(46 days)
The IBD-QUIK CHEK™ test is an immunochromatographic test for the qualitative detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test can be used as an in vitro diagnostic aid to help identify patients with active inflammatory bowel disease (IBD) and rule out those with active noninflammatory irritable bowel syndrome (IBS). FOR IN VITRO DIAGNOSTIC USE.
The IBD-OUIK CHEKM test is a 10-minute immunochromatographic device for the detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. The test utilizes the same polyclonal antibodies against human lactoferrin as our previously cleared I.F.UKO-12ST® and IBD-CHEK™ test. The polyclonal antibodies to human lactoferrin are immobilized on nitrocellulose and the conjugate consists of the same antibodies linked to colloidal gold particles.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for IBD-QUIK CHEK™ test 1.12
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Correlation with LEUKO-TEST® (for fecal leukocytes detection) | 88.1% |
| Correlation with Microscopy (for fecal leukocytes detection) | 97.5% (when compared with LEUKO-TEST® and microscopy, implying the IBD-QUIK CHEK™ performed similarly or better than LEUKO-TEST® against microscopy) |
| Ability to distinguish active IBD from active IBS (IBD-CHEK™ comparison) | No specific percentage provided for comparison to IBD-CHEK™. However, the clinical evaluation states: |
- Active IBD Group (n=58): 100% positive (46 active Crohn's, 12 active ulcerative colitis)
- Inactive IBD Group (n=35): 2 (5.7%) false positives in Crohn's disease
- Active IBS Group (n=17): 100% negative
- Healthy Adults (n=27): 100% negative |
| Detection of elevated levels of lactoferrin, a marker for fecal leukocytes and an indicator of intestinal inflammation. | Implied by the strong correlations with LEUKO-TEST® and microscopy, which are established methods for detecting fecal leukocytes, and by the clinical evaluation results showing high positivity in active IBD and negativity in IBS/healthy controls. |
| Aid to physicians in distinguishing active IBD from active IBS (non-inflammatory condition). | Supported by 100% positivity in active IBD and 100% negativity in active IBS. |
2. Sample Size Used for the Test Set and Data Provenance
- Correlation Study (vs. LEUKO-TEST® and Microscopy): Not explicitly stated. The text mentions "the same study" for both comparisons but does not give a sample size.
- Clinical Evaluation Study (vs. Clinical Assessments and IBD-CHEK™):
- Total Patients: 58 (active IBD) + 35 (inactive IBD) + 17 (active IBS) + 27 (healthy) = 137 individuals.
- Data Provenance: Not explicitly stated, but clinical evaluations typically use prospective patient cohorts. Given the context of a 510(k) submission, it's highly likely to be a prospective study conducted in a clinical setting, but the country of origin is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the summary. For the correlation study with microscopy, a "microscopy" gold standard implies expert review of slides, but the number and qualifications of experts are not described.
- For the clinical evaluation study, "clinical assessments" are used, which would typically involve physicians or specialists. However, the exact number and their qualifications (e.g., gastroenterologists, years of experience) are not detailed.
4. Adjudication Method for the Test Set
- Not explicitly stated. For the microscopy comparison, it is implied that microscopy served as a direct ground truth. For the clinical assessment study, it's likely that a treating physician's diagnosis and possibly additional diagnostic tests (e.g., endoscopy, histology) formed the "clinical assessment," but the adjudication process (e.g., if multiple clinicians reviewed cases, or if a consensus was required) is not described.
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
- Not applicable. This device is an in vitro diagnostic test, not an AI or imaging device where human readers interact with AI assistance. The comparisons are between the device and existing tests/clinical assessments, not human interpretation aided by AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes. This device is a standalone diagnostic test. Its performance metrics (correlations, sensitivity, specificity implied by positive/negative rates) are reported for the device itself, without human intervention in its result generation. The test produces a direct positive or negative result.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- Correlation Study:
- Microscopy: Likely expert visual assessment of fecal samples for leukocytes, potentially considered as a form of expert consensus or established laboratory methodology.
- LEUKO-TEST®: Another existing diagnostic test, used as a comparative standard.
- Clinical Evaluation Study:
- Clinical Assessments: This would encompass a combination of clinical diagnosis, patient history, symptoms, and potentially other diagnostic tests (e.g., endoscopy, biopsies, imaging) and follow-up, which can lead to a 'clinical ground truth' or 'outcomes data' in terms of confirmed IBD, IBS, or healthy status.
- IBD-CHEK™ test results: Another existing diagnostic test, used as a comparative standard.
8. The Sample Size for the Training Set
- Not applicable / Not explicitly stated. For an immunochromatographic device like this, there isn't typically a "training set" in the machine learning sense. The device's performance is based on its inherent biochemical properties and manufacturing consistency, not an algorithm "trained" on data. The polyclonal antibodies and colloidal gold conjugates are pre-determined components.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As explained in point 8, there isn't a training set in the context of this type of diagnostic device. The ground truth for validating the device's performance (i.e., the test set ground truth) is described in point 7.
§ 866.5570 Lactoferrin immunological test system.
(a)
Identification. A lactoferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the lactoferrin (an iron-binding protein with the ability to inhibit the growth of bacteria) in serum, breast milk, other body fluids, and tissues. Measurement of lactoferrin may aid in the diagnosis of an inherited deficiency of this protein.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.