UNI-GOLD STREP A TEST KIT

{0}------------------------------------------------ NOV 0 82001 # KO117 ## 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 K 011709. | Submitter Information (21 CFR 807.92 (a) (1)) | | |-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Submitter: | Trinity Biotech, plc<br>IDA Business Park<br>Bray<br>Co. Wicklow<br>Ireland | | Contact: | Fiona Campbell<br>Regulatory Affairs Manager<br>Trinity Biotech, plc<br>Phone: 011 353 2769800<br>Fax: 011 353 2769888 | | Summary Date: | May 30, 2001 | | Name of Device and Classification (21 CFR 807.92 (a) (2)) | | | Name (trade): | Uni-GoldTM Strep A test kit | | Name (usual): | Streptococcus spp. serological reagents | | Classification: | 21 CFR 866.3740, Class 1, GTZ | ## Identification of Legally Marketed Predicate Device(s) (21 CFR 807.92 (a) (3)) The Uni-Gold™ Strep A test kit is substantially equivalent to the Quidel Quick Vue® In-line One-Step Strep A Test (Quidel Corporation, 10165 McKellar Court, San minne CA 92121). The Uni-Gold™ Strep A test kit is identical, or similar to, its predicate device in terms of : antigen detection, technology/methodology, testing matrix, result interpretation, and clinical performance. {1}------------------------------------------------ #### Description of Device (21 CFR 807.92 (a) (4)) The extracted sample flows through an absorbent pad containing anti-Strep A antibody conjugated to colloidal gold which binds group A Streptoccal antigen if present, forming an antigen-antibody complex. As this complex travels along the membrane, it becomes immobilised at the test region, which is impregnated with a rabbit polyclonal anti-Strep A antibody, resulting in the formation of a pink/red line. A pink/red line will also appear in the control region of the test indicating proper functioning of the test. In the absence of group A Streptococcal antigen, a pink/red line will only appear in the control line. #### Intended Use 21 CFR 807.92 (a) (5)) The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also be used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the rapid diagnosis of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture. #### Similarities to the Predicate(s) (21 CFR 807.92 (a) (6)) A summary of the similarities and differences between the Uni-Gold™ Strep A test kit and the predicate device follows. {2}------------------------------------------------ | Characteristics | Uni-GoldTM Strep A | Predicate device | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Intended for the rapid, in vitro<br>qualitative detection of group A<br>Streptococcal antigen from human<br>throat swabs. It can also be used as<br>a confirmation of beta-haemolytic<br>colonies obtained from blood agar<br>plates. The test is intended for<br>professional use in physicians'<br>offices and hospital laboratories as<br>an aid in the diagnosis and<br>confirmation of group A<br>Streptococcal pharyngitis. | Allows for the rapid detection of<br>group A streptococcal antigen<br>directly from patient throat swab<br>specimens. The test is intended<br>for use as an aid in the diagnosis<br>of group A Streptococcal<br>infection. | | Methodology | Immunoassay | Immunoassay | | Antigen<br>Detected | Group A Strep | Group A Strep | | Type of Test | Qualitative | Qualitative | | Principle of the<br>Test | The extracted sample flows<br>through an absorbent pad<br>containing anti-Strep A antibody<br>conjugated to colloidal gold which<br>binds group A Streptococcal<br>antigen if present, forming an<br>antigen-antibody complex. As this<br>complex travels along the<br>membrane, it becomes<br>immobilised at the test region,<br>which is impregnated with a rabbit<br>polyclonal anti-Strep A antibody,<br>resulting in the formation of a<br>pink/red line. A pink/red line will<br>also appear in the control region of<br>the test indicating proper<br>functioning of the test. In the<br>absence of group A Streptococcal<br>antigen, a pink/red line will only<br>appear in the control line. | The extracted sample migrates<br>through a label pad consisting of<br>a pink label containing rabbit<br>polyclonal anti-Strep A antibody<br>and a blue control label. If the<br>extracted solution contains Strep<br>A antigen, the antigen will bind<br>to the antibody on the pink test<br>label which, in turn, will bind a<br>second rabbit polyclonal anti-<br>Strep A antibody spotted on the<br>membrane, resulting in the<br>formation of a pink-to-purple<br>Test line. A blue Control line<br>will also appear next to the letter<br>"C" on the test cassette<br>indicating proper functioning of<br>the test. If Strep A is not present<br>or present at very low levels,<br>only a blue Control line will be<br>visible. | | Characteristics | Uni-Gold TM Strep A | Predicate device | | Materials<br>required but<br>not supplied | Timer or Stopwatch<br>Tongue depressor<br>Gloves | Timer<br>Tongue blade or spoon<br>Gloves | | Test Matrix/<br>Specimen type | Throat swab | Throat swab | | Specimen<br>Collection and<br>Preparation | Use only swabs provided. Collect<br>throat swab specimens using<br>standard throat swab collection<br>methods. Depress the tongue with<br>a tongue depressor. Be careful not<br>to touch the teeth, tongue, sides or<br>top of the mouth with the swab.<br>Rub a sterile swab on the posterior<br>pharynx, tonsils and inflamed<br>areas. Process specimen samples<br>as soon as possible after<br>collection. Swabs can be held in a<br>clean, dry paper sleeve at 15-30°C<br>for up to 4 hours or at 2-8°C for up<br>to 24 hours before processing. | Use only swabs provided.<br>Collect throat swab specimens<br>by standard clinical methods.<br>Depress the tongue with a<br>tongue blade or spoon. Be<br>careful not to touch the tongue,<br>sides or top of the mouth with<br>the swab. Rub the swab on the<br>back of the throat, on the tonsils,<br>and in any other area where there<br>is redness, inflammation or pus.<br>Process specimen samples as<br>soon as possible after collection.<br>Swabs can be held in any clean,<br>dry plastic tube or sleeve at 15-<br>30°C for up to 4 hours or 24<br>hours refrigerated (2-8°C) before<br>processing. | | Controls<br>provided | 1 Positive control vial and 1<br>Negative control vial | 1 Positive control swab and 1<br>Negative control swab | | Extraction<br>Buffers | 2 | 2 | | Assay Read<br>Time | 5 minutes | 5 minutes | | Result<br>Interpretation | Positive or Negative for Strep A<br>antigen | Positive or Negative for Strep A<br>antigen | | Stability of<br>Results | Results should be read after 5<br>minutes | Results should be read after 5<br>minutes | | CLIA Waived | To be requested | Yes | | Characteristics | Uni-Gold TM Strep A | Predicate device | | Re Use of Kit Controls | Yes. Controls are supplied<br>enough for multiple tests | No. Only 1 positive and 1<br>negative control swab supplied<br>each for single use only | | Extraction Time | 3 minutes | none | | Storage<br>Temperature | 2-27°C (entire kit) | 15-30°C (entire kit) | ## Similarities Between Uni-Gold™ Strep A test kit and Predicate Device {3}------------------------------------------------ ## Similarities Between Uni-Gold™ Strep A test kit and Predicate Device (Continued) ## Differences Between Uni-Gold™ Strep A test kit and Predicate Device {4}------------------------------------------------ ## Brief Discussion of Nonclinical Data (21 CFR 807.92 (b) (1)) Differ Discussion of Nore conducted to evaluate analytical sensitivity (lowest limit of Laboratory studies were contacted rross-reactivity testing from potential interferents). Summary description and results from those studies are provided below. #### Analytical Sensitivity Analytical Sensitivity Serial dilutions were prepared from two cultures of group A Streptococcus, and were tested with the Uni-Gold™ Strep A test kit until the interpretations became "negative". The results indicate that the lowest level of detection of the Uni-Gold™ Strep A test kit is 1 x 105 cells per swab. #### Analytical Specificity The Uni-Gold™ Strep A test kit was used to test a variety of organisms at The Uni Ook - Survimately 1 x 10' cells per swab. Negative results were obtained in all cases. ## Brief Discussion of Clinical Data (21 CFR 807.92 (b) (2)) #### Accuracy Accuracy of the Trinity Biotech Uni-Gold™ Strep A test kit was determined through the analysis of 501 fresh throat samples tested both in the immunoassay and by routine culture. The results from comparative testing between Uni-Gold™ vs. routine culture are presented below. | n = 501 samples | | Routine | Culture | |--------------------|---|---------|---------| | | | + | - | | Uni-GoldTM Strep A | + | 97 | 3 | | | - | 12 | 389 | | Reference Totals | | 109 | 392 | ## Uni-Gold™ Strep A Test Kit Results vs. Routine Culture Results {5}------------------------------------------------ The data indicated the Uni-Gold™ Strep A test kit correctly identified 97 of 109 The data indicated the Cin Com Com 30.0% and correctly identified 389 of 992 negative positive rosults for a sensions - The overall agreement between Uni-Gold™ Strep A test kit and routine culture was 97.0% (486/501). These data demonstrate good agreement between the two methods. #### Uni-Gold™ Strep A vs predicate device The results from the direct comparison of the two immunoassays are presented below. | | Uni-GoldTM | Predicate device | Number | Percent of<br>Total | |---------------------------|------------|------------------|--------|---------------------| | Concordant Results | + | + | 86 | | | | - | - | 398 | 96.6% | | Discordant Results | + | - | 14 | | | | - | + | 3 | 3.4% | | Total Specimens<br>Tested | | | 501 | 100% | Concordance results between Uni-Gold™ Strep A and Predicate device Good agreement was observed between the Uni-Gold™ Strep A test kit and predicate device. There was positive concordance in 96.6% of samples (86/89), and negative device. There was possfar oles (398/412). Overall concordance was seen in 96.6% of the samples (484/501). #### Culture Confirmation The Uni-Gold ™ Strep A test kit was used to confirm the identification of group A The Onl-Ood agar plates. Samples that were visually positive on the culture assay Surp on blood agar places. Danples A test kit and a Streptococcal latex grouping test kit as the predicate to confirm a positive result. The Uni-Gold TM Strep A test kit correctly identified 105/109 samples as group A The Only - Burepensitivity of 96.3%. 2 of the 4 samples positive for Strep A on Streplococcus giving a sensitivity of 70.57%. 2 or the Feat. kit were identified by the Culture but negative by ag est as mixed cultures containing group A Streptococcus. Streplococcal lates grouping tost as immed canasative by the Uni-Gold ™ Strep A test kit were identified as non group A Streptococcus (group B Streptococcus and a mixed kil were ficmined as non group F Streptococcus) . Thus, the Uni-Gold TM Strep A test kit {6}------------------------------------------------ correctly identified 105/107 samples as group A Streptococcus giving a sensitivity of 98.1% as compared against a Streptococcal latex grouping test. In a further study of 224 samples, 117 of these were identified as non- Strep A colonies by morphology and the absence of beta-haemolysis. These were tested on the Uni-Gold The Strep A test where all negative samples were correctly identified. The results are summarized in the table below. | n = 224 samples | | Strep A Culture (confirmed by Beta-<br>haemolysis and morphology) | | |-------------------|---|-------------------------------------------------------------------|-----| | | | + | - | | Uni-Gold™ Strep A | + | 105 | 0 | | | - | 2 | 117 | | Reference Totals | | 107 | 117 | Culture Confirmation Study In a separate study, colonies of 2 group A beta-haemolytic organisms and 4 non group A beta-haemolytic organisms were tested in duplicate in a blinded manner by 2 independent physicians. Correct results were obtained in all cases. #### Performance Data - Conclusions (21 CFR 807.92 (b) (3)) Analytical sensitivity of the Uni-Gold™ Strep A test kit was determined to be 1 x 100 cells per swab as demonstrated by the testing of serial dilutions in the assay. Analytical specificity testing demonstrated no interference by other organisms (pathological and nonpathological) routinely found in the throat. The Uni-Gold™ Strep A test kit and the predicate device, with discordant results resolved against culture, revealed a relative sensitivity of Uni-Gold™ Strep A test kit of 99.0% (97/98 positive results) and a relative specificity of 99.3% (400/403 negative results). The relative overall agreement was 99.2% (497/501). {7}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, superimposed over three horizontal lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 NOV 0 82001 Ms. Fiona Campbell Regulatory Affairs Manager Trinity Biotech, plc IDA Business Park Bray, Co. Wicklow Ireland Re: K011709 Trade/Device Name: Trinity Biotech Uni-Gold™ Strep A Test Kit Regulation Number: 21 CFR 866.3740 Regulation Name: Streptococcus spp. Serological Reagents Regulatory Class: I Product Code: GTY Dated: August 17, 2001 Received: August 22, 2001 Dear Ms. Campbell: We have reviewed your Section 510(k) notification of intent to market the device referenced we have love have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, 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 1 coolar 1 ood, Dreg, and sions of the Act. The general controls provisions of the Act include the general octin 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 ( Femanover device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through Praction GMP inspections, the Food and Drug Administration (FDA) will verify such periodio Oril miliposmossions with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal addition, I Drimary texthis response to your premarket notification submission does not affect reefister. Freason wight have under sections 531 through 542 of the Act for devices under the any obtigation you thegation Electronic Product Radiation Control provisions, or other Federal laws or regulations. {8}------------------------------------------------ Page 2 - This letter will allow you to begin marketing your device as described in your 510(k) prematice I his letter will allow you to ocen maneting your device to a legally marketed notification. The FDA inding of succeantal equit data. Thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and If you desire specific advice for your do rices), please contact the Office of Compliance at additionally 809.10 for in the diagnotions on the promotion and advertising of your device, (301) 394-4588. Additionally, for quest. It (1) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general entitled, "Wisoraliding by relevelled to premained from the Division of Small information on your responsibilities under the Act may be obtained from the 1800 632, 2011 and information on your responsionals and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers International and Colliberties "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Steven Butman 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 {9}------------------------------------------------ NOV 0 82001 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Trinity Biotech Uni-Gold™ Strep A test kit Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: The Trinity Biotech Uni-Gold™ Strep A test kit is intended for the rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs. It can also De used as a confirmation test of beta-haemolytic colonies obtained from blood agar plates. The test is intended for professional use in physicians offices as an aid in the rapid diagnosis of group A Streptococcal pharyngitis. The test may also be used in hospital laboratories as an aid in the may also of group A Streptococcal pharyngitis and the confirmation of group A Streptococcus from culture. #### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurence of CDRH, Office of Device Evaulation (ODE) | Prescription use | <span style="text-decoration: underline;">✓</span> | Or | Over the counter Use | <span style="text-decoration: underline;">____</span> | |----------------------|----------------------------------------------------|----|----------------------|-------------------------------------------------------| | (per 21 CFR 801.109) | | | | (Optional Format 3-10-98) | Luddi lu-Cook (Division Sign-Off) Division of Clinical Laboratory Devices | 510(k) Number | <span style="text-decoration: underline;">K011709/51</span> | |---------------|-------------------------------------------------------------| |---------------|-------------------------------------------------------------|