(24 days)
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No
The summary describes a reagent for a quantitative determination of HbA1c, which is a standard laboratory test and does not mention any AI/ML components.
No
This device is an in-vitro diagnostic (IVD) intended for measuring HbA1c to monitor diabetic control, not for treating any condition.
Yes
The 'Intended Use / Indications for Use' states, "For in-vitro diagnostic use only," which explicitly identifies the device as a diagnostic one.
No
The 510(k) summary describes reagents for in-vitro diagnostic use, which are chemical substances used in laboratory tests, not software.
Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
- "Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples." This describes a test performed on a biological sample (human whole blood) outside of the body.
- "For in-vitro diagnostic use only." This is a direct statement indicating the device's intended purpose as an in-vitro diagnostic.
These statements clearly align with the definition of an IVD, which are medical devices used to examine specimens taken from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.
Product codes
LCP
Device Description
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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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).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with flowing lines, positioned to the right. Encircling the figure is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA". The text is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 9 2007
Diazyme Laboratories Division of General Atomics c/o Dr. Abhijit Datta 3550 General Atomics Court San Diego, CA 92121
Re: K070734
Trade/Device Name: Diazyme Direct Enzymatic HbA1c Assay Regulation Number: 21 CFR§ 864.7470 Regulation Name: Glycosylated hemoglobin assay. Regulatory Class: Class II Product Code: LCP Dated: March 15, 2007 Received: March 19, 2007
Dear Dr. Datta:
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) 276-0490. 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
2
Pre-market Notification-Diazyme Direct Enzymatic HbA1c Assay
Indications for Use
14070734 510(k) Number (if known):
Device Name: Diazyme Direct Enzymatic HbA1c Assay
Indications for Use: Diazyme Direct Enzymatic Hemoglobin A1c (glycated hemoglobin A1c; A1c; HbAlc) reagents are intended for use in the quantitative determination of stable HbAlc in human whole blood samples. Measurement of hemoglobin A1c is a valuable indicator for long-term diabetic control. For in-vitro diagnostic use only.
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 C. Benam
Action Sign-Off
Tice of In Vitro Diagnostic Device valuation and Safety
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