Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard HPLC system for hemoglobin analysis and does not mention any AI or ML components in the device description, intended use, or performance studies.

Therapeutic

No

The device is an in vitro diagnostic (IVD) system used to analyze hemoglobin species in blood samples, which aids in diagnosis and monitoring, rather than providing direct therapy to patients.

Diagnostic

Yes

The device performs quantitative analysis of normal hemoglobin and qualitative detection of major variant hemoglobin in blood samples, which are used to determine a patient's health status.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system "consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software," indicating it includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

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

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In Vitro Diagnostic Use."
Nature of the Test: The system performs the separation and quantitative/qualitative analysis of hemoglobin species in venous whole blood samples. This is a laboratory test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic test.
Intended User and Setting: It is intended for "Professional Laboratory Use only," further indicating its use in a clinical laboratory setting for diagnostic purposes.
Device Description: The description details a system that analyzes biological samples (whole blood) using laboratory techniques (HPLC).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.

The Premier Resolution System is intended for Professional Laboratory Use only.

The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.

The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.

For In Vitro Diagnostic Use.

Product codes (comma separated list FDA assigned to the subject device)

GKA

Device Description

The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult, adolescent, children and infant populations.

Intended User / Care Setting

Professional Laboratory Use only.

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Correlation (Method Comparison)

Study Type: Method Comparison Study
Sample Size: 780 unique patient samples
Data Source: Three (3) professional external laboratory sites
Key Results: The Premier Resolution System was compared to the Bio-Rad Variant™ II Beta Thalassemia.

Premier Resolution Quick Scan Assay:
- HbF: comparable, mean bias -0.3 (1.1 to 48.9%), 160 patient results.
- HbA: comparable, mean bias 0.7 (2.5 to 89.7%), 682 patient results.
- HbA2: comparable, mean bias 0.1 (1.6 to 6.1%), 602 patient results.
- HbS: comparable, mean bias 0.3 (6.8 to 67.1%), 106 patient samples.
- HbC: comparable, mean bias -1.1 (9.5 to 82.8%), 49 patient results.
- HbD-LA: comparable, mean bias 1.6 (11.6 to 82.7%), 17 patient results.
- HbE: comparable, mean bias -3.0 (5.5 to 70.4%), 25 patient results.
Premier Resolution High Resolution Assay:
- HbF: comparable, mean bias -0.4 (1.1 to 46.6%), 158 patient results.
- HbA: comparable, mean bias 2.4 (3.5 to 90.5%), 586 patient results.
- HbA2: comparable, mean bias 0.1 (1.6 to 6.0%), 598 patient results.
- HbS: comparable, mean bias 1.3 (1.9 to 67.9%), 110 patient samples.
- HbC: comparable, mean bias -1.0 (10.2 to 82.5%), 49 patient results.
- HbD-LA: comparable, mean bias 2.7 (11.7 to 84.1%), 17 patient results.
- HbE: comparable, mean bias -4.9 (5.3 to 66.7%), 25 patient results.

Single Site Precision

Study Type: Precision Study (CLSI EP05-A3)
Sample Size: 80 data points for each analyte
Data Source: Not specified, presumed in-house.
Annotation Protocol: 20x2x2 study design (20 days, 2 runs/day, 2 replicates/run).
Key Results: Precision data (SD, %CV for Repeatability, Between-Run, Between-Day, Within-Laboratory) for HbA, A2, F, S, C, D, E in both Quick Scan and High Resolution modes.

Multisite Precision

Study Type: Precision Study (CLSI EP05-A3)
Sample Size: Not specified directly, but 75 replicates given for each analyte across sites.
Data Source: Three (3) external sites
Annotation Protocol: 3x5x5 study design (3 sites, 5 days, 5 replicates/day).
Key Results: Precision data (SD, %CV for Repeatability, Between-Day, Between-Site, Reproducibility) for HbF, A, S, C, A2, D, E for various samples (FASC, A2+F I, A2+F II, A2, C-Trait, D-Trait, E-Trait) in both Quick Scan and High Resolution modes.

Limits of Detection

Study Type: Limit of Detection (CLSI EP17-A2)
Sample Size: 60 determinations of low-level samples for each analyte
Key Results: Established LoD and LoQ for HbA, A2, F, S, C, D-Los Angeles, and E in both Quick Scan and High Resolution modes.

Analytical Specificity

Study Type: Analytical Specificity
Key Results: No statistical significance of interference from Bilirubin, acetylsalicylic, Sodium Heparin, Lithium Heparin, K2EDTA, K3EDTA at specified concentrations for HbF, A, A2, S, C, D-Los Angeles, and E. Also tested D-Glucose and Acetaldehyde.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Multisite Precision - Quick Scan

FASC F: Repeatability 0.52%, Reproducibility 5.07%
FASC A: Repeatability 0.52%, Reproducibility 1.22%
FASC S: Repeatability 0.51%, Reproducibility 0.99%
FASC C: Repeatability 0.78%, Reproducibility 2.11%
A2+F I F: Repeatability 1.33%, Reproducibility 4.59%
A2+F I A: Repeatability 0.38%, Reproducibility 1.89%
A2+F I A2: Repeatability 1.17%, Reproducibility 3.15%
A2+F II F: Repeatability 1.36%, Reproducibility 4.28%
A2+F II A: Repeatability 0.52%, Reproducibility 0.96%
A2+F II S: Repeatability 0.65%, Reproducibility 1.22%
A2 A2: Repeatability 2.12%, Reproducibility 4.04%
C-Trait C: Repeatability 0.85%, Reproducibility 3.17%
D-Trait D: Repeatability 0.57%, Reproducibility 1.99%
E-Trait E: Repeatability 1.47%, Reproducibility 3.75%

Multisite Precision - High Resolution

FASC F: Repeatability 0.64%, Reproducibility 8.31%
FASC A: Repeatability 0.60%, Reproducibility 0.91%
FASC S: Repeatability 0.72%, Reproducibility 0.98%
FASC C: Repeatability 1.17%, Reproducibility 1.65%
A2+F I F: Repeatability 2.47%, Reproducibility 3.62%
A2+F I A: Repeatability 0.37%, Reproducibility 1.40%
A2+F I A2: Repeatability 1.90%, Reproducibility 2.49%
A2+F II F: Repeatability 1.11%, Reproducibility 4.27%
A2+F II A: Repeatability 0.67%, Reproducibility 1.44%
A2+F II S: Repeatability 0.66%, Reproducibility 1.81%
A2 A2: Repeatability 3.33%, Reproducibility 4.18%
C-Trait C: Repeatability 0.71%, Reproducibility 1.51%
D-Trait D: Repeatability 1.03%, Reproducibility 1.60%
E-Trait E: Repeatability 1.23%, Reproducibility 2.76%

Limits of Detection

Premier Resolution Quick Scan Assay:
- HbF: LoD 0.2%, LoQ 1.1%
- HbA: LoD 0.1%, LoQ 2.3%
- HbA2: LoD 0.1%, LoQ 1.5%
- HbS: LoD 0.1%, LoQ 1.0%
- HbC: LoD 0.1%, LoQ 1.0%
- HbD-Los Angeles: LoD 0.1%, LoQ 1.5%
- HbE: LoD 0.1%, LoQ 1.5%
Premier Resolution High-Resolution Assay:
- HbF: LoD 0.1%, LoQ 1.1%
- HbA: LoD 0.7%, LoQ 2.2%
- HbA2: LoD 0.2%, LoQ 1.5%
- HbS: LoD 0.3%, LoQ 0.9%
- HbC: LoD 0.3%, LoQ 1.7%
- HbD-Los Angeles: LoD 0.1%, LoQ 1.4%
- HbE: LoD 0.6%, LoQ 2.7%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Bio-Rad Variant II Beta Thalassemia (K991127)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 864.7415 Abnormal hemoglobin assay.

(a)
Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.(b)
Classification. Class II (special controls). A control intended for use with an abnormal hemoglobin assay is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 4, 2023

Trinity Biotech (Primus Corporation, dba Trinity Biotech) Kaitlyn Eastman Regulatory Supervisor 4231 E. 75th Terrace Kansas City, Missouri 64132

Re: K222635

Trade/Device Name: Premier Resolution System Regulation Number: 21 CFR 864.7415 Regulation Name: Abnormal Hemoglobin Assay Regulatory Class: Class II Product Code: GKA Dated: August 30, 2022 Received: August 31, 2022

Dear Kaitlyn Eastman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image contains the text "Min Wu-S". The text is written in a simple, sans-serif font and is black. The background is white, with a light blue watermark in the background.

Min Wu, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K222635

Device Name Premier Resolution System

Indications for Use (Describe)

The Premier Resolution System is an automated High Performance Liquid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A, A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.

The Premier Resolution System is intended for Professional Laboratory Use only.

The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.

The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.

For In Vitro Diagnostic Use.

Type of Use (Select one or both , as applicable)
----------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a blue triangle on the left and the words "Trinity Biotech" on the right. The triangle is made up of three smaller triangles, and the words "Trinity Biotech" are written in a sans-serif font.

Section 5: 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

1. Submitter / Sponsor

Trinity Biotech 4231 E. 75th Terrace Kansas City, MO 64132 USA

Phone: 716.483.7423 Fax: 816.361.1974

Contact Person: Kaitlyn Eastman Date Prepared: July 25, 2023

2. Device

Name of Device:	Premier Resolution System
Classification Name:	Abnormal Hemoglobin Assay
Regulation:	21 CFR § 864.7415
Regulatory Class:	Class II
Product Code:	GKA

3. Predicate Device

Bio-Rad Variant II ß -thalassemia (K991127)

4. Device Description

The Premier Resolution System consists of a high performance liquid chromatographic analyzer, reagents, analytical column and software which allows for the fractionation and quantitation of fetal hemoglobin (Hb F), and hemoglobin A2 (Hb A2), and with fractionation and presumptive identification of abnormal hemoglobin variants. This is accomplished using the principles of ion-exchange (IEX) high performance liquid chromatography (HPLC).

5. Indications for Use Statement and Intended Uses

The Premier Resolution System is an automated High Performance Liguid Chromatography (HPLC) system which performs the separation of hemoglobin species in venous whole blood samples for the quantitative analysis of normal hemoglobin (A. A2, and F), and the qualitative detection of major variant hemoglobin S, C, D-Los Angeles, and E in adult, adolescent, children and infant populations. The assays are performed on venous whole blood samples collected in tubes containing K2EDTA as anticoagulant.

The Premier Resolution System is intended for Professional Laboratory Use only.

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Image /page/4/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a blue triangle made up of three smaller triangles, followed by the text "Trinity Biotech" in a sans-serif font. The text is also blue, matching the color of the triangle symbol.

The Premier Resolution System is intended for use with analytical components and reagents provided by Trinity Biotech.

The Premier Resolution System is intended to be used in conjunction with other laboratory and clinical findings.

For In Vitro Diagnostic Use.

6. Comparison of Technological Characteristics with the Predicate Device

| Aspect
or Feature | Predicate
Bio-Rad Variant™ II Beta
Thalassemia K991127 | Premier Resolution System |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Variant™ II B-thalassemia
Program is intended for the
separation and area percent
determinations of hemoglobins A2
and F and as an aid in the
identification of abnormal
hemoglobins in whole blood using
ion-exchange high performance
liquid chromatography (HPLC).

The Variant™ II B-thalassemia
Program is intended for use only
with the Bio-Rad Variant™ II
Hemoglobin Testing System.

For in vitro diagnostic use only. | The Premier Resolution System is an
automated High Performance Liquid
Chromatography (HPLC) system which
performs the separation of hemoglobin
species in venous whole blood samples for
the quantitative analysis of normal
hemoglobin (A, A2, and F), and the
qualitative detection of major variant
hemoglobin S, C, D-Los Angeles, and E in
adult, adolescent, children and infant
populations. The assays are performed on
venous whole blood samples collected in
tubes containing K2EDTA as anticoagulant.

The Premier Resolution System is intended
for Professional Laboratory Use only.

The Premier Resolution System is intended
for use with analytical components and
reagents provided by Trinity Biotech.

The Premier Resolution System is intended to
be used in conjunction with other laboratory
and clinical findings.

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Image /page/5/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a blue triangle pointing upwards and to the left, followed by the text "Trinity Biotech" in a blue sans-serif font. The text is aligned horizontally with the triangle, and the overall design is clean and modern.

Premarket Notification

7. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Correlation (Method Comparison)

To establish equivalence, the method comparison study was conducted at three (3) professional external laboratory sites with both the Premier Resolution System and the Bio-Rad Variant™ II Beta Thalassemia. A total of 780 unique patient samples were collected and analyzed in both the Quick Scan and High Resolution assay modes. The following results are presented for the Premier Resolution Quick Scan and High Resolution assay modes:

Premier Resolution Quick Scan Assay

The Premier Resolution is comparable to the Bio-Rad Variant II for HbF on the Quick Scan Assay by a mean bias of -0.3 between the intervals of 1.1 to 48.9% with 160 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbA on the Quick Scan Assay by a mean bias of 0.7 between the intervals of 2.5 to 89.7% with 682 patient results.

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Image /page/6/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a blue triangle made up of three smaller triangles, followed by the text "Trinity Biotech" in a sans-serif font, also in blue. The logo is simple and modern, with a clean design.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbA2 on the Quick Scan Assay by a mean bias of 0.1 between the intervals of 1.6 to 6.1% with 602 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbS on the Quick Scan Assay by a mean bias of 0.3 between the intervals of 6.8 to 67.1% with 106 patient samples.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbC on the Quick Scan Assay by a mean bias of -1.1 between the intervals of 9.5 to 82.8% with 49 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbD-LA on the Quick Scan Assay by a mean bias of 1.6 between the intervals of 11.6 to 82.7% with 17 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbE on the Quick Scan Assay by a mean bias of -3.0 between the intervals of 5.5 to 70.4% with 25 patient results.

Premier Resolution High Resolution Assay

The Premier Resolution is comparable to the Bio-Rad Variant II for HbF on the High Resolution Assay by a mean bias of -0.4 between the intervals of 1.1 to 46.6% with 158 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbA on the High Resolution Assay by a mean bias of 2.4 between the intervals of 3.5 to 90.5% with 586 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbA2 on the High Resolution Assay by a mean bias of 0.1 between the intervals of 1.6 to 6.0% with 598 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbS on the High Resolution Assay by a mean bias of 1.3 between the intervals of 1.9 to 67.9% with 110 patient samples.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbC on the High Resolution Assay by a mean bias of -1.0 between the intervals of 10.2 to 82.5% with 49 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbD-LA on the High Resolution Assay by a mean bias of 2.7 between the intervals of 11.7 to 84.1% with 17 patient results.

The Premier Resolution is comparable to the Bio-Rad Variant II for HbE on the High Resolution Assay by a mean bias of -4.9 between the intervals of 5.3 to 66.7% with 25 patient results.

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Image /page/7/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a blue triangle shape on the left, followed by the text "Trinity Biotech" in a sans-serif font. The triangle is made up of three smaller triangles, with the colors transitioning from a darker blue to a lighter blue.

Single Site Precision

The Single-Site precision study was conducted following EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline – Third Edition. Samples of varying concentrations of HbA, A2, and F were analyzed on the Premier Resolution using the Quick Scan and High-Resolution assay mode for the quantitation hemoglobin fractions. The retention time and relative retention time precision was also determined for each hemoglobin fraction. The 20x2x2 study design was conducted over 20 days, with two runs per day and two replicates per run. The study yielded 80 data points for each analyte to establish a balanced dataset.

Single Site Precision - Quick Scan

| Sample
Description | N | Mean
Value | Repeatability | | Between-Run | | Between-Day | | Within-
Laboratory | |
|-----------------------|----|---------------|---------------|-------|-------------|-------|-------------|-------|-----------------------|-------|
| A High | 80 | 83.56 | 0.25 | 0.30% | 0.37 | 0.44% | 2.98 | 3.57% | 3.01 | 3.61% |
| A Mid | 80 | 51.24 | 0.35 | 0.68% | 0.15 | 0.30% | 0.25 | 0.50% | 0.46 | 0.89% |
| A2 Mid | 80 | 2.57 | 0.04 | 1.63% | 0.03 | 1.07% | 0.03 | 1.08% | 0.06 | 2.23% |
| A2 Low | 80 | 1.75 | 0.04 | 2.02% | 0.02 | 0.90% | 0.10 | 5.57% | 0.10 | 5.99% |
| F High | 80 | 11.38 | 0.05 | 0.43% | 0.03 | 0.26% | 0.10 | 0.92% | 0.12 | 1.05% |
| F Mid | 80 | 1.67 | 0.04 | 2.42% | 0.00 | 0.00% | 0.04 | 2.18% | 0.05 | 3.26% |
| S High | 80 | 74.63 | 0.33 | 0.44% | 0.18 | 0.24% | 0.55 | 0.74% | 0.67 | 0.89% |
| S Mid | 80 | 30.61 | 0.14 | 0.47% | 0.14 | 0.45% | 0.22 | 0.73% | 0.30 | 0.98% |
| C High | 80 | 81.22 | 0.41 | 0.50% | 0.43 | 0.53% | 0.23 | 0.28% | 0.63 | 0.78% |
| C Mid | 80 | 31.91 | 0.46 | 1.43% | 0.26 | 0.81% | 0.20 | 0.61% | 0.56 | 1.75% |
| D High | 80 | 69.98 | 0.70 | 1.00% | 0.71 | 1.01% | 0.86 | 1.23% | 1.32 | 1.88% |
| D Mid | 80 | 38.14 | 0.30 | 0.79% | 0.37 | 0.97% | 0.61 | 1.61% | 0.78 | 2.04% |
| E High | 80 | 81.22 | 1.38 | 1.70% | 0.00 | 0.00% | 1.85 | 2.28% | 2.31 | 2.84% |
| E Mid | 80 | 22.30 | 0.14 | 0.62% | 0.17 | 0.75% | 0.65 | 2.90% | 0.68 | 3.06% |

Single Site Precision - High Resolution

| Sample | | Mean | Repeatability | | Between-Run | | Between-Day | | Within-
Laboratory | |
|-------------|----|-------|---------------|-------|-------------|-------|-------------|-------|-----------------------|-------|
| Description | N | Value | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| A High | 80 | 83.64 | 0.43 | 0.52% | 0.38 | 0.45% | 2.98 | 3.56% | 3.03 | 3.63% |
| A Mid | 80 | 50.60 | 0.41 | 0.81% | 0.48 | 0.94% | 0.30 | 0.59% | 0.69 | 1.37% |
| A2 Mid | 80 | 2.48 | 0.10 | 4.13% | 0.15 | 5.92% | 0.00 | 0.00% | 0.18 | 7.22% |
| A2 Low | 80 | 1.59 | 0.06 | 3.92% | 0.09 | 5.98% | 0.00 | 0.00% | 0.11 | 7.15% |
| F High | 80 | 11.11 | 0.12 | 1.07% | 0.03 | 0.27% | 0.37 | 3.31% | 0.39 | 3.49% |
| F Mid | 80 | 1.34 | 0.08 | 5.78% | 0.04 | 3.23% | 0.08 | 6.24% | 0.12 | 9.10% |

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Image /page/8/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a blue triangle on the left side and the words "Trinity Biotech" in blue on the right side. The triangle is a gradient of blue, with the darker shade on the left and the lighter shade on the right.

Premier Resolution System

	Premarket Notification
--	------------------------

| Sample | | Mean | Repeatability | | Between-Run | | Between-Day | | Within-
Laboratory | |
|-------------|----|-------|---------------|-------|-------------|-------|-------------|-------|-----------------------|-------|
| Description | N | Value | SD | %CV | SD | %CV | SD | %CV | SD | %CV |
| S High | 80 | 76.89 | 0.57 | 0.74% | 0.42 | 0.54% | 0.74 | 0.96% | 1.02 | 1.33% |
| S Mid | 80 | 32.01 | 0.30 | 0.92% | 0.23 | 0.73% | 0.39 | 1.22% | 0.54 | 1.69% |
| C High | 80 | 81.07 | 0.51 | 0.63% | 0.49 | 0.61% | 0.61 | 0.75% | 0.94 | 1.15% |
| C Mid | 80 | 32.84 | 0.44 | 1.34% | 0.00 | 0.00% | 0.50 | 1.52% | 0.67 | 2.03% |
| D High | 80 | 73.83 | 1.07 | 1.45% | 0.89 | 1.21% | 0.84 | 1.14% | 1.62 | 2.20% |
| D Mid | 80 | 39.80 | 0.34 | 0.84% | 0.23 | 0.58% | 0.33 | 0.84% | 0.53 | 1.32% |
| E High | 80 | 77.26 | 0.93 | 1.20% | 0.94 | 1.21% | 3.33 | 4.31% | 3.58 | 4.63% |
| E Mid | 80 | 22.46 | 0.13 | 0.57% | 0.22 | 0.98% | 0.66 | 2.93% | 0.70 | 3.14% |

Multisite Precision

The Multisite Precision Study was conducted in accordance with CLSI EP05-A3 Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline -Third Edition. A 3x5x5 study design was performed across three (3) external sites over five (5) days with five (5) replicates per day. Three (3) Premier Resolution Systems, one per site and Mobile Phase 1, 2, and Diluent reagents (one lot of each), analytical column, and precision samples for the study were provided to the external sites. The study assessed instrument-to-instrument, operator and site-to-site precision.

Quick Scan
Sample
Description	N	Mean
Value	Repeatability		Between-Day		Between-Site		Reproducibility
			SD	%CV	SD	%CV	SD	%CV	SD	%CV
FASC F	75	17.16	0.09	0.52%	0.27	1.55%	0.82	4.80%	0.87	5.07%
FASC A	75	42.89	0.22	0.52%	0.33	0.78%	0.34	0.78%	0.52	1.22%
FASC S	75	12.87	0.07	0.51%	0.06	0.50%	0.09	0.69%	0.13	0.99%
FASC C	75	14.14	0.11	0.78%	0.08	0.57%	0.26	1.87%	0.30	2.11%
A2+F I F	75	2.94	0.04	1.33%	0.04	1.39%	0.12	4.17%	0.14	4.59%
A2+F I A	75	82.75	0.31	0.38%	1.00	1.21%	1.16	1.40%	1.57	1.89%
A2+F I A2	75	3.11	0.04	1.17%	0.06	2.04%	0.06	2.08%	0.10	3.15%
A2+F II F	75	7.23	0.10	1.36%	0.12	1.70%	0.27	3.69%	0.31	4.28%
A2+F II A	75	45.53	0.24	0.52%	0.24	0.53%	0.27	0.60%	0.44	0.96%
A2+F II S	75	27.63	0.18	0.65%	0.21	0.77%	0.19	0.69%	0.34	1.22%
A2 A2	75	1.63	0.03	2.12%	0.03	1.80%	0.05	2.92%	0.07	4.04%
C-Trait C	75	30.51	0.26	0.85%	0.36	1.17%	0.86	2.82%	0.97	3.17%
D-Trait D	75	35.03	0.20	0.57%	0.34	0.96%	0.58	1.64%	0.70	1.99%
E-Trait E	75	23.08	0.34	1.47%	0.31	1.36%	0.73	3.17%	0.87	3.75%

Multisite Precision - Quick Scan

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Multisite Precision - High Resolution

High Resolution
Sample
Description	N	Mean
Value	Repeatability
SD	Repeatability
%CV	Between-Day
SD	Between-Day
%CV	Between-Site
SD	Between-Site
%CV	Reproducibility
SD	Reproducibility
%CV
FASC F	75	17.31	0.11	0.64%	0.06	0.35%	1.43	8.28%	1.44	8.31%
FASC A	75	43.97	0.26	0.60%	0.04	0.08%	0.30	0.68%	0.40	0.91%
FASC S	75	13.46	0.10	0.72%	0.06	0.45%	0.07	0.50%	0.13	0.98%
FASC C	75	14.30	0.17	1.17%	0.07	0.47%	0.15	1.05%	0.24	1.65%
A2+F I F	75	2.89	0.07	2.47%	0.04	1.30%	0.07	2.30%	0.10	3.62%
A2+F I A	75	85.21	0.32	0.37%	0.97	1.14%	0.62	0.73%	1.20	1.40%
A2+F I A2	75	3.03	0.06	1.90%	0.05	1.52%	0.02	0.50%	0.08	2.49%
A2+F II F	75	7.29	0.08	1.11%	0.09	1.27%	0.29	3.93%	0.31	4.27%
A2+F II A	75	46.13	0.31	0.67%	0.50	1.09%	0.30	0.65%	0.66	1.44%
A2+F II S	75	28.99	0.19	0.66%	0.32	1.09%	0.37	1.28%	0.52	1.81%
A2 A2	75	1.59	0.05	3.33%	0.03	1.73%	0.03	1.85%	0.07	4.18%
C-Trait C	75	30.53	0.22	0.71%	0.26	0.86%	0.31	1.03%	0.46	1.51%
D-Trait D	75	36.65	0.38	1.03%	0.22	0.59%	0.39	1.07%	0.59	1.60%
E-Trait E	75	22.25	0.27	1.23%	0.30	1.35%	0.46	2.06%	0.61	2.76%

Limits of Detection

The Limit of Detection Study was conducted in accordance with CLSI EP17-A2 Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition. This study determined the limit of quantitation, blank, and lower limits of detection, for hemoglobins A, A2, F, S, C, D-Los Angeles, and E on the Trinity Biotech Premier Resolution. For the Limit of Detection evaluation, human whole blood samples containing 4 different levels of hemoglobins A, A2, F, S, C, D-Los Angeles and E were tested on the Premier Resolution System in the Quick Scan and High Resolution modes.

Premier Resolution Quick Scan Assay:

The limit of detection (LoD) for HbF is 0.2% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbF is 1.1% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbA is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

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The limit of quantitation (LoQ) for HbA is 2.3% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbA2 is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbA2 is 1.5% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbS is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of guantitation (LoQ) for HbS is 1.0% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbC is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbC is 1.0% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbD-Los Angeles is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbD-Los Angeles is 1.5% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbE is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbE is 1.5% of the total area based on 60 determinations of low-level samples.

Premier Resolution High-Resolution Assay:

The limit of detection (LoD) for HbF is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbF is 1.1% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbA is 0.7% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbA is 2.2% of the total area based on 60 determinations of low-level samples.

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The limit of detection (LoD) for HbA2 is 0.2% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbA2 is 1.5% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbS is 0.3% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbS is 0.9% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbC is 0.3% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbC is 1.7% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbD-Los Angeles is 0.1% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbD-Los Angeles is 1.4% of the total area based on 60 determinations of low-level samples.

The limit of detection (LoD) for HbE is 0.6% of the total area based on 60 determinations of low-level samples where the limit of blank (LoB) is set at 0.0% of the total area.

The limit of quantitation (LoQ) for HbE is 2.7% of the total area based on 60 determinations of low-level samples.

Premier Resolution Analytical Specificity

In studies on the analytical specificity of the quantitation of common hemoglobins by the Premier Resolution Analyzer, the Quick Scan assay and High Resolution assay were evaluated.

The analyte hemoglobins F, A, A2, S, C, D - Los Angeles, and E showed no statistical significance of interference with 20mg/dL of Bilirubin, 90mg/dL of acetylsalicylic, 85 UI concentration of Sodium Heparin anticoagulant,

85 Ul concentration of Lithium Heparin anticoagulant, 9 mg/mL concentration of K2EDTA anticoagulant, and 9 mg/mL concentration of K3EDTA anticoagulant when analyzed in Quick Scan and High Resolution assay using Premier Resolution System.

Therefore, there is no interference with the quantitation of hemoglobins; HbF, Hb A, Hb A2, Hb S, Hb C, Hb D-Los Angeles and Hb E from the following interferent and concentrations stated in the table below:

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Premarket Notification

Interferent	Concentration
D-Glucose (HbF Only)	5000mg/dl
Acetaldehyde	20mg/dL
Lipemia (Triglycerides)	4500mg/dL
Icterus (Unconjugated Bilirubin)	20mg/dL
Icterus (Conjugated Bilirubin)	10mg/dL
Acetylsalicylic Acid	90mg/dL
Sodium Heparin	85 UI
Lithium Heparin	85 UI
K2EDTA	9 mg/mL
K3EDTA	9 mg/mL

8. Conclusions

Performance testing has demonstrated that the similarities of the use of the same technology, ion exchange HPLC, and the excellent concordance between the two devices, it can be concluded that the Premier Resolution System is substantially equivalent to the predicate device, the Bio-Rad VARIANT II β Thalassemia. Based on the establishment of substantial equivalence, the safety and effectiveness of the Premier Resolution System has been confirmed.