(58 days)
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No
The device description details a homogeneous immunoassay based on light scattering and agglutination, which is a standard chemical analysis technique. There is no mention of AI, ML, or any computational learning processes in the device description, intended use, or performance studies.
No.
This device is an in vitro diagnostic reagent system used to measure Hemoglobin A1c levels for monitoring diabetes, not to treat a condition.
Yes
The "Intended Use / Indications for Use" states that the device is "intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus," which is a diagnostic purpose to assess a medical condition.
No
The device description clearly states it is an "in vitro reagent system" and includes "reagent 1, 2a, 2b and a hemolysis buffer" in liquid format, as well as "four lyophilized positive calibrators" and a "liquid solution". These are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the DRI® Hemoglobin A1c Assay is an "in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood". The term "in vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
- Device Description: The description details a "homogeneous immunoassay that measures the DRY Helliogioun' ATC Assay, Including callbraters, 18 a ministry analyzers. The assay s based on the HDATC In human while blood doing automation of microparticles." This describes a laboratory test performed on a biological sample (human whole blood) using reagents and an analyzer.
- Performance Studies: The performance studies describe laboratory-based evaluations of the assay's characteristics, such as Limit of Detection, Precision, Linearity, and Method Comparison, all of which are typical for IVD devices.
The entire description points to a product designed to be used in a laboratory setting to analyze a biological sample for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus.
The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assay in human whole blood.
Product codes (comma separated list FDA assigned to the subject device)
LCP, KRZ
Device Description
DRY® Hemoglobin A1c Assay, including calibrators, is a homogeneous immunoassay that measures the DRY Helliogioun' ATC Assay, Including callbraters, 18 a ministry analyzers. The assay s based on the HDATC In human while blood doing automation of microparticles. Hemoglobin and HbA1c in measurement of light boation non specifically at the same rate. When HbA1c specific Samples bird to micropartioloo by adoelphon to HbA1c on the microparticles resulting in agglutination. The amibody is introduced, the antibody birde to the percent in the Use of HBA to present in the Uit hemoglobin extent or aggiatifically propertically. This technology used in the DRI hemoglobin A1c assay is an established method (ref 1).
DRI Hemoglobin A1c Assay kit contains reagent 1, 2a, 2b and a hemolysis buffer. All are in liquid format.
DRI Hemoglobin A1c Calibrator kit contains four lyophilized positive calibrators with different hemoglobin Dr. Hemogrobin ATC Galibrator int colution that serves as negative hemoglobin calibrator.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the assay were conducted using DRI Hemoglobin A1c Assay kit and calibrator kit are summarized below:
Performance:
Limit of Detection: 0.2%
Precision (n=80):
Normal HbA1c Sample: Within run 0.67%CV, Total run 2.03% CV
Elevated HbA1c Sample: Within run 0.62% CV, Total run 2.36%CV
Assay Linearity: 5.2% to 16% HbA1c concentration
Interference: No interference observed with
Billirubin: 50 mg/dL
Ascorbic Acid: 50 mg/dL
Triglycerides: 1000 mg/dL
EDTA: 6 mg/mL
Heparin: 75 units/mL
Citrate: 9 mg/mL
Oxalate: 15 mg/mL
Method Comparison (n=80):
DRI HbA1c vs Tosoh (n=80):
Deming (95% CI): Slope 0.999 (0.969 to 1.028), Intercept 0.176 (-0.067 to 0.419), Std Err Est 0.254, Correlation 0.9915
Regular (95%CI): Slope 0.995 (0.965 to 1.024), Intercept 0.210 (-0.033 to 0.453), Std Err Est 0.254
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer: HbA1c Variant Analysis Mode.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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 shows the logo for "microgenics". The logo consists of the word "microgenics" in a serif font, with a dot above the "i". To the left of the word is a circular design made up of many short, thick lines radiating outward from the center. The word "microgenics" has a line underneath it.
FER 3 2006
Section II
510(k) SUMMARY
General Information Required for Premarket Notification per 21 CFR 807.87
| 510k Number: | K053411 |
|---|---|
| Submitter: | Microgenics Corporation |
| 46360 Fremont Blvd | |
| Fremont, CA 94538 | |
| Telephone: (510)-979-5000 | |
| Facsimile: (510) 979-5255 | |
| Contact Person: | Tony C. Lam |
| Telephone: (510)-979-5055 | |
| Facsimile: (510) 979-5255 | |
| tlam@microgenics.com | |
| Device's Trade Name: | DRI® Hemoglobin A1c Assay |
| Device's Classification Name: | Glycosylated Hemoglobin Assay |
| Registration Number: | 2937369 (Microgenics Corp. Fremont, CA, US) |
| Regulation Number: | 21 CFR 864.7470 |
| Classification: | Class II |
| Product Code: | LCP |
Predicate Device(s):
Tosoh G7 Automated High Performance Liquid Chromatography (HPLC) Analyzer: HbA1c Variant Analysis Mode.
Device Description:
DRY® Hemoglobin A1c Assay, including calibrators, is a homogeneous immunoassay that measures the DRY Helliogioun' ATC Assay, Including callbraters, 18 a ministry analyzers. The assay s based on the HDATC In human while blood doing automation of microparticles. Hemoglobin and HbA1c in measurement of light boation non specifically at the same rate. When HbA1c specific Samples bird to micropartioloo by adoelphon to HbA1c on the microparticles resulting in agglutination. The amibody is introduced, the antibody birde to the percent in the Use of HBA to present in the Uit hemoglobin extent or aggiatifically propertically. This technology used in the DRI hemoglobin A1c assay is an established method (ref 1).
1
DRI Hemoglobin A1c Assay kit contains reagent 1, 2a, 2b and a hemolysis buffer. All are in liquid format.
DRI Hemoglobin A1c Calibrator kit contains four lyophilized positive calibrators with different hemoglobin Dr. Hemogrobin ATC Galibrator int colution that serves as negative hemoglobin calibrator.
Intended Use:
The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to richlogiobili / (1) in human wood glucose control in individuals with diabetes mellitus.
The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assav in human whole blood.
DRI® Hemoglobin A1c Assay comparison to Predicate Device(s):
The DRI® Hemoglobin A1c Assay, including calibrators, is substantially equivalent to Tosoh G7 HPLC The DNY "Tichlogines" ATO ASSULT In and in the quantitative determination of HbA1c concentration in whole blood sample.
| Device
Characteristics | Subject Device
(DRI HbA1C Assay) | Predicate Device
(Tosoh G7 Automated HPLC Analyzer:
HbA1c Variant Analysis Mode) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The DRI® Hemoglobin A1c Assay is an in
vitro reagent system for the quantitative
determination of Hemoglobin A1c in human
whole blood using automated clinical
chemistry analyzers. It is intended to aid in
monitoring long-term blood glucose control
and compliance in individuals with diabetes
mellitus.
The DRI® Hemoglobin A1c Calibrators are
intended for use in the calibration of the
DRI® Hemoglobin A1c Assay in human
whole blood. | The Tosoh G7 automated HPLC Analyzer-
HbA1c Variant Analysis mode is intended
for in vitro diagnostic use for the
measurement of hemoglobin A1c (HbA1c) in
whole blood specimens. Hemoglobin A1c
measurements are used in the clinical
management of diabetes to assess the long-
term efficacy of diabetic control. |
| Analyte | Hemoglobin A1c | Hemoglobin A1c and total Hemoglobin A |
| Matrix | Whole blood | Whole blood |
| Calibrator Level | 5 levels calibrators including a negative | 2 points |
Summary:
The information provided in this pre-market notification demonstrates that the DRI® Hemoglobin A1c Assay including calibrators is substantially equivalent to Tosoh G7 Automated HPLC Analyzer. Tosoh G7 Automated HPLC Analyzer is certified by the National Glycohemoglobin Standardization Program (NGSP). It is used as a reference method for establishing traceable results of other methods to the Diabetes Control and Complications Trial (DCCT). Data and results provided in this premarket notification were collected and prepared, respectively, in accordance with the NGSP and NCCLS quidance. The performance of the DRI Hemoglobin A1c Assay including calibrators is substantially equivalent to Tosoh G7 Automated HPLC Analyzer for the quantitative determination of HbA1c, as approved by NGSP manufacturer certification (see attached NGSP certification).
2
The performance of the assay were conducted using DRI Hemoglobin A1c Assay kit and calibrator kit are summarized below:
| Performance | Results | |
|---|---|---|
| Limit of Detection | 0.2% | |
| Precision (n=80) | Normal HbA1c Sample | Elevated HbA1c Sample |
| Within run | 0.67%CV | 0.62% CV |
| Total run | 2.03% CV | 2.36%CV |
| Assay Linearity | 5.2% to 16% HbA1c concentration | |
| Interference | No interference observed with | |
| Billirubin | 50 mg/dL | |
| Ascorbic Acid | 50 mg/dL | |
| Triglycerides | 1000 mg/dL | |
| EDTA | 6 mg/mL | |
| Heparin | 75 units/mL | |
| Citrate | 9 mg/mL | |
| Oxalate | 15 mg/mL | |
| Method Comparison | ||
| DRI HbA1c vs Tosoh (n=80) | Deming (95% CI) | Regular (95%CI) |
| Slope | 0.999 (0.969 to 1.028) | 0.995 (0.965 to 1.024) |
| Intercept | 0.176 (-0.067 to 0.419) | 0.210 (-0.033 to 0.453) |
| Std Err Est | 0.254 | 0.254 |
| Correlation | 0.9915 |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Tony C. Lam, MS Vice President, Regulatory, Quality & Compliance Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538
FEB 3 2006
K053411 Re: Trade/Device Name: DRI® Hemoglobin A1c Assay DRI® Hemoglobin A1c Calibrators Regulation Number: 21 CFR § 864.7470 Regulation Name: Glycosylated hemoglobin assay Regulatory Class: Class II Product Code: LCP, KRZ Dated: November 30, 2005 Received: December 7, 2005
Dear Mr. Lam:
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 your 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) 276-0484. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Alberto Guts
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
SECTION III
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
DRI® Hemoglobin A1c Assay Device name: DRI® Hemoglobin A1c Calibrators
Indications for Use:
The DRI® Hemoglobin A1c Assay is an in vitro reagent system for the quantitative determination of Hemoglobin A1c in human whole blood using automated clinical chemistry analyzers. It is intended to aid in monitoring long-term blood glucose control in individuals with diabetes mellitus.
The DRI® Hemoglobin A1c Calibrators are intended for use in the calibration of the DRI® Hemoglobin A1c Assay in human whole blood.
Prescription Use X (Part 21 CFR §801 Subpart D) AND/OR
Over-the Counter Use (21 CFR §807 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)
Aim Chappis
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Office of In Vitro Diagnostic Device Evaluation and Safety
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