The Trinity Biotech Uni-Gold™ Strep A Test Kit is a rapid immunoassay for the qualitative detection of Streptococcal A antigen from throat swabs, or the confirmation of beta-hemolytic colonies obtained from blood agar plates.

The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.

Device Description

Immunoassay: Strep A antigen, when present, binds to the anti-Strep A antibody conjugated to a gold dye. As this complex travels along the membrane, it becomes immobilized at the test region, resulting in the formation of a red line. Excess antibodygold conjugate further migrates along the membrane and binds to the control region, forming another red line. In the absence of Strep A antigen, a red line will only be formed at the control region.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Acceptance Criteria and Device Performance Study for Uni-Gold™ Strep A Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or percentage format. Instead, it describes analytical performance parameters that the device demonstrated. The primary "acceptance" for this 510(k) submission is substantial equivalence to the predicate device, which implies comparable performance in key areas.

Parameter	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Uni-Gold™ Strep A Test Kit)
Analytical Sensitivity	Comparable to predicate device's sensitivity	1.0 x 10^5 cells/swab
Analytical Specificity	No cross-reactivity with common interfering organisms	No false positives with tested organisms at 1 x 10^6 concentration (Staphylococcus aureus at 1 x 10^6 organisms)

2. Sample Size Used for the Test Set and Data Provenance

The document focuses on analytical studies rather than clinical studies with patient samples for the test set.

Analytical Sensitivity Test Set: Serial dilutions of S. pyogenes cultures. The exact number of dilutions or individual tests performed is not specified, only that testing continued until interpretations became "negative."
Analytical Specificity Test Set: The sample size for the analytical specificity (cross-reactivity) test set includes 19 different organisms. For each organism, testing was performed at a concentration of approximately 1 x 10^6 (or 1 x 10^6 for Staphylococcus aureus).
Data Provenance: The studies are described as "Laboratory studies" and did not involve human subjects. Thus, data provenance in terms of country of origin or retrospective/prospective is not applicable in the typical clinical sense. These are in-house, non-clinical evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This section is not applicable. The studies described are analytical (laboratory-based) and do not involve human interpretation of results for establishing ground truth. The "ground truth" for analytical sensitivity was known concentrations of S. pyogenes, and for analytical specificity, the known identity and concentration of non-Strep A organisms.

4. Adjudication Method for the Test Set

This section is not applicable as the studies are analytical and do not involve human adjudication of results in the way clinical studies often do. The results (positive/negative) would be determined by the visual presence or absence of a red line.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes laboratory analytical performance, not a study evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, the studies described are standalone in the sense that they evaluate the performance of the device itself (the immunoassay) without human-in-the-loop performance being a variable. The test results (red line present/absent) are interpreted directly from the device's output.

7. Type of Ground Truth Used

Analytical Sensitivity: Known concentrations of Streptococcus pyogenes (Strep A) cultures.
Analytical Specificity: Known identities and concentrations of various non-Strep A organisms.

8. Sample Size for the Training Set

This information is not applicable. The Uni-Gold™ Strep A Test Kit is an immunoassay (a rapid diagnostic test), not an AI/Machine Learning algorithm. Therefore, there is no "training set" in the context of AI development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI algorithm.

Summary

{0}------------------------------------------------

2/11/99

Image /page/0/Picture/1 description: The image shows the text "K982373" in a handwritten style on the left side. On the right side, there is a logo for "Trinity biotech" with the word "Trinity" in a bold, sans-serif font inside a black triangle. Below the triangle, the word "biotech" is written in a smaller, sans-serif font. The bottom of the image contains some illegible text.

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: K982373.

Submitter Information (21 CFR 807.92(a)(1)) Trinity Biotech, plc Submitter: IDA Business Park Bray County Wicklow, Ireland

Contact:

Dr. Jim Walsh Chief Operating Officer Trinity Biotech, plc phone: 011 353 1 276 9800 011 353 1 276 9888 fax:

November 19, 1998 Summary Date:

Name of Device and Classification (21 CFR 807.92(a)(2)) Uni-Gold™ Strep A Test Kit Name (trade):

Streptococcus spp. serological reagents Name (usual):

21 CFR 866.3740, Class I, GTZ Classification:

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 TestPack® +Plus Strep A, (TestPack), Abbott Laboratories Inc., Chicago, IL. The Uni-Gold™ Strep A Test Kit is identical, or similar to, its predicate in terms of: intended use, antigen detected, technology/methodology, testing matrix, result interpretation, and clinical performance.

Trinity Biotech, plc Uni-Gold™ Strep A Test Kit pic. Registered in Ireland. Registration Number 183476 "soimh, CEO, 8 K Farrell | A O' Connell, Dr. | Walsh Dr. D Berger, Dr. A D Pronovos

510(k) Summary Page 9-2

{1}------------------------------------------------

Description of Device (21 CFR 807.92 (a)(4))

Intended Use (21 CFR 807.92 (a)(5))

The Trinity Biotech Uni-Gold™ Strep A Test Kit is intended for use in hospital laboratories and physicians' offices as an aid in the diagnosis of Group A Streptococcal pharyngitis.

Similarities to the Predicate(s) (21 CFR 807.92 (a)(6))

A summary table of the similarities and differences between the Uni-Gold™ Strep A Test Kit and the predicate device (TestPack + Plus Strep A) follows.

{2}------------------------------------------------

CHARACTERISTIC	UNI-GOLD TM Strep A	TESTPACK® +PLUS Strep A
Intended Use	qualitative detection ofGroup A Streptococcalantigen from throat swabs, orGroup A confirmation fromculture plates	qualitative detection of Group AStreptococcal antigen fromthroat swab specimens orconfirmation of presumptiveGroup A Streptococcal coloniesrecovered from culture
Antigen Detected	Group A Strep	Group A Strep
Methodology/Technology	Immunoassay: Strep Aantigen, when present, bindsto the anti-Strep A antibodyconjugated to a gold dye. Asthis complex travels along themembrane, it becomesimmobilized at the testregion, resulting in theformation of a red line.Excess antibody-goldconjugate further migratesalong the membrane andbinds to the control region,forming another red line. Inthe absence of Strep Aantigen, a red line will onlybe formed at the controlregion.	Immunoassay: A positive sampleproceeds through the membrane,and immobilizes the anti-Strep Aantibody coated colloid. Thesample and antibody-colloidcomplex migrate through themembrane to the Group Acapture region, and then onto theend of the membrane. When theend of the assay window turnsred, the result can be interpreted.If a red plus sign appears in thewindow, it indicates the presenceof Group A antigen. The absenceof the antigen will result in aminus sign.
Testing Matrix	throat swab or cultureconfirmation	throat swab or cultureconfirmation
Result Interpretation	positive or negative forStrep A antigen	positive or negative forStrep A antigen
Assay Read Time	5 minutes	5 minutes
Conjugate Label	Colloidal Gold	Colloidal Gold
Extraction Time	3 minutes	3 minutes
Extraction Buffers	2	2
Testing Environment	professional use	professional use

Similarities Between Uni-Gold™ Strep A Test Kit and TestPack +Plus Strep A

Differences Between Uni-Gold™ Strep A Test Kit and TestPack +Plus Strep A

CHARACTERISTIC	UNI-GOLD™ Strep A	TESTPACK® +PLUS Strep A
Stability of Results	should be read after 5 minutes,not more than 10 minutes	should be read after 5 minutes
Neutralizing buffer	none	one
Storage Temperature	2-27° C (entire kit)	2-8° C devices,2-27° C buffers

{3}------------------------------------------------

Brief Discussion of Nonclinical Data (21 CFR 807.92(b)(1))

Laboratory studies were conducted to evaluate analytical sensitivity (lowest limit of detection) and analytical specificity (cross-reactivity testing from potential interferents). Summary description and results from those studies are provided below.

Analytical Sensitivity

Serial dilutions were prepared from colonies of Strep A cultures, and were tested with the Uni-Gold™ Strep A test Kit until the interpretations became "negative." The assay demonstrated a sensitivity of 1.0 x 105 cells/swab.

Analytical Specificity

The Uni-Gold™ Strep A Test Kit was used to test the following organisms at concentrations of approximately 1 x 10°. Negative results were obtained in all cases. NOTE: Staphylococcus aureus was tested at 1 x 106 organisms.

Bordetella pertussis	Staphylococcus aureus
Branhamella catarrhalis	Staphylococcus epidermidis
Candida albicans	Streptococcus mutans
Corynebacterium diphtheria	Streptococcus pneumoniae
Escherichia coli	Streptococcus pyogenes, Lancefield group B
Hemophilus influenzae	Streptococcus pyogenes, Lancefield group C
Klebsiella pneumoniae	Streptococcus pyogenes, Lancefield group D
Neisseria gonorrhoeae	Streptococcus pyogenes, Lancefield group F
Neisseria meningitidis	Streptococcus pyogenes, Lancefield group G
Neisseria sicca	Streptococcus sanguis
Pseudomonas aeruginosa	Streptococcus sanguis

{4}------------------------------------------------

Image /page/4/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 1 1999

Trinity Biotech, PLC c/o Erika B. Ammirati Ammirati Regulatory Consulting 575 Shirlynn Court Los Altos, CA 94022

K982373 Re:

Trade Name: Uni-Gold™ Strep A Test Kit Regulatory Class: I Product Code: GTY Dated: January 4, 1999 Received: January 12, 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 (QS) 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.

{5}------------------------------------------------

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 your 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 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

{6}------------------------------------------------

Page of

1982373 510(k) Number (if known). Strep A Test Kit Device Name: Gold

Indications For Use:

The Trinity Brotech Uni-Gold Steep A test Kit is a rapid for the gualitative detection of Streptococcal immunoassay from threat swaps or the confirmation of beta-hemolytic colonies obtained from blood agar It is intended for use in hospital laboratories and brians offices as an and in the dragmosis of Streptoco coal pharyng Nis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubois

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K982373

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.