(223 days)
The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.
The InSure® ONE™ – One Day Fecal Immunochemical Test qualitatively detects human hemoglobin from blood in fecal samples. The fecal sample is generally collected by the test subject at home. Toilet bowl water samples are taken using long handled brushes to collect a small volume of water from around the defecated stool. The toilet water test sample once collected is placed on an InSure ONE Test Card. The InSure ONE Test Card then serves as a means to transport the dried samples to the laboratory. The InSure ONE test detects human hemoglobin in toilet bowl water. The test is developed in the laboratory or medical professional office with appropriate quality control. The FOBT Controls (K101831) are recommended for use as external controls.
Components of InSure® ONE™ - One Day Fecal Immunochemical Test:
- a. The InSure® ONE™ Collection Kit* contains:
- InSure® ONE™ Instructions for Use-Patient ●
- InSure® ONE™ Test Card ●
- Brush Kit containing 2x brushes and a waste bag ●
- Business reply form and envelope ●
- b. The InSure® ONE™ or InSure® FIT Developer Kit* (for development and interpretation of the test) contains:
- InSure® ONE™ Instructions for Use-Professional Laboratory .
- InSure® ONETM Test Strips: The Test Strips contain mouse monoclonal anti-. human hemoglobin test line antibodies and a conjugate-specific polyclonal (donkey anti-goat) antibody control line, and a conjugate of anti-human hemoglobin polyclonal (goat) antibodies bound to colored (colloidal gold) particles.
- . InSure® ONE™ Run Buffer: Contains borate salts, ethanol, bovine serum albumin, and sodium azide as preservative.
- c. The InSure® ONE™ or InSure® FIT FOBT Controls contains:
- · Instructions for Use
- · Positive Control
- · Negative Control
*The above kits and components are supplied in a variety of packaging configurations and sold in combination or separately to meet customer requirements.
Here's the breakdown of the acceptance criteria and study information for the InSure® ONE™ – One Day Fecal Immunochemical Test based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Analytical Sensitivity: Reliably detects 50 ug hemoglobin/gram stool for up to 14 days after sample collection. | Assay Cut-off Study: - At 50 ug Hb/g stool: Positive Percent Agreement (PPA) of 97.5% (87.1% to 99.6% CI). - At 40 ug Hb/g stool: PPA of 92.5% (80.1% to 97.4% CI). Officially, the cut-off was determined to be 50 ug hemoglobin/g stool. |
| Method Comparison (Clinical Performance): Acceptable overall agreement with InSure® FIT™ (predicate device) in clinical positive predictive value (PPV) and clinical negative predictive value (NPV). No statistically significant differences in test results between the new InSure ONE sampling method (two aliquots from one bowel movement) and the predicate InSure FIT method (one aliquot from two separate bowel movements). | The study demonstrated that there were no statistically significant differences in the test results obtained from two fecal water sample aliquots taken from one bowel movement (new sampling method InSure ONE), when compared to one fecal water sample aliquot taken from two separate bowel movements (predicate sampling method InSure FIT). The InSure ONE test is substantially equivalent to the predicate device. |
Study Details
2. Sample size used for the test set and the data provenance:
- Analytical Sensitivity (Assay Cut-off Study):
- Sample Size: 40 samples per hemoglobin concentration level, across 9 different concentrations, totaling 360 prepared samples.
- Data Provenance: The text describes the preparation of spiked stool samples and the simulation of toilet water. This suggests a retrospective, laboratory-based study rather than collection from actual patients.
- Method Comparison (Clinical Study):
- Sample Size: 859 patients.
- Data Provenance: Patients were recruited from three intended use sites, and the study was performed at one intended use site in Australia. This was a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Analytical Sensitivity (Assay Cut-off Study): No external experts are mentioned for establishing ground truth. The ground truth was based on the known, spiked hemoglobin concentrations.
- Method Comparison (Clinical Study): The text states, "Tissue samples collected at colonoscopy were histopathologically examined for the type of lesion (i.e., cancer, advanced adenoma, etc.)." This implies that pathologists established the ground truth based on histopathological examination. The number and specific qualifications (e.g., years of experience) of these pathologists are not specified in the provided text.
4. Adjudication method for the test set:
- Analytical Sensitivity (Assay Cut-off Study): Not applicable, as the ground truth was based on predefined concentrations. The determination of whether a test was positive or negative was likely by trained laboratory personnel following a specific protocol.
- Method Comparison (Clinical Study): The text does not explicitly mention an adjudication method for the histopathological examination of tissue samples. It is standard practice in pathology for samples to be reviewed by at least one pathologist, and potentially a second for complex cases or discrepancies, but this is not detailed in the provided information.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a Fecal Immunochemical Test (FIT), which is a diagnostic assay, not an AI-assisted diagnostic imaging or analysis tool that typically involves human readers interpreting results with or without AI assistance. The study compares the performance of two different sampling methods for the FIT itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance was done for both studies.
- Analytical Sensitivity (Assay Cut-off Study): This study directly assessed the device's ability to detect hemoglobin at various concentrations, which is the standalone performance of the test kit itself.
- Method Comparison (Clinical Study): This study evaluated the performance of the InSure ONE test (device and sampling method) in detecting occult blood, independent of a human interpreting complex outputs to derive a diagnosis. The "human-in-the-loop" aspect here is the patient collecting the sample and laboratory staff developing it, but the intrinsic performance of the test strip itself is being evaluated.
7. The type of ground truth used:
- Analytical Sensitivity (Assay Cut-off Study): Predefined concentrations of hemoglobin in spiked stool samples.
- Method Comparison (Clinical Study): Pathology results from histopathological examination of tissue samples collected during colonoscopy (e.g., cancer, advanced adenoma).
8. The sample size for the training set:
- The provided text does not mention a training set as this is a diagnostic test kit (FIT), not a machine learning or AI algorithm that typically requires a large training dataset to learn patterns. The studies described are performance and method comparison studies for the physical test device.
9. How the ground truth for the training set was established:
- As no training set is mentioned for this type of device, this information is not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 13, 2017
ENTERIX INC. c/o RONALD SCHOENGOLD PRINCIPAL 19000 SARATOGA GLEN PLACE SARATOGA, CA 95070
Re: K170548
Trade/Device Name: InSure® ONE™ – One Day Fecal Immunochemical Test Regulation Number: 21 CFR 864.6550 Regulation Name: Occult blood test Regulatory Class: Class II Product Code: KHE Dated: August 28, 2017 Received: September 5, 2017
Dear Mr. Schoengold:
This letter corrects our substantially equivalent letter of October 5, 2017.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 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" (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 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,
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) K170548
Device Name
InSure® ONE™ One Day Fecal Immunochemical Test
Indications for Use (Describe) Intended Use/Indications for Use
The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONE™ test is used to aid in the detection of lower gastrointestinal bleeding.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart |
|---|
| ☑ Over-The-Counter Use (21 CFR 801 Subpart |
D) InSure® ONE™ Developer Kit Components
☑ Over-The-Counter Use (21 CFR 801 Subpart
C) InSure® ONETM Sample Collection Kit
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Image /page/3/Picture/0 description: The image shows the logo for Clinical Genomics. The logo features a stylized human figure with a curved line extending from the figure's head down to the base. The text "Clinical Genomics" is written in a sans-serif font to the right of the figure. The color scheme is primarily black and blue.
510(k) Summary (As required by 21CFR 807.92)
Submitter Enterix Inc., A Clinical Genomics Inc. Company 236 Fernwood Avenue Edison, NJ 08837, USA 732 429 1899
Contact Person Michele Houldsworth, Vice President Regulatory Affairs
Date of Preparation September 30, 2017
Device Name InSure® ONE™ One Day Fecal Immunochemical Test
Common Name Fecal Occult Blood Test
Classification Name Fecal Immunochemical Test
Regulation Number 21 CFR 864.6550
Product Code KHE
Predicate Devices InSure® FIT™ (Fecal Immunochemical Test)
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Device Description
The InSure® ONE™ – One Day Fecal Immunochemical Test qualitatively detects human hemoglobin from blood in fecal samples. The fecal sample is generally collected by the test subject at home. Toilet bowl water samples are taken using long handled brushes to collect a small volume of water from around the defecated stool. The toilet water test sample once collected is placed on an InSure ONE Test Card. The InSure ONE Test Card then serves as a means to transport the dried samples to the laboratory. The InSure ONE test detects human hemoglobin in toilet bowl water. The test is developed in the laboratory or medical professional office with appropriate quality control. The FOBT Controls (K101831) are recommended for use as external controls.
Components of InSure® ONE™ - One Day Fecal Immunochemical Test:
- a. The InSure® ONE™ Collection Kit* contains:
- InSure® ONE™ Instructions for Use-Patient ●
- InSure® ONE™ Test Card ●
- Brush Kit containing 2x brushes and a waste bag ●
- Business reply form and envelope ●
- b. The InSure® ONE™ or InSure® FIT Developer Kit* (for development and interpretation of the test) contains:
- InSure® ONE™ Instructions for Use-Professional Laboratory .
- InSure® ONETM Test Strips: The Test Strips contain mouse monoclonal anti-. human hemoglobin test line antibodies and a conjugate-specific polyclonal (donkey anti-goat) antibody control line, and a conjugate of anti-human hemoglobin polyclonal (goat) antibodies bound to colored (colloidal gold) particles.
- . InSure® ONE™ Run Buffer: Contains borate salts, ethanol, bovine serum albumin, and sodium azide as preservative.
- c. The InSure® ONE™ or InSure® FIT FOBT Controls contains:
- · Instructions for Use
- · Positive Control
- · Negative Control
*The above kits and components are supplied in a variety of packaging configurations and sold in combination or separately to meet customer requirements.
Intended Use
The InSure® ONE™ is a fecal immunochemical test (FIT) that qualitatively detects human hemoglobin from blood in fecal samples. The samples will generally be collected by the test subject at home and the test developed at laboratories or professional offices. The InSure® ONETM test is used to aid in the detection of lower gastrointestinal bleeding.
Analytical Sensitivity
The InSure® ONE™ reliably detects 50ug hemoglobin/gram stool for up to 14 days after sample collection.
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Assay Cut-off Study
Fecal test samples were prepared by spiking stool samples with human blood of known hemoglobin concentration, to obtain the following fecal hemoglobin concentrations: 0 ug Hb/g stool, 5 µg Hb/g stool, 10 µg Hb/g stool, 20 µg Hb/g stool, 30 µg Hb/g stool, 40 µg Hb/g stool, 50 ug Hb/g stool, 60 ug Hb/g stool and 80 ug Hb/g stool. Pre-measured quantities of stool spiked with different levels of hemoglobin were placed in a pre-measured volume of water to simulate toilet water in which stool will be deposited. Following deposition of the stool, water samples were taken at 2 minutes with the InSure sample collection brushes and applied to Test Cards using the InSure FIT and the InSure ONE sampling procedures. Testing was performed side-byside with the predicate by comparing the test results of the device with that of the predicate. Test Cards were prepared on Day 0, stored at room temperature (20-25°C) and developed on Day 5 to simulate the time span between the patient collecting the fecal water sample on the Test Card and transporting the sampled Test Card to the laboratory by mail. The cut-off was determined to be 50 ug hemoglobin/g stool.
| HbConcentration(ng/mL) | N | InSure ONE | Negative PercentAgreement(95% CI1) | Positive PercentAgreement(95% CI1) | |
|---|---|---|---|---|---|
| 0 | 40 | 40 | 0 | 100%(91.2% to 100%) | 0%(0% to 8.8%) |
| 5 | 40 | 38 | 2 | 95.0%(83.5% to 98.6%) | 5.0%(1.4% to 16.5%) |
| 10 | 40 | 31 | 9 | 77.5%(62.5% to 87.7%) | 22.5%(12.3% to 37.5%) |
| 20 | 40 | 19 | 21 | 47.5%(32.9% to 62.5%) | 52.5%(37.5% to 67.1%) |
| 30 | 40 | 8 | 32 | 20.0%(10.5% to 34.8%) | 80.0%(65.2% to 89.5%) |
| 40 | 40 | 3 | 37 | 7.5%(2.6% to 19.9%) | 92.5%(80.1% to 97.4%) |
| 50 | 40 | 1 | 39 | 2.5%(0.4% to 12.9%) | 97.5%(87.1% to 99.6%) |
| 60 | 40 | 1 | 39 | 2.5%(0.4% to 12.9%) | 97.5%(87.1% to 99.6%) |
| 80 | 40 | 0 | 40 | 0%(0% to 8.8%) | 100%(91.2% to 100%) |
Cut-off Study
CI=confidence interval, Hb=hemoglobin
1 Wilson Score
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Method Comparison
A method comparison of InSure® ONE™ with the predicate test, InSure® FIT™, was conducted to determine if there was a significant difference in test performance between sampling two separate fecal samples once each or a single fecal sampled twice, for detection of occult blood. Patients were recruited from three intended use sites and the study was performed at one intended use site in Australia. A total of 859 patients collected fecal water samples using both InSure FIT and InSure ONE Test Cards before undergoing colonoscopy. Test Card A was the InSure FIT sampling procedure, the predicate device. Test Card B and Test Card C was the InSure ONE sampling procedure, the test device.
Tissue samples collected at colonoscopy were histopathologically examined for the type of lesion (i.e., cancer, advanced adenoma, etc.). Statistical analysis of the test results for clinical positive predictive value (PPV) and clinical negative value (NPV) showed that the InSure ONE test results have acceptable overall agreement with InSure FIT test results. The study demonstrated that there were no statistically significant differences in the test results obtained from two fecal water sample aliquots taken from one bowel movement (new sampling method InSure ONE), when compared to one fecal water sample aliquot taken from two separate bowel movements (predicate sampling method InSure FIT). The InSure ONE test is substantially equivalent to the predicate device.
Summary
The InSure ONE One Day Fecal Immunochemical test has the same intended use, technological characteristics as the predicate device, InSure FIT. The InSure ONE is an easy to use screening method to reliably detect human hemoglobin from blood in toilet bowl water containing defecated stool that may be an indication of gastrointestinal pathology. The clinical performance of the InSure ONE sampling and test method support a substantial equivalence claim.
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.