FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The OlAstat-Dx Respiratory Panel Mini is a multiplexed nucleic acid test intended for use with the OlAstat-Dx system for the simultaneous in vitro qualitative detection of multiple respiratory viral nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals with clinical signs and symptoms of respiratory tract infections, including Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2).

The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza B. Respiratory Syncytial Virus, Human Rhinovirus, and SARS-CoV-2.

Nucleic acids from viral organisms identified by this test are generally detectable in NPS specimens during the acute phase of infection. Detecting and identifying specific viral nucleic acids from individuals presenting with signs and symptoms of a respiratory infection aids in the diagnosis of respiratory infection, if used in conjunction with other clinical, epidemiological and laboratory findings. The results of this test should not be used as for diagnosis, treatment or other patient management decisions.

Negative results in the presence of a respiratory illness may be due to infection with pathogens that are not detected by the test or due to lower respiratory tract infection that is not detected by a NPS specimen.

Conversely, positive results are indicative of the identified microorganism, but do not rule out co-infection with other pathogens not detected by the QlAstat-Dx Respiratory Panel Mini. The agent(s) detected by the QlAstat-Dx Respiratory Panel Mini may not be the definite cause of disease.

The use of additional laboratory testing (e.g., bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection.

Device Description

The QIAstat-Dx Respiratory Panel Mini (Cat. no. 691218) assay is a modified device (reduced version) of the QIAstat-Dx Respiratory Panel Plus (Cat. no. 691224). The QIAstat-Dx Respiratory Panel Mini is identical to the QIAstat-Dx Respiratory Panel Plus (K233100) with the exception of the labeling and Assay Definition File (ADF), which masks all but five pathogens (targets) from the QIAstat-Dx Respiratory Panel Plus. The following viruses are identified using the OlAstat-Dx Respiratory Panel Mini: Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The OIAstat-Dx Respiratory Panel Mini is part of the QIAstat-Dx system and works with the QIAstat-Dx Analyzer 1.0.

The QIAstat-Dx Respiratory Panel Mini is intended to be used with I nasopharyngeal swab (NPS) eluted in Universal Transport Media (UTM), which is not provided with the QIAstat-Dx Respiratory Panel Mini.

Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 1 hour. When the test is finished, the cartridge is removed by the user and discarded. The QlAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen. The results can be printed using a connected printer if needed. The detected analytes are displayed in red. All other tested but not detected analytes are listed in green. The analyzer will report if an error occurs during processing, in which case the test will fail and no results will be provided (screen will show "FAIL").

All the reagents required for the complete execution of the test are pre-loaded and selfcontained in the QIAstat-Dx Respiratory Panel Mini cartridge. The user does not need to manipulate any reagents. During the test, reagents are handled by pneumatically-operated microfluidics without any direct contact with the user or the analyzer actuators.

Within the cartridge, multiple steps are automatically performed in sequence by using pneumatic pressure and a multiport valve to transfer sample and fluids via the Transfer Chamber (TC) to their intended destinations. Following the introduction of the sample from a disposable transfer pipette, the following assay steps occur automatically and sequentially:

Resuspension of Internal Control ●
Cell lysis using mechanical and/or chemical means ●
Membrane-based nucleic acid purification ●
. Mixing of the purified nucleic acid with lyophilized master mix reagents
Transfer of defined aliquots of eluate/master mix to different reaction chambers
Performance of multiplex real-time RT-PCR testing within each reaction chamber. ●

AI/ML Overview

The provided text describes the QIAstat-Dx Respiratory Panel Mini, a molecular diagnostic device, and its substantial equivalence to a predicate device (QIAstat-Dx Respiratory Panel Plus). However, the document does not contain specific acceptance criteria, detailed results of a study proving those criteria were met, or information on aspects like sample size, data provenance, expert ground truth establishment, or clinical study methods typically associated with AI/imaging device validation.

The text states that "The performance data for the QIAstat-Dx Respiratory Panel Mini is equivalent to the QIAstat-Dx Respiratory Panel Plus (K233100) with the exception it only includes data for the five analytes detected by the QIAstat-Dx Respiratory Panel Mini (Influenza A, Influenza B, Respiratory Syncytial Virus, Human Rhinovirus, and Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2). Please see the Qiagen QIAstat-Dx Respiratory Panel Mini Instructions for Use for performance tables." This indicates that the detailed performance data and acceptance criteria would be found in the device's Instructions for Use, which is not included in the provided document.

Therefore,Based on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail. The document primarily focuses on establishing substantial equivalence to a predicate device by noting that the "Mini" version is a "reduced version" of the "Plus" version, masking certain pathogens through a software update (Assay Definition File).

Here's what can be inferred and what is missing, based on your request and the provided text:

Inferences (based on typical diagnostic device clearance and the nature of the device):

Device Type: The QIAstat-Dx Respiratory Panel Mini is an in vitro diagnostic (IVD) device, specifically a multiplexed nucleic acid test. It detects viral nucleic acids (RNA/DNA) directly. This is not an AI-based imaging device, and therefore, many of the requested criteria (like number of experts, MRMC studies, human reader improvement with AI, etc.) are not applicable to this type of device.
Acceptance Criteria (Implied): For a molecular diagnostic test, acceptance criteria typically revolve around metrics like:
- Sensitivity: The ability of the test to correctly identify positive samples (true positive rate).
- Specificity: The ability of the test to correctly identify negative samples (true negative rate).
- Limit of Detection (LoD): The lowest concentration of an analyte that can be reliably detected.
- Cross-reactivity: Ensuring the test does not falsely detect non-target organisms.
- Reproducibility/Precision: Consistency of results when tested multiple times under various conditions.
- Interference: Lack of impact from common substances found in clinical samples.
  The text states the performance is "equivalent" to the predicate, implying these types of criteria were met.
Study Proving Acceptance Criteria: The study would be a clinical performance study and potentially analytical performance studies comparing the device's results against a known reference method or clinical consensus. The document references the "Instructions for Use for performance tables," which would contain these details.

Addressing Your Specific Points (based only on the provided text):

A table of acceptance criteria and the reported device performance:
- Not provided in the text. The text refers to the "Instructions for Use for performance tables" for this information.
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided in the text.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for this type of molecular diagnostic device in the same way it would be for an AI-based imaging device. Ground truth for molecular tests is typically established through a combination of:
  - Reference molecular methods: Highly sensitive and specific laboratory-developed tests or other cleared/approved molecular tests.
  - Clinical diagnosis: A combination of patient signs, symptoms, clinical course, and results from other diagnostic tests.
  - Culture: For some pathogens, though molecular tests often have higher sensitivity.
- The document implies ground truth was established to demonstrate "equivalence" of the five remaining analytes, but no specifics are given.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not provided. This is relevant for subjective assessments like imaging interpretation. For molecular diagnostics, discrepancies are typically resolved through re-testing, using an orthogonal method, or clinical correlation.
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:
- No, this was not done. This is an IVD device, not an AI-assisted imaging device. Human "readers" (interpreters) are not involved in the direct output of this automated molecular test; results are automatically interpreted by the analyzer.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in spirit. A molecular diagnostic test like this is inherently a "standalone" algorithm in a lab setting. The device automatically processes the sample and interprets results. While lab personnel initiate the test and retrieve results, there isn't a "human-in-the-loop" subjective interpretation component as there would be with an AI imaging system. The performance of the device is what's evaluated.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in the provided text. For molecular diagnostics, ground truth often involves a combination of:
  - Comparator molecular methods (e.g., PCR assays with known performance).
  - Clinical diagnosis and follow-up (for some studies).
  - Sequencing (for definitive identification of viral strains).
The sample size for the training set:
- Not provided in the text. This device isn't explicitly described as having a "training set" in the context of an AI model that learns from large datasets. It's a biochemical/molecular assay with a fixed set of reactions and an "Assay Definition File (ADF)" that controls which stored results are displayed. The "training" would be more akin to assay development and optimization, rather than machine learning training.
How the ground truth for the training set was established:
- No "training set" for an AI model is described. Assay development and optimization would rely on characterized positive and negative control materials, and potentially spiked samples, to establish performance parameters.

Summary of what the document does tell us about the "study":

The core of the documentation provided is a claim of substantial equivalence (510(k) clearance) based on the QIAstat-Dx Respiratory Panel Mini being a modified version of a previously cleared device, the QIAstat-Dx Respiratory Panel Plus (K233100).

Modification: The "Mini" version is simply the "Plus" version with a software change (Assay Definition File - ADF) that masks the results for all but five specific pathogens.
Proof: The manufacturer validated and verified this software change to demonstrate "there is no change in safety and effectiveness" for the five remaining analytes compared to their performance on the predicate device. This means the underlying assay chemistry and detection capabilities for those five analytates are presumed to be identical.
Conclusion: Because the underlying technology and performance characteristics for the detected analytes are identical to a previously cleared device, and the only change is the masking of additional targets, the FDA determined Substantial Equivalence without requiring a full de novo performance study for the entire device. Performance data for the five analytes from the predicate device's clearance would implicitly serve as the basis for the "Mini" version.

Summary

Regulation Number and Section

§ 866.3981 Device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test.

(a)
Identification. A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device intended for the detection and identification of SARS-CoV-2 and other microbial agents when in a multi-target test in human clinical respiratory specimens from patients suspected of respiratory infection who are at risk for exposure or who may have been exposed to these agents. The device is intended to aid in the diagnosis of respiratory infection in conjunction with other clinical, epidemiologic, and laboratory data or other risk factors.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The intended use in the labeling required under § 809.10 of this chapter must include a description of the following: Analytes and targets the device detects and identifies, the specimen types tested, the results provided to the user, the clinical indications for which the test is to be used, the specific intended population(s), the intended use locations including testing location(s) where the device is to be used (if applicable), and other conditions of use as appropriate.
(2) Any sample collection device used must be FDA-cleared, -approved, or -classified as 510(k) exempt (standalone or as part of a test system) for the collection of specimen types claimed by this device; alternatively, the sample collection device must be cleared in a premarket submission as a part of this device.
(3) The labeling required under § 809.10(b) of this chapter must include:
(i) A detailed device description, including reagents, instruments, ancillary materials, all control elements, and a detailed explanation of the methodology, including all pre-analytical methods for processing of specimens;
(ii) Detailed descriptions of the performance characteristics of the device for each specimen type claimed in the intended use based on analytical studies including the following, as applicable: Limit of Detection, inclusivity, cross-reactivity, interfering substances, competitive inhibition, carryover/cross contamination, specimen stability, precision, reproducibility, and clinical studies;
(iii) Detailed descriptions of the test procedure(s), the interpretation of test results for clinical specimens, and acceptance criteria for any quality control testing;
(iv) A warning statement that viral culture should not be attempted in cases of positive results for SARS-CoV-2 and/or any similar microbial agents unless a facility with an appropriate level of laboratory biosafety (
e.g., BSL 3 and BSL 3+, etc.) is available to receive and culture specimens; and(v) A prominent statement that device performance has not been established for specimens collected from individuals not identified in the intended use population (
e.g., when applicable, that device performance has not been established in individuals without signs or symptoms of respiratory infection).(vi) Limiting statements that indicate that:
(A) A negative test result does not preclude the possibility of infection;
(B) The test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician;
(C) There is a risk of incorrect results due to the presence of nucleic acid sequence variants in the targeted pathogens;
(D) That positive and negative predictive values are highly dependent on prevalence;
(E) Accurate results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results; and
(F) When applicable (
e.g., recommended by the Centers for Disease Control and Prevention, by current well-accepted clinical guidelines, or by published peer-reviewed literature), that the clinical performance may be affected by testing a specific clinical subpopulation or for a specific claimed specimen type.(4) Design verification and validation must include:
(i) Detailed documentation, including performance results, from a clinical study that includes prospective (sequential) samples for each claimed specimen type and, as appropriate, additional characterized clinical samples. The clinical study must be performed on a study population consistent with the intended use population and compare the device performance to results obtained using a comparator that FDA has determined is appropriate. Detailed documentation must include the clinical study protocol (including a predefined statistical analysis plan), study report, testing results, and results of all statistical analyses.
(ii) Risk analysis and documentation demonstrating how risk control measures are implemented to address device system hazards, such as Failure Modes Effects Analysis and/or Hazard Analysis. This documentation must include a detailed description of a protocol (including all procedures and methods) for the continuous monitoring, identification, and handling of genetic mutations and/or novel respiratory pathogen isolates or strains (
e.g., regular review of published literature and periodic in silico analysis of target sequences to detect possible mismatches). All results of this protocol, including any findings, must be documented and must include any additional data analysis that is requested by FDA in response to any performance concerns identified under this section or identified by FDA during routine evaluation. Additionally, if requested by FDA, these evaluations must be submitted to FDA for FDA review within 48 hours of the request. Results that are reasonably interpreted to support the conclusion that novel respiratory pathogen strains or isolates impact the stated expected performance of the device must be sent to FDA immediately.(iii) A detailed description of the identity, phylogenetic relationship, and other recognized characterization of the respiratory pathogen(s) that the device is designed to detect. In addition, detailed documentation describing how to interpret the device results and other measures that might be needed for a laboratory diagnosis of respiratory infection.
(iv) A detailed device description, including device components, ancillary reagents required but not provided, and a detailed explanation of the methodology, including molecular target(s) for each analyte, design of target detection reagents, rationale for target selection, limiting factors of the device (
e.g., saturation level of hybridization and maximum amplification and detection cycle number, etc.), internal and external controls, and computational path from collected raw data to reported result (e.g., how collected raw signals are converted into a reported signal and result), as applicable.(v) A detailed description of device software, including software applications and hardware-based devices that incorporate software. The detailed description must include documentation of verification, validation, and hazard analysis and risk assessment activities, including an assessment of the impact of threats and vulnerabilities on device functionality and end users/patients as part of cybersecurity review.
(vi) For devices intended for the detection and identification of microbial agents for which an FDA recommended reference panel is available, design verification and validation must include the performance results of an analytical study testing the FDA recommended reference panel of characterized samples. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(vii) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens, the design verification and validation must include a detailed description of the identity, phylogenetic relationship, or other recognized characterization of the Influenza A and B viruses that the device is designed to detect, a description of how the device results might be used in a diagnostic algorithm and other measures that might be needed for a laboratory identification of Influenza A or B virus and of specific Influenza A virus subtypes, and a description of the clinical and epidemiological parameters that are relevant to a patient case diagnosis of Influenza A or B and of specific Influenza A virus subtypes. An evaluation of the device compared to a currently appropriate and FDA accepted comparator method. Detailed documentation must be kept of that study and its results, including the study protocol, study report for the proposed intended use, testing results, and results of all statistical analyses.
(5) When applicable, performance results of the analytical study testing the FDA recommended reference panel described in paragraph (b)(4)(vi) of this section must be included in the device's labeling under § 809.10(b) of this chapter.
(6) For devices with an intended use that includes detection of Influenza A and Influenza B viruses and/or detection and differentiation between the Influenza A virus subtypes in human clinical specimens in addition to detection of SARS-CoV-2 and similar microbial agents, the required labeling under § 809.10(b) of this chapter must include the following:
(i) Where applicable, a limiting statement that performance characteristics for Influenza A were established when Influenza A/H3 and A/H1-2009 (or other pertinent Influenza A subtypes) were the predominant Influenza A viruses in circulation.
(ii) Where applicable, a warning statement that reads 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 departments for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
(iii) Where the device results interpretation involves combining the outputs of several targets to get the final results, such as a device that both detects Influenza A and differentiates all known Influenza A subtypes that are currently circulating, the device's labeling must include a clear interpretation instruction for all valid and invalid output combinations, and recommendations for any required followup actions or retesting in the case of an unusual or unexpected device result.
(iv) A limiting statement that if a specimen yields a positive result for Influenza A, but produces negative test results for all specific influenza A subtypes intended to be differentiated (
i.e., H1-2009 and H3), this result requires notification of appropriate local, State, or Federal public health authorities to determine necessary measures for verification and to further determine whether the specimen represents a novel strain of Influenza A.(7) If one of the actions listed at section 564(b)(1)(A) through (D) of the Federal Food, Drug, and Cosmetic Act occurs with respect to an influenza viral strain, or if the Secretary of Health and Human Services determines, under section 319(a) of the Public Health Service Act, that a disease or disorder presents a public health emergency, or that a public health emergency otherwise exists, with respect to an influenza viral strain:
(i) Within 30 days from the date that FDA notifies manufacturers that characterized viral samples are available for test evaluation, the manufacturer must have testing performed on the device with those influenza viral samples in accordance with a standardized protocol considered and determined by FDA to be acceptable and appropriate.
(ii) Within 60 days from the date that FDA notifies manufacturers that characterized influenza viral samples are available for test evaluation and continuing until 3 years from that date, the results of the influenza emergency analytical reactivity testing, including the detailed information for the virus tested as described in the certificate of authentication, must be included as part of the device's labeling in a tabular format, either by:
(A) Placing the results directly in the device's labeling required under § 809.10(b) of this chapter that accompanies the device in a separate section of the labeling where analytical reactivity testing data can be found, but separate from the annual analytical reactivity testing results; or
(B) In a section of the device's label or in other labeling that accompanies the device, prominently providing a hyperlink to the manufacturer's public website where the analytical reactivity testing data can be found. The manufacturer's website, as well as the primary part of the manufacturer's website that discusses the device, must provide a prominently placed hyperlink to the website containing this information and must allow unrestricted viewing access.