(446 days)
No
The summary describes a standard in vitro diagnostic instrument using an optical method for quantitative measurement, with no mention of AI, ML, or related concepts.
No
This device is an in vitro diagnostic instrument used to measure HbA1c levels, which is a diagnostic function, not a therapeutic one. It monitors a condition rather than treating it.
Yes
The device is described as a "rapid in vitro diagnostic test" for measuring glycated hemoglobin and an "in vitro diagnostic instrument." Its purpose is to monitor long-term glucose control in individuals with diabetes mellitus, which is a diagnostic function.
No
The device description explicitly states it is an "in vitro diagnostic instrument" with physical dimensions and the capability to analyze samples, indicating it is a hardware device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why, based on the provided text:
- Intended Use / Indications for Use: Explicitly states it is a "rapid in vitro diagnostic test".
- Device Description: Describes the instrument as an "in vitro diagnostic instrument".
- Anatomical Site: Specifies it uses "human blood from finger stick or venous samples", which is a biological sample analyzed outside the body.
- Intended User / Care Setting: Indicates use in "clinical laboratory and point-of-care use", typical settings for IVD devices.
N/A
Intended Use / 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.
Product codes
LCP, JJE
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory and point-of-care use.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
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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".
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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 Corporation |
| dba Primus Diagnostics | |
| 4231 E. 75 th Terrace | |
| Kansas City, MO 64132 | |
| Contact Person: | Britt Einspahr, MS, MBA, CHMM |
| Manager, Quality Assurance and Compliance | |
| Email: BEinspahr@PrimusDiagnostics.Com | |
| Phone: 816-214-4102 (Direct) or 800-377-4752 Ext.102 | |
| Fax: 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 Assay |
| Trade Name: TRI•stat™ Instrument and A1Care Assay | |
| Classification: 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. |
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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".
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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
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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".
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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 Automated |
| Requires Sample Insertion | ||
| and Tube Insertion in | ||
| Instrument | ||
| Sample | Venous EDTA | |
| or Finger Stick | Venous EDTA | |
| or Finger Stick | ||
| Sample | Whole Blood or | |
| Pre-diluted | Applied Direct, | |
| No Dilution | ||
| Results | Results as Hemoglobin | |
| A1c, Glycated Hemoglobin. | ||
| and IFCC by using | ||
| standard formulas | Results as Hemoglobin | |
| A1c, Glycated Hemoglobin, | ||
| and IFCC by using | ||
| standard 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).
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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
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
sll(k) K062658