K Number

Device Name

UNI-GOLD STREP A TEST KIT

Manufacturer

TRINITY BIOTECH, PLC

Date Cleared

2001-11-08

(157 days)

Product Code

GTZ GTY

Regulation Number

866.3740

Intended 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 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.

Device Description

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K 011709

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a lateral flow immunoassay based on antigen-antibody binding and visual interpretation of lines, with no mention of computational analysis, algorithms, or learning processes.

Therapeutic

No.
This device is an in vitro diagnostic test intended to aid in the rapid diagnosis of group A Streptococcal pharyngitis, not to treat or prevent a disease.

Diagnostic

Yes

The intended use explicitly states that the test is "an aid in the rapid diagnosis of group A Streptococcal pharyngitis."

SaMD (Software as a Medical Device)

The device description clearly outlines a physical immunoassay test kit involving chemical reactions and a visual readout (pink/red lines), which is a hardware-based diagnostic method. There is no mention of software being the primary or sole component performing the medical function.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test kit is intended for the "rapid, in vitro qualitative detection of group A Streptococcal antigen from human throat swabs." The term "in vitro" is a key indicator of an IVD.
Device Description: The description details a test that analyzes a biological sample (extracted sample from a throat swab) outside of the body to detect a specific analyte (group A Streptococcal antigen). This is the fundamental nature of an IVD.
Performance Studies: The document describes studies evaluating the performance of the test in detecting the target analyte in human samples, which is a requirement for IVD devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GTZ, GTY

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

human throat swabs

Indicated Patient Age Range

Not Found

Intended User / Care Setting

professional use in physicians offices, hospital laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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
Uni-Gold™ Strep A +: Routine Culture + 97, Routine Culture - 3
Uni-Gold™ Strep A -: Routine Culture + 12, Routine Culture - 389
Reference Totals: Routine Culture + 109, Routine Culture - 392

The Uni-Gold™ Strep A test kit was used to confirm the identification of group A Strep on blood agar plates. Samples that were visually positive on the culture assay were tested by the Uni-Gold™ Strep A test kit and a Streptococcal latex grouping test kit as the predicate to confirm a positive result.
The Uni-Gold™ Strep A test kit correctly identified 105/109 samples as group A Streptococcus giving a sensitivity of 96.3%.
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™ Strep A test where all negative samples were correctly identified.
n = 224 samples
Uni-Gold™ Strep A +: Strep A Culture (confirmed by Beta-haemolysis and morphology) + 105, Strep A Culture (confirmed by Beta-haemolysis and morphology) - 0
Uni-Gold™ Strep A -: Strep A Culture (confirmed by Beta-haemolysis and morphology) + 2, Strep A Culture (confirmed by Beta-haemolysis and morphology) - 117
Reference Totals: Strep A Culture (confirmed by Beta-haemolysis and morphology) + 107, Strep A Culture (confirmed by Beta-haemolysis and morphology) - 117
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.

Key Metrics

Analytical sensitivity of the Uni-Gold™ Strep A test kit was determined to be 1 x 10^5 cells per swab.
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).

Predicate Device(s)

K 011709. Quidel Quick Vue® In-line One-Step Strep A Test

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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
IDA Business Park
Bray
Co. Wicklow
Ireland
Contact:	Fiona Campbell
Regulatory Affairs Manager
Trinity Biotech, plc
Phone: 011 353 2769800
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.

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

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

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.

Characteristics	Uni-GoldTM Strep A	Predicate device
Intended Use	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 of beta-haemolytic
colonies obtained from blood agar
plates. The test is intended for
professional use in physicians'
offices and hospital laboratories as
an aid in the diagnosis and
confirmation of group A
Streptococcal pharyngitis.	Allows for the rapid detection of
group A streptococcal antigen
directly from patient throat swab
specimens. The test is intended
for use as an aid in the diagnosis
of group A Streptococcal
infection.
Methodology	Immunoassay	Immunoassay
Antigen
Detected	Group A Strep	Group A Strep
Type of Test	Qualitative	Qualitative
Principle of the
Test	The extracted sample flows
through an absorbent pad
containing anti-Strep A antibody
conjugated to colloidal gold which
binds group A Streptococcal
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.	The extracted sample migrates
through a label pad consisting of
a pink label containing rabbit
polyclonal anti-Strep A antibody
and a blue control label. If the
extracted solution contains Strep
A antigen, the antigen will bind
to the antibody on the pink test
label which, in turn, will bind a
second rabbit polyclonal anti-
Strep A antibody spotted on the
membrane, resulting in the
formation of a pink-to-purple
Test line. A blue Control line
will also appear next to the letter
"C" on the test cassette
indicating proper functioning of
the test. If Strep A is not present
or present at very low levels,
only a blue Control line will be
visible.
Characteristics	Uni-Gold TM Strep A	Predicate device
Materials
required but
not supplied	Timer or Stopwatch
Tongue depressor
Gloves	Timer
Tongue blade or spoon
Gloves
Test Matrix/
Specimen type	Throat swab	Throat swab
Specimen
Collection and
Preparation	Use only swabs provided. Collect
throat swab specimens using
standard throat swab collection
methods. Depress the tongue with
a tongue depressor. Be careful not
to touch the teeth, tongue, sides or
top of the mouth with the swab.
Rub a sterile swab on the posterior
pharynx, tonsils and inflamed
areas. Process specimen samples
as soon as possible after
collection. Swabs can be held in a
clean, dry paper sleeve at 15-30°C
for up to 4 hours or at 2-8°C for up
to 24 hours before processing.	Use only swabs provided.
Collect throat swab specimens
by standard clinical methods.
Depress the tongue with a
tongue blade or spoon. Be
careful not to touch the tongue,
sides or top of the mouth with
the swab. Rub the swab on the
back of the throat, on the tonsils,
and in any other area where there
is redness, inflammation or pus.
Process specimen samples as
soon 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 24
hours refrigerated (2-8°C) before
processing.
Controls
provided	1 Positive control vial and 1
Negative control vial	1 Positive control swab and 1
Negative control swab
Extraction
Buffers	2	2
Assay Read
Time	5 minutes	5 minutes
Result
Interpretation	Positive or Negative for Strep A
antigen	Positive or Negative for Strep A
antigen
Stability of
Results	Results should be read after 5
minutes	Results should be read after 5
minutes
CLIA Waived	To be requested	Yes
Characteristics	Uni-Gold TM Strep A	Predicate device
Re Use of Kit Controls	Yes. Controls are supplied
enough for multiple tests	No. Only 1 positive and 1
negative control swab supplied
each for single use only
Extraction Time	3 minutes	none
Storage
Temperature	2-27°C (entire kit)	15-30°C (entire kit)

Similarities Between Uni-Gold™ Strep A test kit and Predicate Device

Similarities Between Uni-Gold™ Strep A test kit and Predicate Device (Continued)

Differences Between Uni-Gold™ Strep A test kit and Predicate Device

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

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
Total |
|---------------------------|------------|------------------|--------|---------------------|
| Concordant Results | + | + | 86 | |
| | - | - | 398 | 96.6% |
| Discordant Results | + | - | 14 | |
| | - | + | 3 | 3.4% |
| Total Specimens
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

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).

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.

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

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
---------------	-------------------------------------------------------------