(28 days)
The QIAstat-Dx GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the OLAstat-Dx Analyzer 1.0 for the simultaneous in vitro qualitative detection of nucleic acids from multiple bacteria and one virus directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following virus and bacteria (including several diarrheagence E. col/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B&V:
- Norovirus
- · Campylobacter
- · Shigella
- · Shiga-like toxin Escherichia coli (STEC)*
- · Salmonella
*Only with Para-Pak C&S, not reported for FecalSwab
Concomitant culture is necessary for organism recovery and further typing of bacterial agents. The QlAstat-Dx GI Panel 2 Mini B&V is indicated as an aid in the diagnosis of gastrontestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Postive results do not rule-out co-infection with organisms not detected by the QlAstat-Dx GI Panel 2 Mini B&V. The organisms detected may not be the sole or definitive cause of the disease.
Negative QIAstat-Dx GI Panel 2 Mini B&V results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assay test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease.
The QIAstat-Dx® GI Panel 2 Mini B&V (Cat. no. 691424) assay is a modified device (reduced version) of the QIAstat-Dx Gastrointestinal Panel 2 (Cat. no. 691421). The QIAstat-Dx GI Panel 2 Mini B&V is identical to the OIAstat-Dx Gastrointestinal Panel 2 (K220062) with the exception of their respective labeling and Assay Definition File (ADF) which masks all but five pathogens (targets) from the OIAstat-Dx Gastrointestinal Panel 2. The following virus and bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the OIAstat-Dx GI Panel 2 Mini B&V: Norovirus, Campvlobacter, Shigella, Shiga-like toxin Escherichia coli (STEC) and Salmonella. The QIAstat-Dx GI Panel 2 Mini B&V is part of the OIAstat-Dx system and works with the OIAstat-Dx Analyzer 1.0.
The QIAstat-Dx GI Panel 2 Mini B&V is intended to be used with stool samples in Para-Pak C&S or FecalSwab transport media.
QIAstat-Dx is based on single-test cartridges with pre-packaged reagents including both wet and dry chemistry to handle the sample preparation and detection steps for the presence of a range of selected analytes by PCR technology. After insertion of the sample, the QIAstat-Dx assay cartridge is processed by the QIAstat-Dx Analyzer 1.0.
Once the cartridge has been inserted into the instrument, the test starts automatically and runs for approximately 78 minutes. When the test is finished, the cartridge is removed by the user and discarded. The QIAstat-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. For other analytes tested, they are displayed in green if not detected or in gray if not applicable or invalid. 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 GI Panel 2 Mini B&V 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:
- Sample Pre-treatment for PCR Inhibitors removal
- Resuspension of Internal Control and Proteinase K ●
- Cell lysis using mechanical and/or chemical means
- Membrane-based nucleic acid purification
- Rehydration of Master Mix ●
- Transfer of defined aliquots of eluate/master mix to different reaction chambers ●
- Performance of multiplex real-time RT-PCR testing within each reaction ● chamber.
The provided text describes a 510(k) premarket notification for a medical device called the QIAstat-Dx GI Panel 2 Mini B&V. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, the QIAstat-Dx Gastrointestinal Panel 2 (K220062), rather than detailing original acceptance criteria and a comprehensive study designed to prove the device meets those criteria from scratch.
The core of the submission is that the QIAstat-Dx GI Panel 2 Mini B&V is a "reduced version" of the predicate device. It is identical in hardware, reagents, and underlying PCR technology, with the only difference being a modified "Assay Definition File (ADF)" that masks results for all but five specific pathogens. Because of this, the performance data for the new device is considered "equivalent" to the predicate device's data for these five analytes.
Therefore, many of the typical elements of an acceptance criteria study (like an independent test set, MRMC study, or detailed ground truth establishment for a new study) are not explicitly present for the QIAstat-Dx GI Panel 2 Mini B&V in this document, as the submission relies on the existing clearance of the predicate device for its performance claims.
However, based on the provided text, here's an attempt to extract and infer the information requested:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of acceptance criteria for this specific submission. Instead, it states that "The performance data for the QIAstat-Dx GI Panel 2 Mini B&V is equivalent to the QIAstat-Dx Gastrointestinal Panel 2 (K220062) with the exception that it only includes data for the five analytes detected by the QIAstat-Dx GI Panel 2 Mini B&V (Norovirus, Campylobacter, Shigella, Shiga-like toxin E. coli (STEC) and Salmonella)."
It then directs the reader to "Please see the QIAGEN QIAstat-Dx GI Panel 2 Mini B&V Instructions for Use for performance tables." Since these tables are not included in the provided text, we cannot present a direct table of acceptance criteria and reported device performance from this document. The implication is that the predicate device's performance, as accepted during its original 510(k) clearance (K220062), serves as the de facto "acceptance criteria" for these five analytes for the new device by virtue of its identical underlying technology.
2. Sample size used for the test set and the data provenance
The document does not describe a new, independent test set for the QIAstat-Dx GI Panel 2 Mini B&V. Instead, it relies on the data collected for the predicate device (QIAstat-Dx Gastrointestinal Panel 2, K220062). The sample size, country of origin, and whether the data was retrospective or prospective for the predicate device's studies are not detailed in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document, as it refers to the predicate device's data rather than a new study with independent expert ground truth establishment for this submission.
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 device is a diagnostic nucleic acid test, not an AI-powered image analysis tool or a device that directly assists human readers in interpreting imaging or other complex data. Therefore, an MRMC study and effects on human reader performance are not applicable to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the assay itself. The performance of the QIAstat-Dx GI Panel 2 Mini B&V (which functions like a standalone test after sample input) is considered "equivalent" to the predicate device's performance for the five detected analytes. The document notes that "The QIAstat-Dx Analyzer 1.0 automatically interprets test results and displays a summary on the analyzer display screen." This implies a standalone (algorithm only) performance for result generation, as long as human intervention refers to the interpretation of the raw data by the user, rather than the final qualitative result presented by the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For nucleic acid amplification tests like this, the ground truth is typically established by well-characterized reference methods, often involving:
- Culture: For bacterial targets, traditional microbiology culture is a common reference standard.
- Reference PCR/Molecular Methods: Highly sensitive and specific laboratory-developed or validated molecular assays.
- Sequencing: For definitive characterization where applicable.
The document does not explicitly state the specific ground truth methods used for the predicate device's studies, but these are the standard approaches for such assays. It does mention that "Concomitant culture is necessary for organism recovery and further typing of bacterial agents" in its indications for use, suggesting culture is an important complementary method in clinical practice.
8. The sample size for the training set
The document does not describe a training set in the context of an AI/machine learning model. This device is a molecular diagnostic assay (PCR-based), not an AI-driven system. Therefore, the concept of a "training set" as it applies to AI models is not relevant here. Development and validation of such assays involve different types of studies (e.g., analytical validation, clinical validation) rather than "training" an algorithm.
9. How the ground truth for the training set was established
As per point 8, the concept of a training set for an AI model is not applicable. The development and validation of PCR assays involve establishing the analytical and clinical performance through rigorous testing against reference methods (as mentioned in point 7) and clinical samples.
§ 866.3990 Gastrointestinal microorganism multiplex nucleic acid-based assay.
(a)
Identification. A gastrointestinal microorganism multiplex nucleic acid-based assay is a qualitativein vitro diagnostic device intended to simultaneously detect and identify multiple gastrointestinal microbial nucleic acids extracted from human stool specimens. The device detects specific nucleic acid sequences for organism identification as well as for determining the presence of toxin genes. The detection and identification of a specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation and other laboratory findings. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.(b)
Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assays for Detection and Identification of Microorganisms and Toxin Genes from Human Stool Specimens.” For availability of the guideline document, see § 866.1(e).