The Fecal Extraction Device is a single use tube containing extraction buffer intended for sampling and extracting human stool specimens and subsequent analysis with the QUANTA Flash Calprotectin assay.

Device Description

The Fecal Extraction Device acquires the amount of stool necessary to perform the QUANTA Flash Calprotectin assay directly from the primary specimen container instead of weighing the sample. The device consists of a tube, containing 2.8 mL of extraction buffer, and a stick shaped with seven grooves for collecting the sample. The upper end of the device is made up of two parts which can be removed with two separate rotations: the white screw cap (connected to the plastic stick with grooves) is removed by twisting counter-clockwise. The red lower part (for retaining the excess material) is removed by twisting clockwise. Once having completed the extraction procedure, remove both the white and red upper parts. The tube containing the extracted sample can be placed directly into the BIO-FLASH instrument sample rack.

AI/ML Overview

The Fecal Extraction Device is intended for sampling and extracting human stool specimens for subsequent analysis with the QUANTA Flash Calprotectin assay. The device underwent several validation studies to demonstrate its performance and substantial equivalence to the predicate device (QUANTA Flash Calprotectin using manual extraction).

1. Table of Acceptance Criteria and Reported Device Performance

Stool Extraction Method Comparison: Fecal Extraction Device vs. Manual Weighing Method

Acceptance Criteria	Reported Device Performance (Fecal Extraction Device vs. Manual Extraction, n=97)
Intercept of regression line ± 15% of cut-off (18 mg/kg)	-1.2 (-9.7 to 6.4) - Met (-2.7 to 2.7 mg/kg is ±15% of cutoff, and -1.2 is within this range)
Slope of regression line between 0.90 and 1.10	0.93 (0.82 to 1.06) - Met
Predicted Bias at cut-off ≤ 15%	-7.8 % (-16.0% to 0.6%) - Met
95% CI of the bias: does not exceed medically significant difference, 20% of cut-off	-16.0% to 0.6% - Met (Not exceeding 20% of 18 mg/kg which is 3.6 mg/kg)
Correlation r > 0.95	0.975 - Met

Device Validation (Amount of Fecal Material Collected)

Acceptance Criteria	Reported Device Performance
Weight collected by FED is 56 mg ±10% (50 to 62 mg)	Mean Sample Weight (95% CI): 56 (55 - 57) mg - Met

Extraction Reproducibility

Acceptance Criteria	Reported Device Performance (Within Laboratory (Total Imprecision) %CV or SD)
Within Laboratory (Total Imprecision) %CV: ≤ 15%	Sample CVs ranged from 10.2% to 25.4% (for Sample 1) and 13.3% (for Sample 8), with only Sample 1 exceeding 15%. This suggests a partial meet depending on the interpretation for lower concentrations. However, the document states "All acceptance criteria were met," so it implies Sample 1's SD criterion was met.
or SD: ≤ 7.5 mg/kg for negative samples	Sample 1 (mean 29.5 mg/kg) had an SD of 7.5 mg/kg. Sample 2 (mean 40.0 mg/kg) had an SD of 6.8 mg/kg. Sample 3 (mean 53.2 mg/kg) had an SD of 7.5 mg/kg. - Met (for samples near cut-off/negative range)

Sample Stability and Handling (Extracted Samples)

Acceptance Criteria	Reported Device Performance
80-120% average recovery	All samples fulfilled the acceptance criteria at each time point for each condition. - Met (Recommended storage: up to 72 hours at room temperature, up to 14 days at 2-8°C, up to 4 freeze/thaw cycles.)

Fecal Extraction Device Stability (Shelf Life - Real Time Stability)

Acceptance Criteria	Reported Device Performance
pH between 7.70 and 7.90	pH values for three lots over 24-26 months ranged from 7.77 to 7.82. - Met
70-130% average recovery (functionality at expiration date)	All samples fulfilled the acceptance criteria. - Met (Supports 2-year expiration date.)

Stability at Room Temperature (Fecal Extraction Device)

Acceptance Criteria	Reported Device Performance
80-120% average recovery	All results obtained using the three different lots of Fecal Extraction Device fulfilled the acceptance criteria. - Met (Supports storage at room temperature up to 72 hours.)

2. Sample Sizes and Data Provenance

Stool Extraction Method Comparison Test Set: 97 human stool samples.
Device Validation (Fecal Material Collection): 5 different human stool samples, tested in replicates of five.
Extraction Reproducibility: 8 samples, with 75 data points per sample (replicates of 5, once a day for 5 days, by 3 independent operators).
Sample Stability and Handling: 7 human stool samples (n=1 indeterminate, n=2 around cut-off, n=4 positive).
Fecal Extraction Device Functionality at Expiration: 15 human stool samples (n=11 negative, n=2 indeterminate, n=1 around cut-off, n=1 positive).
Fecal Extraction Device Stability at Room Temperature: 6 human stool samples (lots 2 and 3: n=1 indeterminate, n=1 around cut-off, n=3 positive; lot 1: n=1 indeterminate, n=1 around cut-off, n=4 positive).

Data Provenance: The document does not explicitly state the country of origin for the human stool samples. Given "Inova Diagnostics, Inc." is located in "San Diego, CA, 92131", it can be inferred that the studies were likely conducted in the United States. The studies are described as analytical performance characteristics, implying they are laboratory-based investigations evaluating the device's technical specifications rather than clinical trials for diagnostic accuracy with patient outcomes. The term "human stool samples" suggests these are clinical specimens, but whether they are retrospective or prospectively collected for the purpose of the study is not specified, though typically such analytical studies would use prospectively collected or banked specimens.

3. Number of Experts and Qualifications

No information is provided regarding the use of experts to establish a "ground truth" for the test sets in the typical sense of medical image interpretation or clinical diagnosis. The studies focus on analytical performance characteristics (e.g., comparison of extraction methods, precision, stability) where the "ground truth" is typically the measured value from a reference method or a known target value.
For the reproducibility study, "three independent operators" were involved in performing extractions, but their specific qualifications beyond being "operators" are not detailed.

4. Adjudication Method

No adjudication method is described as these studies focus on quantitative analytical performance rather than diagnostic interpretation where adjudication by multiple experts would be common. The "Stool Extraction method comparison" uses a statistical method (Passing-Bablok fit) to compare results from the new device against a manual weighing method. Replicates were used for precision studies, but not for settling disputes between reader interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was performed. The document describes a comparison between two extraction methods (Fecal Extraction Device vs. Manual weighing method) and various performance characteristics of the Fecal Extraction Device itself. This is an analytical device for sample preparation, not a diagnostic imaging or interpretative AI device that typically undergoes MRMC studies to assess human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance

The studies described are for the "Fecal Extraction Device," which is a physical device for sample preparation, not a standalone software algorithm or AI. Its performance is evaluated in conjunction with the QUANTA Flash Calprotectin assay. The comparison study directly assesses the performance of the extraction device alone against a reference extraction method.

7. Type of Ground Truth Used

For the "Stool Extraction method comparison," the ground truth is implicitly the quantitative calprotectin concentration obtained using the "manual weighing method," which serves as the reference method.
For "Device Validation" (fecal material collection), the ground truth is the measured weight of the collected fecal material, with an expected target range of 56 mg ± 10%.
For "Reproducibility Studies," the ground truth is the mean calprotectin concentration values of the samples, against which the precision (SD and %CV) of repeated measurements is assessed.
For "Stability Studies," the ground truth for extracted sample stability is the initial measurement (time zero/zero cycles) or the pH of fresh devices for device stability, against which recovered concentrations or pH values are compared over time/conditions.

8. Sample Size for the Training Set

The document describes validation studies for a medical device (Fecal Extraction Device), not an AI or machine learning algorithm. Therefore, there is no concept of a "training set" in the context of the provided information.

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

As there is no training set for an AI/ML algorithm involved, this question is not applicable.

Summary

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October 16, 2018

Inova Diagnostics, Inc. Roger Albesa Manager 9900 Old Grove Road San Diego, California 92131-1638

Re: K180971

Trade/Device Name: Fecal Extraction Device Regulation Number: 21 CFR 866.5180 Regulation Name: Fecal calprotectin immunological test system Regulatory Class: Class II Product Code: NXO Dated: April 11, 2018 Received: April 13, 2018

Dear Roger Albesa:

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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Leonthena R. Carrington -S

Lea Carrington 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)

Device Name Fecal Extraction Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Fecal Extraction Device

Page 1 of 9

Table of Contents
Administrative data	2
Predicate device	3
Device description	3
Intended use(s)	4
Indications for use	4
Substantial equivalence	4
Comparison to predicate device	5
Analytical performance characteristics	6
Stool Extraction method comparison: Fecal Extraction Device vs. Manual weighing method	6
Device Validation	7
Reproducibility Studies	7
Sample Stability and Handling	8
Fecal Extraction Device Stability	8
Clinical performance characteristics	9

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

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Administrative data

Submitter:	Inova Diagnostics, Inc9900 Old Grove Road,San Diego, CA, 92131
Purpose of submission:	The reason for submission is the addition of an optional new device toaid in the stool extraction process, the Fecal Extraction Device, to workwith the QUANTA Flash Calprotectin assay.
Devices in the submission:	Fecal Extraction Device
Scientific contact:	Roger Albesa, Manager, Research and DevelopmentInova Diagnostics, Inc.9900 Old Grove Road, San Diego, CA, 92131Phone: 858-586-9900 x1391Fax: 858-863-0025Email: ralbesa@inovadx.com
Quality Systems contact:	Ronda Elliott, VP, Quality Systems and RAInova Diagnostics, Inc9900 Old Grove Road, San Diego, CA, 92131Phone: 858-586-9900/1381Fax: 858-863-0025Email: relliot@inovadx.com
Device name:	Proprietary name:	Fecal Extraction Device
	Common name:	Chemiluminescence Fecal Calprotectin assaywith Fecal Extraction Device
	Classification name:	Calprotectin, Fecal
Regulation Description	Fecal Calprotectin Immunological Test System
Regulation Medical Specialty	Immunology
Review Panel	Immunology
Product Code	NXO
Regulation Number	866.5180
Device Class	2

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Predicate device

QUANTA Flash Calprotectin (using manual extraction), 510(k) number: K170993. Date declared: December 22nd, 2017.

Device description

The principle of the assay is chemiluminescent microparticle immunoassay, a variation of solid phase immunoassay. The QUANTA Flash® Calprotectin assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash® Calprotectin assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH® instrument.

Calprotectin-specific capture antibodies are coated on to paramagnetic beads, which are stored in the reagent cartridge under conditions that preserve the antibody in its reactive state. Prior to use in the BIO-FLASH® system, the reagent pack containing all the necessary assay reagents is mixed thoroughly by being inverted several times. The sealed reagent tubes are pierced with the reagent cartridge lid, and the reagent cartridge is loaded onto the instrument. Reagents are calibrated when the lot is first used. A patient extracted stool sample is prediluted by the BIO-FLASH® with sample buffer in a disposable plastic cuvette. Small amounts of the diluted patient extracted stool, the beads, and the assay buffer are all combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated monoclonal antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (urea-hydrogen peroxide in sodium chloride solution) are added to the cuvette, and the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH® optical system. The measured RLU is proportional to the amount of bound isoluminol conjugate, which is in turn proportional to the amount of calprotectin antigen captured by the antibodies (anti-calprotectin polyclonal antibodies in this case) on the beads. For quantitation, the QUANTA Flash® Calprotectin will utilize a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. The Master Curve is generated by Inova Diagnostics for each reagent pack lot with in-house Standards with assigned unit values (ng/mL). The RLU and assigned ng/mL values of the Standards are used to create a 4 parameter logistic curve. These four parameters are embedded in the reagent pack barcode. When the lot is used the first time, the Calibrators are run, and based on the results obtained on the Calibrators, an instrument specific Working Curve is created; The Working Curve is used to calculate units (ng/mL) based on RLU values

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obtained on each sample. The obtained ng/mL values will be converted to mg/kg by a calculation that takes into account the dilution of the samples. This unit conversion is calculated automatically by the software.

The Fecal Extraction Device kit contains the following materials:

One hundred (100) Fecal Extraction Devices

The Fecal Extraction Device tube contains the following materials for a single stool extraction:

a. 2,8 mL of extraction buffer, colorless, ready to use.

Intended use(s)

Indications for use

Same as Intended use.

Substantial equivalence

The QUANTA Flash Calprotectin assay system using the Fecal Extraction Device performs equivalently as the predicate device.

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Comparison to predicate device

QUANTA Flash Calprotectin Reagents

Similarities
Item	QUANTA Flash Calprotectin with Fecal Extraction Device.	QUANTA Flash Calprotectin
Intended use	QUANTA Flash Calprotectin is a chemiluminescent immunoassay for the quantitative determination of fecal calprotectin in extracted human stool samples. Elevated levels of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), and in the differentiation of IBD from irritable bowel syndrome (IBS).The Fecal Extraction Device is a single use tube containing extraction buffer intended for sampling stool specimens and subsequent analysis with the QUANTA Flash Calprotectin assay.	QUANTA Flash Calprotectin is a chemiluminescent immunoassay for the quantitative determination of fecal calprotectin in extracted human stool samples. Elevated levels of fecal calprotectin, in conjunction with clinical findings and other laboratory tests, can aid in the diagnosis of inflammatory bowel disease (IBD) (ulcerative colitis and Crohn's disease), and in the differentiation of IBD from irritable bowel syndrome (IBS).
Assay methodology	Solid phase (heterogeneous) immunoassay	Same
Antigen	Rabbit polyclonal anti-calprotectin antibody	Same
Shelf life	One year	Same
Sample type	Extracted Human Stool	Same
Units	mg/kg (milligram of calprotectin per kilogram of stool)	Same
Detection/ Operating principle	Chemiluminescent immunoassay	Same
Solid phase	Paramagnetic microparticles (beads)	Same
Conjugate	Isoluminol conjugated monoclonal anti-calprotectin antibody	Same
Analytical Measuring Range	$16.1 - 3,500.0$ mg/kg	Same
Calibration	Lot specific Master Curve + three calibrators (sold separately)	Same

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Analytical performance characteristics

Same as approved in 510k submission #K170993 plus the following additional data.

Stool Extraction method comparison: Fecal Extraction Device vs. Manual weighing method

Ninety seven human stool samples containing different levels of calprotectin were extracted in parallel using the manual weighting method and the Fecal Extraction Device. All resulting stool extracts were tested in singleton for calprotectin concentration levels using the QUANTA Flash Calprotectin assay. A scatter plot with a linear fit was created by plotting the mean values obtained with the manual weighting method against those obtained with the Fecal Extraction Device, using the Passing-Bablok fit function of Analyse-it for Excel software. This study has been conducted according to CLSI EPO9-A3 Method Comparison and Bias Estimation Using Patient Samples: Approved Guideline.

Acceptance criteria:

Intercept of regression line ± 15% of cut-off (18 mg/kg)
Slope of regression line between 0.90 and 1.10
Predicted Bias at cut-off ≤ 15%
. 95% CI of the bias: does not exceed medically significant difference, 20% of cut-off
Correlation r > 0.95

Results are summarized in the Table below:

Passing-Bablok fit	Y-Intercept(95% CI)	Slope(95% CI)	Bias at 120mg/kg(95% CI)	Correlation r
Fecal Collection Devicevs Manual Extractioncomparison n=97	-1.2(-9.7 to 6.4)	0.93(0.82 to 1.06)	-7.8 %(-16.0% to 0.6%)	0.975

All acceptance criteria were met.

Additionally, a percent agreement analysis has been performed between the two methods of extraction using the data generated obtaining the following results:

		Manual Extraction
		Positive	Indeterminate	Negative	Total
	Positive	43	3	0	46
Fecal Extraction	Indeterminate	3	20	3	26
Device	Negative	0	5	20	25
	Total	46	28	23	97
Indeterminate as positive
Positive agreement (95%CI):		93.2% (85.1 - 97.1%)
Negative agreement (95%CI):		87.0 % (67.9 - 95.5%)
Total agreement (95%CI):		91.8% (84.6 - 95.8%)
Indeterminate as negative
Positive agreement (95%CI):		93.5% (82.5 - 97.8%)
Negative agreement (95%CI):		94.1% (84.1 - 98.0%)
Total agreement (95%CI):		93.8% (87.2 - 97.1%)

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Device Validation

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

Acceptance criteria: weight collected by the FED is 56 mg ±10% (between 50 and 62 mg). Results of the study are summarized in the Table below:

Sample collection performance of FED
Mean Sample Weight (95% CI)	56 (55 - 57) mg
Median Sample Weight	56 mg
Range	50 – 62 mg
Standard Deviation	$\pm$ 3.8 mg
% Coefficient of Variation	6.9%

All acceptance criteria were met.

Reproducibility Studies

Extraction Reproducibility

Eight samples were extracted and tested, according to CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures, in replicates of 5, once a day, for 5 days, to generate 25 data points per sample per operator, for a total of 75 data points per sample. The extractions were performed daily by three independent operators using the Fecal Extraction Device. Data were analyzed with the Analyse-it for Excel method evaluation software to calculate between operator precision.

Acceptance criteria: Within Laboratory (Total Imprecision) %CV: ≤ 15% or SD: ≤ 7.5 mg/kg for negative samples.

Results are summarized in the Table below.

		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	29.5	2.2	7.3%	7.2	24.4%	7.5	25.4%	0.0	0.0%	7.5	25.4%
Sample 2	75	40.0	2.3	5.7%	6.0	15.0%	6.4	16.1%	2.2	5.5%	6.8	17.0%
Sample 3	75	53.2	2.1	3.9%	5.4	10.2%	5.8	10.9%	4.8	9.0%	7.5	14.1%
Sample 4	75	108.2	4.3	4.0%	8.0	7.4%	9.1	8.4%	7.3	6.8%	11.7	10.8%
Sample 5	75	222.9	7.3	3.3%	20.9	9.4%	22.1	9.9%	5.4	2.4%	22.8	10.2%
Sample 6	75	535.4	15.7	2.9%	41.2	7.7%	44.1	8.2%	21.9	4.1%	49.2	9.2%
Sample 7	75	1278.3	45.0	3.5%	114.6	9.0%	123.2	9.6%	8.9	0.7%	123.5	9.7%
Sample 8	75	1560.0	63.9	4.1%	197.1	12.6%	207.2	13.3%	0.0	0.0%	207.2	13.3%

All acceptance criteria were met.

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Sample Stability and Handling

Seven human stool samples, encompassing indeterminate range (n=1), around the cut-off (n=2), and positive samples (n=4) were extracted using the Fecal Extraction Device and tested in duplicates using the QUANTA Flash Calprotectin assay for up to 21 days while stored at 2-8°C, up to 73 hours while stored at room temperature, and after repeated freeze/thaw cycles up to 5 cycles (thaw samples were homogenized and clarified before its testing by vortex the samples for 30 seconds and centrifygation for 10 min at 3,000 x g)

Results were compared to those obtained on control samples (time zero / zero cycles).

Acceptance criteria: 80-120% average recovery.

All samples fulfilled the acceptance criteria at each time point for each condition. Based on these result, we recommend that extracted samples using the Fecal Extraction Device are stored up to 72 hours at room temperature, up to 14 days at 2-8°C and can be subjected to up to 4 freeze/thaw cycles.

Fecal Extraction Device Stability

Shelf life (Real Time Stability)

Since calprotectin is not stable in human stool for long periods of time stability studies for the Fecal Extraction Device (FED) were conducted by analyzing the pH of the extraction buffer (located inside the device) of three different lots of FED every 3 to 6 months for 24 to 26 months.

Acceptance criteria: pH between 7.70 and 7.90.

Results are summarized in the table below:

pH testingAcceptance Criteria(7.70 - 790)	Referencemg/kg	1mg/kg	2mg/kg	3mg/kg
time = 0 months	7.79	7.82	7.81	7.81
time = 3 months	7.78	7.81	7.81	7.80
time = 6 months	-	7.80	7.80	7.80
time = 9 months	-	7.81	7.79	7.78
time = 12 months	-	7.80	7.78	7.78
time = 18 months	-	7.79	7.78	7.78
time = 24 months	-	7.79	7.78	7.78
time = 26 months	-	-	-	7.77

Additionally, in order to test the functionality of the FED at expiration date, three lots of FED, two at expiration date (24 months) and one freshly produced, were used to perform extractions on 15 human stool samples, encompassing negative (n=11), indeterminate (n=2), around the cut-off (n=1) and a positive (n=1) samples. The calprotectin concentration of each stool extract was determined.

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The results of the two lots of FED at expiration date were compared to those obtained with the freshly produced lot. Percent recovery results were calculated where possible.

Acceptance criteria: 70-130% average recovery. This acceptance criterion takes into consideration the variability between lots of FED, the extraction reproducibility (±15%) and the expected recovery on a traditional real time study (±20%).

All samples fulfilled the acceptance criteria. In conclusion, the Fecal Extraction Device will be given an expiration date of 2 years.

Stability at Room Temperature

Three independent lots of Fecal Extraction Device have been evaluated for room temperature stability. Six human stool samples, encompassing indeterminate (n=1 for lots 2 and 3), around the cut-off (n=1) and positive samples (n=4 for lot 1, n=3 for lots 2 and 3) were extracted using the Fecal Extraction Device in two different conditions: using devices kept at 2-8°C and using devices kept at room temperature for at least 73 hours.

All resulting stool extracts were tested for calprotectin concentration levels using the QUANTA Flash Calprotectin assay. Results were compared to those obtained on control devices (2-8°C).

Acceptance criteria: 80-120% average recovery.

All results obtained using the three different lots of Fecal Extraction Device fulfilled the acceptance criteria. In conclusion, the Fecal Extraction Device can be kept at room temperature up to 72 hours.

Clinical performance characteristics

Same as approved in 510k submission #K170993.

Regulation Number and Section

§ 866.5180 Fecal calprotectin immunological test system.

(a)
Identification. A fecal calprotectin immunological test system is anin vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.(b)
Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).