CalprestNG, EasyCal

K191592 · Eurospital S.P.A. · NXO · Jul 10, 2019 · Immunology

Device Facts

• Record ID: K191592
• Device Name: CalprestNG, EasyCal
• Applicant: Eurospital S.P.A.
• Product Code: NXO · Immunology
• Decision Date: Jul 10, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.5180
• Device Class: Class 2

Indications for Use

The CalprestNG is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of calprotectin in human stool samples. It is intended as an aid in the diagnosis of inflammatory gastrointestinal disorders.

Device Story

Calprest®NG is a quantitative ELISA for fecal calprotectin detection. The system uses antibodies against calprotectin adsorbed to plastic wells; enzyme-conjugated antibodies bind captured antigen; substrate conversion produces color proportional to calprotectin concentration. EasyCal is an optional, single-use pre-analytical accessory consisting of a tube with 2.8 mL extraction buffer and a grooved stick for stool collection. It eliminates the need for manual weighing of stool samples. The device is used in clinical laboratories; operators include technicians or laboratory staff. The output is a quantitative concentration (mg/kg) of calprotectin. Healthcare providers use these results alongside clinical and laboratory findings to diagnose IBD and differentiate it from IBS, potentially reducing the need for invasive diagnostic procedures.

Clinical Evidence

No new clinical diagnostic studies were performed. Bench testing included a method comparison study (n=100 stool samples) between EasyCal and manual extraction, showing a correlation (r) of 0.954 and a slope of 0.9778. Qualitative agreement (borderline as positive) showed 99.0% total agreement. Precision/reproducibility studies (5x5x3 scheme) confirmed performance across the quantification range. Stability studies confirmed EasyCal shelf life (24 months at 4°C) and extracted sample stability.

Technological Characteristics

ELISA-based immunological test system. Modification includes EasyCal accessory for fecal sample extraction. Fundamental technology (calprotectin quantification) remains consistent with predicate. No changes to energy source or software.

Indications for Use

Indicated for the quantitative determination of calprotectin in human stool samples to aid in the diagnosis of inflammatory gastrointestinal disorders in patients suspected of having such conditions.

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

• Calprest®NG (K160447)

Submission Summary (Full Text)

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
www.fda.gov

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number
K191592

B Applicant
Eurospital S.p.A.

C Proprietary and Established Names
CalprestNG, EasyCal

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.
K160447 CalprestNG

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).

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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**.

This change was for addition of an optional accessory, the EasyCal, to the cleared device, CalprestNG. The EasyCal allows extraction of calprotectin from the specific amount of collected fecal sample required to perform the CalprestNG assay.

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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