The Primus A1care Assay A1c test, for use with the TRI•stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

Device Description

The Primus TRI•stat™ Instrument is a small (10"Wx11"Lx4"H), in vitro diagnostic instrument used with the Primus A1care Assay test to quantitate HbA1c using a patented two-phase optical method. The TRI•stat™ is capable of analyzing a total of 3 samples simultaneously.

AI/ML Overview

The provided document is a 510(k) summary for the Primus TRI•stat™ Instrument and A1Care Assay, indicating substantial equivalence to a predicate device (K891235, Primus Boronate Affinity HPLC Method). However, it does not contain detailed information about specific acceptance criteria, study methodologies, sample sizes, ground truth establishment, or expert qualifications that would typically be found in a comprehensive study report.

The document primarily focuses on establishing equivalent intended use, technology, and performance to the predicate device. It states: "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrate that the instrument and test substantially equivalent to the predicate device and are safe and effective for their intended use."

Without the actual study reports, the following information cannot be extracted:

Here's a table based on the information not available in the provided document, indicating what would typically be requested for such a description:

Acceptance Criteria and Device Performance (Not Provided in Document)

Metric	Acceptance Criteria	Reported Device Performance
Accuracy / Bias	Not specified	Not specified
Precision (Within-run, Between-run, Total)	Not specified	Not specified
Linearity / Measuring Range	Not specified	Not specified
Interference	Not specified	Not specified
Method Comparison (vs. Predicate/Reference Method)	Not specified	Not specified
Correlation Coefficient (R)	Not specified	Not specified
Regression Equation (Slope, Intercept)	Not specified	Not specified

Here's a breakdown of the other requested information, indicating what is available and what is not:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the provided document. The document only mentions "comprehensive studies."
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as the device measures a quantitative biomarker (HbA1c). Ground truth for such devices is typically established through reference methods or certified reference materials, not expert consensus in the diagnostic imaging sense. The document implies comparison to the predicate device (Primus Boronate Affinity HPLC Method) and "known standards."
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for a quantitative diagnostic assay. Performance is assessed by statistical comparison to a reference method or certified values.
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 is a standalone in-vitro diagnostic instrument for measuring a biomarker, not an AI-assisted diagnostic imaging device that involves human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the TRI•stat™ Instrument and A1Care Assay as standalone in-vitro diagnostic device. It quantifies HbA1c using a "patented two-phase optical method." While the instrument is "Partially Automated" and "Requires Sample Insertion and Tube Insertion," the measurement and result generation appear to be fully automated once the sample is loaded. Therefore, performance evaluation would be standalone. The document states "The Primus TRI•stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies."
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The document implies that performance is benchmarked against "known standards" and the predicate device (Primus Boronate Affinity HPLC Method). For HbA1c measurements, ground truth would typically be established by:
  - Reference methods: Such as HPLC methods (like the predicate device) or methods traceable to IFCC reference systems.
  - Certified reference materials: Samples with known, validated HbA1c concentrations.
The sample size for the training set
- Not specified. The document does not describe the development or training of any machine learning model, only the evaluation of the full device. It mentions "factory calibrated" for optical measurements, which implies internal calibration data but not a distinct "training set" in the context of machine learning.
How the ground truth for the training set was established
- Not applicable as no specific "training set" for a machine learning model is mentioned. Calibration and performance are likely based on reference materials and comparisons to established methods.

Summary

{0}------------------------------------------------

K062658

Image /page/0/Picture/1 description: The image shows the logo for Primus Diagnostics. The logo consists of a diamond shape made up of small squares, followed by the word "PRIMUS" in bold, black letters. To the right of "PRIMUS" is the word "Diagnostics" in a smaller, italicized font. Below the words is the phrase "A Trinity Biotech Company".

Page: 1 of 3

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFG 807.92.

Assigned 510(k) Number:	K062658
Submitter:	Primus Corporationdba Primus Diagnostics4231 E. 75 th TerraceKansas City, MO 64132
Contact Person:	Britt Einspahr, MS, MBA, CHMMManager, Quality Assurance and ComplianceEmail: BEinspahr@PrimusDiagnostics.ComPhone: 816-214-4102 (Direct) or 800-377-4752 Ext.102Fax: 816-214-4410
	NOV 2 6 2007
Date of Summary Preparation:	October 24, 2007
Device Name:	TRI•stat™ Instrument and A1Care Assay
Device Type:	Common Name: Glycated Hemoglobin AssayTrade Name: TRI•stat™ Instrument and A1Care AssayClassification: Assay, Glycosylated Hemoglobin
Predicate Device:	K891235, Primus Boronate Affinity HPLC Method
Statement of Intended Use:	The Primus A1care Assay A1c test, for use with the TRI•stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for "PRIMUS Diagnostics", with the word "PRIMUS" in large, bold letters and the word "Diagnostics" in a smaller, italicized font. To the left of the word "PRIMUS" is a square made up of smaller squares. Below the word "PRIMUS" is the text "A Trinity Biotech Company".

Page: 2 of 3

Device Description:

The TRI�stat™ Instrument

The Primus TRI�stat™ Instrument is a small (10"Wx11"Lx4"H), in vitro diagnostic instrument used with the Primus A1care Assay test to quantitate HbA1c using a patented two-phase optical method. The TRI�stat™ is capable of analyzing a total of 3 samples simultaneously.

Theory of measurement

The chemistry of Primus A1care Assay and that of the predicate device are comparable. However, the A1care Assay utliizes a solid phase media like that used in conventional chromatography but in a different manner. The basis of Primus' column chromatography is a boronate affinity gel that retains glycated proteins and elutes these in a secondary buffer.

The Primus A1care Assay uses the boronate affinity in a patented two-phase optical assay. The sample is mixed in an optical cuvette with a suspension of the solid phase particles in a fluorescent buffer. The buffer also contains a lysing agent to break up the red blood cells. After the glycated hemoglobin (HbA1c) adheres to the solid phase, gel particles with A1c attached separate by sedimentation. Optical measurement of hemoglobin is by fluorescence quenching. The wavelength of light absorbance by hemoclobin overlaps the wavelength of excitation of the fluorescent dye. In the presence of hemoglobin there is less light available to excite fluorescence (the quenching effect), and this effect is linear with hemoglobin concentration. The patented twophase assay optically examines the position where the solid phase particles settle. The measurement is made before settling for total hemoglobin, and after complete settling for Hemoglobin A1c only. The HbA1c-gel sedimentation process is monitored by an optical system examining fluorescence intensities generated between the suspension and the settled solid phase, the proportion of which is factory calibrated to give results comparable to known standards.

Comparison of TRI�stat™ to the Predicate Device

The candidate device and the predicate device are substantially equivalent as they employ the same affinity methodology to binding glycated hemoglobin to immobilized aminophenylboronic acid, thus providing the means of separating glycated hemoglobin from the non-glycated hemoglobins. They have the same intended use, the same indications for use, the same manufacturer, the same analyte and the same controls.

Both Primus HPLC and A1care Assay depend on separating the glycated Hb from non-glycated Hb, measuring each separately and calculating a percent of the divcated Hb. A solid phase is most often used for such separation. There are in general two types of solid phases in use. One depends on general ion exchange differences between the glycated and non-glycated species. The other method uses specific affinity for separating the glycated from the non-glycated molecules. Affinity separation is performed with a boronic acid compound known to have general affinity for sugars. The usual means for using either method, column chromatography, is replaced by the two-phase assay in the A1care Assay.

Differences between the predicate device and Primus A1care Assay are as follows. Primus HPLC methods use conventional HPLC column chromatography with a boronate affinity matrix suitable for HPLC. TRI�stat™ uses the same boronate affinity principle with a boronate modified agarose matrix with suitable transparency for optical reading, TRI�stat™ uses a bulk extraction of A1c into the boronate matrix that is measured in the same container as the extraction. In place of having two solution phases read sequentially as effluents from a column, as in the predicate device, TRI�stat™ measures two optical phases, a total hemoglobin, suspension phase, and a settled matrix phase containing only glycated hemoglobin. Primus HPLC uses an ammonium acetate buffer at pH 9 as the solution for binding A1c to the boronate matrix. TRI�stat™ uses a qlycine buffer at pH 9.1 to bind A1c to its boronate matrix. In Primus HPLC there is a second buffer to

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for "PRIMUS Diagnostics", with a geometric design to the left of the word "PRIMUS". The "R" in "PRIMUS" is partially obscured by the geometric design. A registered trademark symbol is to the right of the word "PRIMUS". Below the word "PRIMUS", it says "A Trinity Biotech Company".

Page: 3 of 3

remove the A1c from the chromatography matrix and to prepare the column for the next sample. In TRI�stat™ there is no removal of A1c since the measurement is made in the matrix. TRI�stat™ uses a single use disposable container. The matrix is not re-used.

Feature	Predicate	TRI+stat™
Chemistry	Boronate Separation	Boronate Separation
pH of Chemistry	9.0	9.1
Separation	Chromatography	Bulk
Solution Phases	2	1
Optical Phases	1	2
Matrix Use	Replenished, Re-Used	Single Use Disposable
Instrumentation	Completely Automated	Partially AutomatedRequires Sample Insertionand Tube Insertion inInstrument
Sample	Venous EDTAor Finger Stick	Venous EDTAor Finger Stick
Sample	Whole Blood orPre-diluted	Applied Direct,No Dilution
Results	Results as HemoglobinA1c, Glycated Hemoglobin.and IFCC by usingstandard formulas	Results as HemoglobinA1c, Glycated Hemoglobin,and IFCC by usingstandard formulas
Results	Display and Print	Display Automatic,Print Optional
Printout	Automatic	Requested by Operator
Output	1 Result per 2 Minutes	3 Results per 10 Minutes
Operation	Continuous	Operator Initiated
Sample ID	Operator Input	Bar Code Reader
Calibration	With Each Run	Factory Calibrated Kit

Comparison of Indication For Use Statement from Predicate Device

The indication statement of the Primus A1care Assay and the predicate device are equivalent and contain no intended differences critical to the intended diagnostic use, safety, or effectiveness of the device when used as labeled.

Conclusion: The Primus TRI�stat™ Instrument and Arcare Assay A1c Test was evaluated for nonclinical and clinical performance characteristics in comprehensive studies. These studies demonstrate that the instrument and test substantially equivalent to the predicate device and are safe and effective for their intended use.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Public Health Service

NOV 2 6 2007

Food and Druq Administration 2098 Gaither Road Rockville MD 20850

Primus Corporation c/o Mr. Britt Einspahr Manager, Quality Assurance and Compliance 4231 E. 75th Terrace Kansas City, MO 64132

Re: K062658

Trade/Device Name: Primus Alcare Assay & Primus TRI · stat™ Instrument Regulation Number: 21 CFR $864.7470 Regulation Name: Glycosylated Hemoglobin Assay. Regulatory Class: Class II Product Code: LCP, JJE Dated: October 26, 2007 Received: October 29, 2007

Dear Mr. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

{4}------------------------------------------------

Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): K062658

Device Name: Primus A1care Assay and TRI�stat™ Instrument

Indications For Use:

The Primus A1care Assay A1c test, for use with the TRI�stat™ Instrument, is a rapid in vitro diagnostic test for measurement of the percent of glycated hemoglobin (%HbA1c) level in human blood from finger stick or venous samples for clinical laboratory and point-of-care use. Measurement of percent HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

Prescription Use × (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)

Carol Benson

Division Sign-Off

Page 1 of 1

Office of In Vitro Diagnostic Device Evaluation and Safety

sll(k) K062658

Regulation Number and Section

§ 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).