Premier Resolution System

K222635 · Trinity Biotech (Primus Corporation, Dba Trinity Biotech) · GKA · Aug 4, 2023 · Hematology

Device Facts

• Record ID: K222635
• Device Name: Premier Resolution System
• Applicant: Trinity Biotech (Primus Corporation, Dba Trinity Biotech)
• Product Code: GKA · Hematology
• Decision Date: Aug 4, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7415
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Automated HPLC system; performs fractionation/quantitation of hemoglobin species (A, A2, F) and presumptive identification of variants (S, C, D-Los Angeles, E). Input: venous whole blood samples in K2EDTA tubes. Operation: automated aspiration from closed tubes; ion-exchange chromatography on analytical column; elution via buffer gradient with increasing ionic strength; detection at 413 nm. Output: quantitative/qualitative hemoglobin results displayed to operator. Used in professional laboratory settings by trained personnel. Results used in conjunction with other clinical/laboratory findings to aid in hemoglobinopathy assessment.

Clinical Evidence

Bench testing only. Studies included precision (repeatability, reproducibility, multisite), linearity, interference, carry-over, and method comparison against the predicate. Method comparison (N=682 for HbA) showed high correlation (r=0.994) and Passing-Bablok regression slopes near 1.0. No clinical sensitivity/specificity studies performed.

Technological Characteristics

Ion-exchange HPLC; silica gel support with polyaspartic acid coating. Dual high-pressure pump system, fixed wavelength detector (413±2nm). Dimensions/form factor: integrated analyzer with autosampler and workstation. Connectivity: LIS integration. Sterilization: N/A. Software: Windows-based application for system control and data processing.

Indications for Use

Indicated for quantitative analysis of normal hemoglobin (A, A2, F) and qualitative detection of major variant hemoglobin (S, C, D-Los Angeles, E) in venous whole blood (K2EDTA) for adult, adolescent, child, and infant populations.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Variant II B-thalassemia (K991127)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 <i>one</i> or <i>both</i> , as applicable) |
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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: [phone] Fax: [phone]

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<br>or Feature | Predicate<br>Bio-Rad Variant™ II Beta<br>Thalassemia K991127 | Premier Resolution System |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Variant™ II B-thalassemia<br>Program is intended for the<br>separation and area percent<br>determinations of hemoglobins A2<br>and F and as an aid in the<br>identification of abnormal<br>hemoglobins in whole blood using<br>ion-exchange high performance<br>liquid chromatography (HPLC).<br><br>The Variant™ II B-thalassemia<br>Program is intended for use only<br>with the Bio-Rad Variant™ II<br>Hemoglobin Testing System.<br><br>For <i>in vitro</i> diagnostic use only. | The Premier Resolution System is an<br>automated High Performance Liquid<br>Chromatography (HPLC) system which<br>performs the separation of hemoglobin<br>species in venous whole blood samples for<br>the quantitative analysis of normal<br>hemoglobin (A, A2, and F), and the<br>qualitative detection of major variant<br>hemoglobin S, C, D-Los Angeles, and E in<br>adult, adolescent, children and infant<br>populations. The assays are performed on<br>venous whole blood samples collected in<br>tubes containing K2EDTA as anticoagulant.<br><br>The Premier Resolution System is intended<br>for Professional Laboratory Use only.<br><br>The Premier Resolution System is intended<br>for use with analytical components and<br>reagents provided by Trinity Biotech.<br><br>The Premier Resolution System is intended to<br>be used in conjunction with other laboratory<br>and clinical findings.<br><br>For <i>In Vitro</i> Diagnostic Use. |
| Chemistry | Ion Exchange HPLC | Ion Exchange HPLC |
| Collection<br>Tubes | K2EDTA, K3EDTA | K2EDTA |
| Sample Tube<br>Processing | Aspiration of hemolysate from<br>closed tube | Aspiration of whole blood from closed tube |
| Sample<br>Hemolysis | Performed automatically by the<br>system | Performed automatically by the system |
| Automated<br>Sample<br>Introduction | Continuous loading with sample<br>racks | Continuous loading with sample racks |
| Separation<br>System | Ion-exchange high performance<br>liquid chromatography (HPLC) | Ion-exchange high performance liquid<br>chromatography (HPLC) protein separation |
| Aspect<br>or Feature | Predicate | Premier Resolution System |
| | Bio-Rad Variant™ II Beta<br>Thalassemia K991127 | |
| | protein separation on analytical<br>column based on ionic interaction<br>with the column material and<br>elution by buffer gradient with<br>increasing ionic strength. | on analytical column based on ionic<br>interaction with the column material and<br>elution by buffer gradient with increasing<br>ionic strength. |
| Separation<br>Unit | Analytical Column | Analytical Column |
| Analysis<br>Throughput | About 6 Minutes | About 4 Minutes - Quick Scan<br>About 8 Minutes - High Resolution |
| Calibration | A2 + F Calibrator | A2+F Calibrator |
| Control | A2+F Control | A2+F Control |
| Use of Other<br>Controls | FASC Position Marker | FASC Position Marker |
| Sample<br>Identification | Barcode on sample tube | Barcode on sample tube |
| Absorbance<br>wavelength | About 413 nm | 413 nm |
| Hb Variants<br>Library | Display and Operator Manual | Display and Operator Manual |

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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<br>Description | N | Mean<br>Value | Repeatability | | Between-Run | | Between-Day | | Within-<br>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-<br>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-<br>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<br>Description | N | Mean<br>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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Image /page/9/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a blue triangle shape on the left, followed by the text "Trinity Biotech" in a matching blue color. The text is positioned to the right of the triangle, creating a unified brand identity.

# Multisite Precision - High Resolution

| High Resolution | | | | | | | | | | |
|-----------------------|----|---------------|---------------------|----------------------|-------------------|--------------------|--------------------|---------------------|-----------------------|------------------------|
| Sample<br>Description | N | Mean<br>Value | Repeatability<br>SD | Repeatability<br>%CV | Between-Day<br>SD | Between-Day<br>%CV | Between-Site<br>SD | Between-Site<br>%CV | Reproducibility<br>SD | Reproducibility<br>%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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Image /page/10/Picture/0 description: The image contains 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 word "Trinity" is slightly larger than the word "Biotech". The overall design is clean and modern.

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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Image /page/11/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 blue sans-serif font. The logo is simple and modern, and the use of blue gives it a professional and trustworthy feel.

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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Image /page/12/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" in blue on the right. The triangle is made up of three smaller triangles, and the words "Trinity Biotech" are in a sans-serif font.

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.