(26 days)
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No
The device description and performance studies focus on a standard ELISA assay and a pre-analytical sample processing device. There is no mention of AI or ML in the text.
No
The device is an in vitro diagnostic (IVD) used to detect fecal calprotectin, aiding in the diagnosis of Inflammatory Bowel Diseases (IBD). It is a diagnostic tool, not a therapeutic device designed for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "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)".
No
The device description clearly outlines a physical device (tube, stick, cap) used for sample collection and processing, which is a hardware component. The ELISA system is also a hardware-based diagnostic method.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that 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." This clearly defines its purpose as a diagnostic tool used outside of the body.
- Device Description: The description details an ELISA system that analyzes a fecal sample to detect and quantify calprotectin. This process is performed in vitro (in a lab setting). The EasyCal device is described as a pre-analytical processing tool for the stool sample, which is part of the overall in vitro diagnostic workflow.
- Intended User / Care Setting: The document lists "in vitro diagnostic" as the intended user/care setting, further confirming its classification.
- Performance Studies: The performance studies described involve testing fecal samples in a laboratory setting to evaluate the device's accuracy and reliability in measuring calprotectin levels, which is characteristic of IVD validation.
- Predicate Device: The mention of a predicate device (K130945; Calprest® using manual extraction) indicates that this device is being compared to an existing, cleared IVD.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NXO
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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stool extraction method comparison: EasyCal vs manual extraction procedure:
Study type: Method comparison
Sample size: One hundred (100) stool samples
Key results: The results demonstrate that the performances of Calprest® with EasyCal is comparable to Calprest® with manual extraction procedure.
Stool sample collection performance of EasyCal:
Study type: Validation study for amount of fecal material collected
Sample size: Five (5) different human stool samples, in replicates of five by three independent operators.
Key results: The results obtained confirm that the stool sample mean weight collected by EasyCal is 56 mg.
Reproducibility study: Extraction Reproducibility:
Study type: Reproducibility study
Sample size: Seven (7) stool samples, extracted and tested in replicate of five, once a day, for five days, by three different operators (scheme 5x5x3).
Key results: Reproducibility of results obtained with Calprest® with EasyCal is confirmed.
Samples stability and handling:
Study type: Stability study
Sample size: Eight (8) stool samples
Key results: 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.
EasyCal device stability (Shelf life - Real time stability study):
Study type: Real time stability study
Sample size: Three lots of EasyCal used for pH and volume variation assessment. Twelve (12) samples extracted with three lots of EasyCal for performance confirmation.
Key results: 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:
Study type: Stability study
Sample size: Six (6) stool samples
Key results: All acceptance criteria were met, therefore, the device is stable for 72h at room temperature and doesn't affect Calprest® performances.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Stool extraction method comparison:
Passing-Bablok regression: Calprest® with EasyCal = -0.3639 + 1.005 Calprest® 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 (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%)
Qualitative Agreement (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%)
Reproducibility study:
Sample 1: Mean (mg/kg) 17.00, Repeatability CV (%) 3.3%, Between-Day CV (%) 4.9%, Within Operator CV (%) 5.9%, Between Operator CV (%) 0.0%, Within Laboratory CV (%) 5.9%
Sample 2: Mean (mg/kg) 54.14, Repeatability CV (%) 3.6%, Between-Day CV (%) 10.8%, Within Operator CV (%) 11.4%, Between Operator CV (%) 0.0%, Within Laboratory CV (%) 11.4%
Sample 3: Mean (mg/kg) 80.72, Repeatability CV (%) 4.6%, Between-Day CV (%) 8.0%, Within Operator CV (%) 9.2%, Between Operator CV (%) 7.7%, Within Laboratory CV (%) 12.0%
Sample 4: Mean (mg/kg) 129.55, Repeatability CV (%) 9.5%, Between-Day CV (%) 10.3%, Within Operator CV (%) 14.0%, Between Operator CV (%) 6.1%, Within Laboratory CV (%) 15.3%
Sample 5: Mean (mg/kg) 213.75, Repeatability CV (%) 5.3%, Between-Day CV (%) 9.4%, Within Operator CV (%) 10.8%, Between Operator CV (%) 3.3%, Within Laboratory CV (%) 11.3%
Sample 6: Mean (mg/kg) 232.23, Repeatability CV (%) 10.2%, Between-Day CV (%) 4.9%, Within Operator CV (%) 11.3%, Between Operator CV (%) 11.2%, Within Laboratory CV (%) 15.9%
Sample 7: Mean (mg/kg) 434.16, Repeatability CV (%) 9.3%, Between-Day CV (%) 9.0%, Within Operator CV (%) 13.0%, Between Operator CV (%) 4.0%, Within Laboratory CV (%) 13.6%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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.
| 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's | |
| Address: | Via Flavia, 122 |
| 34147 Trieste | |
| Italy | |
| Submitter's | |
| contact: | Mrs Chiara Pelillo |
| Regulatory Affairs Specialist | |
| Phone: 0039 0408997266 | |
| Fax: 0039 040280944 | |
| Email: cpelillo@eurospital.it | |
| Device name: | Proprietary name: Calprest® |
| Common name: Fecal Calprotectin enzyme- | |
| linked immunosorbent assay with EasyCal | |
| Regulation | |
| Description: | Fecal Calprotectin Immunological Test |
| System | |
| Regulation Medical | |
| Specialty | 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
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.
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-analytical | ||
| processing | ||
| procedure | Manual extraction procedure | |
| or | ||
| Stool extraction procedure using | ||
| EasyCal, a tube containing 2.8 ml | ||
| of extraction solution and a stick | ||
| shaped with seven grooves for | ||
| collecting the sample. | Manual extraction procedure. |
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Image /page/8/Picture/1 description: The image shows the Eurospital logo. The word "Eurospital" is written 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 plants or waves.
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 + 1.005
Calprest® 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 manual
| weight | |||||
|---|---|---|---|---|---|
| Calprest with EasyCal | |||||
| Calprest with manual | |||||
| weight | 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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Image /page/9/Picture/1 description: The image shows the logo for Eurospital. The word "Eurospital" is written in a sans-serif font in blue. To the right of the word is a graphic of curved lines in blue and green. The lines appear to be stylized waves or leaves.
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 | Between | |||||||||
| Operator | Within | |||||||||||
| Laboratory | ||||||||||||
| 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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Image /page/10/Picture/1 description: The image shows the Eurospital logo. The word "Eurospital" is written 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 wind.
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).