(338 days)
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.
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).
This document describes the performance data for the "Premier Resolution System," an automated High Performance Liquid Chromatography (HPLC) system for hemoglobin analysis. The study aims to demonstrate that the device is substantially equivalent to a predicate device, the Bio-Rad Variant II ß-thalassemia (K991127).
1. Acceptance Criteria and Reported Device Performance:
The document outlines comparative performance against a predicate device (Bio-Rad Variant II ß-thalassemia) and precision studies. The acceptance criteria are implicitly defined by demonstrating comparability and acceptable precision, rather than explicit thresholds for each metric. The reported device performance includes:
| Acceptance Criteria (Implicit) | Reported Premier Resolution System Performance (Quick Scan Assay) | Reported Premier Resolution System Performance (High Resolution Assay) |
|---|---|---|
| Correlation (Method Comparison) - Mean Bias vs. Predicate (Bio-Rad Variant II) | ||
| HbF comparability | -0.3 bias (1.1 to 48.9% interval) with 160 patient results | -0.4 bias (1.1 to 46.6% interval) with 158 patient results |
| HbA comparability | 0.7 bias (2.5 to 89.7% interval) with 682 patient results | 2.4 bias (3.5 to 90.5% interval) with 586 patient results |
| HbA2 comparability | 0.1 bias (1.6 to 6.1% interval) with 602 patient results | 0.1 bias (1.6 to 6.0% interval) with 598 patient results |
| HbS comparability | 0.3 bias (6.8 to 67.1% interval) with 106 patient samples | 1.3 bias (1.9 to 67.9% interval) with 110 patient samples |
| HbC comparability | -1.1 bias (9.5 to 82.8% interval) with 49 patient results | -1.0 bias (10.2 to 82.5% interval) with 49 patient results |
| HbD-LA comparability | 1.6 bias (11.6 to 82.7% interval) with 17 patient results | 2.7 bias (11.7 to 84.1% interval) with 17 patient results |
| HbE comparability | -3.0 bias (5.5 to 70.4% interval) with 25 patient results | -4.9 bias (5.3 to 66.7% interval) with 25 patient results |
| Precision (Single Site) - Within-Laboratory %CV | ||
| HbA (High) | 3.61% | 3.63% |
| HbA (Mid) | 0.89% | 1.37% |
| HbA2 (Mid) | 2.23% | 7.22% |
| HbA2 (Low) | 5.99% | 7.15% |
| HbF (High) | 1.05% | 3.49% |
| HbF (Mid) | 3.26% | 9.10% |
| HbS (High) | 0.89% | 1.33% |
| HbS (Mid) | 0.98% | 1.69% |
| HbC (High) | 0.78% | 1.15% |
| HbC (Mid) | 1.75% | 2.03% |
| HbD (High) | 1.88% | 2.20% |
| HbD (Mid) | 2.04% | 1.32% |
| HbE (High) | 2.84% | 4.63% |
| HbE (Mid) | 3.06% | 3.14% |
| LoD/LoQ (Quick Scan) | ||
| HbF LoD | 0.2% | 0.1% |
| HbF LoQ | 1.1% | 1.1% |
| HbA LoD | 0.1% | 0.7% |
| HbA LoQ | 2.3% | 2.2% |
| HbA2 LoD | 0.1% | 0.2% |
| HbA2 LoQ | 1.5% | 1.5% |
| HbS LoD | 0.1% | 0.3% |
| HbS LoQ | 1.0% | 0.9% |
| HbC LoD | 0.1% | 0.3% |
| HbC LoQ | 1.0% | 1.7% |
| HbD-LA LoD | 0.1% | 0.1% |
| HbD-LA LoQ | 1.5% | 1.4% |
| HbE LoD | 0.1% | 0.6% |
| HbE LoQ | 1.5% | 2.7% |
2. Sample Size and Data Provenance (Test Set):
- Correlation (Method Comparison): A total of 780 unique patient samples were collected and analyzed. The data provenance is described as being collected and analyzed at three (3) professional external laboratory sites. It is implicit that these were retrospective real-world samples, as they are referred to as "patient samples" used for method comparison against an existing device. The country of origin is not explicitly stated, but given the FDA submission, it is likely the US.
- Precision (Single Site): The sample size for each analyte was 80 data points, generated by a 20x2x2 study design over 20 days, with two runs per day and two replicates per run. These were "samples of varying concentrations" and not explicitly patient samples.
- Precision (Multisite): The sample size for each analyte was 75 data points (3x5x5 study design across three external sites, over five days with five replicates per day). These were "precision samples."
- Limits of Detection: 60 determinations of low-level samples for each hemoglobin type. These were "human whole blood samples" with varying levels of hemoglobins.
3. Number of Experts and Qualifications for Ground Truth (Test Set):
This device is an in-vitro diagnostic (IVD) instrument for quantitative and qualitative analysis of hemoglobin species. The ground truth for such devices is typically established by well-characterized reference methods or by comparison to a legally marketed predicate device. In this submission, the primary method for establishing the device's performance is:
- Correlation (Method Comparison): Comparison against the Bio-Rad Variant II ß-thalassemia, which serves as the "ground truth" or reference for establishing substantial equivalence. No human experts are described as establishing ground truth for the test set, as the ground truth is the measurement from the predicate device.
4. Adjudication Method for the Test Set:
Not applicable. The study design involves direct comparison of quantitative measurements from two analytical instruments (device under review vs. predicate device), and precision of the device itself. There is no subjective interpretation requiring adjudication by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is an in-vitro diagnostic device that provides quantitative and qualitative measurements, not an image-based diagnostic system requiring human interpretation with or without AI assistance. Therefore, an MRMC study is not relevant.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop):
Yes, the entire study focuses on the standalone performance of the "Premier Resolution System" as an automated HPLC system. There is no human-in-the-loop component described for its routine operation or for the performance studies presented. The device performs the analysis and provides results independently.
7. Type of Ground Truth Used:
The ground truth for the device's performance is established mainly through:
- Comparison to a legally marketed predicate device: The Bio-Rad Variant II ß-thalassemia, for method comparison (correlation).
- Internal consistency and statistical measures: For precision (repeatability, within-laboratory, reproducibility) and limits of detection/quantitation. This relies on the inherent analytical capabilities and controls of the new device itself.
8. Sample Size for the Training Set:
The document does not explicitly describe a "training set" in the context of machine learning or AI models. This device is an automated HPLC system, where performance is based on chemical separation principles, not a learning algorithm that requires a separate training phase with labeled data in the AI sense. Its "training" or development would involve chemical and engineering optimization.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a "training set" in the context of an AI/ML model for this device. The development of an HPLC system involves instrument design, reagent formulation, and software development, which are validated through analytical performance studies like those presented (precision, linearity, method comparison, etc.).
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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 (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)
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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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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
| Aspector Feature | PredicateBio-Rad Variant™ II BetaThalassemia K991127 | Premier Resolution System |
|---|---|---|
| Intended Use | The Variant™ II B-thalassemiaProgram is intended for theseparation and area percentdeterminations of hemoglobins A2and F and as an aid in theidentification of abnormalhemoglobins in whole blood usingion-exchange high performanceliquid chromatography (HPLC).The Variant™ II B-thalassemiaProgram is intended for use onlywith the Bio-Rad Variant™ IIHemoglobin Testing System.For in vitro diagnostic use only. | The Premier Resolution System is anautomated High Performance LiquidChromatography (HPLC) system whichperforms the separation of hemoglobinspecies in venous whole blood samples forthe quantitative analysis of normalhemoglobin (A, A2, and F), and thequalitative detection of major varianthemoglobin S, C, D-Los Angeles, and E inadult, adolescent, children and infantpopulations. The assays are performed onvenous whole blood samples collected intubes containing K2EDTA as anticoagulant.The Premier Resolution System is intendedfor Professional Laboratory Use only.The Premier Resolution System is intendedfor use with analytical components andreagents provided by Trinity Biotech.The Premier Resolution System is intended tobe used in conjunction with other laboratoryand clinical findings.For In Vitro Diagnostic Use. |
| Chemistry | Ion Exchange HPLC | Ion Exchange HPLC |
| CollectionTubes | K2EDTA, K3EDTA | K2EDTA |
| Sample TubeProcessing | Aspiration of hemolysate fromclosed tube | Aspiration of whole blood from closed tube |
| SampleHemolysis | Performed automatically by thesystem | Performed automatically by the system |
| AutomatedSampleIntroduction | Continuous loading with sampleracks | Continuous loading with sample racks |
| SeparationSystem | Ion-exchange high performanceliquid chromatography (HPLC) | Ion-exchange high performance liquidchromatography (HPLC) protein separation |
| Aspector Feature | Predicate | Premier Resolution System |
| Bio-Rad Variant™ II BetaThalassemia K991127 | ||
| protein separation on analyticalcolumn based on ionic interactionwith the column material andelution by buffer gradient withincreasing ionic strength. | on analytical column based on ionicinteraction with the column material andelution by buffer gradient with increasingionic strength. | |
| SeparationUnit | Analytical Column | Analytical Column |
| AnalysisThroughput | About 6 Minutes | About 4 Minutes - Quick ScanAbout 8 Minutes - High Resolution |
| Calibration | A2 + F Calibrator | A2+F Calibrator |
| Control | A2+F Control | A2+F Control |
| Use of OtherControls | FASC Position Marker | FASC Position Marker |
| SampleIdentification | Barcode on sample tube | Barcode on sample tube |
| Absorbancewavelength | About 413 nm | 413 nm |
| Hb VariantsLibrary | Display and Operator Manual | Display and Operator Manual |
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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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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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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
| SampleDescription | N | MeanValue | 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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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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SampleDescription | N | MeanValue | 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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| SampleDescription | N | MeanValue | RepeatabilitySD | Repeatability%CV | Between-DaySD | Between-Day%CV | Between-SiteSD | Between-Site%CV | ReproducibilitySD | 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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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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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.
§ 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.