BÜHLMANN fCAL® turbo and CALEX® Cap

K232057 · Bühlmann Laboratories AG · NXO · Feb 6, 2024 · Immunology

Device Facts

• Record ID: K232057
• Device Name: BÜHLMANN fCAL® turbo and CALEX® Cap
• Applicant: Bühlmann Laboratories AG
• Product Code: NXO · Immunology
• Decision Date: Feb 6, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5180
• Device Class: Class 2

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 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.

Device Story

BÜHLMANN fCAL® turbo is a particle-enhanced turbidimetric immunoassay (PETIA) for quantifying fecal calprotectin in human stool. Stool samples are prepared using the CALEX® Cap, a single-use tube containing extraction buffer and a dosing pin. During the assay, calprotectin in the extract mediates immunoparticle agglutination; resulting turbidity is proportional to calprotectin concentration. The device is used on clinical chemistry analyzers (e.g., Roche cobas® c501/c502) in clinical laboratory settings. Analyzers measure light absorbance and interpolate results against a calibration curve. Healthcare providers use these quantitative results alongside other clinical and laboratory findings to diagnose IBD and differentiate it from IBS, facilitating appropriate patient management.

Clinical Evidence

No new clinical data provided. Substantial equivalence is supported by analytical stability testing conducted in accordance with CLSI EP25 to validate the shelf-life extension of CALEX® Cap extracts, leveraging existing performance data from the predicate device.

Technological Characteristics

Particle-enhanced turbidimetric immunoassay (PETIA). Components include reagent kit, calibrator kit, and control kit. Sample preparation via CALEX® Cap single-use tube with dosing pin. Validated for use on clinical chemistry analyzers (e.g., Roche cobas® c501/c502).

Indications for Use

Indicated for patients requiring quantitative measurement of fecal calprotectin to aid in the diagnosis of IBD (Crohn's disease and ulcerative colitis) and differentiation of IBD from IBS.

Regulatory Classification

Identification

A fecal calprotectin immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended for in 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.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.5180 with special controls. The special control guidance document, "Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems" will be available shortly.

*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).

Predicate Devices

• BÜHLMANN fCAL® turbo (K191718)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K232057

B Applicant

BÜHLMANN Laboratories AG

C Proprietary and Established Names

BÜHLMANN fCAL turbo and CALEX Cap

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| NXO | Class II | 21 CFR 866.5180 - Fecal Calprotectin Immunological Test System | IM - Immunology |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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This change was for extension of CALEX Cap extract stability: up to 15 days at 2–8°C and up to 2 days (48 hours) at 18–28°C.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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