(92 days)
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix InSure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.
Enterix InSure FIT FOBT Controls is a two-level, aqueous control solution. Enterix InSure FIT FOBT Controls is intended for use to verify the performance of Enterix InSure FIT product. The Enterix InSure FIT Test method is based on the detection of human hemoglobin (hHb). Human hemoglobin indicates the presence of blood in the stool. The test detects the globin (protein) portion of the hHb molecule. Because globin does not survive passage through the upper gastrointestinal (GI) tract, any globin in the stool indicates that there is bleeding in the lower colon or rectum, the region where colorectal cancers originate. The product is packaged in plastic bottles with dropper tips for application of the solution to test strips.
Enterix InSure FIT FOBT Controls is a non-hazardous aqueous solution containing bovine albumin, salts, buffers preservatives and in addition contains human hemoglobin in the positive control.
Here's the breakdown of the acceptance criteria and study information for the Enterix® InSure® FIT™ FOBT Controls, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The provided document describes the device as a quality control solution for the Enterix InSure FIT product. Its primary function is to verify the performance of the InSure FIT test. Therefore, the acceptance criteria are directly tied to how the control solutions behave when tested with the InSure FIT Kit.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Requirement | Reported Device Performance (Enterix InSure FIT FOBT Controls) |
|---|---|
| Negative Control Performance | When tested with the Enterix® InSure® FIT™ Kit, the Negative Control must yield a "Negative test line" and a "Positive control line." |
| Positive Control Performance | When tested with the Enterix® InSure® FIT™ Kit, the Positive Control must yield a "Positive test line" and a "Positive control line." |
| Closed bottle stability (Shelf-life) | Tests were conducted to verify this specific performance requirement. (Specific duration or criteria not detailed in this summary, but the study was performed). |
| Stability after opening (Use-life) | Tests were conducted to verify this specific performance requirement. (Specific duration or criteria not detailed in this summary, but the study was performed). |
| Transport Stability | Tests were conducted to verify this specific performance requirement. (Specific conditions or criteria not detailed in this summary, but the study was performed). |
| Test response | The control solution contains bovine albumin, salts, buffers, preservatives, and (for the positive control) human hemoglobin, optimized to simulate the response of fecal occult blood samples on the Enterix InSure FIT Product. Tests were conducted to verify test response. |
Study Information
The provided document is a 510(k) summary for a control solution, not the primary diagnostic test itself. Therefore, the studies primarily focus on the performance and stability of the control solution rather than extensive clinical validation of a diagnostic algorithm.
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Sample size used for the test set and the data provenance:
- The document does not specify explicit sample sizes (e.g., number of runs, number of vials) for the stability or test response studies. It only states that "Tests were conducted to verify specific performance requirements."
- Data Provenance: Not specified as being from a particular country. These are likely internal laboratory studies conducted by Bionostics, Inc. The studies are non-clinical tests as explicitly stated ("Summary of non-clinical tests submitted with the premarket notification for the device.").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable to this submission. The "ground truth" for a control solution's performance is its expected reactivity with the intended diagnostic kit (e.g., negative control should be negative, positive control should be positive). The evaluation of these controls would be based on the instrument/kit's reading, not expert interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The evaluation of control solution performance on an in vitro diagnostic test typically involves observing the expected reaction (e.g., appearance of a line) on the test strip, rather than expert adjudication of complex clinical images or diagnoses.
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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 MRMC study was done (or is applicable). This device is a control solution for an IVD kit, not an AI-powered diagnostic tool requiring human reader interpretation or assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a control solution for an in vitro diagnostic test, not an algorithm or AI device. The "performance" is whether the control solution produces the expected result on the test kit.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is intrinsic to the design of the control solutions:
- Negative Control: Designed to lack human hemoglobin, thus expected to yield a negative result on the InSure FIT test.
- Positive Control: Designed to contain stabilized human hemoglobin, thus expected to yield a positive result on the InSure FIT test.
- The verification of this ground truth is done by testing the controls with the InSure FIT Kit and observing the qualitative outcome (presence/absence of test lines, presence of control line).
- The "ground truth" is intrinsic to the design of the control solutions:
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The sample size for the training set:
- Not applicable for this type of device (control solution). There is no "training set" in the context of machine learning or AI models. The controls are manufactured to specified formulations.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set. The "ground truth" for the performance of the control solutions is established by their intended chemical composition and expected reactivity with the InSure FIT test.
§ 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.