Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set

K161721 · Diazyme Laboratories · CDD · Sep 20, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161721
• Device Name: Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
• Applicant: Diazyme Laboratories
• Product Code: CDD · Clinical Chemistry
• Decision Date: Sep 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

The Diazyme Vitamin B12 Assay is for the quantitative determination of Vitamin B12 levels in human serum. Measurements of vitamin B12 may be used in the diagnosis of Vitamin B12 deficiency. For in vitro diagnostic use only. The Diazyme Vitamin B12 Calibrator Set is intended for use in the calibration of the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only. The Diazyme Vitamin B12 Control Set is intended for use as quality controls for the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only.

Device Story

Diazyme Vitamin B12 Assay is an in vitro diagnostic test for quantitative measurement of Vitamin B12 in human serum. Used in clinical laboratory settings by trained personnel to assist in diagnosing Vitamin B12 deficiency. The system includes a calibrator set and control set for quality assurance. Operates via standard laboratory instrumentation for biochemical analysis. Provides numerical concentration values to clinicians to support diagnostic decision-making regarding patient nutritional status and deficiency-related conditions.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=80 per sample). Linearity established from 96.7 to 2000 pg/mL (R^2=0.9985). Method comparison with predicate (k121994) using 99 samples yielded Y = 0.969x - 5.77 (R=0.9847). Reference range established using 211 healthy individuals (213.7–908.9 pg/mL). No clinical diagnostic studies performed.

Technological Characteristics

In vitro diagnostic assay for serum Vitamin B12; includes calibrator and control sets; intended for use on clinical chemistry analyzers.

Indications for Use

Indicated for the quantitative determination of Vitamin B12 levels in human serum to aid in the diagnosis of Vitamin B12 deficiency. For prescription use only.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 image of three human profiles facing right, resembling a bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DIAZYME LABORATORIES ABHIJIT DATTA DIRECTOR, TECHNICAL OPERATIONS 12889 GREGG COURT POWAY CA 92130

September 20, 2016

Re: K161721

Trade/Device Name: Diazyme Vitamin B12 Assay. Diazyme Vitamin B12 Calibrator Set. Diazyme Vitamin B12 Control Set Regulation Number: 21 CFR 862.1810 Regulation Name: Vitamin B12 test system Regulatory Class: II Product Code: CDD, JIT, JJX Dated: June 21, 2016 Received: June 22, 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 [phone] or [phone] 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 [phone] or [phone] 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) k161721

Device Name

Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrator Set, Diazyme Vitamin B12 Control Set

Indications for Use (Describe)

The Diazyme Vitamin B12 Assay is for the quantitative determination of Vitamin B12 levels in human serum. Measurements of vitamin B12 may be used in the diagnosis of B12 deficiency. For in vitro diagnostic use only.

The Diazyme Vitamin B12 Calibrator Set is intended for use in the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only.

The Diazyme Vitamin B12 Control Set is intended for use as quality controls for the Diazyme Vitamin B12 Assay. For in vitro diagnostic use only.

| Type of Use (Select one or both, as applicable) | |
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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