IBD-QUIK CHEK by TECHLAB, INC. | FDA 510(k) Summary

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.

Device Description

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.

AI/ML Overview

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.

Summary

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510(k) Summary of the IBD-QUIK CHEK™ test 1.12

030704

The IBD-QUIK CHEK™ test is substantially cquivalent to the LEUKO-TEST® Tor the detection of fecal leukocytes and to the IBD-CHER® test for distinguishing active IBD from IBS, targeting the same detection level of lactoferrin. The tests are similar in that all three assays delect the presence of fecal loukocyles. The differences between the assays consist of variations in formals. The LEUKO-TEST® is a latex agglutination test. the IBD-CIIEK™ test is an enzyme-linked immunoassay and the IBD-QUIK CHEK™ test is an immunochromatographic device (lateral flow).

The IBD-QUIK CHIEK" test was compared directly with the LEUKO-TEST® microscopy and the IBD-C.HEKM test. When compared with the LEUKO-TEST® and microscopy, the IBD-OUIK CHEK™ test showed a correlation of 97.5%. In the same study, when the IBD-QUIK CHEK™ was compared to the LEUKO-TEST®, the correlation was 88.1%.

In an additional clinical cvaluation, the IBD-OUIK CHEK™ test was compared to clinical assessments and IBD-CHEK™ test results of IBD patients, active IBS patients and healthy persons. In the IBD group, there were 58 (46 with active Crohn's discass and 12 with active ulcerative colitis) with active discasc and 35 with inactive disease. In the active group, 100% tested positive in the IBD-OUIK CHILK™ test. In the inactive eroup, 2 (5.7%) of the patients with Crohn's discasc tested positive. Of the 46 1131.) paticats with active Crohn's disease, 100% tested positive. Of the 12 1812 paticats with active ulccrative colitis, 100% tested positive in the IBD-OUIK CHEKM test. All 17 persons (100%) with active irritable bowel syndrome and all 27 healthy adults (100%) tested negative in the IBD-OUIK CHEKTM test.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 1 2003

David M. Lyerly Vice President of Research and Development TECHLABS®, Inc. 1861 Pratt Drive. STE 1030 Corporate Research center Blacksburg, VA 24060-6364

Re: K030704 Trade/Device Name: IBS-QUICK CHECKTM Regulation Number: 21CFR 866.5570 Regulatory Class: Class I Product Code: DEG Dated: March 5, 2003 Received: March 6, 2003

Dear Dr. Lyerly:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (304) 594-3084. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97), You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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2.0 STATEMENT OF INTENDED USE

510(k) Number (if known): K030704

Device Name: IBD-QUIK CHEKTM

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

(Optional format 1-2-96)
Reuss for J. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K030704

Regulation Number and Section

§ 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.