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System (cobas® Influenza A/B & RSV) is an automated multiplex real-time RT-PCR assay for the rapid in vitro qualitative detection and discrimination of Influenza A virus. Influenza B virus and respiratory syncytial virus (RSV) RNA in nasopharyngeal swab specimens from patients with signs and symptoms of respiratory infection in conjunction with clinical and epidemiological risk factors. The test is intended for use as an aid in the differential diagnosis of Influenza A. Influenza B. and RSV in humans and is not intended to detect Influenza C. Negative results do not preclude Influenza virus or RSV 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. Performance characteristics for Influenza A were established during the 2013-2014 and the 2014-2015 Influenza seasons when Influenza A/H3 and 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 BSL3+ facility is available to receive and culture specimens.
The cobas® Strep A nucleic acid test for use on the cobas® Liat® System (cobas® Strep A) is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes (Group A ß-hemolytic Streptococcus, Strep A) in throat swab specimens from patients with signs and symptoms of pharyngitis.
The cobas® Strep A assay utilizes nucleic acid purification and polymerase chain reaction (PCR) technology to detect Streptococcus pyogenes by targeting a segment of the Streptococcus pyogenes genome.
The cobas® Strep A Nucleic acid test for use on the cobas® Liat® System is intended for professional use in a clinical laboratory setting or point-of care (POC) location.
The cobas® Influenza A/B Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for qualitative detection and differentiation of Influenza type A and type B viral RNA. The assay is performed on the cobas® Liat® System. The system automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using real-time RT-PCR assays. The cobas® Liat® Analyzer consists of an instrument and preloaded software for running tests and viewing the results. The cobas® Liat® System consists of the analyzer and a single-use disposable cobas® Influenza A/B assay tube that holds the sample purification and RT-PCR reagents and hosts the sample preparation and RT-PCR processes. Other than adding the sample to the cobas® Influenza A/B assay tube, no reagent preparation or additional steps are required. Because each cobas® Influenza A/B assay tube is self-contained, cross-contamination between samples is minimized. Turnaround time for a test is 20 minutes.
The cobas® Liat® Influenza A/B & RSV Nucleic Acid Test for use on the cobas® Liat® System is an automated in vitro diagnostic test for the qualitative detection of Influenza B, and RSV RNA in nasopharyngeal swab (NPS) specimens. The sample-to-result time is ~20 minutes.
The assay is performed on the Analyzer which automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples using realtime PCR assays. The assay targets a well-conserved region of the matrix gene of Influenza A (Inf A target), the non-structure protein gene of Influenza B (Inf B target), and the matrix gene of RSV (RSV target). An Internal Process Control (IPC) is also included. The IPC is present to control for adequate processing of the target virus through all steps of the assay process and to monitor the presence of inhibitors in the RT-PCR reactions.
The System consists of an instrument and preloaded software for running tests and viewing the results. The system requires the use of a single-use disposable cobas® Influenza A/B & RSV assay tube that holds the nucleic acid purification and RT-PCR reagents, and hosts the sample preparation and RT-PCR processes.
The cobas® Strep Nucleic Acid Test for use on the cobas® Liat® System is a rapid, automated in vitro diagnostic test for the qualitative detection of Streptococcus pyogenes (Group A B -hemolytic Streptococcus, Strep A) DNA in throat swab specimens in Amies media.
The assay utilizes silica magnetic bead-based nucleic acid extraction, and TagMan probe-based real-time PCR amplification and detection. The assay targets a well-conserved region of the spy1258 gene of Strep A. An Internal Process Control (IPC) is also included. The IC is present to control for adequate processing of the target bacteria and to monitor the presence of inhibitors in the sample preparation and PCR.
The cobas® Liat® System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequence in biological samples. Other than adding the sample to the cobas® Strep A assay tube, no reagent preparation or additional steps are required.
The system consists of an instrument with integrated software for running tests and analyzing the results. The system requires the use of a single-use disposable cobas® Strep A assay tube that holds all the sample purification and PCR reagents and hosts the sample preparation and PCR processes.
The provided text describes three distinct devices:
- cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
- cobas® Strep A Nucleic acid test for use on the cobas® Liat® System
The submission K200065 is a 510(k) premarket notification for an update to the core software (Software 3.3) for these existing devices, rather than a new device or a new clinical study to establish primary performance. The key point is that the assay performance of each device was evaluated to ensure that the software changes did not impact the overall assay performance or claims when compared to the previously cleared software versions. Therefore, the provided document explicitly states that "analytical or clinical performance has not changed."
This means that the acceptance criteria and performance data for these devices were established in their original 510(k) submissions (K191729 for cobas Influenza A/B, K153544 for cobas Influenza A/B & RSV, and K141338 for cobas Strep A). The current submission (K200065) refers to these predicate devices for their performance characteristics.
Given this, I will extract the relevant performance data from the descriptions of the predicate devices as provided in the "Comparison of the... Assay with cobas® Liat® Analyzer Software 3.3 to the Predicate Device" tables for each assay.
1. cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System
1. Table of Acceptance Criteria and Reported Device Performance
None of the provided sections for the cobas® Influenza A/B test (pages 5-13) specify explicit acceptance criteria or numerical performance metrics for Influenza A/B, beyond stating its intended use for qualitative detection and discrimination. The comparison table (pages 9-10) focuses on technological characteristics and states "Same" for most items, including a clinical laboratory improvement amendments (CLIA) waiver (CW150003). The conclusion explicitly states that "Performance of the cobas® Influenza A/B assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version." This implies that the performance as established in K191729 is maintained. However, the specific metrics from K191729 are not detailed in this document.
2. Sample size used for the test set and the data provenance
Not provided in this document as it refers to prior clearance (K191729). The current submission is for a software update, and performance was "evaluated" to ensure no impact.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this software update.
4. Adjudication method for the test set
Not applicable/provided for this software update.
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
Not applicable. This is a nucleic acid test, not an imaging AI diagnostic.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an automated in vitro diagnostic test, which inherently operates in a standalone manner. The results are output on a screen.
7. The type of ground truth used
Not detailed as this submission is for a software update. The original K191729 likely used a reference method (e.g., culture or another FDA-cleared molecular assay) as the ground truth.
8. The sample size for the training set
Not applicable/provided as this is a software update for an existing assay.
9. How the ground truth for the training set was established
Not applicable/provided.
2. cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (pages 14-22) does not specify explicit numerical acceptance criteria for sensitivity or specificity for Flu A, Flu B, or RSV. However, it lists several performance characteristics from the predicate device (K153544) that were confirmed to be unchanged by the software update.
| Performance Characteristic | Reported Performance (from Predicate Device K153544) | Acceptance Criteria (Implied: Must remain "Same" as predicate) |
|---|---|---|
| Limit of Detection | $10^{-3} - 10^{-1}$ TCID50/mL | Must be maintained |
| Reactivity | Reactive against 28 Flu A, 15 Flu B, and 7 RSV strains tested | Must be maintained |
| Cross Reactivity | 35 microorganisms and human genomic DNA tested. No cross reactivity found. | Must be maintained |
| Interfering Microorganisms | 35 microorganisms and human genomic DNA tested. No effect on detection found. | Must be maintained |
| Interfering Substances | 10 substances tested. No effect on detection found. | Must be maintained |
| Reproducibility | ≥99.8% total percent agreement | Must be maintained |
Study Proving Device Meets Acceptance Criteria:
The document states: "Performance of the cobas® Influenza A/B & RSV assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Influenza A/B & RSV assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version." (page 21). This evaluation confirms that the modified device (with Software 3.3) maintains the performance characteristics established by the predicate device (K153544). Specific details of this evaluation (e.g., sample size, specific tests) are not provided in this summary.
2. Sample size used for the test set and the data provenance
The document does not detail the sample size or provenance for the evaluation performed for this software update (K200065). These details would have been part of the original K153544 submission. For the current submission, a "performance evaluation" was conducted to ensure no impact from the software changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this software update.
4. Adjudication method for the test set
Not applicable/provided for this software update.
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
Not applicable. This is a nucleic acid test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is an automated in vitro diagnostic test, operating in a standalone manner with results displayed directly to the user.
7. The type of ground truth used
Not detailed in this document. For the original K153544, it would have been a reference method such as viral culture or another FDA-cleared molecular assay.
8. The sample size for the training set
Not applicable/provided.
9. How the ground truth for the training set was established
Not applicable/provided.
3. cobas® Strep A Nucleic acid test for use on the cobas® Liat® System
1. Table of Acceptance Criteria and Reported Device Performance
The provided text (pages 23-30) does not specify explicit numerical acceptance criteria for sensitivity or specificity for Strep A. However, it lists several performance characteristics from the predicate device (K141338) that were confirmed to be unchanged by the software update.
| Performance Characteristic | Reported Performance (from Predicate Device K141338) | Acceptance Criteria (Implied: Must remain "Same" as predicate) |
|---|---|---|
| Limit of Detection | $100 – 101$ CFU per test | Must be maintained |
| Reactivity | Reactive against 9 Strep A strains tested | Must be maintained |
| Cross Reactivity | 63 human pathogens tested (13 other Streptococcus, 42 other bacteria, 8 viruses). No cross reactivity found. | Must be maintained |
| Interfering Microorganisms | 63 human pathogens tested. No effect on detection. | Must be maintained |
| Interfering Substances | 28 substances at medically and/or physiologically relevant concentrations at near LOD. No effect on detection. | Must be maintained |
| Sensitivity | 98.5% (95% CI: 95.6% – 99.5%) | Must be maintained |
| Specificity | 94.2% (95% CI: 91.6 - 96.1%) | Must be maintained |
Study Proving Device Meets Acceptance Criteria:
The document states: "Performance of the cobas® Strep A assay with cobas® Liat® Analyzer Software 3.3 was evaluated. The result of this evaluation determined that the overall cobas® Strep A assay performance and claims were not impacted by changes implemented in cobas® Liat® Analyzer Software 3.3, when compared to the current commercially available core software version." (page 29). This evaluation confirms that the modified device (with Software 3.3) maintains the performance characteristics established by the predicate device (K141338). Specific details of this evaluation (e.g., sample size, specific tests) are not provided in this summary.
2. Sample size used for the test set and the data provenance
The document does not detail the sample size or provenance for the evaluation performed for this software update (K200065). These details would have been part of the original K141338 submission. For the current submission, a "performance evaluation" was conducted to ensure no impact from the software changes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided for this software update.
4. Adjudication method for the test set
Not applicable/provided for this software update.
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
Not applicable. This is a nucleic acid test.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is an automated in vitro diagnostic test, operating in a standalone manner with results displayed directly to the user.
7. The type of ground truth used
Not detailed in this document. For the original K141338, it would have been a reference method such as bacterial culture or another FDA-cleared molecular assay.
8. The sample size for the training set
Not applicable/provided.
9. How the ground truth for the training set was established
Not applicable/provided.
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