(132 days)
No
The summary describes a standard HPLC system with associated software for data analysis, but there is no mention of AI or ML capabilities. The performance studies focus on traditional analytical metrics like precision, accuracy, and linearity.
No
The device is an in vitro diagnostic (IVD) device used to measure HbA1c for monitoring glycemic control in individuals with diabetes; it does not directly treat or prevent a disease.
Yes
Explanation: The device measures hemoglobin A1c (HbA1c) for monitoring long-term glycemic control in individuals with diabetes mellitus, which is a diagnostic purpose. The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
No
The device description explicitly states it is a "compact, integrated HPLC system and workstation," indicating it includes hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use only." This is a clear and definitive statement that the device is intended for use in diagnosing conditions outside of the living body.
- Measurement of Biomarkers: The device is intended for the quantitative measurement of hemoglobin A1c (HbA1c) in human whole blood. HbA1c is a biomarker used for monitoring glycemic control in individuals with diabetes mellitus, which is a diagnostic purpose.
- Sample Type: The device analyzes human capillary and venous whole blood, which are biological samples taken from the body for diagnostic testing.
- Device Description: The description details a system that performs a laboratory test (HPLC with boronate affinity chemistry) on these biological samples.
All of these factors align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
LCP
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Actual number of days involved in the experiment, and number 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, individual values not pooled
- Number of reagent lots: 1 reagent lot number per reagent/column
- Number of calibration cycles and calibration lots: 14 total recalibrations once study started, 1 lot of Calibrator used
Accuracy:
- The r value when analyzing IFCC HbA1c Standards is 0.9998.
- The r value when analyzing 51 samples vs. ultra2 is 0.9976.
Linearity:
- The demonstrated linearity is from 3.7% - 18.5%HbA1c.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Intra-run Precision - All Sites - Hemolysate:
| 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:
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 = (Sr/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 = (ST/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 |
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a triangle pointing to the left, followed by the text "Trinity Biotech" in a sans-serif font. Below the company name, the text "YOUR DIAGNOSTICS PARTNER" is written in a smaller, sans-serif font.
K 11 2015
NOV 2 2 2 2011 Page: 1 of 5
510(k) Summary – Premier Hb9210™
| 510(k) Number
| Assigned: | |
|---|---|
| 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 Biotech | |
| 4231 E. 75th Terrace | |
| Kansas City, MO 64132 USA | |
| Submitter and | |
| Owner: | Contact Person: Britt Einspahr, Manager of Quality Assurance & Compliance |
| Email: Britt.Einspahr@TrinityUSA.Com | |
| Phone: 716-483-7402 | |
| Fax: 816-214-4410 | |
| Contact Person: Bonnie DeJoy, Corporate VP of RA (Official Correspondent) | |
| Email: Bonnie.DeJoy@TrinityUSA.Com | |
| Phone: 716-483-3851 Extension 1030 | |
| Fax: 716-488-1990 | |
| Date Prepared: | 8 July 2011 |
| Device Name: | Proprietary Name: Premier Hb9210™ HbA1c Analyzer |
| Common Names: Premier Hb9210™ | |
| Premier - HbA1c | |
| Premier - A1c | |
| Classification Name: Glycosylated Hemoglobin Assay | |
| Classification: | Class II, IVD |
| Product Code: | LCP |
| Device | |
| Description: | 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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Image /page/1/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle on the left and the words "Trinity Biotech" on the right. Below the company name is the phrase "YOUR DIAGNOSTICS PARTNER".
| 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 the
percentage of total glycated hemoglobins in
whole blood. For in vitro diagnostic 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." |
| Chemistry | Patented Boronate Affinity | Same |
| Sample Types | Venous EDTA
or Finger Stick | Venous EDTA, Heparin or Sodium Fluoride
or Finger Stick |
| Method | HPLC | Same |
| HbA1c Species
Separation | Chromatography | Same |
| Instrumentation
Control | Windows Operating System with
Proprietary 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 |
| Chromatography
Integration | Peak Separation and Area Determination | Same |
| Detector UV Wavelength | 413 nm | Same |
| Detector UV Light | Incandescent Lamp | LED |
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Image /page/2/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the words "Trinity Biotech" on the right. Below the company name is the text "YOUR DIAGNOSTICS PARTNER".
.
| Aspect or Feature | Predicate
(K891235) | Premier Hb9210™ |
|------------------------------------------------------------|---------------------------------------------------|--------------------------------------------------------------------|
| Calibration | With Each Run
Cal Data Used For Each Sample | Same |
| Sample ID | Operator Input or
Bar Code Reader | Same |
| Controls | With each run per clinical
laboratory 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 Final
HbA1c Value | $%HbA1c = 0.588 * %GHb + 1.706$ | $%HbA1c = 0.588 * %GHb + 1.706mmol/mol = (%HbA1c - 2.15) / 0.0915$ |
| Safety Stds for
Electrical Equip for Lab
and IVD Use | IEC61010 Certified | Same |
| Electromagnetic
Compatibility | EMC Certified | Same |
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Image /page/3/Picture/0 description: The image shows the logo for Trinity Biotech. The logo consists of a triangle shape on the left and the words "Trinity Biotech" on the right. Below the company name are the words "YOUR DIAGNOSTICS PARTNER".
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, and
| number 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, individual |
| values not pooled | |
| Number of reagent lots: | 1 reagent lot number per |
| reagent/column | |
| Number of calibration cycles and calibration lots: | 14 total recalibrations once |
| study started, 1 lot of | |
| Calibrator 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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Image /page/4/Picture/0 description: The image contains the logo for Trinity Biotech. The logo consists of a triangle on the left and the words "Trinity Biotech" on the right. Below the company name is the text "YOUR DIAGNOSTICS PARTNER".
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.
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, which is a traditional symbol of medicine.
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).
6
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
7
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
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