(148 days)
The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
The D-10 Hemoglobin Testing System uses the principles of high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c on a cation exchange cartridge.
This document describes the Bio-Rad D-10™ Hemoglobin A1c Program, a device intended for the percent determination of hemoglobin A1c in human whole blood. The submission focuses on establishing substantial equivalence to a predicate device, the VARIANT™ II Hemoglobin A1c Program.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for novel devices. Instead, it aims to demonstrate substantial equivalence to a predicate device through method correlation. Therefore, the "acceptance criteria" can be inferred as achieving excellent correlation with the predicate device.
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (D-10 Hemoglobin A1c Program vs. VARIANT II Hemoglobin A1c Program) |
|---|---|
| Excellent correlation between methods (slope and intercept demonstrating linearity close to y=x) | Regression Method: Least Squares Slope: Not directly reported, but implied to be close to 1 given the conclusion of "excellent correlation". Intercept: Not directly reported, but implied to be close to 0 given the conclusion of "excellent correlation". (The provided regression table is corrupted and unreadable. The text states "excellent correlation".) |
2. Sample Size used for the test set and the data provenance:
- Sample Size: 40 anticoagulated whole blood samples.
- Data Provenance: Not explicitly stated but clinical samples of human whole blood. The document doesn't specify the country of origin or if it's retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic device, these samples would likely be collected specifically for the study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is an analytical performance study comparing two similar devices for measuring HbA1c, not a study involving expert interpretation of images or clinical outcomes. The "ground truth" for the test set samples is the measurement provided by the predicate device (VARIANT II Hemoglobin A1c Program).
4. Adjudication method for the test set:
Not applicable. This study compares quantitative measurements, not subjective assessments requiring 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 is an analytical performance study of an in vitro diagnostic device, not an AI-assisted diagnostic imaging study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Yes, this is a standalone performance assessment of the D-10 Hemoglobin A1c Program against the predicate device. The device reports a quantitative value (percent HbA1c) directly.
7. The type of ground truth used:
The "ground truth" for this study is the measurement obtained from the predicate device, the VARIANT™ II Hemoglobin A1c Program. Both devices are standardized to the Diabetes Control and Complications Trial (DCCT) reference method and IFCC, and certified via the National Glycohemoglobin Standardization Program (NGSP).
8. The sample size for the training set:
Not applicable. This device is a pre-programmed ivD based on established HPLC principles, not a machine learning or AI model that requires a training set in the typical sense. Its "training" is inherent in its design and calibration processes, which are themselves subject to standardization (DCCT, IFCC, NGSP).
9. How the ground truth for the training set was established:
Not applicable. As above, this is an analytical instrument, not an AI/ML model with a distinct training set and ground truth establishment methodology. The device's accuracy relies on its adherence to established analytical principles and standardization protocols (DCCT, IFCC, NGSP).
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Bio-Rad Laboratories
Diagnostics Group 4000 Alfred Nobel Drive Hercules, California 94547 Telephone: 510 724-7000 Fax: 510 741-5824
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 CFR 807.92.
The assigned 510(k) number is: K034043
| Submitter: | Bio-Rad Laboratories, Inc.Clinical Diagnostics Group4000 Alfred Nobel Drive,Hercules, California 94547Phone: (510) 741-5309FAX: (510) 741-6471 |
|---|---|
| Contact Person: | Jackie BuckleyRegulatory Affairs Representative |
| Date of Summary Preparation: | March 31, 2003 |
| Device Name: | D-10™ Hemoglobin A1c Program |
| Classification Name: | Assay, Glycosylated Hemoglobin, 81LCP |
| Predicate Device: | VARIANT™ II Hemoglobin A1c ProgramK984268Bio-Rad Laboratories, Inc. |
| Statement of Intended Use: | The Bio-Rad D-10 Hemoglobin A1c Program is intended forthe percent determination of hemoglobin A1c in human wholeblood using ion-exchange high performance liquidchromatography (HPLC). The D-10 Hemoglobin A1c isintended for use only with the Bio-Rad D-10 HemoglobinTesting System.For In Vitro Diagnostic Use. |
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Description of Device:
The D-10 Hemoglobin Testing System uses the principles of high performance liquid chromatography The D-10 Hemoglobin A1c Program is based on chromatographic separation of Hemoglobin A1c (HPLC). on a cation exchange cartridge.
Technical Characteristics Compared to Predicate:
D-10 and VARIANT II systems have the same technical characteristics that are summarized in the table below:
| Characteristics | D-10 Hemoglobin A1c | VARIANT II Hemoglobin A1c |
|---|---|---|
| Analyte Measured: Reported | %Alc | %Alc |
| Intended Use | The Bio-Rad D10 Hemoglobin A1cProgram is intended for the percentdetermination of hemoglobin A1c inhuman whole blood using ion-exchange high performance liquidchromatography (HPLC). | The Bio-Rad VARIANT IIHemoglobin A1c Program is intendedfor the percent determination ofhemoglobin Alc in human whole bloodusing ion-exchange high performanceliquid chromatography (HPLC). |
| Assay Principle | Cation exchange high performanceliquid chromatography | Cation exchange high performanceliquid chromatography |
| Sample Type | Human anticoagulated whole blood(EDTA) | Human anticoagulated whole blood(EDTA) |
| Visible Detection | 415 nm | 415 nm |
| Standardization | Traceable to the Diabetes Controland Complications Trial (DCCT)reference method and IFCC.Certified via the NationalGlycohemoglobin StandardizationProgram (NGSP). | Traceable to the Diabetes Control andComplications Trial (DCCT) referencemethod and IFCC. Certified via theNational GlycohemoglobinStandardization Program (NGSP). |
Testing To Establish Substantial Equivalence:
Method correlation between D-10 Hemoglobin Are Program and VARIANT II Hemoglobin A1c Program was evaluated with 40 anticoagulated whole blood samples ranging from 4.98% to 12.15% HbAIc. The results are presented in the following table:
| Regression Method | lone | ntercept | |
|---|---|---|---|
| egetSquares | 00/ | 0 07 4 0 7 4 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 2 6 1 | 2070. Ju |
Conclusion:
When considering the similarities of the intended use, general characteristics of the use of the same technology and excellent correlation between the two methods, it can be concluded that the D-10 Hemoglobin Atc Program and VARIANT II Hemoglobin Aic Program are substantially equivalent.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 2 7 2003
Ms. Jackie Buckley Regulatory Affairs Representative Bio-Rad Laboratories, Inc. Diagnostics Group 4000 Alfred Nobel Drive Hercules, CA 94547
Re: K031043
Trade/Device Name: D-10 Hemoglobin A1c Regulation Number: 21 CFR 864.7470 Regulation Name: Glycosylated Hemoglobin Assay Regulatory Class: Class II Product Code: LCP Dated: July 25, 2003 Received: July 29, 2003
Dear Ms. Buckley:
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
510(k) Number:
Device Name:
Indications for Use:
Bio-Rad D-10™ Hemoglobin Ale Program
The Bio-Rad D-10 Hemoglobin A1c Program is intended for the percent determination of hemoglobin A1c in human whole blood using ion-exchange high performance liquid chromatography (HPLC). The D-10 Hemoglobin A1c Program is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System.
For In Vitro Diagnostic Use.
Adam Cooper
(Division Sign-Off) Division of Clinical Laborato 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptive Use
(Per 21 CFR 801.109)
OR Over-The-counter Use ___
§ 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).