(132 days)
The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.
The Premier Hb9210™ is an update of the predicate HPLC device, the Ultra2, which is the current model under K891235. The Premier Hb9210™ is a compact, integrated HPLC system and workstation with the Trinity Biotech AFFINITY Software for the quantitative determination of glycated hemoglobin using the patented boronate affinity chemistry with high performance liquid chromatography.
Here's an analysis of the provided information, addressing your requested points:
Device: Trinity Biotech Premier Hb9210™ HbA1c Analyzer
The Premier Hb9210™ is an automated High-Performance Liquid Chromatography (HPLC) system designed for the quantitative measurement of HbA1c in human capillary and venous whole blood. This device uses boronate affinity chemistry for HbA1c measurement, building upon the technology of its predicate device, the Ultra2 (K891235).
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the performance metrics in a pass/fail format. Instead, it presents the results of performance tests aimed at demonstrating substantial equivalence to a predicate device. For the purpose of this response, I will interpret the reported performance from the precision and accuracy studies as the device's demonstrated performance.
Note: The document focuses on demonstrating substantial equivalence to a predicate device (Ultra2, K891235), not necessarily meeting specific pre-defined acceptance criteria for novel device approval.
| Performance Metric | Reported Device Performance (Premier Hb9210™) |
|---|---|
| Intra-run Precision (Hemolysate - All Sites) | |
| %HbA1c Concentration | 5.76% |
| Repeatability SD (Sr) | 0.07 |
| Repeatability %CV | 1.26 |
| Within-device Precision SD (ST) | 0.09 |
| Within-device Precision %CV | 1.62 |
| Accuracy (vs IFCC HbA1c Standards) | r = 0.9998 |
| Accuracy (vs Predicate Device Ultra2 - 51 samples) | r = 0.9976 |
| Linearity | 3.7% - 18.5% HbA1c |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Precision Test Set:
- Three hemolysate samples, each representing normal, decision point, and abnormal levels of %HbA1c.
- Each of these three samples was analyzed 80 times per site (2 analyses per run, 2 runs per day, over 20 non-consecutive days) across 3 sites.
- Total replicates: 240 replicates per HbA1c level (3 HbA1c levels * 80 replicates per site * 3 sites) if referring to individual measurements contributing to the overall analysis. The document states "a total of 80 replicates of each level per site, 240 replicates overall".
- Total observations for precision study: 1200 total observations (implicitly across the 3 HbA1c levels and 3 sites).
- Sample Size for Accuracy Test Set (vs. predicate): 51 samples.
- Data Provenance: Not explicitly stated, but the study was conducted at one internal and two external sites. The phrase "aliquotted and frozen whole blood" suggests controlled sample handling, but the origin country of the patient samples or whether they were retrospective or prospective samples is not specified. Given the context of a 510(k) submission, it's typically based on controlled laboratory studies rather than a full clinical trial with diverse patient populations and retrospective/prospective designations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This device is an in vitro diagnostic (IVD) for quantitative measurement, not an AI/ML-driven diagnostic requiring human expert interpretation for ground truth. Therefore, the concept of "experts establishing ground truth" in the way it applies to image interpretation or clinical diagnosis by human readers does not apply in this context.
- Ground truth for the HbA1c levels in the precision study samples would have been established by a highly accurate reference method or certified reference materials, not by human expert consensus or adjudication.
- For the accuracy study comparing to the predicate device, the predicate device itself served as the reference for comparison of the 51 samples.
- For the accuracy study against IFCC HbA1c Standards, the standards themselves provide the ground truth.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, this is a quantitative measurement device, not one where human interpretation requires adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is an automated standalone in vitro diagnostic analyzer, not an AI-assisted diagnostic tool that aids human readers. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the performance studies described (precision, accuracy, linearity) are inherently standalone performance studies for the Premier Hb9210™ analyzer. The device performs the measurement and outputs the HbA1c value without human interpretative input in the measurement process itself.
7. The Type of Ground Truth Used
- Precision Study: Hemolysate samples representing different HbA1c levels. The "actual" concentrations were likely assigned using a reference method or certified values.
- Accuracy Study (IFCC HbA1c Standards): Certified IFCC HbA1c Standards. These are internationally recognized reference materials providing an agreed-upon "true" value for comparison.
- Accuracy Study (against predicate): The predicate device (Ultra2) results were used as the comparator for the 51 samples. While the predicate device itself is not "ground truth" in the strictest sense of a gold standard, it serves as the benchmark against which substantial equivalence is claimed.
8. The Sample Size for the Training Set
Not applicable. This document describes an in vitro diagnostic device using a well-established chemical and physical principle (boronate affinity HPLC). It is not an AI/ML device that requires a "training set" of data in the common sense of machine learning. The device's operational parameters are determined through engineering and chemical optimization, not through data-driven training of an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of IVD device in the context of an AI/ML algorithm.
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K 11 2015
NOV 2 2 2 2011 Page: 1 of 5
510(k) Summary – Premier Hb9210™
| 510(k) NumberAssigned: | |
|---|---|
| Introduction: | Trinity Biotech hereby submits this summary for the Premier Hb9210™ traditional 510(k) in accordance with the requirements of 21 CFR 807.92 for the demonstration of safety and effectiveness and substantial equivalence to the patented K891235 boronate affinity HPLC analyzer and HbA1c assay. |
| Trinity Biotech4231 E. 75th TerraceKansas City, MO 64132 USA | |
| Submitter andOwner: | Contact Person: Britt Einspahr, Manager of Quality Assurance & ComplianceEmail: Britt.Einspahr@TrinityUSA.ComPhone: 716-483-7402Fax: 816-214-4410 |
| Contact Person: Bonnie DeJoy, Corporate VP of RA (Official Correspondent)Email: Bonnie.DeJoy@TrinityUSA.ComPhone: 716-483-3851 Extension 1030Fax: 716-488-1990 | |
| Date Prepared: | 8 July 2011 |
| Device Name: | Proprietary Name: Premier Hb9210™ HbA1c Analyzer |
| Common Names: Premier Hb9210™Premier - HbA1cPremier - A1c | |
| Classification Name: Glycosylated Hemoglobin Assay | |
| Classification: | Class II, IVD |
| Product Code: | LCP |
| DeviceDescription: | The Premier Hb9210™ is an update of the predicate HPLC device, the Ultra2, which is the current model under K891235. The Premier Hb9210™ is a compact, integrated HPLC system and workstation with the Trinity Biotech AFFINITY Software for the quantitative determination of glycated hemoglobin using the patented boronate affinity chemistry with high performance liquid chromatography. |
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| Intended Use: | The Premier Hb9210™ system is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only." |
|---|---|
| ---------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Predicate Device: K891235 – Boronate Affinity HPLC Method – Current Model: ultra2
Comparison to The following table provides comparison of the Premier Hb9210™ and HbA1c Predicate: assay to the predicate device.
| Aspect or Feature | Predicate(K891235) | Premier Hb9210 ™ |
|---|---|---|
| Intended Use | For the quantitative measurement of thepercentage of total glycated hemoglobins inwhole blood. For in vitro diagnostic use. | The Premier Hb9210™ system is intendedfor the quantitative measurement ofhemoglobin A1c (HbA1c) in human capillaryand venous whole blood. HbA1c is used forthe monitoring of long-term glycemic controlin individuals with diabetes mellitus. For in vitro diagnostic use only." |
| Chemistry | Patented Boronate Affinity | Same |
| Sample Types | Venous EDTAor Finger Stick | Venous EDTA, Heparin or Sodium Fluorideor Finger Stick |
| Method | HPLC | Same |
| HbA1c SpeciesSeparation | Chromatography | Same |
| InstrumentationControl | Windows Operating System withProprietary Assay Software | Same |
| Automation | Completely Automated | Same |
| Operation | Continuous | Same |
| Column | Boronate Affinity Matrix | Same |
| Column Matrix | Replenished, Re-Used | Same |
| Reagents | Boronate Affinity Chemistry | Same |
| Solution Phases | 2 | Same |
| Optical Phases | 1 | Same |
| ChromatographyIntegration | Peak Separation and Area Determination | Same |
| Detector UV Wavelength | 413 nm | Same |
| Detector UV Light | Incandescent Lamp | LED |
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| Aspect or Feature | Predicate(K891235) | Premier Hb9210™ |
|---|---|---|
| Calibration | With Each RunCal Data Used For Each Sample | Same |
| Sample ID | Operator Input orBar Code Reader | Same |
| Controls | With each run per clinicallaboratory policies | Same |
| Standards / Traceability | IFCC, NGSP | Same |
| Test Time | 1 Result per 2 Minutes | 1 Result per 1 Minute |
| Results Output | Display and Print | Same |
| Printout | Automatic, User Select | Same |
| Reporting Units | % HbA1c (NGSP / DCCT) | % HbA1c (NGSP / DCCT)mmol/mol (IFCC) |
| Equation Used for FinalHbA1c Value | $%HbA1c = 0.588 * %GHb + 1.706$ | $%HbA1c = 0.588 * %GHb + 1.706mmol/mol = (%HbA1c - 2.15) / 0.0915$ |
| Safety Stds forElectrical Equip for Laband IVD Use | IEC61010 Certified | Same |
| ElectromagneticCompatibility | EMC Certified | Same |
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Summary of Performance Testing
Intra-run Precision - All sites - Hemolysate: The between-run precision study consists of three hemolysate samples (1:100 dilution), representing normal, decision point and abnormal levels of %HbA1c. They were analyzed on 20 non-consecutive days. One internal and 2 external sites were involved, each site was provided with the same sample set (aliguotted and frozen whole blood) and directed to perform 2 analyses of each sample per run with 2 runs per day (a total of 80 replicates of each level per site, 240 replicates overall. The study lasted 35 calendar days. The estimates of imprecision for each sample result obtained from all 3 study sites (all results averaged) analysis are given in the table below:
| Actual number of days involved in the experiment, andnumber of sites: | 49days, 3 sites |
|---|---|
| Actual total number of runs (if applicable): | 120 total runs |
| Total number of observations (including controls): | 1200 total observations |
| Number of instruments/devices used in the evaluation,and how results were pooled: | 3 instruments, individualvalues not pooled |
| Number of reagent lots: | 1 reagent lot number perreagent/column |
| Number of calibration cycles and calibration lots: | 14 total recalibrations oncestudy started, 1 lot ofCalibrator used |
All Sites:
| Concentrations at which claim is made; %HbA1c | 5.76 | 7.07 | 10.96 |
|---|---|---|---|
| Estimate of repeatability SD, (Sr) | 0.07 | 0.05 | 0.09 |
| Repeatability %CV = (Sr/mean)*100 | 1.26 | 0.72 | 0.85 |
| Estimate of within-device precision SD, (ST) | 0.09 | 0.09 | 0.16 |
| Within-device precision %CV = (ST/mean)*100 | 1.62 | 1.28 | 1.50 |
Intra-run Precision - Individual Sites - Hemolysate:
The between-run precision study data for each individual site is as follows:
Site A: External
| Concentrations at which claim is made; %HbA1c | 5.70 | 7.06 | 10.96 |
|---|---|---|---|
| Estimate of repeatability SD, (Sr) | 0.07 | 0.06 | 0.09 |
| Repeatability %CV = (Sr/mean)*100 | 1.24 | 0.79 | 0.78 |
| Estimate of within-device precision SD, (ST) | 0.10 | 0.11 | 0.18 |
| Within-device precision %CV = (ST/mean)*100 | 1.84 | 1.58 | 1.62 |
Site B: External
| Concentrations at which claim is made; %HbA1c | 5.71 | 7.08 | 10.88 |
|---|---|---|---|
| Estimate of repeatability SD, (Sr) | 0.05 | 0.06 | 0.09 |
| Repeatability %CV = $(S_r/mean)*100$ | 0.85 | 0.79 | 0.85 |
| Estimate of within-device precision SD, (ST) | 0.08 | 0.09 | 0.18 |
| Within-device precision %CV = $(S_T/mean)*100$ | 1.47 | 1.20 | 1.62 |
Site C: Internal
| Concentrations at which claim is made; %HbA1c | 5.85 | 7.06 | 11.03 |
|---|---|---|---|
| Estimate of repeatability SD, (Sr) | 0.10 | 0.04 | 0.10 |
| Repeatability %CV = (Sr/mean)*100 | 1.68 | 0.57 | 0.92 |
| Estimate of within-device precision SD, (ST) | 0.09 | 0.07 | 0.14 |
| Within-device precision %CV = (ST/mean)*100 | 1.55 | 1.04 | 1.27 |
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Accuracy - The r value when analyzing IFCC HbA1c Standards is 0.9998 and the r value when analyzing 51 samples vs. ultra2 is 0.9976.
Linearity - The demonstrated linearity is from 3.7% - 18.5%HbA1c.
Substantial Equivalence: The Trinity Biotech Premier Hb9210™ and the predicate device are based on the same method, technology, materials, and engineering with the Premier Hb9210™ being a new model in the high performance liquid chromatography boronate affinity product line. All key elements and performance aspects are either identical or functionally equivalent. In conclusion, the Premier Hb9210™ is functionally equivalent and safe and effective for the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
10903 New Hampshire Avenue Silver Spring, MD 20993
NOV 2 2 2011
Primus Corporation DBA Trinity Biotech c/o Britt Einspahr Manager of Quality Assurance & Compliance 4231 E 75th Terrace Kansas City, MO 64132
Re: K112015
Trade Name: Premier Hb9210 Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP Dated: October 07, 2011 Received: October 17, 2011
Dear Britt Einspahr:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolly the (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/ludustry/default.htm
Sincerely yours.
N
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K112015
Device Name: Premier Hb9210
Indications for Use:
The Premier Hb9210 System is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human capillary and venous whole blood. HbA1c is used for the monitoring of long-term glycemic control in individuals with diabetes mellitus. For in vitro diagnostic use only.
Prescription Use X (Part 21 CFR 801 Subpart D)
..........
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Officer
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510k
Page 1 of 1
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).