(267 days)
Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's disease and ulcerative colitis, and to differentiate IBD from Irritable Bowel Syndrome (IBS) in conjunction with other clinical and laboratory findings.
Calprest®NG is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of antibodies 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.
Calprest®NG: Acceptance Criteria and Performance Study
This document outlines the acceptance criteria and performance of the Calprest®NG device, an in-vitro diagnostic ELISA for detecting fecal calprotectin to aid in the diagnosis of Inflammatory Bowel Diseases (IBD) and differentiation from Irritable Bowel Syndrome (IBS).
1. Acceptance Criteria and Reported Device Performance
The provided document details various performance characteristics. For acceptance criteria, the "Clinical Performance" and "Method Comparison" sections are most relevant, establishing performance benchmarks against a predicate device and clinical diagnoses.
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance (Calprest®NG) |
|---|---|---|
| Clinical Performance (Borderline values Positive) | To be substantially equivalent to predicate device performance. | Sensitivity: 94.6% (95% CI: 89.2% - 97.8%) |
| Specificity: 90.2% (95% CI: 84.1% - 94.5%) | ||
| PPV: 89.8% (95% CI: 83.4% - 94.3%) | ||
| NPV: 94.9% (95% CI: 89.7% - 97.9%) | ||
| Clinical Performance (Borderline values Negative) | To be substantially equivalent to predicate device performance. | Sensitivity: 83.1% (95% CI: 75.5% - 89.1%) |
| Specificity: 97.9% (95% CI: 94.0% - 99.6%) | ||
| PPV: 97.3% (95% CI: 92.3% - 99.4%) | ||
| NPV: 86.4% (95% CI: 80.2% - 91.3%) | ||
| Method Comparison (Borderline Value as Positive) | Positive Agreement with predicate device. | 96.6% (95% CI: 91.5% - 98.7%) |
| Negative Agreement with predicate device. | 100.0% (95% CI: 91.2% - 100.0%) | |
| Overall Agreement with predicate device. | 97.5% (95% CI: 93.9% - 99.0%) | |
| Method Comparison (Borderline Value as Negative) | Positive Agreement with predicate device. | 96.1% (95% CI: 89.0% - 98.6%) |
| Negative Agreement with predicate device. | 96.3% (95% CI: 89.7% - 98.7%) | |
| Overall Agreement with predicate device. | 96.2% (95% CI: 91.9% - 98.2%) | |
| Linearity (Matrix) | % Recovery Rate between 80-120%. | 86.91% - 112.84% |
| Linearity (Aqueous) | % Recovery Rate between 80-120%. | 93.00% - 118.68% |
| Calprotectin Recovery | Recovery % between 80-120%. | 94.8% - 112.1% |
| Interfering Substances | No significant interference observed (typically within +/- 20% deviation). | All tested interfering substances and bacteria resulted in % deviation between 90.8% and 110.4% in Table 2a, and between 90.8% and 110% in Table 2b, indicating no significant interference. |
2. Sample size and data provenance for the test set
- Clinical Performance Test Set: The "Clinical Performance" table shows a total of 273 samples were used for the clinical evaluation. The document does not explicitly state the country of origin or whether the data was retrospective or prospective.
- Method Comparison Test Set: A total of 157 samples were used for the method comparison study against the predicate device. The document does not explicitly state the country of origin or whether the data was retrospective or prospective.
3. Number of experts and their qualifications used to establish ground truth for the test set
Not applicable. This device is an in-vitro diagnostic test. "Experts" in the traditional sense of clinicians or radiologists establishing image-based ground truth is not relevant here. The ground truth for clinical performance would be an established diagnosis of IBD or IBS, likely based on a combination of clinical, endoscopic, histological, and other laboratory findings, which are considered the "gold standard" for these conditions. The document does not specify the number of clinicians or the exact method of establishing these clinical diagnoses.
4. Adjudication method for the test set
Not applicable. As this is an in-vitro diagnostic, adjudication method in the context of human interpretation of medical images is not relevant. The device output is a quantitative measurement of fecal calprotectin concentration.
5. Multi-reader multi-case (MRMC) comparative effectiveness study
Not applicable. This is an in-vitro diagnostic device that provides a quantitative measurement, not an AI-assisted diagnostic tool that humans interpret. Therefore, an MRMC study and the concept of human readers improving with AI assistance are not relevant.
6. Standalone (algorithm only without human-in-the-loop) performance
Yes, this is a standalone device. The Calprest®NG is an ELISA system that provides a direct quantitative measurement of fecal calprotectin. Its performance is evaluated independently of human interpretation of the assay result, although a clinician will interpret the final numerical result in the context of other clinical findings. The reported sensitivity, specificity, and agreement values represent the standalone performance of the assay.
7. Type of ground truth used
- Clinical Performance: For the "Clinical Performance" study, the ground truth was clinical diagnosis of Inflammatory Bowel Disease (IBD) (Crohn's disease and ulcerative colitis) or Irritable Bowel Syndrome (IBS). This is an outcome-based ground truth, derived from standard clinical work-up which may include endoscopy, histology, imaging, and other diagnostic tests.
- Method Comparison: For the "Method Comparison" study, the ground truth was the results obtained from the predicate device, Calprest® (K130945), which serves as a comparator for substantial equivalence.
- Other performance studies (Precision, Linearity, Recovery, Interfering Substances): The ground truth for these studies are precisely prepared reference materials with known concentrations.
8. Sample size for the training set
The document does not explicitly mention a "training set" in the context of machine learning. This device is an immunoassay (ELISA), which relies on chemical and biological reactions, not a machine learning algorithm that requires a training set in the typical sense. The term "training set" is not applicable here. The assay is developed and validated through a series of analytical and clinical performance studies, rather than "training" an AI model.
9. How the ground truth for the training set was established
Not applicable. As explained in point 8, the concept of a "training set" and its associated ground truth is not relevant for this type of immunoassay device. The device's performance is established through rigorous analytical verification and clinical validation studies as described in the summary.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked formation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 10, 2016
Eurospital S. p. A. C/O Ms. Catherine L. Wong U.S. Agent 2832 Via Pacheco Palos Verdes Estates, CA 90274
Re: K160447
Trade/Device Name: Calprest NG Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal Calprotectin Immunological Test System Regulatory Class: II Product Code: NXO Dated: September 29, 2016 Received: October 3, 2016
Dear Ms. Wong:
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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. 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
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 Industry and Consumer Education 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,
Kelly Oil
FOR
Leonthena R. Carrington, MS, MBA, MT(ASCP) 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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Indications for Use
510(k) Number (if known) K160447
Device Name Calprest®NG
Indications for Use (Describe)
Calprest®NG is a quantitative ELISA for detecting concentration of fecal calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically 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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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: K160447
-
- 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 – I 34147 Trieste, Italy |
| Submitter's Telephone Number: | Tel. +39 0408997285 |
| Submitter's Contact Name: | Claudia Brandolin, Quality Assurance Manager |
-
- Name of the device, including the trade or proprietary name, the common or usual name and the classification name:
| Proprietary Name: | Calprest®NG |
|---|---|
| Common Name: | Fecal calprotectin immunological test system |
| Classification Name: | Calprotectin, Fecal; 21 CFR 866.5180Class IIProduct Code: NXO |
-
- ldentification of the legally marketed device to which the submitter claims substantial equivalence:
| Predicate Device Name: | Calprest® |
|---|---|
| 510(k) Number: | K130945 |
| Regulation Number: | 21CFR866.5180 |
| Regulation Class: | Class II |
4. Description of the device
Calprest®NG is an enzyme-linked immunosorbent assay (ELISA) system with colorimetric detection based on the use of antibodies 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.
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5. Statement of the intended use of the device
Calprest®NG is a quantitative ELISA for detecting concentration of fecal Device Intended Use: calprotectin, which can be used as an in vitro diagnostic to aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically 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 NG and Calprest Test are manufactured by Eurospital S.p.A. Trieste, Italy. Comparing to Calprest , the differences of Calprest NG include the name of the test on the labels, detection antibody, the use of a Horse-radish peroxidase / TMB conjugate/substrate system, the provided Stop solution, the concentration of calibrators and controls in the kit and the dynamic range of the assay.
7. Summary of performance characteristics
7.1. Expected Values
| Calprotectin Concentration | Interpretation | Follow-Up |
|---|---|---|
| 27.1 - <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 valuesconsidered Positive | Calprest®NG | IBD$ | Total | Borderline valuesconsidered Negative | IBD | Total | ||
|---|---|---|---|---|---|---|---|---|
| Positive | Negative | Calprest®NG | Positive | Negative | ||||
| Positive | 123 | 14 | 137 | Positive | 108 | 3 | 111 | |
| Negative | 7 | 129 | 136 | Negative | 22 | 140 | 162 | |
| Total | 130 | 143 | 273 | Total | 130 | 143 | 273 | |
| Sensitivity | 94.6% | 95%C.I.§ | (89.2% - 97.8%) | Sensitivity | 83.1% | (95% C.I. 75.5% - 89.1%) | ||
| Specificity | 90.2% | 95%C.I. (84.1% - 94.5%) | Specificity | 97.9% | (95% C.I. 94.0% - 99.6%) | |||
| PPV* | 89.8% | 95%C.I. (83.4% - 94.3%) | PPV* | 97.3% | (95% C.I. 92.3% - 99.4%) | |||
| NPV** | 94.9% | 95%C.I. (89.7% - 97.9%) | NPV** | 86.4% | (95% C.I. 80.2% - 91.3%) |
$ IBD: Inflammatory Bowel Disease
- PPV: Positive Predictive Value
- ** NPV: Negative Predictive Value
- Ş CI: Confidence Interval
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7.3. Extraction Reproducibility
Values are reported in mg/kg
| Extracted stool sample No. | 1 | 2 | 3 | 4 |
|---|---|---|---|---|
| Mean (mg/kg) | 29.6 | 52.7 | 227.0 | 1973.3 |
| SD | 4.3 | 5.8 | 15.5 | 117.3 |
| % CV | 14.6 | 11.1 | 6.8 | 5.9 |
7.4. Comparison Study
7.4.1.Device Comparison
Reagents: Calprest"NG, code 9069, (manufactured by Eurospital S.p.A.)
Predicate device: Calprest® code 9031 (K130945, manufactured by Eurospital S.p
| Similarities | ||
|---|---|---|
| Item | New deviceCalprest®NG, code 9069 | Predicate (K130945)Calprest®, code 9031 |
| Intended use | Calprest®NG is a quantitative ELISAfor detecting concentration of fecalcalprotectin, which can be used as anin vitro diagnostic to aid in thediagnosis of Inflammatory BowelDiseases (IBD), specifically Crohn'sdisease and ulcerative colitis, and todifferentiate IBD from Irritable BowelSyndrome (IBS) in conjunction withother clinical and laboratory findings. | Calprest® is a quantitative ELISA kit fordetecting concentration of fecalcalprotectin which can be used as invitro diagnostic to aid in the diagnosisof Inflammatory Bowel Diseases (IBD,Crohn's disease and ulcerative colitis)and to differentiate IBD from IrritableBowel Syndrome (IBS) in conjunctionwith other clinical and laboratoryfindings. |
| Technology | ELISA | ELISA |
| Antigen | Calprotectin | Calprotectin |
| Assay format | Quantitative | Quantitative |
| Positive and Negativecontrols | Ready to use | Ready to use |
| Sample type | Stool | Stool |
| Sample volume | 1-5 g stool | 1-5 g stool |
| Extraction solution | 2.5x concentrate | 2.5x concentrate |
| Sample buffer diluent | 10x concentrate | 10x concentrate |
| Wash buffer | 20x concentrate | 20x concentrate |
| Platform | 96 well microtiter plate | 96 well microtiter plate |
| Cut-off | 50 mg/kg (µg/g) | 50 mg/kg (µg/g) |
| Differences | ||
|---|---|---|
| Item | New device | Predicate (K130945) |
| Calprest®NG, code 9069 | Calprest®, code 9031 | |
| Calibrators | 6 levels:0, 2.5, 12.5, 25, 50, 150 ng/ml | 6 levels:6.25, 12.5, 25, 50, 100, 200 ng/ml |
| Sample dilution | 1:20000 | 1: 2500 |
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| Differences | ||
|---|---|---|
| Item | New device | Predicate (K130945) |
| Calprest®NG, code 9069 | Calprest®, code 9031 | |
| Incubation time | 60-30-15 minutes at RoomTemperature (RT) | 45-45-30 minutes at RT |
| Conjugate | HRP Horse Radish Peroxidase (IgGmouse) | Alkaline phosphatase (IgG, rabbit) |
| Substrate | TMB | pNPP |
| OD Reading | 450 nm | 405 nm |
| Stop Solution | H2SO4 (0.5M) | None |
7.4.2.Method Comparison
| Borderline Valueconsidered as Positive | Calprest® | |||
|---|---|---|---|---|
| Pos | Neg | |||
| Calprest®NG | Pos | 113 | 0 | 113 |
| Neg | 4 | 40 | 44 | |
| 117 | 40 | 157 | ||
| Positive Agreement | 96.6% | (95% C.I. 91.5% - 98.7%) | ||
| Negative Agreement | 100.0% | (95% C.I. 91.2% - 100.0%) | ||
| Overall agreement | 97.5% | (95% C.I. 93.9% - 99.0%) |
| Borderline Valueconsidered as Negative | Calprest® | |||
|---|---|---|---|---|
| Pos | Neg | |||
| Calprest®NG | Pos | 73 | 3 | 76 |
| Neg | 3 | 78 | 81 | |
| 76 | 81 | 157 | ||
| Positive Agreement | 96.1% | (95% C.I. 89.0% - 98.6%) | ||
| Negative Agreement | 96.3% | (95% C.I. 89.7% - 98.7%) | ||
| Overall agreement | 96.2% | (95% C.I. 91.9% - 98.2%) |
Deming Regression Analysis (y: Calprest®NG, x: Calprest®)
| Slope (95% CI) | Y-intercept (95% CI) | |
|---|---|---|
| Y = 0.92x + 0.13 | 0.92 (0.84 to 1.01) | 0.13 (-4.64 to 4.90) |
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7.5. Precision
| SampleID°# | N | mean(mg/kg) | Within RunSD | Within Run%CV | Between RunSD | Between Run%CV | Between DaySD | Between Day%CV | Between OperatorSD | Between Operator%CV | TotalSD | Total%CV |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 120 | 170.88 | 3.40 | 2.0% | 6.77 | 4.0% | 5.51 | 3.2% | 0.80 | 0.5% | 9.40 | 5.5% |
| 2 | 120 | 741.60 | 17.38 | 2.3% | 43.12 | 5.8% | 55.37 | 7.5% | 0.00 | 0.0% | 72.30 | 9.7% |
| 3 | 120 | 248.74 | 6.44 | 2.6% | 11.98 | 4.8% | 12.21 | 4.9% | 0.00 | 0.0% | 18.28 | 7.3% |
| 4 | 120 | 42.60 | 1.28 | 3.0% | 4.30 | 10.1% | 0.00 | 0.0% | 0.55 | 1.3% | 4.52 | 10.6% |
| 5 | 120 | 1193.10 | 52.91 | 4.4% | 73.33 | 6.1% | 118.78 | 10.0% | 60.32 | 5.1% | 161.01 | 13.5% |
| 6 | 120 | 1006.17 | 41.69 | 4.1% | 39.67 | 3.9% | 55.80 | 5.5% | 28.24 | 2.8% | 84.98 | 8.4% |
| 7 | 120 | 2267.29 | 223.08 | 9.8% | 83.22 | 3.7% | 155.52 | 6.9% | 58.33 | 2.6% | 290.31 | 12.8% |
7.5.1.Single-Site Precision Evaluation study: Results
7.5.2.Multisite Precision Evaluation Study: Results
| SampleID# | N | mean(mg/kg) | Repeatability | Within-Site Precision | Reproducibility | |||
|---|---|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | |||
| A | 75 | 433.80 | 13.43 | 3.1% | 63.99 | 14.8% | 64.55 | 14.9% |
| B | 75 | 36.54 | 3.69 | 10.1% | 5.11 | 14.0% | 5.11 | 14.0% |
| C | 75 | 1180.64 | 71.08 | 6.0% | 156.16 | 13.2% | 156.16 | 13.2% |
| D | 75 | 682.76 | 35.88 | 5.3% | 49.57 | 7.3% | 78.95 | 11.6% |
| E | 75 | 1629.44 | 96.29 | 5.9% | 214.76 | 13.2% | 226.84 | 13.9% |
| F | 75 | 62.08 | 4.19 | 6.8% | 5.64 | 9.1% | 8.68 | 14.0% |
| G | 75 | 356.84 | 12.00 | 3.4% | 30.07 | 8.4% | 51.93 | 14.6% |
| H | 75 | 2152.20 | 173.58 | 8.1% | 308.13 | 14.3% | 312.19 | 14.5% |
| SampleID# | Repeatability 95% CIs | Within-Site Precision 95% CIs | Reproducibility 95% CIs | |||
|---|---|---|---|---|---|---|
| SD | %CV | SD | %CV | SD | %CV | |
| A | 11.395 to 16.346 | 2.6% to 3.8% | 46.388 to 103.087 | 10.7% to 23.8% | 47.256 to 101.796 | 10.9% to 23.5% |
| B | 3.132 to 4.493 | 8.6% to 12.3% | 4.166 to 6.611 | 11.4% to 18.1% | 4.166 to 6.611 | 11.4% to 18.1% |
| C | 60.329 to 86.539 | 5.1% to 7.3% | 117.995 to 230.930 | 10.0% to 19.6% | 119.470 to 225.503 | 10.1% to 19.1% |
| D | 30.452 to 43.682 | 4.5% to 6.4% | 40.416 to 64.137 | 5.9% to 9.4% | 49.284 to 193.644 | 7.2% to 28.4% |
| E | 81.724 to 117.230 | 5.0% to 7.2% | 162.277 to 317.595 | 10.0% to 19.5% | 168.946 to 345.240 | 10.4% to 21.2% |
| F | 3.559 to 5.105 | 5.7% to 8.2% | 4.634 to 7.222 | 7.5% to 11.6% | 5.419 to 21.291 | 8.7% to 34.3% |
| G | 10.186 to 14.611 | 2.9% to 4.1% | 22.561 to 45.073 | 6.3% to 12.6% | 31.114 to 149.229 | 8.7% to 41.8% |
| H | 147.319 to 211.322 | 6.8% to 9.8% | 240.599 to 428.660 | 11.2% to 19.9% | 242.642 to 437.935 | 11.3% to 20.3% |
7.6. Linearity
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7.6.1.Matrix Linearity
| Test Rangeµg/g (mg/kg) | Slope (95% CI) | Y-intercept (95% CI) | R2 | % Recovery Rate(Obtained/Theoretical) |
|---|---|---|---|---|
| 25.21 - 3066.02 | 1.01 (0.99 - 1.04) | 9.28 (-26.54 - 45.10) | 0.99 | 86.91% - 112.84% |
7.6.2. Aqueous Linearity
| Test Range µg/g(mg/kg) | Slope (95% CI) | Y-intercept (95% CI) | R2 | % Recovery Rate(Obtained/Theoretical) |
|---|---|---|---|---|
| 27.81 – 2889.04 | 1.03 (1.01 - 1.06) | -5.75 (-36.40 - 24.91) | 1.00 | 93.00 - 118.68 |
Image /page/8/Figure/4 description: The image contains two scatter plots, each displaying a linear relationship between 'Theoretical conc' on the x-axis and 'Observed value' on the y-axis. The plot on the left shows a linear equation of y = 1.014x + 9.2789. The plot on the right shows a linear equation of y = 0.9687x + 6.0221 with an R-squared value of 1.
Matrix linearity graph
Aqueous linearity graph
7.7. Calprotectin Recovery
| Calprotectin Recovery Data | |||||||
|---|---|---|---|---|---|---|---|
| Sample Description | #1 | #2 | #3 | #4 | #5 | #6 | #7 |
| Baseline (mg/kg) | 9.3 | 51.7 | 162.7 | 307.7 | 458.3 | 1204.0 | 1975.2 |
| Spike Value (mg/kg) | 32.3 | 32.3 | 32.3 | 115.0 | 115.0 | 115.0 | 115.0 |
| Theoretical (Baseline+Spike) (mg/kg) | 41.7 | 84.0 | 195.0 | 422.7 | 573.3 | 1319.0 | 2090.2 |
| Observed (Baseline+Spike) (mg/kg) | 42.3 | 79.7 | 200.7 | 425.3 | 592.3 | 1397.7 | 2343.8 |
| Recovery (%) | 101.6 | 94.8 | 102.9 | 100.6 | 103.3 | 106.0 | 112.1 |
7.8. LoB, LoD, LoQ
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LoB = 17.5 µg/g (mg/kg) LoD = 23.4 µg/g (mg/kg) LoQ = 27.1 µg/g (mg/kg)
7.9. Interfering Substance
A number of potential interfering foods, pharmaceutical substances were tested. No interferences were observed.
| Pool | Noadditionµg/g(mg/kg) | E coli | Salmonella spp | Shigella spp | Yesinia spp | Klebsiella spp | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | ||
| A | 2068.6 | 2009.7 | 97.2 | 2100.1 | 101.5 | 2026.6 | 98.0 | 2021.1 | 97.7 | 2062.5 | 99.7 |
| B | 674.7 | 665.4 | 98.6 | 687.9 | 102.0 | 642.9 | 95.3 | 649.7 | 96.3 | 699.0 | 103.6 |
| C | 256.0 | 268.5 | 104.9 | 269.9 | 105.4 | 255.0 | 99.6 | 265.8 | 103.8 | 265.6 | 103.8 |
| D | 79.3 | 82.1 | 103.6 | 87.5 | 110.4 | 72.0 | 90.8 | 78.4 | 98.9 | 73.2 | 92.4 |
| E | 37.2 | 37.3 | 100.1 | 35.2 | 94.5 | 37.5 | 100.8 | 40.6 | 109.2 | 38.8 | 104.3 |
| Pool | Noaddition | Addition of Drugs, Nutrients and Hemoglobin - Table 2a | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vancomycin | Ciproflaxin hcl | Vitamin E | Prevacid | Azathioprine | ||||||||
| µg/g(mg/kg) | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g (mg/kg) | Δ% | µg/g (mg/kg) | Δ% | ||
| A | 2089.5 | 2197.4 | 105% | 2261.1 | 108% | 2097.6 | 100% | 2085.5 | 100% | 1986.0 | 95% | |
| B | 603.8 | 626.5 | 104% | 623.2 | 103% | 600.3 | 99% | 589.1 | 98% | 590.5 | 98% | |
| C | 279.2 | 269.6 | 97% | 290.3 | 104% | 290.4 | 104% | 265.1 | 95% | 277.3 | 99% | |
| D | 82.4 | 79.7 | 97% | 88.1 | 107% | 86.0 | 104% | 83.8 | 102% | 83.9 | 102% | |
| E | 35.9 | 33.3 | 93% | 33.2 | 92% | 34.2 | 95% | 34.7 | 97% | 37.4 | 104% |
| Noadditionµg/g(mg/kg) | Addition of Drugs, Nutrients and Hemoglobin - Table 2b | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pool | Pentasa | Asacol | Prednisone | Multivitamin | Hemoglobin | |||||||
| µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g(mg/kg) | Δ% | µg/g (mg/kg) | Δ% | µg/g (mg/kg) | Δ% | |||
| A | 2089.5 | 2260.9 | 108% | 1937.50 | 93% | 2151.30 | 103% | 2284.80 | 109% | 2119.30 | 101% | |
| B | 603.8 | 586.7 | 97% | 599.80 | 99% | 592.90 | 98% | 589.90 | 98% | 583.70 | 97% | |
| C | 279.2 | 279.4 | 100% | 271.70 | 97% | 280.10 | 100% | 272.60 | 98% | 275.40 | 99% | |
| D | 82.4 | 80.0 | 97% | 75.90 | 92% | 84.60 | 103% | 83.90 | 102% | 80.60 | 98% | |
| E | 35.9 | 34.1 | 95% | 33.00 | 92% | 35.70 | 100% | 33.90 | 95% | 36.80 | 103% |
§ 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).