K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

K014293 · Kamiya Biomedical Co. · DBF · Feb 19, 2002 · Immunology

Device Facts

• Record ID: K014293
• Device Name: K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET
• Applicant: Kamiya Biomedical Co.
• Product Code: DBF · Immunology
• Decision Date: Feb 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5340
• Device Class: Class 2

Intended Use

The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative determination of ferritin (an iron-storing protein) in human serum and in the determination of ferritin aid in the particle-enhanced immunoturbidimetric assay. These and as hemochromatosis (iron overload) and iron deficiency anemia. The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay. For in vitro diagnostic use.

Device Story

K-ASSAY Ferritin is an in vitro diagnostic reagent kit used for quantitative measurement of ferritin in human serum. The device utilizes a particle-enhanced immunoturbidimetric assay principle. It is intended for use in clinical laboratory settings by trained professionals. The assay provides quantitative results that assist clinicians in diagnosing iron-related disorders such as iron deficiency anemia and hemochromatosis. The system includes a dedicated calibrator set for assay standardization. The output is a concentration value of ferritin, which informs clinical decision-making regarding iron status and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay; in vitro diagnostic reagent; quantitative measurement of ferritin protein in human serum.

Indications for Use

Indicated for the quantitative determination of ferritin in human serum to aid in the diagnosis of iron-related conditions, including hemochromatosis (iron overload) and iron deficiency anemia.

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)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 9 2002

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

Re: k014293 Trade/Device Name: K-ASSAY Ferritin and K-ASSAY Ferritin Calibrator Set

Regulation Number: 21 CFR § 866.5340 Regulation Name: Ferritin Immunological Test System Regulatory Class: II Product Code: DBF Dated: January 31, 2002 Received: February 11, 2002

Dear Mr. Getty:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association 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 r ou may , ateres, include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your device to such 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 i lease of advised that I Driseanse or our device complies with other requirements of the Act that I Dr has made a sond regulations administered by other Federal agencies. You must or any I oderal batates and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or N Fart 677, accems (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by overne (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nouncation. The I Dry imaling of succioin for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific active for your actic devices), please contact the Office of Compliance at additionally 607.10 for in True allestions on the promotion and advertising of your device, [phone]. Fudinonally, Ior questions of [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mionimation on your responsional and Consumer Assistance at its toll-free number [phone] or Manufacturers International and Collecs "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K-ASSAY Ferritin and K-ASSAY Ferritin Calibrator Set Device Name:

## Indications For Use:

The K-ASSAY Ferritin assay is an in vitro diagnostic reagent for the quantitative The K-ASSAY Fernun assay is an in viro diagnosan roag loagness and platex
determination of ferritin (an iron-storing protein) in human serum and in the determination of lemin (an fron-storing provins of ferritin aid in the particle-ennanced immunoturblumethe accey. These and as hemochromatosis (iron overload) and iron deficiency anemia.

The K-ASSAY Ferritin Calibrator Set is an in vitro diagnostic reagent for calibration of the K-ASSAY Ferritin Assay.

For in vitro diagnostic use.

in sau

(Division Sign-Off) Division of Clinical Laboratory Devices

510(k) Number K614293

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | ✓ |
|----------------------|---|
| (Per 21 CFR 801.109) | |

OR

Over-The-Counter Use _

Optional Format 1-2-96) 12/19/2001

Ferritin \$10(k) KAMIYA BIOMEDICAL COMPANY