DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET

K133083 · Diazyme Laboratories · DBF · Jun 24, 2014 · Immunology

Device Facts

• Record ID: K133083
• Device Name: DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
• Applicant: Diazyme Laboratories
• Product Code: DBF · Immunology
• Decision Date: Jun 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only. The Diazyme Ferritin Calibrator Set is intended for use in the Diazyme Ferritin Assay. For in vitro diagnostic use only. The Diazyme Ferritin Control Set is intended for use as quality controls for the Diazyme Ferritin Assay. For in vitro diagnostic use only.

Device Story

Diazyme Ferritin Assay is an in vitro diagnostic test for quantitative ferritin measurement in human serum, K2EDTA plasma, and lithium heparin plasma. Designed for use on Hitachi 917 analyzers in clinical laboratory settings. Operates via immunological test system principles to measure ferritin levels. Output provides quantitative data used by clinicians to assess iron status and diagnose related conditions. Includes dedicated calibrator and control sets for quality assurance.

Clinical Evidence

Bench testing only. Precision evaluated per CLSI EP5-A2 (n=80 measurements per sample). Linearity evaluated per CLSI EP6-A (range 13–1000 ng/mL). Method comparison with predicate (n=91) showed strong correlation (Deming regression: y=0.996x - 4.162, R²=0.996). Matrix comparison (serum vs. plasma) showed bias ≤ 10%. Reference intervals established using 258 healthy individuals (age > 21). No clinical diagnostic sensitivity/specificity studies performed.

Technological Characteristics

Latex-enhanced immunoturbidimetric assay. Reagents: Tris buffer, latex particles coated with goat anti-human ferritin antibodies. Measuring range: 13–1000 ng/mL. Instrument: Hitachi 917. Calibration: 5-point curve using saline and 4 calibrator levels. Traceable to WHO reference material 94/572. Stability: 12-month shelf-life at 2–8°C; 28-day on-board stability.

Indications for Use

Indicated for quantitative determination of ferritin in human serum, K₂EDTA plasma, and lithium heparin plasma in patients aged > 21 years. For prescription use only.

Regulatory Classification

Identification

A ferritin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ferritin (an iron-storing protein) in serum and other body fluids. Measurements of ferritin aid in the diagnosis of diseases affecting iron metabolism, such as hemochromatosis (iron overload) and iron deficiency amemia.

Submission Summary (Full Text)

{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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

June 24, 2014

DIAZYME LABORATORIES C/O DR. ABHIJIT DATTA DIRECTOR, TECHNICAL OPERATIONS 12889 GREGG COURT POWAY CA 92064

Re: k133083

Trade/Device Name: Diazyme Ferritin Assay Diazyme Ferritin Calibrator Set Diazyme Ferritin Control Set Regulation Number: 21 CFR 866,5340 Regulation Name: Ferritin immunological test system Regulatory Class: II Product Code: DBF, JJX, JIT Dated: May 21, 2014 Received: May 23, 2014

#### 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. 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 subiect 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 (OS) regulation (21 CFR Part 820); and if applicable, the

{1}------------------------------------------------

Page 2-Dr. Datta

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

# Elizabeth A. Stafford -S

for Maria Chan, Ph.D.

Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) k133083

#### Device Name

Diazyme Ferritin Assay, Diazyme Ferritin Calibrator Set, Diazyme Ferritin Control Set

#### Indications for Use (Describe)

The Diazyme Ferritin Assay is for the quantitative determination of ferritin in human serum. K2EDTA plasma, and lithium heparin plasma on Hitachi 917 analyzer. For in vitro diagnostic use only

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

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

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabeth A. Stafford -S

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."