Diazyme EZ Vitamin D Assay

K172992 · Diazyme Laboratories · MRG · Jan 11, 2018 · Clinical Chemistry

Device Facts

• Record ID: K172992
• Device Name: Diazyme EZ Vitamin D Assay
• Applicant: Diazyme Laboratories
• Product Code: MRG · Clinical Chemistry
• Decision Date: Jan 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1825
• Device Class: Class 2

Intended Use

The Diazyme EZ Vitamin D assay is intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) in human serum and plasma on automated chemistry analyzers. Measurement of 25-hydroxyvitamin D (25-OH-D) is used for the assessment of the vitamin D sufficiency. For in vitro diagnostic use only.

Device Story

The Diazyme EZ Vitamin D Assay is an in vitro diagnostic reagent kit used for the quantitative measurement of 25-hydroxyvitamin D in human serum and plasma samples. The assay is designed for use on automated clinical chemistry analyzers in a laboratory setting. It functions by measuring 25-OH-D levels to assist clinicians in assessing a patient's vitamin D status. The output is a quantitative concentration value provided by the analyzer, which healthcare providers use to evaluate vitamin D sufficiency and inform clinical decision-making regarding patient supplementation or treatment. The device is intended for professional use only.

Clinical Evidence

No clinical data. Bench testing only. Precision study (n=240 replicates) showed total CVs ranging from 2.5% to 16.6%. Linearity confirmed across 7.6–147.8 ng/mL (R²=0.9994). Method comparison with predicate (n=171) yielded slope 1.062, intercept -3.03, R=0.9785. Interference testing demonstrated no significant bias (<10%) for common substances. Reference range established using 145 healthy individuals (7.2–41.6 ng/mL).

Technological Characteristics

In vitro diagnostic reagent kit for automated chemistry analyzers. Principle of operation is a competitive binding immunoassay or enzymatic assay (as implied by the class). Designed for use with human serum and plasma. The device is a standalone reagent system used on existing laboratory instrumentation.

Indications for Use

Indicated for the quantitative determination of 25-hydroxyvitamin D in human serum and plasma to assess vitamin D sufficiency in patients. For use in clinical laboratories by professional personnel.

Regulatory Classification

Identification

A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.

Special Controls

*Classification.* Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and (2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.

Predicate Devices

• Diazyme 25-OH Vitamin D Assay (k133410)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 11, 2018

Diazyme Laboratories Abhijit Datta VP of Technical Operations 12889 Gregg Court Poway, CA 92130

Re: K172992

Trade/Device Name: Diazyme EZ Vitamin D Assay Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: November 29, 2017 Received: November 30, 2017

Dear 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. Iisting 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 Part 801 and Part 809); medical device 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

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Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Kellie B. Kelm -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) k172992

Device Name Diazyme EZ Vitamin D Assay

#### Indications for Use (Describe)

The Diazyme EZ Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25hydroxyvitamin D (25-OH-D) in human serum and plasma on automated chemistry analyzers. Measurement of 25hydroxyvitamin D (25-OH-D) is for the assessment of vitamin D sufficiency. For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

| | Prescription Use (Part 21 CFR 801 Subpart D) |
|--|----------------------------------------------|
| | Over-The-Counter Use (21 CFR 801 Subpart C) |

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