The QIAstat-Dx GI Panel 2 Mini B 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 directly from preserved stool samples (Para-Pak C&S or FecalSwab) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B:

Campylobacter
Shigella
Shiga-like toxin Escherichia coli (STEC)*
Salmonella
Yersinia enterocolitica

*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 is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness, in conjunction with other clinical, laboratory, and epidemiological data. Postive results do not rule out co-infection with organisms not detected by the QIAstat-Dx GI Panel 2 Mini B. The organisms detected may not be the sole or definitive cause of the disease.

Negative QIAstat-Dx GI Panel 2 Mini B 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.

Device Description

The QIAstat-Dx® GI Panel 2 Mini B (Cat. no. 691423) assay is a modified device (reduced version) of the OIAstat-Dx Gastrointestinal Panel 2 (Cat. no. 691421). The OIAstat-Dx GI Panel 2 Mini B is identical to the QIAstat-Dx Gastrointestinal Panel 2 (K220062) but uses an Assay Definition File (ADF) which masks all but five pathogens (targets) from the OIAstat-Dx Gastrointestinal Panel 2. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the OIAstat-Dx GI Panel 2 Mini B: Campvlobacter. Shigella, Shiga-like toxin E. coli (STEC), Salmonella and Yersinia enterocolitica. The QIAstat-Dx GI Panel 2 Mini B is part of the QIAstat-Dx system and works with the OIAstat-Dx Analyzer 1.0. It will be available in a separately labeled kit.

The QIAstat-Dx GI Panel 2 Mini B 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 is inserted into the instrument, the test starts automatically and runs for about 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 grav 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 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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a study that explicitly proves the device meets those criteria in a format with numerical results and statistical analyses typical for such studies. It states that the performance data for the QIAstat-Dx GI Panel 2 Mini B is equivalent to the predicate device (QIAstat-Dx Gastrointestinal Panel 2, K220062) for the five specific analytes it detects. It also mentions that the "QIAGEN QIAstat-Dx GI Panel 2 Mini B Instructions for Use" should be consulted for performance tables, which are not included in this document.

However, based on the information provided, I can infer the general nature of the acceptance criteria (qualitative detection of specific pathogens) and describe the comparative nature of the "study" (equivalence to a predicate device).

Here's an attempt to structure the information based on your request, with significant caveats that detailed numerical results, sample sizes, expert qualifications, and study methodologies for the actual performance are not present in the provided text.

Acceptance Criteria and Device Performance for QIAstat-Dx GI Panel 2 Mini B

The QIAstat-Dx GI Panel 2 Mini B is a modified version of the predicate device, QIAstat-Dx Gastrointestinal Panel 2 (K220062). The device performance for the QIAstat-Dx GI Panel 2 Mini B is presented as being equivalent to the predicate device for the five target analytes it identifies.

1. Table of Acceptance Criteria and Reported Device Performance

Since specific numerical acceptance criteria and performance metrics (e.g., sensitivity, specificity, PPV, NPV) are not provided in this document, the table below reflects the qualitative nature of the information given. The "acceptance criteria" are inferred from the demonstrated performance equivalence to the predicate device for the detected analytes.

Analyte (Bacteria)	Acceptance Criteria (Inferred)	Reported Device Performance (Summary)
Campylobacter	Qualitative detection equivalent to predicate device (K220062)	Performance equivalent to QIAstat-Dx Gastrointestinal Panel 2 (K220062) for Campylobacter
Shigella	Qualitative detection equivalent to predicate device (K220062)	Performance equivalent to QIAstat-Dx Gastrointestinal Panel 2 (K220062) for Shigella
Shiga-like toxin Escherichia coli (STEC)	Qualitative detection equivalent to predicate device (K220062)	Performance equivalent to QIAstat-Dx Gastrointestinal Panel 2 (K220062) for STEC
Salmonella	Qualitative detection equivalent to predicate device (K220062)	Performance equivalent to QIAstat-Dx Gastrointestinal Panel 2 (K220062) for Salmonella
Yersinia enterocolitica	Qualitative detection equivalent to predicate device (K220062)	Performance equivalent to QIAstat-Dx Gastrointestinal Panel 2 (K220062) for Yersinia enterocolitica

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). It simply states that the performance data for the modified device is "equivalent" to the predicate device. To find this information, one would need to refer to the 510(k) submission K220062 for the predicate device and/or the "QIAGEN QIAstat-Dx GI Panel 2 Mini B Instructions for Use."

3. Number of Experts and Qualifications

The document does not mention the number of experts used to establish ground truth or their qualifications. This information would typically be found in the detailed performance study report of the predicate device, or IFU for the current device. Given that the device detects nucleic acids for specific bacteria, ground truth is likely established through culture or other confirmed molecular methods, rather than expert consensus on images.

4. Adjudication Method

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. This type of method is more common in image-based AI studies where human interpretation can vary; for a nucleic acid test, ground truth is typically established by definitive laboratory methods.

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

An MRMC comparative effectiveness study was not applicable or performed for this device as it is a standalone in vitro diagnostic (IVD) device for nucleic acid detection, not an AI-assisted diagnostic tool for human readers. Therefore, there is no effect size related to human reader improvement with AI assistance.

6. Standalone Performance

Yes, a standalone performance assessment was conducted. The QIAstat-Dx GI Panel 2 Mini B is an in vitro diagnostic device, meaning its performance (analytical and clinical performance) is evaluated independently without human interpretation as part of a human-in-the-loop system. The document states its performance is "equivalent" to the predecessor device, which would have undergone rigorous standalone performance testing.

7. Type of Ground Truth Used

While not explicitly stated for this specific submission, for a nucleic acid-based assay like the QIAstat-Dx GI Panel 2 Mini B, the ground truth would typically be established by:

Culture: Bacterial culture for viability and identification of the target organisms.
Reference Molecular Methods: e.g., validated PCR assays or sequencing for definitive detection and identification of microbial nucleic acids.
Composite Reference Method (CRM): A combination of multiple methods, often including culture, microscopy, and/or multiple molecular methods, to establish the presence or absence of the target pathogen.

8. Sample Size for the Training Set

The document does not provide the sample size for the training set. For an IVD like this, "training set" might refer to the data used for initial assay development and optimization rather than a machine learning context. This information would be in the detailed development reports.

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

The document does not describe how the ground truth for the training set was established. Similar to the test set, it would likely involve established laboratory methods such as culture or reference molecular assays for the target pathogens.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

February 28, 2025

QIAGEN GmbH % Sonia Pablo Senior Manager, Regulatory Affairs STAT-Dx Life, S.L. (A QIAGEN company) Carrer Baldiri Reixac. 4 Barcelona, 08028 Spain

Re: K250324

Trade/Device Name: QIAstat-Dx GI Panel 2 Mini B Regulation Number: 21 CFR 866.3990 Regulation Name: Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay Regulatory Class: Class II Product Code: PCH Dated: February 5, 2025 Received: February 5, 2025

Dear Sonia Pablo:

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 (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.

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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 mediation-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

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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 -> 0ate: 2025.02.28
07:46:03 -05'00'

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

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Indications for Use

510(k) Number (if known) K250324

Device Name QIAstat-Dx GI Panel 2 Mini B

Indications for Use (Describe)

Campylobacter
Shigella
Shiga-like toxin Escherichia coli (STEC)*
Salmonella
Yersinia enterocolitica

*Only with Para-Pak C&S, not reported for FecalSwab

Negative QIAstat-Dx GI Panel 2 Mini B results in the setting of clinical illness compatible with gastroentertis 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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510(k) Summary

General Information

Submitted by:	QIAGEN GmbHQIAGEN Strasse 1Hilden, Germany 40724
Contact Person:	Sonia PabloSenior Manager, Regulatory AffairsSTAT-Dx Life, S.L. (A QIAGEN Company)Carrer Baldiri Reixac, 408028 BarcelonaSpainPhone: +34 696 85 81 85Email: sonia.pablo@qiagen.com
Date Prepared:	February 4, 2025
Device Name:	QIAstat-Dx® GI Panel 2 Mini B
Classification:	21 CFR 866.3990 - Gastrointestinal Pathogen Panel MultiplexNucleic Acid-Based Assay System
Product Code:	PCH
Predicate Device:	QIAstat-Dx® Gastrointestinal Panel 2, K220062

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Device Description

The QIAstat-Dx GI Panel 2 Mini B is intended to be used with stool samples in Para-Pak C&S or FecalSwab transport media.

Sample Pre-treatment for PCR Inhibitors removal ●
Resuspension of Internal Control and Proteinase K ●
Cell lysis using mechanical and/or chemical means

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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 OIAstat-Dx® GI Panel 2 Mini B 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 directly from preserved stool samples (Para-Pak® C&S or FecalSwab™) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B:

Campylobacter ●
Shigella
Shiga-like toxin Escherichia coli (STEC)*
Salmonella
Yersinia enterocolitica ●

*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 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. The organisms detected may not be the sole or definitive cause of the disease.

Negative OIAstat-Dx GI Panel 2 Mini B results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this assav 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 and the Predicate Device

Similarities and differences between the QIAstat-Dx GI Panel 2 Mini B and the predicate device are shown in Table 1.

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Characteristic	Modified Device	Predicate
Name	QIAstat-Dx® GI Panel 2 Mini B	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 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 directly from preserved stool samples (Para-Pak® C&S or FecalSwab™) obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including several diarrheagenic E. coli/Shigella pathotypes) are identified with the QIAstat-Dx GI Panel 2 Mini B:Campylobacter Shigella Shiga-like toxin Escherichia coli (STEC)* Salmonella Yersinia enterocolitica *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 FecalSwab™) 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/F41 Astrovirus Norovirus GI/GII Rotavirus A Campylobacter ( C. jejuni, C. coli and C. upsaliensis ) Shigella/ Enteroinvasive Escherichia coli (EIEC) Enteropathogenic Escherichia coli (EPEC)* Enterotoxigenic Escherichia coli (ETEC) lt/st Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 (including specific identification of E. coli O157 serogroup within STEC)*
Characteristic	Modified Device	Predicate
	Concomitant culture isnecessary for organismrecovery and further typing ofbacterial agents. The QIAstat-Dx GI Panel 2 Mini B isindicated as an aid in thediagnosis of specific agentsof gastrointestinal illness, inconjunction with otherclinical, laboratory, andepidemiological data. Positiveresults do not rule-out co-infection with organisms notdetected by the QIAstat-DxGI Panel 2 Mini B. Theorganisms detected may notbe the sole or definitive causeof the disease.Negative QIAstat-Dx GIPanel 2 Mini B results in thesetting of clinical illnesscompatible withgastroenteritis may be due toinfection by pathogens thatare not detected by this assaytest or non-infectious causessuch as ulcerative colitis,irritable bowel syndrome, orCrohn's disease.	• Salmonella• Plesiomonas shigelloides• Yersinia enterocolitica• Cryptosporidium• Cyclospora cayetanensis• Entamoeba histolytica• Giardia lamblia (also known asGiardia intestinalis and Giardiaduodenalis)*Only with Para-Pak C&S, notreported for FecalSwabConcomitant culture is necessary fororganism recovery and further typingof bacterial agents.The QIAstat-Dx® GastrointestinalPanel 2 is indicated as an aid in thediagnosis of specific agents ofgastrointestinal illness, in conjunctionwith other clinical, laboratory, andepidemiological data. Positive resultsdo not rule-out co-infection withorganisms not detected by theQIAstat-Dx Gastrointestinal Panel 2.The organisms detected may not bethe sole or definitive cause of thedisease.Negative QIAstat-Dx®Gastrointestinal Panel 2 results in thesetting of clinical illness compatiblewith gastroenteritis may be due toinfection by pathogens that are notdetected by this assay test or non-infectious causes such as ulcerativecolitis, irritable bowel syndrome, orCrohn's disease.
SpecimenType	Same	Preserved stool in Para-Pak C&S orFecalSwab transport media
AnalyteDetected	Same(DNA only)	RNA/DNA
Characteristic	Modified Device	Predicate
OrganismsDetected	See above	See above
Amplificationand DetectionTechnology	Same	PCR
Assay Controls	Same	One internal control in each cartridgeto control for sample processing that issubjected to all nucleic acid extractionand amplification steps similar topatient samples. Labeling recommendsuse of negative and positive externalcontrols regularly. Use transport mediaas the external Negative Control, andpreviously characterized positivesamples or negative sample spikedwith well characterized targetorganisms as external positivecontrols.
Nucleic AcidExtraction	Same	Extraction of nucleic acids using silicamembrane
Technology	Same	QIAstat-Dx Gastrointestinal Panel 2detection of amplified targets uses anincrease in fluorescence due tospecific probe binding to generate theassay results.
Operational	Same	The sample is loaded straight into thecartridge.
Amplificationand DetectionInstrumentSystem	Same	QIAstat-Dx Analyzer 1.0
Differences
Assay Targets	The QIAstat-Dx GI Panel 2Mini B detects five (5) targets	The QIAstat-Dx Gastrointestinal Panel2 detects sixteen (16) targets

mparison of the QLAstat-Dx GI P م ته 1 ملطاه Tahla 1

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Summary of Performance Data

The performance data for the QIAstat-Dx GI Panel 2 Mini B is equivalent to the QIAstat-Dx Gastrointestinal Panel 2 (K220062) with the exception that it only includes data for the five analytes reported by the QIAstat-Dx GI Panel 2 Mini B (Campylobacter, Shigella, Shiga-like toxin E. coli (STEC), Salmonella and Yersinia enterocolitica). Please see the QIAGEN QIAstat-Dx GI Panel 2 Mini B Instructions for Use for performance tables.

Conclusions

The technological characteristics and performance of the QIAstat-Dx GI Panel 2 Mini B 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.

Regulation Number and Section

§ 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).