Calprest is a quantitative ELISA for detecting concentration of fecal calprest can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.

Device Description

Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against calprotectin. Calprotectin present in the diluted sample is bound by the antibody adsorbed to the surface of the plastic well. The enzyme conjugated antibody binds to the captured antigen and subsequently the enzyme catalyzes the conversion of the substrate to a colored product. The intensity of the color is proportional to the amount of conjugate bound, and thus to the amount of captured calprotectin. Concentration of calprotectin in the samples is calculated using the provided standards.

EasyCal is a single-use device for stool sample pre-analytical processing that allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG assays.

The device consists of a tube, containing 2.8 ml of extraction solution, a stick shaped with seven grooves for collecting the sample. The upper end is made up by two components which can be removed by opposite rotations. The screw cap (white) connected to the shaped stick traps the sample excess and can be then removed by counter-clockwise rotation. Once the extraction procedure has been completed, the sample can be transferred to an automated ELISA instrumentation, placing it directly into the sample rack. EasyCal allows an easy, reliable and reproducible way to sample from primary containers and analyze the extract directly from the device, without the need to weight the stool sample.

AI/ML Overview

The provided document describes the 510(k) premarket notification for the Calprest device with the EasyCal accessory, a fecal calprotectin immunological test system. This submission primarily focuses on demonstrating that the addition of the EasyCal pre-analytical processing accessory does not negatively impact the performance of the previously cleared Calprest assay.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the requirement for the new device with EasyCal to be "comparable" and "perform equivalently" to the predicate device (Calprest with manual extraction). Specific quantitative acceptance criteria are not explicitly listed in a typical "table" format with pass/fail thresholds for each metric. Instead, the study results are presented, demonstrating agreement or reproducibility within expected analytical variations for laboratory tests.

Here's a breakdown of the reported performance demonstrating equivalence:

Performance Characteristic	Acceptance Criteria (Implied)	Reported Performance
Method Comparison	Equivalence/Comparability of results between EasyCal and Manual Extraction methods (e.g., small bias, high correlation, high qualitative agreement).	Passing-Bablok Regression: - Slope: 1.005 (95% CI: 0.9603 to 1.060) - Y-intercept: -0.3639 (95% CI: -3.977 to 2.056) - Correlation (r): 0.968 - Bias at 120 mg/kg: 0.2% (95% CI: -3.7% to 5.6%) Qualitative Agreement (with 120 mg/kg cutoff): - Total Agreement: 97.0% (95% CI: 91.5 to 99.0%) (Borderline as positive) / 92.0% (95% CI: 85.0 to 95.9%) (Borderline as negative) - Negative Agreement: 96.4% (82.3 to 99.4%) (Borderline as positive) / 94.2% (84.4 to 98.0%) (Borderline as negative) - Positive Agreement: 97.2% (90.4 to 99.2%) (Borderline as positive) / 89.6% (77.8 to 95.5%) (Borderline as negative)
Stool Sample Collection Weight	Consistency in amount of fecal material collected by EasyCal.	Mean stool sample weight collected by EasyCal: 56 mg.
Reproducibility	Acceptable Coefficient of Variation (CV) and Standard Deviation (SD) across different operators, days, and within laboratory.	Within Laboratory CVs: Ranged from 5.9% to 15.9% across 7 samples with varying calprotectin concentrations. (Specific SDs reported for repeatability, between-day, within-operator, between-operator, and within-laboratory). Reproducibility was "confirmed."
Sample Stability (Extracted Stool)	Maintenance of calprotectin concentration in extracted samples over time and freeze/thaw cycles.	All samples "met the acceptance criteria" for: - Storage at 2-8°C: up to 21 days tested (recommendation states "up to 14 days"). - Storage at Room Temperature: up to 73 hours tested (recommendation states "up to 72h"). - Freeze/Thaw Cycles: up to 5 cycles tested (recommendation states "not to exceed 4 freeze-thaw cycles"). Percent recovery was calculated.
EasyCal Device Stability	Maintenance of extraction buffer pH and volume, and no impact on Calprest performance over shelf life and at room temperature.	Shelf Life (Real time stability): pH values between 7.77 and 7.84, volume variation 99.4%-100.6%. All measures "met the acceptance criteria" up to 25 months. The device is stable for 24 months at 4°C and "does not affect Calprest®'s performances." Room Temperature Stability: All acceptance criteria were met for EasyCal stored at room temperature for 72h, confirming it "doesn't affect Calprest® performances."

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

Method Comparison: 100 stool samples.
Stool Sample Collection Performance: 5 different human stool samples, collected in replicates of five (total 25 collections per operator for each sample consistency implicitly).
Reproducibility Study: 7 stool samples, tested in replicate of five, once a day, for five days (5x5x3 scheme), resulting in 75 data points per sample.
Sample Stability and Handling: 8 stool samples.
EasyCal Device Stability (Shelf life): Data on 3 lots of EasyCal devices. Separately, 12 samples extracted with 3 lots of devices stored at 2-8°C for up to 25 months and a freshly produced one.
EasyCal Device Stability (Room Temperature): 6 stool samples extracted with 3 different lots of EasyCal.

Data Provenance: The document does not explicitly state the country of origin for the samples or if the data was retrospective or prospective. Given it's a 510(k) submission for an in vitro diagnostic device, it's highly likely these were laboratory studies using clinical samples collected prospectively for the purpose of validation, or samples obtained from biobanks.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This device is an in-vitro diagnostic (IVD) test for measuring fecal calprotectin concentration. The "ground truth" for such a device is typically the known concentration of an analyte or the established "true" diagnosis or condition based on comprehensive clinical assessment.

For the analytical performance studies (method comparison, reproducibility, stability), the ground truth is implicitly the true calprotectin concentration within the samples. This is established by rigorous laboratory practices, reference methods, and quality control materials, not by human expert consensus on images or clinical cases.
The document mentions "three independent operators" for the stool sample collection performance and "three different operators" for the reproducibility study. These are laboratory personnel performing the assays, not clinical experts establishing a medical "ground truth." Their qualifications are not specified beyond being "operators."

4. Adjudication Method for the Test Set

Not applicable in the typical sense for an IVD test validation like this one. Adjudication methods (like 2+1, 3+1) are common in studies evaluating diagnostic imaging or AI algorithms where subjective human interpretation of complex data (e.g., radiologic images) is involved in establishing ground truth. For an IVD, the assays produce quantitative results, and the comparison is statistical between methods, not between human interpretations of the raw data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. These studies are specifically designed to evaluate the impact of AI on human reader performance, typically in the context of image interpretation (e.g., radiology). This submission is for an IVD kit, which measures a biomarker and does not involve human interpretation of complex images or clinical cases in the same way. The primary comparison is between two methods of sample preparation for the same quantitative assay, not between human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies presented are essentially "standalone" in the sense that they evaluate the analytical performance of the combined "Calprest with EasyCal" system. The system provides a quantitative output (calprotectin concentration). The performance metrics (method comparison, reproducibility, stability) evaluate the accuracy, precision, and reliability of this quantitative output directly, not how it assists a human in a diagnostic task. The "human-in-the-loop" here refers to the laboratory technician performing the test, and the studies confirm the consistency of the results regardless of operator or processing method (EasyCal vs. manual).

7. The Type of Ground Truth Used

The ground truth used for these studies is analytical truth regarding fecal calprotectin concentration in stool samples. This is established by:

Using samples with a "different levels of calprotectin evenly distributed and covering the quantification range" (method comparison).
Performing assays according to established protocols to obtain the most accurate measurement possible for each sample.
Using established statistical methods (e.g., Passing-Bablok regression, CLSI guidelines) for comparing the new method to the predicate method.

It is not based on:

Expert consensus (as in radiology reads).
Pathology (though a clinical diagnosis might correlate with calprotectin levels, the ground truth for the analytical performance is the concentration itself).
Outcomes data (as in long-term patient follow-up).

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of an AI/ML algorithm that requires labeled data for model training. This is a conventional IVD device, not an AI/ML diagnostic tool. The "studies" presented are analytical validation studies, demonstrating the performance of the device itself (measurement accuracy, precision, stability), not for training a predictive model.

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

As there is no AI/ML "training set" in the context of this device, this question is not applicable. The device itself performs the measurement based on a biochemical reaction (ELISA), not a learned algorithm. The ground truth for the analytical validation (as described in point 7) is established through laboratory measurement and comparison to an existing validated method.

Summary

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July 10, 2019

Eurospital S.p.A. Chiara Pelillo Regulatory Affairs Specialist Via Flavia 122 Trieste, 34147 Italy

Re: K191589

Trade/Device Name: Calprest, EasyCal Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal Calprotectin Immunological Test System Regulatory Class: Class II Product Code: NXO Dated: June 11, 2019 Received: June 14, 2019

Dear Chiara Pelillo:

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.

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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 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,

Doug Jeffery, Ph.D. Branch Chief Immunology and Flow Cytometry Branch Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K191589

Device Name Calprest

Indications for Use (Describe)

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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This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

1. Administrative data

Submitter:	Eurospital S.p.A.
Submitter'sAddress:	Via Flavia, 12234147 TriesteItaly
Submitter'scontact:	Mrs Chiara PelilloRegulatory Affairs SpecialistPhone: 0039 0408997266Fax: 0039 040280944Email: cpelillo@eurospital.it
Device name:	Proprietary name: Calprest®Common name: Fecal Calprotectin enzyme-linked immunosorbent assay with EasyCal
RegulationDescription:	Fecal Calprotectin Immunological TestSystem
Regulation MedicalSpecialty	Immunology
Review Panel	Immunology
Product Code	NXO
Regulation Number	21 CFR 866.5180
Device Class	2
Date of 510(k)Preparation:	June 11th, 2019

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2. Predicate device

Calprest® (using manual extraction), 510(k) number K130945. Date of clearance: January 16th, 2014.

3. Device description

The EasyCal kit provides the materials listed below:

One hundred (100) EasyCal kits.
Each tube of EasyCal contains:
2,8 ml of extraction buffer, colorless, ready to use. ●

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4. Intended use and Indications for use

Calprest® is a quantitative ELISA for detecting concentration of fecal calprotectin. Calprest® can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.

ട്. Pre-Analytical Processing

The device object of the present submission is the same in terms of chemical composition, formulation, principle of operations to the device cleared in 2014 (K130945). The change is due to the introduction of the EasyCal, which is an optional single-use device for stool sample pre-analytical processing sold separately from Calprest®. It allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG calprotectin determination assays.

6. Substantial equivalence

The new device and the predicate Device (K130945) have the same Intended Use/Indications for Use, same fundamental technological characteristics, principles of operation and comparable performances characteristics. The modifications consist in the addition of an optional accessory, the EasyCal device, which is a single-use device for stool sample pre-analytical processing as alternative to the manual extraction procedure. It allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprest® and Calprest®NG calprotectin determination assays.

As evidenced by Risk Assessment and Validation Studies, no new questions were raised regarding the Safety, Effectiveness, Performance, Indication for Use, Technology and the Principles of Operation. Therefore, Calprest® in combination with EasyCal as stool extraction device performs equivalently as the predicate device, Calprest® in combination with manual extraction procedure Device.

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7. Comparison to predicate device

Item	New device	Predicate (K130945)
	Calprest® with EasyCal	Calprest®
Intended use	Calprest® is a quantitative ELISA for detecting concentration of fecal calprotectin. Calprest® can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.	Calprest® is a quantitative ELISA for detecting concentration of fecal calprotectin. Calprest® can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD, Crohn's disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
Assay methodology	ELISA	Same
Antigen	Calprotectin	Same
Conjugate	Alkaline phosphatase	Same
Shelf life	18 months	Same
Sample type	Extracted human stool	Same
Sample dilution	1:2500	Same
Sample units	mg/kg (mg of calprotectinper kg of stool)	Same
Detection/ operating principle	Colorimetric assay	Same
Analytical Measuring Range	15.6– 500 mg/kg	Same
Calibration	6 calibrators: 6.25, 12.5, 25, 50, 100, 200 ng/ml	Same
Differences
Item	New device	Predicate (K130945)
	Calprest® with EasyCal	Calprest®
Pre-analyticalprocessingprocedure	Manual extraction procedureorStool extraction procedure usingEasyCal, a tube containing 2.8 mlof extraction solution and a stickshaped with seven grooves forcollecting the sample.	Manual extraction procedure.

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8. Analytical performance characteristics

Same as approved in 510(k) submission #K130945 plus the following additional data.

Stool extraction method comparison: EasyCal vs manual extraction 8.1. procedure

One hundred (100) stool samples containing different levels of calprotectin evenly distributed and covering the quantification range of Calprest®, were extracted in parallel with the EasyCal and using the manual extraction procedure. All the extracted stool samples were tested in duplicate for calprotectin concentration using the Calprest® assay according to the package insert. The following parameters were analyzed with Passing-Bablok regression and Analyse-it software: intercept, slope, predicted bias at cut-off, 95% CI, correlation index (r). The study was conducted according to the CLSI EP09c "Measurement Procedure Comparison and Bias Estimation Using Patient Samples, 3rd Edition" (June 2018)

The results are summarized in the table below:

Table 1. Method comparison Calprest® with EasyCal (y) versus Calprest® with manual extraction procedure (x)

Passing-Bablok regression	Calprest® with EasyCal = -0.3639 + 1.005Calprest® manual extraction procedure
Slope (95% CI)	1.005 (0.9603 to 1.060)
Y-intercept (95% CI)	-0.3639 (-3.977 to 2.056)
Correlation - r	0.968
Bias at 120 mg/kg (95% CI)	0.2% (-3.7% to 5.6%)

Qualitative agreement Calprest with EasyCal versus Calprest with manualweight
		Calprest with EasyCal
Calprest with manualweight		Borderline	Negative	Positive	Total
Borderline		19	2	3	24
Negative		1	27	0	28
Positive		5	0	43	48
Total		25	29	46	100

		Borderline as positive
	Negative Agreement (95% CI)	96.4% (82.3 to 99.4%)
	Positive Agreement (95% CI)	97.2% (90.4 to 99.2%)
	Total Agreement (95% CI)	97.0% (91.5 to 99.0%)
		Borderline as negative
	Negative Agreement (95% CI)	94.2% (84.4 to 98.0%)
	Positive Agreement (95% CI)	89.6% (77.8 to 95.5%)
	Total Agreement (95% CI)	92.0% (85.0 to 95.9%)

The results demonstrate that the performances of Calprest® with EasyCal is comparable to Calprest® with manual extraction procedure.

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8.2. Stool sample collection performance of EasyCal

To validate the amount of fecal material that is collected by the EasyCal, five different human stool samples, encompassing different stool consistencies, were collected using EasyCal in replicates of five by three independent operators. Data were analyzed with Analyse-it software to calculate weight distribution.

The results obtained confirm that the stool sample mean weight collected by EasyCal is 56 mg.

8.3. Reproducibility study: Extraction Reproducibilitv

Seven (7) stool samples covering the quantification range of Calprest® assay were extracted and tested in replicate of five, once a day, for five days, by three different operators (scheme 5x5x3).

CV(%) and standard deviation were calculated for each set of analysis performed with Analyse-it software.

Faecal extracts tested with Calprest®
			Repeatability		Between-Day		Within Operator		BetweenOperator		WithinLaboratory
Sample ID	N	Mean(mg/kg)	SD(mg/kg)	CV(%)	SD(mg/kg)	CV(%)	SD(mg/kg)	CV(%)	SD(mg/kg)	CV(%)	SD(mg/kg)	CV(%)
Sample 1	75	17.00	0.56	3.3%	0.84	4.9%	1.01	5.9%	0.00	0.0%	1.01	5.9%
Sample 2	75	54.14	1.96	3.6%	5.86	10.8%	6.18	11.4%	0.00	0.0%	6.18	11.4%
Sample 3	75	80.72	3.72	4.6%	6.46	8.0%	7.45	9.2%	6.23	7.7%	9.71	12.0%
Sample 4	75	129.55	12.26	9.5%	13.32	10.3%	18.10	14.0%	7.96	6.1%	19.77	15.3%
Sample 5	75	213.75	11.34	5.3%	20.14	9.4%	23.11	10.8%	6.97	3.3%	24.14	11.3%
Sample 6	75	232.23	23.59	10.2%	11.27	4.9%	26.14	11.3%	25.99	11.2%	36.86	15.9%
Sample 7	75	434.16	40.46	9.3%	39.21	9.0%	56.35	13.0%	17.55	4.0%	59.02	13.6%

The study was conducted according to the CLSI EP05A3 "Evaluation of Precision of Quantitative Measurement Procedures, 3rd Edition" (October 2014).

Reproducibility of results obtained with Calprest® with EasyCal is confirmed.

Samples stability and handling 8.4.

Eight (8) stool samples covering the quantification range of Calprest® assay were extracted with EasyCal and tested, using Calprest® assay, for stability of the extracted stool sample at 2-8 °C up to 21 days (day 0, day 1, day 3, day 7, day 14 and day 21), at room temperature up to 73h (0h, 16h, 24h, 48h, 72h and 73h) and after up to 5 freeze/thaw cycles (0 cycle, 1 cycle, 2 cycles, 4 cycles and 5 cycles). Data related to the extracted stool samples were analyzed compared to those obtained at time zero/cycle zero and the percentage of recovery was calculated.

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All samples met the acceptance criteria at 21 days, 73 hours and after five cycle of freeze-thaw, therefore, the extracted stool samples in the EasyCal can be stored: up to 14 days at 2-8 °C and up to 72h at RT. Even though after five freeze-thaw cycles all samples met the acceptance criteria, we recommend not to exceed 4 freeze-thaw cycles to remain in a safety stability condition.

8.5. EasyCal device stability

8.5.1. Shelf life (Real time stability study)

To evaluate the real time stability of EasyCal, pH values for the extraction buffer were assessed and variation of the volume (evaporation) was verified by weighting the devices at time zero and up to 25 months (0; 7; 13; 19; 24 and 25 months) on three lots. Data were compared to those obtained at time zero.

The pH measures were between 7.77 and 7.84 (mean 7.80) and volume variation expressed in percentage was between 99.4% and 100.6% (mean 100.0%); all measures met the acceptance criteria up to 25 months.

Additionally, to confirm that EasyCal stability guarantees no changes in Calprest® s performances, twelve (12) samples were extracted with three lots of EasyCal stored at 2-8 °C up to 25 months (24 and 25 months) and with a freshly produced one for comparison. The extracted stool samples were tested using Calprest® assay.

All acceptance criteria were met at 25 months, therefore the EasyCal device is stable for 24 months when kept at 4 °C and does not affect Calprest®'s performances.

Calprest® performances with EasyCal stored at room temperature 8.5.2.

Six (6) stool samples, covering the quantification range of Calprest® assay, were extracted with three different lots of EasyCal stored at 2-8 °C or at room temperature up to 73h and tested using Calprest® assay. The results obtained with the EasyCal stored at room temperature were compared to those obtained with the EasyCal stored at 2-8 °C and the percentage of recovery calculated.

All acceptance criteria were met, therefore, the device is stable for 72h at room temperature and doesn't affect Calprest® performances.

9. Clinical performance characteristics

Same as approved in 510(k) submission # K130945

10. Conclusions

The Calprest®, with EasyCal is a modification of existing and legally marketed IVD device Calprest®. The modification consist in the introduction of a stand-alone optional accessory, the EasyCal , which is a single-use device for stool sample pre-analytical processing. It allows the extraction of calprotectin from the specific amount of collected fecal sample required to perform Eurospital's Calprotectin determination assays. This modification does not affect their intended use either the technological characteristics of the cleared Calprest® assay (K130945)

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Image /page/11/Picture/1 description: The image shows the word "Eurospital" in a blue sans-serif font. To the right of the word is a graphic of curved lines in shades of blue and green. The lines appear to be stylized representations of waves or medical symbols. The overall design is clean and modern, suggesting a healthcare or medical-related company.

The design validation of Calprest® plus EasyCal has been performed following same standards and verification-validation testing already approved for Calprest®.

The IVD medical device design validation revealed compliant and without affecting the requirements of safety and effectiveness of Calprest®.

Therefore, the Calprest® plus EasyCal is substantially equivalent to the cleared Calprest® (K130945).

Regulation Number and Section

§ 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).