IBD-QUIK CHEK

K030704 · Techlab, Inc. · DEG · Apr 21, 2003 · Immunology

Device Facts

• Record ID: K030704
• Device Name: IBD-QUIK CHEK
• Applicant: Techlab, Inc.
• Product Code: DEG · Immunology
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5570
• Device Class: Class 1

Indications for Use

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 Story

Immunochromatographic lateral flow device; detects human lactoferrin in fecal samples as marker for fecal leukocytes/intestinal inflammation. Utilizes polyclonal antibodies against human lactoferrin immobilized on nitrocellulose; conjugate uses same antibodies linked to colloidal gold particles. 10-minute test time. Used in clinical laboratory settings to assist physicians in differentiating active IBD from active IBS. Provides qualitative visual output; positive result indicates elevated lactoferrin/inflammation; negative result suggests noninflammatory condition. Aids clinical decision-making by identifying patients requiring further investigation for IBD versus those with IBS.

Clinical Evidence

Clinical evaluation compared IBD-QUIK CHEK™ to LEUKO-TEST® and IBD-CHEK™. Correlation with LEUKO-TEST®/microscopy was 97.5%; correlation with LEUKO-TEST® alone was 88.1%. In a study of 58 active IBD patients (46 Crohn's, 12 ulcerative colitis) and 35 inactive IBD patients, 100% of active cases tested positive. 5.7% of inactive Crohn's patients tested positive. 100% of 17 active IBS patients and 27 healthy adults tested negative.

Technological Characteristics

Immunochromatographic lateral flow assay. Materials: Polyclonal antibodies against human lactoferrin, nitrocellulose membrane, colloidal gold particles. Qualitative visual readout. Standalone device; no external energy source or software required.

Indications for Use

Indicated for patients suspected of having intestinal inflammation to aid in distinguishing active inflammatory bowel disease (IBD) from active noninflammatory irritable bowel syndrome (IBS).

Regulatory Classification

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.

Predicate Devices

• LEUKO-TEST®
• IBD-CHEK™ test

Submission Summary (Full Text)

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

030704

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. The IBD-OUIK CHEKTM test results can be used to aid the physician in distinguishing active IBD (inflammatory bowel discasc) from active II3S (irritable bowel syndrome noninflammatory condition).

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 [phone]. 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 [phone] or [phone] 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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

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