UNI-GOLD H. PYLORI

{0}------------------------------------------------ K991697 Image /page/0/Picture/1 description: The image shows the logo for Trinity Biotech. The word "Trinity" is in bold, white letters against a black triangle. Below that, the word "biotech" is in smaller, black letters. Trinity Biotech plc. IDA Business Park. Bray, Co. Wicklow, Ireland. Tel: (353) 1 276 9800, Fax: (353) 1 276 9888 e-mail: info@trinitybiotech.ie. #### 510(k) SUMMARY This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is: K991697. DEC 2 1 1999 Submitter Information (21 CFR 807.92(a)(1)) Trinity Biotech, plc Submitter: IDA Business Park Bray Contact: Dr. Jim Walsh Chief Operating Officer Trinity Biotech, plc phone: 011 353 1 276 9800 fax: 011 353 1 276 9888 County Wicklow, Ireland November 5, 1999 Summary Date: Name of Device and Classification (21 CFR 807.92(a)(2)) Name (trade): Uni-Gold™ H. pylori test kit Name (usual): Helicobacter pylori serological reagents Classification: 21 CFR 866.3110, Class I, LYR Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a)(3)) The Uni-Gold H. pylori test kit is substantially equivalent to the Quidel QuickVue One-Step H. pylori Test (QuickVue), Quidel Corporation, San Diego, CA. The Uni-Gold H. pylori test kit is identical, or similar to, its predicate in terms of: intended use, antibodies detected, technology/methodology, testing matrices, and result interpretation. {1}------------------------------------------------ #### Description of Device (21 CFR 807.92 (a)(4)) As the sample flows laterally through the membrane, the specific antibody bindingprotein dye conjugate binds to the human immunoglobulins in the sample. If the sample contains IgG antibodies to H. pylori, the complex binds to the antigens on the solid phase of the device's test region producing a red/pink (red) line. In the absence of H. pylori antibodies, no line appears in the test region of the device. A procedural-functional control is built in to each device. As the sample migrates across the control region, the appearance of a red line at the control region indicates correct procedure and a functional device. #### Intended Use (21 CFR 807.92 (a)(5)) The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. #### Similarities to the Predicate(s) (21 CFR 807.92 (a)(6)) A summary table of the similarities and differences between the Uni-Gold H. pylori test kit and the predicate device (QuickVue) follows. {2}------------------------------------------------ | CHARACTERISTIC | UNI-GOLD™ H. PYLORI | QUICKVUE | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | immunoassay for the rapid<br>qualitative detection of IgG<br><i>Helicobacter pylori</i> antibodies<br>in adult human whole blood,<br>serum, or plasma. The test is<br>intended for professional use in<br>physicians' offices and hospital<br>laboratories as an aid in the<br>diagnosis of <i>H. pylori</i> infection<br>in patients with clinical signs<br>and symptoms of<br>gastrointestinal disease. | immunoassay for the rapid,<br>qualitative detection of IgG<br>antibodies specific to<br><i>Helicobacter pylori</i> in human<br>serum, plasma, or whole<br>blood as an aid in the<br>diagnosis of <i>H. pylori</i><br>infection in patients with<br>clinical signs and symptoms<br>of gastrointestinal disease.<br>The test is intended for<br>professional/laboratory use. | | Antibodies Detected | <i>Helicobacter pylori</i> | <i>Helicobacter pylori</i> | | Methodology/Technology | As the sample flows laterally<br>through the membrane, the<br>specific antibody binding-<br>protein dye conjugate binds to<br>the human immunoglobulins in<br>the sample. If the sample<br>contains IgG antibodies to <i>H.<br/>pylori</i> , the complex binds to the<br>antigens on the solid phase of<br>the device's test region<br>producing a red/pink (red) line.<br>In the absence of <i>H. pylori</i><br>antibodies, no line appears in the<br>test region of the device. A<br>procedural-functional control is<br>built in to each device. As the<br>sample migrates across the<br>control region, the appearance of<br>a red line at the control region<br>indicates correct procedure and a<br>functional device. | Sample flows through a pad<br>containing purified <i>H. pylori</i><br>antigen coupled to red beads<br>and blue control beads. If the<br>sample contains <i>H. pylori</i><br>specific IgG antibody, it will<br>bind to the antigen coupled to<br>the red beads, which, in turn,<br>will bind to a monoclonal<br>anti-human IgG antibody<br>spotted on the membrane. As<br>the <i>H. pylori</i> antigen-antibody<br>complex is captured, a red<br>Test Line will appear in the<br>Result Window. A blue<br>Procedural Control Line will<br>also appear if proper fluid<br>volume entered the device<br>and capillary flow occurred.<br>If <i>H. pylori</i> IgG antibody is<br>not present, or is present at<br>very low levels, only a blue<br>Control Line will be visible. | | Testing Matrices | whole blood, serum, plasma | whole blood, serum, plasma | | Result Interpretation | positive or negative for<br><i>H. pylori</i> antibodies | positive or negative for<br><i>H. pylori</i> antibodies | | Assay Read Time | 10 minutes | 10 minutes | | CHARACTERISTIC | UNI-GOLD H. PYLORI | QUICKVUE | | Assay Procedure | 1 drop of sample followed by 3 drops of wash | 3 drops of sample | | Sample Volume | 30 $\mu$ L | >100 $\mu$ L | | Storage Temperature | 2-27° C | 15-30° C | i # Similarities Between Uni-Gold™ H. pylori test kit and QuickVue {3}------------------------------------------------ #### Differences Between Uni-Gold H. pylori Test Kit and QuickVue ### Brief Discussion of Nonclinical Data (21 CFR 807.92(b)(1)) Studies were conducted to evaluate cross reactivity, effects of hematocrit, sample stability, and test performance in various matrices (whole blood [fingerstick and venous], serum, and plasma). No cross reactivity was observed with the testing of the following organisms: Campylobacter jejuni, Campylobacter coli, Campylobacter fetus, and Escherichia. coli, and Borrelia burgdorferi antibodies (Lyme disease positive samples). Further, there was no effect from the addition of very high levels of bilirubin, albumin, and hemoglobin. The Uni-Gold™ H. pylori assay provided accurate results with hematocrits ranging from 39% to 53%. Serum and plasma samples may be assayed when stored at 2-8℃ for up to three days, and when stored frozen at -20°C for longer intervals. Also, there were equivalent results in whole blood, serum, and plasma matrices. # Brief Discussion of Clinical Data (21 CFR 807.92 (b)(2) The clinical sensitivity and specificity (accuracy) of the Uni-Gold™ H. pylori test kit was determined by the analysis of 348 clinical samples (164 positive and 184 negative) at three independent sites (USA, Canada, and Sweden). The clinical trials were performed on patients of mixed populations of race, sex, and age who presented with various gastrointestinal symptoms. All patients underwent venipuncture for detection of antibodies to H. pylori by the Uni-Gold™ H. pylori test kit, and a commercially available ELISA kit, as well as gastric biopsy for culture and histology for the detection of H. pylori infection. Biopsy "positive" was defined as culture and histology positive or culture positive, and biopsy "negative" was defined as negative for both culture and histology, or negative for culture. Biopsy results were considered the gold standard reference results for the detection of active H. pylori infection. The results are summarized below. {4}------------------------------------------------ | n = 348 samples | | Biopsy | | Results | | |---------------------|---|--------|---|---------|-----| | | | + | - | + | - | | Uni-Gold™ H. pylori | + | 136 | | | 32 | | | - | 28 | | | 152 | | Reference Totals | | 164 | | | 184 | Uni-Gold™ H. pvlori Test Kit Results vs Biopsy Results The data demonstrated the Uni-Gold™ H. pylori test kit correctly identified 136 of the 164 biopsy-positive samples for a sensitivity of 83%, and correctly identified 152 of 184 biopsy-negative samples for a specificity of 83%. The overall accuracy was 83%. # Uni-Gold™ H. pylori test kit Vs Biopsy In Conjunction with ELISA ELISA results were used to evaluate the 60 discrepant results (28 false negative and 32 false positive) between the Uni-Gold H. pylori test kit and biopsy. The ELISA method detects the presence of human IgG antibodies to H. pylori, and the ELISA testing was performed on all samples (* sample volume permitting). * only 52 of the 60 results are reported as there was either insufficient sample for ELISA testing, or ELISA results were inconclusive. The data indicate that, of the 52 available results, 20 were found to be positive by both the Uni-Gold™ H. pylori test and ELISA, and five were found to be negative by both methods. # Performance Data - Conclusions (21 CFR 807.92 (b)(3)) The studies demonstrated the substantial equivalence of the Uni-Gold™ H. pylori test kit to existing products already marketed. Cross-reactivity studies confirmed the specificity of the assay, and clinical studies confirmed the assay's accuracy. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its wings. DEC 2 1 1999 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Trinity Biotech, plc c/o Ms. Erika B. Ammirati, RAC, MT(ASCP) Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, California 94022 Re: K991697 Trade Name: Uni-Gold™ H. pylori Regulatory Class: I Product Code: LYR Dated: November 5, 1999 Received: November 8, 1999 Dear Ms. Ammirati: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {6}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. This letter will allow you to begin marketing your device as described in your 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 vour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours. Steven Autman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Page_1_of_1 510(k) Number (if known): K991697 Device Name:_Uni-Gold™ H. pylori Indications For Use: The Trinity Biotech Uni-Gold™ H. pylori assay is intended for the rapid in-vitro qualitative detection of IgG antibodies to Helicobacter pylori (H. pylori) in adult human serum, plasma, or whole blood as an aid in the diagnosis of H. pylori infection in patients with clinical signs and symptoms of gastrointestinal disease. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) L.M. Poole acting for W.R. Dubois; (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number K991697 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)