(287 days)
Not Found
No
The device description details a standard ELISA assay which relies on chemical reactions and colorimetric detection, not AI/ML algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
This device is an in-vitro diagnostic test used to aid in the diagnosis and differentiation of certain conditions. It does not provide treatment or directly interact with the patient's body for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" states that the device is "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)". This clearly indicates its diagnostic purpose.
No
The device description clearly outlines a laboratory-based ELISA system involving physical reagents, antibodies, and colorimetric detection, which are hardware components. It is an in-vitro diagnostic test, not a software-only device.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: Explicitly states "can be used as an in-vitro diagnostic".
- Device Description: Describes an "enzyme-linked immunosorbent assay (ELISA) system" which is a common type of in-vitro diagnostic test.
- Intended User / Care Setting: States "in-vitro diagnostic".
The description clearly indicates that the device is intended to be used outside of the body to examine a sample (fecal) for the presence and concentration of a specific substance (calprotectin) to aid in the diagnosis of a disease (IBD). This aligns perfectly with the definition of an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NXO
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fecal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The summary includes descriptions of repeatability, reproducibility, linearity, accuracy, and interference studies.
- Clinical Performance:
- Study Type: Diagnostic accuracy study (comparison to IBD diagnosis).
- Sample Size: 138 patients (98 IBD positive, 40 IBD negative).
- Key Results:
- Borderline considered Positive: 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 considered Negative: 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%).
- Extraction Reproducibility: Coefficients of Variation (%CV) ranging from 7.0% to 13.6% for different mean calprotectin concentrations.
- Device Comparison (Method Comparison):
- Study Type: Comparison between Calprest® and PhiCal™ Test.
- Sample Size: Not explicitly stated but implied from agreement tables.
- Key Results:
- Borderline considered as Positive: 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 considered as Negative: 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 = 0.98x - 1.85 (Slope: 0.98 (0.96 to 1.01), Y-intercept: -1.85 (-3.96 to 0.96)).
- Intra-assay Precision: %CV ranging from 3.3% to 12.4% for different mean calprotectin concentrations.
- Inter-assay Precision: %CV ranging from 7.7% to 12.4% for different mean calprotectin concentrations.
- Inter-lot Precision: Overall %CV ranging from 3.1% to 12.4% across different lots.
- Site-to-site precision: %CV ranging from 3.1% to 10.4% across different sites.
- Linearity (Matrix and Aqueous):
- Matrix Linearity: R2 = 0.9946 for range 20.4 to 492.8 µg/g; % Recovery Rate 87.0% to 113.2%.
- Aqueous Linearity: R2 = 0.9990 for range 8.2 to 538.5 µg/g; % Recovery Rate 95.2% to 109.3%.
- Calprotectin Recovery: % Recovery ranging from 100.5% to 113.4%.
- LoB and LoD: LoB = 3.04 mg/kg, LoD = 3.98 mg/kg.
- Interfering Substance: No interferences observed from tested substances (bacteria, drugs, nutrients, hemoglobin).
Key Metrics
Sensitivity, Specificity, PPV (Positive Predictive Value), NPV (Negative Predictive Value), %CV (Coefficient of Variation), Positive Agreement, Negative Agreement, Overall Agreement, Slope, Y-intercept, R2, % Recovery Rate.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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, 122 |
| 34147 Trieste | |
| Italy | |
| 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 II | |
| Product 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
1
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 |
|---|---|---|
| 120 mg/kg | Abnormal | Repeat as clinically indicated |
7.2 Clinical Performance
| Borderline considered
| Positive | 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 considered
| Negative | 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
2
7.3 Extraction Reproducibility
Values are reported in mg/kg
| Extracted stool sample
| No. | 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 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. | 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 |
3
| 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 stool
| sample 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 stool
| sample 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 |
4
7.7 Inter-lot Precision
| Lot # 5637 | Lot # 5888 | Lot # 5488 | Overall | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Extracted stool | |||||||||
| sample 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.
| Pool
No. | 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% |
5
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.
גע
6
| Pool | No addition
mg/kg | E coli
mg/kg | Δ% | Salmonella spp
mg/kg | Δ% | Shigella spp
mg/kg | Δ% | Yesinia spp
mg/kg | Δ% | Klebsiella spp
mg/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 |
.
. . . . .
:
: . . . . .
and the control control of the control of the control of
.
: : :
.
| 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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7
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.
8
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
9
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)
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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.