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.

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.

AI/ML Overview

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.

Summary

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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.

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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 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

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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 -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

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Indications for Use

510(k) Number (if known) K243813

Device Name QIAstat-Dx GI Panel 2 Mini B&V

Indications for Use (Describe)

Norovirus
· Campylobacter
· Shigella
· Shiga-like toxin Escherichia coli (STEC)*
· Salmonella

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

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:	Colleen AdamsSenior Director, Regulatory AffairsQIAGEN19300 Germantown RoadGermantown, 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 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&V 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 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.

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.

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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 MiniB&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 2Mini B&V is a multiplexednucleic acid test intended foruse with the QIAstat-DxAnalyzer 1.0 for thesimultaneous in vitroqualitative detection andidentification of nucleic acidsfrom multiple bacteria andone virus directly frompreserved stool samples(Para-Pak® C&S orFecalSwabTM) obtained fromindividuals with signs and/orsymptoms of gastrointestinalinfection. The following virusand bacteria (includingseveral diarrheagenic E. coli/Shigella pathotypes) areidentified with the QIAstat-Dx GI Panel 2 Mini B&V:NorovirusCampylobacterShigellaShiga-like toxinEscherichia coli(STEC)SalmonellaOnly with Para-Pak C&S,not reported for FecalSwab	The QIAstat-Dx® GastrointestinalPanel 2 is a multiplexed nucleic acidtest intended for use with the QIAstat-Dx Analyzer 1.0 for the simultaneousin vitro qualitative detection andidentification of nucleic acids frommultiple viruses, bacteria, andparasites directly from preserved stoolsamples (Para-Pak® C&S orFecalSwabTM) obtained fromindividuals with signs and/orsymptoms of gastrointestinal infection.The following viruses, bacteria(including several diarrheagenic E. coli/ Shigella pathotypes), andparasites are identified with theQIAstat-Dx® Gastrointestinal Panel 2:Adenovirus F40/F41AstrovirusNorovirus GI/GIIRotavirus ACampylobacter ( C. jejuni, C. coliand C. upsaliensis ) Shigella/ EnteroinvasiveEscherichia coli (EIEC)Enteropathogenic Escherichia coli(EPEC)*Enterotoxigenic Escherichia coli(ETEC) lt/stShiga-like toxin-producingEscherichia coli (STEC) stx1/stx2(including specific identification of)
Characteristic	Modified Device	Predicate
	Concomitant culture isnecessary for organismrecovery and further typing ofbacterial agents. The QIAstat-Dx GI Panel 2 Mini B&V 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&V. Theorganisms detected may notbe the sole or definitive causeof the disease.Negative QIAstat-Dx GIPanel 2 Mini B&V results inthe setting 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.	E. coli O157 serogroup withinSTEC)• 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, or
SpecimenType	Same	Crohn's disease.Preserved stool in Para-Pak C&S orFecalSwab transport media
Characteristic	Modified Device	Predicate
AnalyteDetected	Same	RNA/DNA
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 AcidExtractionTechnology	Same	Extraction of nucleic acids using silicamembrane
	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
Assay Targets	The QIAstat-Dx GI Panel 2Mini B&V detects five (5)targets	The QIAstat-Dx Gastrointestinal Panel2 detects sixteen (16) targets

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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.

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).