(287 days)
Calprest® is a quantitative ELISA for detecting the concentration of fecal calprest@can be used as an in-vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other laboratory findings.
Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against 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.
Here's a breakdown of the acceptance criteria and study information for the CALPREST® device, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the CALPREST® device are not explicitly stated as distinct acceptance criteria in the document. Instead, the performance characteristics are presented as the results of the studies conducted. Therefore, I will present the reported performance, which implicitly serves as the "met acceptance criteria" based on the FDA's clearance.
Key Performance Characteristics of CALPREST®
| Performance Metric | Reported Device Performance - Borderline considered Positive | Reported Device Performance - Borderline considered Negative |
|---|---|---|
| Clinical Performance (vs. IBD) | ||
| Sensitivity | 96.9% (95% CI 91.3% - 99.4%) | 79.6% (95% CI 70.3% - 87.1%) |
| Specificity | 85.0% (95% CI 70.2% - 94.3%) | 92.5% (95% CI 79.6% - 98.4%) |
| Positive Predictive Value (PPV) | 94.1% (95% CI 87.5% - 97.8%) | 96.3% (95% CI 89.6% - 99.2%) |
| Negative Predictive Value (NPV) | 91.9% (95% CI 78.1% - 98.3%) | 64.9% (95% CI 51.1% - 77.1%) |
| Method Comparison (vs. PhiCal™ Test) | (Borderline considered Positive) | (Borderline considered Negative) |
| Positive Agreement | 94.9% (95% C.I. 87.4% - 98.6%) | 91.5% (95% C.I. 79.6% - 97.6%) |
| Negative Agreement | 98.1% (95% C.I. 89.9% - 100.0%) | 97.6% (95% C.I. 91.7% - 99.7%) |
| Overall Agreement | 96.2% (95% C.I. 91.3% - 98.7%) | 95.4% (95% C.I. 90.3% - 98.3%) |
| Deming Regression Analysis (y: Calprest, x: PhiCal) | ||
| Slope | 0.98 (0.96 to 1.01) | |
| Y-intercept | -1.85 (-3.96 to 0.96) | |
| Reproducibility/Precision | ||
| Extraction Reproducibility (% CV) | 7.0 - 13.6% | |
| Intra-assay Precision (% CV) | 3.3 - 12.4% | |
| Inter-assay Precision (% CV) | 7.7 - 12.4% | |
| Inter-lot Precision (% CV) | 3.1 - 12.4% | |
| Site-to-site Precision (% CV) | 3.1 - 10.4% | |
| Linearity | ||
| Matrix Linearity (R^2) | 0.9946 | |
| Aqueous Linearity (R^2) | 0.9990 | |
| % Recovery Rate | 87.0% to 113.2% (Matrix); 95.2% to 109.3% (Aqueous) | |
| Calprotectin Recovery | 100.5% - 113.4% | |
| LoB and LoD | LoB = 3.04 mg/kg; LoD = 3.98 mg/kg | |
| Interference Testing | No interferences observed (for tested substances) |
2. Sample Sizes and Data Provenance
- Clinical Performance Test Set:
- Sample Size: 138 samples (98 IBD positive, 40 IBD negative).
- Data Provenance: Not explicitly stated (e.g., country of origin). The study appears to be retrospective as it's a diagnostic test comparing against an established diagnosis.
- Method Comparison Test Set (vs. PhiCal™ Test):
- Sample Size:
- "Borderline considered Positive" comparison: 131 samples (78 positive, 53 negative by PhiCalTM). This implies 75 Calprest positive and 56 Calprest negative.
- "Borderline considered Negative" comparison: 131 samples (47 positive, 84 negative by PhiCalTM). This implies 45 Calprest positive and 86 Calprest negative.
- Data Provenance: Not explicitly stated. Likely retrospective samples used for a comparative study.
- Sample Size:
- Other Studies (reproducibility, linearity, recovery, interference): Sample sizes vary by study (e.g., 3 samples for extraction reproducibility, multiple pools for linearity and interference, 8 samples for intra/inter-assay precision, 7 samples for recovery), but detailed provenance is not specified.
3. Number of Experts and Qualifications (Ground Truth)
- Clinical Performance: Not explicitly stated in the document. For "aid in the diagnosis of Inflammatory Bowel Diseases (IBD...)" and "differentiate IBD from Irritable Bowel Syndrome (IBS)", the ground truth (IBD vs. non-IBD) would typically be established by clinical diagnosis, potentially involving a multidisciplinary team of gastroenterologists, endoscopists, pathologists, etc. However, the exact number and qualifications of experts for defining the IBD status of the 138 samples are not provided.
- Method Comparison: The ground truth for this comparison is the performance of the predicate device, PhiCal™ Test, which itself is a Fecal calprotectin immunological test system.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method for the clinical performance test set (e.g., for resolving discrepancies in IBD diagnosis). The IBD diagnosis is treated as a given "ground truth" against which the device's performance is measured. For the method comparison, the "ground truth" is the result from the predicate device, PhiCal™ Test, thus no adjudication between readers/methods is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned. This device is an in-vitro diagnostic (IVD) test, not an image-based AI device designed for human-in-the-loop assistance in analysis. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable in this context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies presented are all standalone performance evaluations of the CALPREST® assay. As an ELISA system, it is an automated laboratory test, and its performance metrics (sensitivity, specificity, precision, linearity, etc.) are inherent to the algorithm/assay itself, without requiring human-in-the-loop adjustments or interpretations beyond standard lab procedures.
7. Type of Ground Truth Used
- Clinical Performance: The ground truth for the clinical performance study is the clinical diagnosis of Inflammatory Bowel Diseases (IBD), presumably established by standard medical diagnostic procedures (e.g., endoscopy, biopsies with pathology, clinical symptoms, and other laboratory findings) in distinguishing IBD from Irritable Bowel Syndrome (IBS).
- Method Comparison: The ground truth for the method comparison is the results obtained from the predicate device, PhiCal™ Test.
- Other Studies (reproducibility, linearity, recovery): Ground truth is typically established by reference methods, known concentrations/spikes, or ideal theoretical values.
8. Sample Size for the Training Set
The document is a 510(k) summary for an ELISA-based IVD, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of machine learning does not directly apply here. The device's calibration curves and assay parameters would be established during its development and manufacturing, using various samples (e.g., calibrators, controls, characterized clinical samples) but not typically referred to as a "training set" in the sense of AI. The provided information focuses on validation and clinical performance rather than a separate "training" phase.
9. How the Ground Truth for the Training Set Was Established
As mentioned above, the concept of a "training set" in the AI sense is not applicable. The assay's parameters (e.g., standard curve for concentration calculation) are established using known concentrations of calprotectin standards provided with the kit. These standards would have their "ground truth" concentration established through rigorous analytical measurement and manufacturing processes.
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510 (k) Summary
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.
The assigned 510(k) number is: K130945
.
-
- Submitter's name, address, telephone, contact person, and the date the summary was prepared:
| Submitter's Name: | Eurospital S.p.A. |
|---|---|
| Submitter's Address: | Via Flavia, 12234147 TriesteItaly |
| Submitter's Telephone Number: | Tel. +39 0408997269 |
| Submitter's Contact Name: | Dr. Claudio G. Frattini, Technical Director |
| Date of 510(k) Preparation: | February 29, 2013 |
- Name of the device, including the trade or proprietary name, the common or usual name and the classification name:
| Proprietary Name: | CALPREST® |
|---|---|
| Common Name: | Fecal calprotectin immunological test system |
| Classification Name: | Calprotectin, Fecal; 21 CFR 866.5180;Class IIProduct Code: NXO |
3. Identification of the legally marketed device to which the substantial equivalence:
PhiCal™ Test Predicate Device Name: 510(k) Number: K050007 Regulation Number: 21CFR866.5180 Requlation Class: Class II Distributed By: Genova Diagnostics Ashville, NC
4. Description of the device
Calprest® is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of polyclonal antibody against 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.
5. Statement of the intended use of the device
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Calprest® is a quantitative ELISA for detecting concentration Device Intended Use: of faecal 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.
6. Summary of the technological characteristics of the device
Calprest ® is identical to PhiCal™ Test in that they are manufactured by Eurospital S.p.A. Trieste, Italy. The only differences are the name of the labels, the number of calibrators in the kit and the dynamic range of the assay.
7. Summary of performance characteristics
7.1 Expected Values
| Calprotectin Concentration | Interpretation | Follow-Up |
|---|---|---|
| <15.6 - 50 mg/kg | Normal | None |
| 50 - 120 mg/kg | Borderline | Re-evaluate at 4-6 weeks |
| >120 mg/kg | Abnormal | Repeat as clinically indicated |
7.2 Clinical Performance
| Borderline consideredPositive | IBD | Total | |
|---|---|---|---|
| Positive | Negative | ||
| Positive | 95 | 6 | 101 |
| Calprest®Negative | 3 | 34 | 37 |
| Total | 98 | 40 | 138 |
| Sensitivity | 96.9% | (95% CI 91.3% - 99.4%)§ | |
| Specificity | 85.0% | (95% CI 70.2% - 94.3%) | |
| PPV* | 94.1% | (95% CI 87.5% - 97.8%) | |
| NPV** | 91.9% | (95% CI 78.1% - 98.3%) |
| Borderline consideredNegative | IBD | Total | ||
|---|---|---|---|---|
| Positive | Negative | |||
| Calprest® | Positive | 78 | 3 | 81 |
| Negative | 20 | 37 | 57 | |
| Total | 98 | 40 | 138 | |
| Sensitivity | 79.6% | (95% CI 70.3% - 87.1%)§ | ||
| Specificity | 92.5% | (95% CI 79.6% - 98.4%) | ||
| PPV* | 96.3% | (95% CI 89.6% - 99.2%) | ||
| NPV** | 64.9% | (95% CI 51.1% - 77.1%) |
PPV: Positive Predictive Value *
** NPV: Negative Predictive Value
ತೆ CI: Confidence Interval
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7.3 Extraction Reproducibility
Values are reported in mg/kg
| Extracted stool sampleNo. | 1 | 2 | 3 |
|---|---|---|---|
| Mean (mg/kg) | 28.4 | 41.1 | 79.4 |
| SD | 3.9 | 3.7 | 5.6 |
| % CV | 13.6 | 8.9 | 7.0 |
7.4 Comparison
7.4.1 Device Comparison
Calprest®, code 9031 manufactured by Eurospital S.p.A. Reagents:
PhiCal Test - FDA 510(k) – K050007 manufactured by Eurospital S.p.A. Predicate device:
| Similarities | ||
|---|---|---|
| Item | New device | Predicate (K050007)PhiCal Test code 9053 |
| Calprest®, code 9031 | ||
| Intended use | to aid in the diagnosis of InflammatoryBowel Diseases (IBD, Crohn'sdisease and ulcerative colitis) and todifferentiate IBD from Irritable BowelSyndrome (IBS) in conjunction withother clinical and laboratory findings. | Same |
| Technology | ELISA | Same |
| Antigen | Calprotectin | Same |
| Assay format | Quantitative | Same |
| Positive and Negative controls | Ready to use | Same |
| Sample type | stool | Same |
| Sample dilution | 1:2500 | Same |
| Incubation time | 45-45-30 minutes at RT | Same |
| Sample volume | 1-5 g stool | Same |
| Extraction solution | 2,5x concentrate | Same |
| Sample buffer diluent | 10x concentrate | Same |
| Wash buffer | 20x concentrate | Same |
| Conjugate | Alkaline phosphatase | Same |
| Substrate | pNPP | Same |
| Platform | 96 well microtiter plate | Same |
| OD Reading | 405 nm | Same |
| Cut-off | 50 mg/kg (μg/g) | Same |
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| Differences | ||
|---|---|---|
| Item | New device | Predicate (K050007) |
| Calprest®, code 9031 | PhiCal Test, code 9053 | |
| Calibrators | 6 levels:6.25, 12.5, 25, 50, 100, 200 ng/ml | 5 levels:6.25, 12.5, 25, 50, 100 ng/ml |
7.4.2 Method Comparison
| Borderline Value considered as Positive | |||||
|---|---|---|---|---|---|
| PhiCalTM | |||||
| Pos | Neg | ||||
| Calprest® | Pos | 74 | 1 | 75 | |
| Neg | 4 | 52 | 56 | ||
| 78 | 53 | ||||
| Positive Agreement | 94.9% | (95% C.I. 87.4% - 98.6%) | |||
| Negative Agreement | 98.1% | (95% C.I. 89.9% - 100.0%) | |||
| Overall agreement | 96.2% | (95% C.I. 91.3% - 98.7%) |
| Borderline Value considered as Negative | ||||
|---|---|---|---|---|
| PhiCalTM | ||||
| Pos | Neg | |||
| Calprest® | Pos | 43 | 2 | 45 |
| Neg | 4 | 82 | 86 | |
| 47 | 84 | |||
| Positive Agreement | 91.5% | (95% C.I. 79.6% - 97.6%) | ||
| Negative Agreement | 97.6% | (95% C.I. 91.7% - 99.7%) | ||
| Overall agreement | 95.4% | (95% C.I. 90.3% - 98.3%) |
Deming Regression Analysis (y: Calprest, x: PhiCal):
| Slope (95% CI) | Y-intercept (95% CI) | |
|---|---|---|
| $y=0.98x-1.85$ | 0.98 (0.96 to 1.01) | -1.85 (-3.96 to 0.96) |
7.5 Intra-assay Precision
Values are reported in mg/kg
| Extracted stoolsample No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
|---|---|---|---|---|---|---|---|---|
| Mean (mg/kg) | 438.7 | 355.2 | 352.9 | 311.7 | 199.9 | 125.7 | 57.8 | 27.7 |
| SD | 33.7 | 43.0 | 43.7 | 38.8 | 6.6 | 9.8 | 2.9 | 1.0 |
| % CV | 7.7 | 12.1 | 12.4 | 12.4 | 3.3 | 7.8 | 5.0 | 3.7 |
7.6 Inter-assay Precision
Values are reported in mg/kg
| Extracted stoolsample No. | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 |
|---|---|---|---|---|---|---|---|---|
| Mean (mg/kg) | 359.9 | 209.8 | 185.5 | 117.0 | 70.4 | 48.8 | 40.9 | 20.6 |
| SD | 27.5 | 17.8 | 17.8 | 9.3 | 6.8 | 4.5 | 3.4 | 2.6 |
| % CV | 7.7 | 8.5 | 9.6 | 8.0 | 9.6 | 9.3 | 8.2 | 12.4 |
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7.7 Inter-lot Precision
| Lot # 5637 | Lot # 5888 | Lot # 5488 | Overall | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Extracted stoolsample No | Mean(mg/kg) | %CV | Mean(mg/kg) | %CV | Mean(mg/kg) | %CV | Mean(mg/kg) | SD | %CV |
| 1 | 106.1 | 5.2 | 103.2 | 2.8 | 113.9 | 1.3 | 107.7 | 5.779 | 5.4 |
| 2 | 63.4 | 4.7 | 60.4 | 2.2 | 65.5 | 6.8 | 63.1 | 3.682 | 5.8 |
| 3 | 185.0 | 3.5 | 177.7 | 13.3 | 192.6 | 0.8 | 185.1 | 14.545 | 7.9 |
| 4 | 44.0 | 2.3 | 43.5 | 4.2 | 43.8 | 3.2 | 43.8 | 1.358 | 3.1 |
| 5 | 36.5 | 3.9 | 38.2 | 7.3 | 33.2 | 7.2 | 36.0 | 3.001 | 8.3 |
| 6 | 354.6 | 13.6 | 340.2 | 13.7 | 340.0 | 12.0 | 344.9 | 42.615 | 12.4 |
7.8 Site-to-site precision
| Sample# | Actual value mg/kg | Site 1 mg/kg | Site 2 mg/kg | Site 3 mg/kg | Mean (mg/kg) | St. Dev. | CV% | Delta % |
|---|---|---|---|---|---|---|---|---|
| G52 | 28.0 | 27.7 | 33.3 | 28.2 | 29.7 | 3.094 | 10.4% | 106% |
| G44 | 66.0 | 74.1 | 66.7 | 69.4 | 70.1 | 3.770 | 5.4% | 106% |
| G11 | 101.0 | 102.1 | 99.9 | 106.2 | 102.7 | 3.210 | 3.1% | 102% |
| G04 | 160.0 | 157.6 | 169.2 | 161.1 | 162.6 | 5.982 | 3.7% | 102% |
| G16 | 349.0 | 332.8 | 356.0 | 326.1 | 338.3 | 15.659 | 4.6% | 97% |
| G54 | 557.0 | 510.8 | 565.6 | 550.4 | 542.2 | 28.255 | 5.2% | 97% |
7.9 Linearity
7.9.1 Matrix Linearity
Image /page/4/Figure/6 description: The image is a graph titled "Matrix Linearity Calprest - Pool 1". The graph plots observed values (ug/g) on the y-axis against theoretical values (ug/g) on the x-axis. A line of best fit is plotted on the graph, and the equation for the line is y = 1.0126x - 3.7769, with an R-squared value of 0.9946.
| PoolNo. | Test Range(µg/g) | Slope(95% CI) | Y-intercept(95% CI) | R2 | % Recovery Rate(Obtained/Theoretical) |
|---|---|---|---|---|---|
| 1 | 20.4 to 492.8 | 1.0126(0.9461 to 1.079) | -3.777(-23.85 to 16.29) | 0.9946 | 87.0% to 113.2% |
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7.9.1 Agueous Linearity
Image /page/5/Figure/1 description: The image is a graph titled "Calprotectin Aqueous Linearity". The graph plots observed values in mg/kg on the y-axis against theoretical values in mg/kg on the x-axis. A line of best fit is plotted on the graph, with the equation y = 0.9853x + 2.714 and an R-squared value of 0.999.
| Sample No. | Test Range (µg/g) | Slope (95% CI) | Y-intercept (95% CI) | R2 | % Recovery Rate (Obtained/Theoretical) |
|---|---|---|---|---|---|
| 1 | 8.2 to 538.5 | 0.9853(0.9498 to 1.0208) | -2.7140(-5.813 to 11.241) | 0.9990 | 95.2% to 109.3% |
7.10 Calprotectin Recovery
| Sample type | Description | #1 | #2 | #3 | #4 | #5 | #6 | #7 |
|---|---|---|---|---|---|---|---|---|
| (a) | Baseline (mg/kg) | 18.3 | 47.5 | 59.4 | 66.5 | 115.2 | 232.5 | 421.9 |
| Spike Value (mg/kg) | 31.2 | 31.2 | 31.2 | 31.2 | 31.2 | 31.2 | 31.2 | |
| (b) | Theoretical(Base + Spike) (mg/kg) | 49.6 | 78.8 | 90.6 | 97.8 | 146.6 | 263.7 | 452.1 |
| Observed(Base + Spike) (mg/kg) | 49.8 | 81.1 | 100.1 | 108.7 | 166.0 | 271.3 | 475.0 | |
| % Recovery | 100.5 | 103.0 | 110.5 | 111.1 | 113.4 | 102.8 | 112.6 |
7.11 LoB and LoD
LoB = 3.04 mg/kg
LoD = 3.98 mg/kg
7.12 Interfering Substance
A number of potential interfering foods, pharmaceutical substances were tested. No interferences were observed.
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| Pool | No additionmg/kg | E colimg/kg | Δ% | Salmonella sppmg/kg | Δ% | Shigella sppmg/kg | Δ% | Yesinia sppmg/kg | Δ% | Klebsiella sppmg/kg | Δ% |
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | 459.3 | 470.8 | 102.5 | 447.9 | 97.5 | 466.7 | 101.6 | 441.9 | 96.2 | 455.5 | 99.2 |
| B | 273.2 | 262.1 | 95.9 | 297.8 | 109.0 | 261.4 | 95.7 | 280.8 | 102.8 | 261.1 | 95.6 |
| C | 143.6 | 137.1 | 95.5 | 146.4 | 102.0 | 148.1 | 103.1 | 136.8 | 95.3 | 150.5 | 104.8 |
| D | 68.2 | 66.3 | 97.2 | 68.0 | 99.7 | 69.7 | 102.2 | 65.0 | 95.3 | 70.5 | 103.4 |
| E | 30.1 | 31.2 | 103.8 | 29.7 | 98.7 | 31.6 | 105.1 | 30.2 | 100.4 | 31.2 | 103.6 |
| iPool | No addition | Addition of Drugs, Nutrients and Hemoglobin - Table 2a | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Vancomycin | Ciproflaxin hcl Vitamin E | Prevacid | Azathioprine | ||||||||
| mg/kg | mg/kg | 4% | mg/kg | 4% | mg/kg | 10% | mg/kg | 4% | lmg/kg | 4% | |
| A | 468,9 | 467,1 | . (89,6 | 479.4 | 102,2 457,9 | 197,7 | 453.5 | 96.7 | 468,4 | ರಿಡಿ, ಇ | |
| B | 268,1 | 272,9 | 101,8 270,9 | 101,0 261,0 | 97.4 | 271,2 | 101,2 263,4 | 98,2 | |||
| C | 145,4 | 141,7 י | 97,5 140,5 | 96.6 | 140.0 | 196,3 | 144.2 | 99.2 143.4 | 198,6 | ||
| D | 68,8 | 69,1 | · 100,4 69,2 | 100,6168,8 | 100.0 68,2 | 99.1 | 68,5 | 99,6 | |||
| ய | 31,2 | 32.1 | 97.2 132.7 | 104,8 32,0 | 99.7 32,6 | 104,5 32,5 | 104,2 |
.
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| Pool | No addition | Pentasa | Asacol | Prednisone | Multivitamin | Hemoglobin | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| mg/kg | mg/kg | Δ% | mg/kg | Δ% | mg/kg | Δ% | mg/kg | Δ% | mg/kg | Δ% | |
| A | 468,9 | 461,8 | 98,5 | 461,5 | 98,4 | 446.7 | 95,3 | 478,4 | 102,0 | 473,3 | 100,9 |
| B | 268,1 | 271,1 | 101,1 | 273,5 | 102,0 | 268,6 | 100,2 | 272,2 | 101,5 | 274,7 | 102,5 |
| C | 145,4 | 150,1 | 103,2 | 138,2 | 95,0 | 138,5 | 95,3 | 146,0 | 100,4 | 146,6 | 100,8 |
| D | 68,8 | 70,7 | 102,8 | 71,0 | 103,2 | 71,1 | 103,3 | 69,2 | 100,6 | 69,6 | 101,2 |
| E | 31,2 | 32,2 | 103,2 | 31.8 | 99.1 | 32,2 | 103,2 | 30,7 | 98,4 | 31,0 | 99,4 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the seal. The eagle is depicted in a simple, abstract style, with bold lines forming its shape.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 16, 2014
EUROSPITAL S.P.A. c/o MR. DAVID DUNN CONSULTANT 3331 EAGLE WATCH DRIVE WOODSTOCK, GA 30189
Re: K130945
Trade/Device Name: CALPREST® Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal calprotectin immunological test system Regulatory Class: II Product Code: NXO Dated: December 11, 2013 Received: December 12, 2013
Dear Mr. Dunn:
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. 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 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. David Dunn
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
for Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological
Health
Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) K130945
Device Name Calprest®
Indications for Use (Describe)
Calpress® is a quantitative ELISA for detecting the concentration of fecal calprest@can be used as an in-vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Disease and ulcerative colitis) and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FOR FOR FOR FOR FOR FOR FOR FOR ::
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/9/Picture/13 description: The image shows the text "Leonthena RDA Carrington -S" in a large, bold font. The words are arranged horizontally, with "Leonthena" on the left, followed by a logo with the letters "RDA" inside of it, then "Carrington" and finally "-S" on the right. The logo is a stylized design with overlapping shapes and lines.
§ 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).