(210 days)
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BUHLMANN fCAL® turbo.
The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms.
The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately.
Sample extracts may be prepared using manual weighing extraction methods or the CALEX® Cap.
The CALEX® Cap is a single use tube filled with extraction buffer. The sampling pin houses a dosing tip which is used to obtain sufficient stool sample for the extraction process. The extraction method leads to stool specimen extracts which can be measured directly using the BÜHLMANN fCAL® turbo assay.
The document discusses the BÜHLMANN fCAL® turbo and CALEX® Cap devices, which are used for quantitative measurement of fecal calprotectin. The primary purpose of this submission is to extend the stability of CALEX® Cap extracts.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative table format. Instead, it refers to a "risk assessment" and a "stability study conducted in accordance with CLSI EP25 to support the shelf-life extension of the CALEX® Cap extracts." The conclusion states that "The stability study supports the claimed extension to CALEX® Cap extract shelf-life." This implies that the performance in the stability study met the internal acceptance criteria established based on the risk assessment and CLSI EP25 guidelines.
2. Sample size used for the test set and the data provenance
The document states, "an extract stability study was conducted in accordance with CLSI EP25." However, it does not provide details on the specific sample size, country of origin of the data, or whether the study was retrospective or prospective.
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. The study mentioned is a stability study, not a clinical study involving human experts establishing ground truth for diagnostic accuracy.
4. Adjudication method for the test set
This information is not provided as the study is a stability study, not a diagnostic accuracy study requiring adjudication.
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
An MRMC study was not performed, nor is it applicable to this device. The BÜHLMANN fCAL® turbo is an in vitro diagnostic (IVD) assay for measuring a biomarker, not an AI-assisted diagnostic imaging or interpretation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable in the context of an immunoassay device. The BÜHLMANN fCAL® turbo is a laboratory test, and its performance is evaluated based on its analytical accuracy and precision in quantifying fecal calprotectin. There is no "algorithm only" performance separate from the assay itself.
7. The type of ground truth used
For the stability study, the "ground truth" would be the known and stable concentration of calprotectin in the samples used, measured at multiple time points to assess the stability of the extract over time. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic accuracy study.
8. The sample size for the training set
This information is not provided and is not applicable in the context of this submission. The submission is about extending the shelf-life of an existing device, which involves stability testing, not the development of a new algorithm requiring a "training set."
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the reasons mentioned above.
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February 6, 2024
BUHLMANN Laboratories AG % Roshana Ahmed, M.A., RAC President Quaras, LLC 2101 Camino Rey Fullerton, California 92833
Re: K232057
Trade/Device Name: BÜHLMANN fCAL turbo and CALEX Cap Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal calprotectin immunological test system Regulatory Class: Class II Product Code: NXO Dated: January 29, 2024 Received: January 29, 2024
Dear Roshana Ahmed:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,
Ying Mao -S
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology 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) K232057
Device Name
BÜHLMANN fCAL® turbo and CALEX® Cap
Indications for Use (Describe)
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BUHLMANN fCAL® turbo.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
BÜHLMANN Laboratories AG Baselstrasse 55 Schönenbuch CH-4124 Switzerland Phone: +41 61 487 12 50
Contact Person: Michael Schneider Date Prepared: February 5, 2024
II. Device
| Device Proprietary Name: | BÜHLMANN fCAL® turbo, CALEX® Cap |
|---|---|
| Common or Usual Name: | Fecal calprotectin immunological test system |
| Classification Name: | Calprotectin, Fecal |
| Regulation Number: | 21 CFR 866.5180 |
| Product Code: | NXO |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following device:
- BÜHLMANN fCAL® turbo, K191718, BÜHLMANN Laboratories AG ●
IV. Device Description
The BÜHLMANN fCAL® turbo, a particle-enhanced turbidimetric immunoassay (PETIA), is performed using patient stool extracts collected without preservatives. Calprotectin within the sample extract mediates immunoparticle agglutination; sample turbidity is proportional to calprotectin concentration. The detected light absorbance allows quantification of calprotectin concentration via interpolation of an established calibration curve. The assay is validated for use on clinical chemistry analyzers such as the Roche cobas® c501/c502 platforms.
The BÜHLMANN fCAL® turbo Reagent Kit is to be used in conjunction with the BÜHLMANN fCAL® turbo Calibrator Kit and BÜHLMANN fCAL® turbo Control Kit, which are available separately.
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Sample extracts may be prepared using manual weighing extraction methods or the CALEX® Cap.
The CALEX® Cap is a single use tube filled with extraction buffer. The sampling pin houses a dosing tip which is used to obtain sufficient stool sample for the extraction process. The extraction method leads to stool specimen extracts which can be measured directly using the BÜHLMANN fCAL® turbo assay.
V. Indications for Use
The BÜHLMANN fCAL® turbo is an in vitro diagnostic assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The BÜHLMANN fCAL® turbo aids in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn's disease (CD) and ulcerative colitis (UC) and aids in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other laboratory and clinical findings.
The BÜHLMANN CALEX® Cap is a single use tube intended for the preparation of human stool samples to be used with the BÜHLMANN fCAL® turbo.
VI. Comparison of Technological Characteristics
The subject device is identical to the predicate device with respect to indications for use and technological characteristics. There have been no changes to the assay components or the design of the CALEX® Cap since prior clearance.
The purpose of this submission is to extend the stability of the CALEX® Cap extracts. This change does not raise different questions of safety or effectiveness and is addressed by the information provided within the submission.
VII. Performance Data
Data from analytical and clinical studies from the applicant's own predicate device is leveraged in support of substantial equivalence.
Based on the results of risk assessment, an extract stability study was conducted in accordance with CLSI EP25 to support the shelf-life extension of the CALEX® Cap extracts.
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VIII. Conclusion
The information provided above supports that the BÜHLMANN fCAL® turbo and CALEX® Cap are as safe and effective as the predicate device. The stability study supports the claimed extension to CALEX® Cap extract shelf-life. Therefore, it is concluded that the BÜHLMANN fCAL® turbo and CALEX® Cap are substantially equivalent to the predicate device.
§ 866.5180 Fecal calprotectin immunological test system.
(a)
Identification. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.(b)
Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).