Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

K161646 · Diazyme Laboratories · CGN · Nov 4, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161646
• Device Name: Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set
• Applicant: Diazyme Laboratories
• Product Code: CGN · Clinical Chemistry
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1295
• Device Class: Class 2

Intended Use

The Diazyme Folate Assay is a homogeneous enzyme method 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.

Device Story

Diazyme Folate Assay is a quantitative, homogeneous enzymatic test for human serum folate. It utilizes alpha-complementation of beta-galactosidase; competition occurs between enzyme donor-folate conjugate, folate binding protein, and sample folate. Higher sample folate results in higher beta-galactosidase activity. The assay uses a nitro-phenyl-beta-galactoside (NPG) substrate; reaction product measured at 415 nm. Used on Roche Hitachi 917 analyzers in clinical laboratory settings by trained personnel. Output is a quantitative folate concentration (ng/mL) used by clinicians to diagnose and monitor anemias. Includes liquid-ready calibrators and controls. Performance is affected by hemolysis and specific cross-reacting pharmaceuticals (methotrexate, leucovorin).

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (N=80 per level, CVs 5.4-7.5%). Linearity (R²=0.996) and LoQ (2.0 ng/mL) established per CLSI guidelines. Method comparison against predicate (N=141) showed Deming regression slope 0.955, intercept 0.125, r=0.9841. Interference testing performed for endogenous substances and drugs. Reference range established using 213 healthy adults.

Technological Characteristics

Homogeneous enzyme immunoassay. Quantitative measurement of folate in human serum. Reagent-based chemistry. Designed for use on automated clinical chemistry analyzers.

Indications for Use

Indicated for quantitative analysis of folate in human serum to aid in the diagnosis and treatment of anemias. For in-vitro diagnostic use by prescription only.

Regulatory Classification

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.

Predicate Devices

• Roche Elecsys Folate III assay (k141426)
• Roche Elecsys Folate III CalSet (k082340)
• Roche Elecsys Preci-Control Anemia (k082340)

Submission Summary (Full Text)

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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 [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) 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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