(142 days)
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No
The summary describes a homogeneous enzyme immunoassay for quantitative analysis of folate, which is a standard laboratory technique and does not mention any AI or ML components.
No.
The device is an in-vitro diagnostic assay used for the quantitative analysis of folate in human serum, which aids in diagnosis but does not provide therapy.
Yes
The text explicitly states: "Folic acid measurements are used in the diagnosis and treatment of anemias." and "For in-vitro diagnostic use only." This indicates its role in disease diagnosis.
No
The device is an in-vitro diagnostic assay, which involves chemical reagents and laboratory procedures, not solely software.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section for all three components (the assay, the calibrator set, and the control set) explicitly states "For in-vitro diagnostic use only."
- Intended Use: The assay is intended for the "quantitative analysis of folate in human serum," which is a laboratory test performed outside of the body to diagnose or monitor a medical condition (anemias).
- Components: The calibrator and control sets are specifically designed to be used with the assay, further indicating its use in a diagnostic laboratory setting.
Therefore, the Diazyme Folate Assay, Calibrator Set, and Control Set are all intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The Diazyme Folate Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of folate in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. For in-vitro diagnostic use only.
The Diazyme Folate Calibrator Set is intended for use in the calibration of the Diazyme Folate Assay. For in vitro diagnostic use only.
The Diazyme Folate Control Set is intended for use as quality controls for the Diazyme Folate Assay. For in vitro diagnostic use only.
Product codes
CGN, JIT, JJX
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
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§ 862.1295 Folic acid test system.
(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol consisting of three stylized human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
DIAZYME LABORATORIES ABHIJIT DATTA, PH.D DIRECTOR, TECHNICAL OPERATIONS 12889 GREGG COURT POWAY CA 92130
November 4, 2016
Re: K161646
Trade/Device Name: Diazyme Folate Assay. Diazyme Folate Calibrator Set. Diazyme Folate Control Set Regulation Number: 21 CFR 862.1295 Regulation Name: Folic acid test system Regulatory Class: II Product Code: CGN, JIT, JJX Dated: September 27, 2016 Received: October 04, 2016
Dear Dr.Abhijit 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161646
Device Name
Diazyme Folate Assay, Diazyme Folate Calibrator Set, Diazyme Folate Control Set
Indications for Use (Describe)
The Diazyme Folate Assay is a homogeneous enzyme immunoassay intended for use in the quantitative analysis of folate in human serum. Folic acid measurements are used in the diagnosis and treatment of anemias. For in-vitro diagnostic use only.
The Diazyme Folate Calibrator Set is intended for use in the calibration of the Diazyme Folate Assay. For in vitro diagnostic use only.
The Diazyme Folate Control Set is intended for use as quality controls for the Diazyme Folate Assay. For in vitro diagnostic use only.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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