(157 days)
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.
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.
- Acceptance Criteria and Reported Device Performance:
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Uni-Gold Strep A) |
|---|---|---|
| Accuracy (vs. Routine Culture) | Not explicitly stated, but expected to demonstrate "good agreement" | Overall agreement: 97.0% (486/501) |
| Sensitivity (vs. Routine Culture) | Not explicitly stated, but expected to be high. | Sensitivity: 89.0% (97/109) |
| Specificity (vs. Routine Culture) | Not explicitly stated, but expected to be high. | Specificity: 99.2% (389/392) |
| Concordance (vs. Predicate Device) | Expected to demonstrate "Good agreement." | Positive Concordance: 96.6% (86/89) Negative Concordance: 96.6% (398/412) Overall Concordance: 96.6% (484/501) |
| Culture Confirmation Sensitivity (vs. Streptococcal latex grouping test) | Not explicitly stated, but expected to be high. | Sensitivity: 96.3% (105/109) initially, then 98.1% (105/107) after resolving mixed cultures. |
| Culture Confirmation Specificity (Identified non-Strep A) | Expected to correctly identify non-Strep A colonies. | 100% (117/117) of negative samples were correctly identified in a separate study. |
| Analytical Sensitivity | Not explicitly stated, but to determine the lowest detection level. | 1 x 10^5 cells per swab |
| Analytical Specificity | Expected to show no cross-reactivity with common throat organisms. | No interference by other organisms (pathological and nonpathological) routinely found in the throat. |
| Relative Sensitivity (vs. Predicate with discordant results resolved against culture) | Expected to be high. | 99.0% (97/98 positive results) |
| Relative Specificity (vs. Predicate with discordant results resolved against culture) | Expected to be high. | 99.3% (400/403 negative results) |
| Relative Overall Agreement (vs. Predicate with discordant results resolved against culture) | Expected to be high. | 99.2% (497/501) |
-
Sample Size for Test Set and Data Provenance:
- Accuracy Study (Test Set 1): 501 fresh throat samples. Data provenance is not explicitly stated regarding country of origin, but it is a retrospective or concurrent collection as it was tested "both in the immunoassay and by routine culture."
- Comparison to Predicate Device (Test Set 2): 501 total specimens tested. Data provenance is not explicitly stated.
- Culture Confirmation Study (Test Set 3):
- Initial: 109 samples visually positive for Strep A on blood agar plates.
- Second part (non-Strep A confirmation): 224 samples, of which 117 were identified as non-Strep A.
- Third part (blinded and duplicate testing): 6 samples (2 Group A beta-haemolytic, 4 non-Group A beta-haemolytic).
- All these studies appear to be "test sets" as they are used to evaluate the device's performance directly.
-
Number of Experts and Qualifications for Ground Truth of Test Set:
- For the core clinical accuracy and comparison studies, the "routine culture" is considered the ground truth. There is no specific mention of "experts" adjudicating these results, as routine culture itself serves as the reference standard in these diagnostic tests.
- For the Culture Confirmation Study (third part), "2 independent physicians" conducted blinded, duplicate testing. Their qualifications are not further specified beyond "physicians."
-
Adjudication Method for Test Set:
- In the primary clinical accuracy study, the Uni-Gold™ Strep A results were compared directly against "routine culture." There isn't an explicit adjudication method described beyond this direct comparison.
- For the comparison between Uni-Gold™ Strep A and the predicate device, discordant results were later "resolved against culture" when calculating relative sensitivity/specificity/agreement. This implies that if the two devices disagreed, a third reference (culture) was used to determine the true positive/negative status for performance calculation. This is a form of an adjudication process, likely a 2+1 type (two devices, one gold standard for resolution).
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly done. The device is an immunoassay, not an imaging device that would typically involve human readers interpreting results with or without AI assistance. The studies performed compare the device's performance against a reference standard (culture) and a predicate device.
-
Standalone (Algorithm Only) Performance:
- Yes, the performance values presented (sensitivity, specificity, agreement, concordance) are for the Uni-Gold™ Strep A test kit operating as a standalone device, without human-in-the-loop assistance in its core detection mechanism. The human interaction is usually limited to performing the test and reading the results, which is inherent to the use of such a diagnostic kit.
-
Type of Ground Truth Used:
- Primary Ground Truth: Routine culture (specifically for Group A Streptococcus). This is a well-established laboratory method for identifying bacterial presence and is considered a high-quality reference standard for infectious disease diagnostics.
- Secondary Ground Truth (for Culture Confirmation): Initial culture results confirmed by "Beta-haemolysis and morphology" and "Streptococcal latex grouping test" for further confirmation.
-
Sample Size for Training Set:
- The document does not provide information about a separate "training set" for the Uni-Gold™ Strep A test kit. As an immunoassay (lateral flow assay), it is a biochemical test, not a machine learning algorithm that typically requires a distinct training phase with a dedicated dataset. The device's components and assays are developed and validated during the manufacturing process, rather than "trained" on data.
-
How Ground Truth for Training Set Was Established:
- Not applicable, as there is no explicit "training set" in the context of this immunoassay device. The scientific principles and reagents are developed based on known biological interactions and established laboratory methods. Analytical studies (sensitivity, specificity) ensure the components function as intended.
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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, plcIDA Business ParkBrayCo. WicklowIreland |
| Contact: | Fiona CampbellRegulatory Affairs ManagerTrinity Biotech, plcPhone: 011 353 2769800Fax: 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.
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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.
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| Characteristics | Uni-GoldTM Strep A | Predicate device |
|---|---|---|
| Intended Use | Intended for the rapid, in vitroqualitative detection of group AStreptococcal antigen from humanthroat swabs. It can also be used asa confirmation of beta-haemolyticcolonies obtained from blood agarplates. The test is intended forprofessional use in physicians'offices and hospital laboratories asan aid in the diagnosis andconfirmation of group AStreptococcal pharyngitis. | Allows for the rapid detection ofgroup A streptococcal antigendirectly from patient throat swabspecimens. The test is intendedfor use as an aid in the diagnosisof group A Streptococcalinfection. |
| Methodology | Immunoassay | Immunoassay |
| AntigenDetected | Group A Strep | Group A Strep |
| Type of Test | Qualitative | Qualitative |
| Principle of theTest | The extracted sample flowsthrough an absorbent padcontaining anti-Strep A antibodyconjugated to colloidal gold whichbinds group A Streptococcalantigen if present, forming anantigen-antibody complex. As thiscomplex travels along themembrane, it becomesimmobilised at the test region,which is impregnated with a rabbitpolyclonal anti-Strep A antibody,resulting in the formation of apink/red line. A pink/red line willalso appear in the control region ofthe test indicating properfunctioning of the test. In theabsence of group A Streptococcalantigen, a pink/red line will onlyappear in the control line. | The extracted sample migratesthrough a label pad consisting ofa pink label containing rabbitpolyclonal anti-Strep A antibodyand a blue control label. If theextracted solution contains StrepA antigen, the antigen will bindto the antibody on the pink testlabel which, in turn, will bind asecond rabbit polyclonal anti-Strep A antibody spotted on themembrane, resulting in theformation of a pink-to-purpleTest line. A blue Control linewill also appear next to the letter"C" on the test cassetteindicating proper functioning ofthe test. If Strep A is not presentor present at very low levels,only a blue Control line will bevisible. |
| Characteristics | Uni-Gold TM Strep A | Predicate device |
| Materialsrequired butnot supplied | Timer or StopwatchTongue depressorGloves | TimerTongue blade or spoonGloves |
| Test Matrix/Specimen type | Throat swab | Throat swab |
| SpecimenCollection andPreparation | Use only swabs provided. Collectthroat swab specimens usingstandard throat swab collectionmethods. Depress the tongue witha tongue depressor. Be careful notto touch the teeth, tongue, sides ortop of the mouth with the swab.Rub a sterile swab on the posteriorpharynx, tonsils and inflamedareas. Process specimen samplesas soon as possible aftercollection. Swabs can be held in aclean, dry paper sleeve at 15-30°Cfor up to 4 hours or at 2-8°C for upto 24 hours before processing. | Use only swabs provided.Collect throat swab specimensby standard clinical methods.Depress the tongue with atongue blade or spoon. Becareful not to touch the tongue,sides or top of the mouth withthe swab. Rub the swab on theback of the throat, on the tonsils,and in any other area where thereis redness, inflammation or pus.Process specimen samples assoon as possible after collection.Swabs can be held in any clean,dry plastic tube or sleeve at 15-30°C for up to 4 hours or 24hours refrigerated (2-8°C) beforeprocessing. |
| Controlsprovided | 1 Positive control vial and 1Negative control vial | 1 Positive control swab and 1Negative control swab |
| ExtractionBuffers | 2 | 2 |
| Assay ReadTime | 5 minutes | 5 minutes |
| ResultInterpretation | Positive or Negative for Strep Aantigen | Positive or Negative for Strep Aantigen |
| Stability ofResults | Results should be read after 5minutes | Results should be read after 5minutes |
| CLIA Waived | To be requested | Yes |
| Characteristics | Uni-Gold TM Strep A | Predicate device |
| Re Use of Kit Controls | Yes. Controls are suppliedenough for multiple tests | No. Only 1 positive and 1negative control swab suppliedeach for single use only |
| Extraction Time | 3 minutes | none |
| StorageTemperature | 2-27°C (entire kit) | 15-30°C (entire kit) |
Similarities Between Uni-Gold™ Strep A test kit and Predicate Device
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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
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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 ofTotal | |
|---|---|---|---|---|
| Concordant Results | + | + | 86 | |
| - | - | 398 | 96.6% | |
| Discordant Results | + | - | 14 | |
| - | + | 3 | 3.4% | |
| Total SpecimensTested | 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
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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-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).
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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.
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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
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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 | ✓ | Or | Over the counter Use | ____ |
|---|---|---|---|---|
| (per 21 CFR 801.109) | (Optional Format 3-10-98) |
Luddi lu-Cook
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K011709/51 |
|---|---|
| --------------- | ------------------------------------------------------------- |
§ 866.3740
Streptococcus spp. serological reagents.(a)
Identification. Streptococcus spp. serological reagents are devices that consist of antigens and antisera (excluding streptococcal exoenzyme reagents made from enzymes secreted by streptococci) used in serological tests to identifyStreptococcus spp. from cultured isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by bacteria belonging to the genusStreptococcus and provides epidemiological information on these diseases. Pathogenic streptococci are associated with infections, such as sore throat, impetigo (an infection characterized by small pustules on the skin), urinary tract infections, rheumatic fever, and kidney disease.(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.