(28 days)
Not Found
No
The description focuses on PCR technology and automated sample processing, with no mention of AI or ML for analysis or interpretation.
No
The device is an in vitro diagnostic (IVD) test used to detect nucleic acids from multiple bacteria and one virus in stool samples to aid in the diagnosis of gastrointestinal illness. It does not provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated as an aid in the diagnosis of gastrointestinal illness."
No
The device description clearly outlines a system that includes physical components such as cartridges with pre-packaged reagents, a QIAstat-Dx Analyzer 1.0 instrument, and the processing of physical stool samples. While software is involved in interpreting results and controlling the analyzer, the device is fundamentally a hardware-based in vitro diagnostic system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device 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...". The phrase "in vitro" is a key indicator of an IVD.
- Sample Type: The device is designed to test biological samples (stool) obtained from the human body.
- Purpose: The test is intended to aid in the diagnosis of gastrointestinal illness by detecting specific pathogens in the sample. This is a diagnostic purpose.
- Device Description: The description details a system that processes biological samples and performs analysis (PCR technology) to detect analytes. This is consistent with the function of an IVD.
N/A
Intended Use / Indications for Use
The QIAstat-Dx GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the OIAstat-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.
Product codes (comma separated list FDA assigned to the subject device)
PCH
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
QIAstat-Dx® Gastrointestinal Panel 2, K220062
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized representation of a caduceus, a traditional symbol of medicine, with intertwined snakes and wings. To the right of the symbol is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue, with "FDA" in a larger font size than the rest of the text.
January 8, 2025
Qiagen GmbH % Colleen Adams Senior Directory, Regulatory Affairs Qiagen 19300 Germantown Road Germantown, Maryland 20874
Re: K243813
Trade/Device Name: QIAstat-Dx GI Panel 2 Mini B&V Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay Regulatory Class: Class II Product Code: PCH Dated: December 11, 2024 Received: December 11, 2024
Dear Colleen Adams:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Bryan M. Bryan M. Grabias -S Grabias -S Date: 2025.01.08 Bryan Grabias, Ph. D. Acting Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243813
Device Name QIAstat-Dx GI Panel 2 Mini B&V
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
510(k) Summary
General Information
| Submitted by: | QIAGEN GmbH
QIAGEN Strasse 1
Hilden, Germany 40724 |
|-------------------|-----------------------------------------------------------------------------------------------------------------|
| | |
| Contact Person: | Colleen Adams
Senior Director, Regulatory Affairs
QIAGEN
19300 Germantown Road
Germantown, MD 20874 |
| Phone: | 608-590-2443 |
| | Email: colleen.adams@qiagen.com |
| Date Prepared: | January 8, 2025 |
| Device Name: | QIAstat-Dx® GI Panel 2 Mini B&V |
| Classification: | 21 CFR 866.3990 - Gastrointestinal Pathogen Panel Multiplex
Nucleic Acid-Based Assay System |
| Product Code: | PCH |
| Predicate Device: | QIAstat-Dx® Gastrointestinal Panel 2, K220062 |
5
Device Description
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
6
- 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.
Intended Use
The QIAstat-Dx® GI Panel 2 Mini B&V is a multiplexed nucleic acid test intended for use with the OIAstat-Dx Analyzer 1.0 for the simultaneous in vitro qualitative detection and identification 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 diarrheagenic E. coli/Shigella pathotypes) are identified with the OIAstat-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 QIAstat-Dx GI Panel 2 Mini B&V is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule-out co-infection with organisms not detected by the OIAstat-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.
Comparison of the QIAstat-Dx GI Panel 2 Mini B&V and the Predicate Device
Similarities and differences between the QIAstat-Dx GI Panel 2 Mini B&V and the predicate device are shown in Table 1.
7
| Table 1: Comparison of the OlAstat-Dx GI Panel 2 Mini B&V with the predicate | |||
|---|---|---|---|
| device |
| Characteristic | Modified Device | Predicate |
|---|---|---|
| Name | QIAstat-Dx® GI Panel 2 Mini | |
| B&V | QIAstat-Dx Gastrointestinal Panel 2 | |
| 510(k) No. | TBD | K220062 |
| Regulation | 21 CFR 866.3990 | 21 CFR 866.3990 |
| Product Code | PCH | PCH |
| Device Class | Class II | Class II |
| Similarities | ||
| Intended Use | The QIAstat-Dx® GI Panel 2 | |
| Mini B&V is a multiplexed | ||
| nucleic acid test intended for | ||
| use with the QIAstat-Dx | ||
| Analyzer 1.0 for the | ||
| simultaneous in vitro | ||
| qualitative detection and | ||
| identification of nucleic acids | ||
| from multiple bacteria and | ||
| one virus directly from | ||
| preserved stool samples | ||
| (Para-Pak® C&S or | ||
| FecalSwabTM) obtained from | ||
| individuals with signs and/or | ||
| symptoms of gastrointestinal | ||
| infection. The following virus | ||
| and bacteria (including | ||
| several diarrheagenic E. coli/Shigella pathotypes) are | ||
| identified with the QIAstat- | ||
| Dx GI Panel 2 Mini B&V: | ||
| NorovirusCampylobacterShigellaShiga-like toxin | ||
| Escherichia coli | ||
| (STEC)*Salmonella | ||
| *Only with Para-Pak C&S, | ||
| not reported for FecalSwab | The QIAstat-Dx® Gastrointestinal | |
| Panel 2 is a multiplexed nucleic acid | ||
| test intended for use with the QIAstat- | ||
| Dx Analyzer 1.0 for the simultaneous | ||
| in vitro qualitative detection and | ||
| identification of nucleic acids from | ||
| multiple viruses, bacteria, and | ||
| parasites directly from preserved stool | ||
| samples (Para-Pak® C&S or | ||
| FecalSwabTM) obtained from | ||
| individuals with signs and/or | ||
| symptoms of gastrointestinal infection. | ||
| The following viruses, bacteria | ||
| (including several diarrheagenic E. coli/ Shigella pathotypes), and | ||
| parasites are identified with the | ||
| QIAstat-Dx® Gastrointestinal Panel 2: | ||
| Adenovirus F40/F41AstrovirusNorovirus GI/GIIRotavirus ACampylobacter ( C. jejuni, C. coli | ||
| and C. upsaliensis ) Shigella/ Enteroinvasive | ||
| Escherichia coli (EIEC)Enteropathogenic Escherichia coli | ||
| (EPEC)*Enterotoxigenic Escherichia coli | ||
| (ETEC) lt/stShiga-like toxin-producing | ||
| Escherichia coli (STEC) stx1/stx2 | ||
| (including specific identification of) | ||
| Characteristic | Modified Device | Predicate |
| Concomitant culture is | ||
| necessary for organism | ||
| recovery and further typing of | ||
| bacterial agents. The QIAstat- | ||
| Dx GI Panel 2 Mini B&V is | ||
| indicated as an aid in the | ||
| diagnosis of specific agents | ||
| of gastrointestinal illness, in | ||
| conjunction with other | ||
| clinical, laboratory, and | ||
| epidemiological data. Positive | ||
| results do not rule-out co- | ||
| infection with organisms not | ||
| detected by the QIAstat-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. | E. coli O157 serogroup within | |
| STEC)* | ||
| • Salmonella | ||
| • Plesiomonas shigelloides | ||
| • Yersinia enterocolitica | ||
| • Cryptosporidium | ||
| • Cyclospora cayetanensis | ||
| • Entamoeba histolytica | ||
| • Giardia lamblia (also known as | ||
| Giardia intestinalis and Giardia | ||
| duodenalis) | ||
| *Only with Para-Pak C&S, not | ||
| reported for FecalSwab | ||
| Concomitant culture is necessary for | ||
| organism recovery and further typing | ||
| of bacterial agents. | ||
| The QIAstat-Dx® Gastrointestinal | ||
| Panel 2 is indicated as an aid in the | ||
| diagnosis of specific agents of | ||
| gastrointestinal illness, in conjunction | ||
| with other clinical, laboratory, and | ||
| epidemiological data. Positive results | ||
| do not rule-out co-infection with | ||
| organisms not detected by the | ||
| QIAstat-Dx Gastrointestinal Panel 2. | ||
| The organisms detected may not be | ||
| the sole or definitive cause of the | ||
| disease. | ||
| Negative QIAstat-Dx® | ||
| Gastrointestinal Panel 2 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 | ||
| Specimen | ||
| Type | Same | Crohn's disease. |
| Preserved stool in Para-Pak C&S or | ||
| FecalSwab transport media | ||
| Characteristic | Modified Device | Predicate |
| Analyte | ||
| Detected | Same | RNA/DNA |
| Organisms | ||
| Detected | See above | See above |
| Amplification | ||
| and Detection | ||
| Technology | Same | PCR |
| Assay Controls | Same | One internal control in each cartridge |
| to control for sample processing that is | ||
| subjected to all nucleic acid extraction | ||
| and amplification steps similar to | ||
| patient samples. Labeling recommends | ||
| use of negative and positive external | ||
| controls regularly. Use transport media | ||
| as the external Negative Control, and | ||
| previously characterized positive | ||
| samples or negative sample spiked | ||
| with well characterized target | ||
| organisms as external positive | ||
| controls. | ||
| Nucleic Acid | ||
| Extraction | ||
| Technology | Same | Extraction of nucleic acids using silica |
| membrane | ||
| Same | QIAstat-Dx Gastrointestinal Panel 2 | |
| detection of amplified targets uses an | ||
| increase in fluorescence due to | ||
| specific probe binding to generate the | ||
| assay results. | ||
| Operational | Same | The sample is loaded straight into the |
| cartridge. | ||
| Amplification | ||
| and Detection | ||
| Instrument | ||
| System | Same | QIAstat-Dx Analyzer 1.0 |
| Assay Targets | The QIAstat-Dx GI Panel 2 | |
| Mini B&V detects five (5) | ||
| targets | The QIAstat-Dx Gastrointestinal Panel | |
| 2 detects sixteen (16) targets |
8
9
10
Summary of Performance Data
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). Please see the OIAGEN OIAstat-Dx GI Panel 2 Mini B&V Instructions for Use for performance tables.
Conclusions
The technological characteristics and performance of the QIAstat-Dx GI Panel 2 Mini B&V are the same as the predicate device except for labeling and the modified Assay Definition File (ADF) that has been verified and validated to demonstrate there is no change in safety and effectiveness. The submitted information provided in this premarket notification is complete and supports a substantial equivalence determination to the predicate device.