(148 days)
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No
The summary describes a device based on HPLC technology for measuring hemoglobin A1c, with no mention of AI or ML in the intended use, device description, or performance studies.
No
Explanation: This device is an in vitro diagnostic (IVD) device used for determining hemoglobin A1c levels, which is a diagnostic function, not a therapeutic one. It analyzes blood samples rather than treating a condition.
Yes
The device is described as "For In Vitro Diagnostic Use" and measures hemoglobin A1c in human whole blood, which is a diagnostic indicator for diabetes.
No
The device description explicitly states it uses high performance liquid chromatography (HPLC) and a cation exchange cartridge, which are hardware components. The "Program" refers to the software that likely controls and processes data from this hardware system.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use."
This statement, along with the description of the device's function (determining hemoglobin A1c in human whole blood using HPLC), clearly indicates that it is intended for use in a laboratory setting to test samples taken from the human body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 is intended for use only with the Bio-Rad D-10 Hemoglobin Testing System. For In Vitro Diagnostic Use.
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.
Product codes (comma separated list FDA assigned to the subject device)
LCP
Device Description
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.
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)
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.
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.
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/1 description: The image shows the logo for BIO-RAD. The logo is in white text on a black background. The text is bold and sans-serif.
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 Group
4000 Alfred Nobel Drive,
Hercules, California 94547
Phone: (510) 741-5309
FAX: (510) 741-6471 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jackie Buckley
Regulatory 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 Program
K984268
Bio-Rad Laboratories, Inc. |
| Statement of Intended Use: | 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 is
intended for use only with the Bio-Rad D-10 Hemoglobin
Testing System.
For In Vitro Diagnostic Use. |
1
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 A1c | |
| Program is intended for the percent | ||
| determination of hemoglobin A1c in | ||
| human whole blood using ion- | ||
| exchange high performance liquid | ||
| chromatography (HPLC). | The Bio-Rad VARIANT II | |
| Hemoglobin A1c Program is intended | ||
| for the percent determination of | ||
| hemoglobin Alc in human whole blood | ||
| using ion-exchange high performance | ||
| liquid chromatography (HPLC). | ||
| Assay Principle | Cation exchange high performance | |
| liquid chromatography | Cation exchange high performance | |
| liquid chromatography | ||
| Sample Type | Human anticoagulated whole blood | |
| (EDTA) | Human anticoagulated whole blood | |
| (EDTA) | ||
| Visible Detection | 415 nm | 415 nm |
| Standardization | Traceable to the Diabetes Control | |
| and Complications Trial (DCCT) | ||
| reference method and IFCC. | ||
| Certified via the National | ||
| Glycohemoglobin Standardization | ||
| Program (NGSP). | Traceable to the Diabetes Control and | |
| Complications Trial (DCCT) reference | ||
| method and IFCC. Certified via the | ||
| National Glycohemoglobin | ||
| Standardization 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 | |
|---|---|---|---|
| eget | |||
| Squares | 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting another figure, representing the department's mission of providing essential services and promoting public health.
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
4
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 ___