FERRITIN CALIBRATOR SET, CATALOG NO. 8203

K053291 · Reference Diagnostics, Inc. · JIT · Mar 13, 2006 · Clinical Chemistry

Device Facts

• Record ID: K053291
• Device Name: FERRITIN CALIBRATOR SET, CATALOG NO. 8203
• Applicant: Reference Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 13, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.

Device Story

RDI Ferritin Calibrator Set provides reference points for immunoturbidimetric ferritin assays. Composed of human ferritin antigen in Tris-buffered saline (TBS) with stabilizers and preservatives. Used in clinical laboratory settings on automated chemistry analyzers. Healthcare providers use the calibrator to establish a standard curve, ensuring accurate quantification of ferritin levels in patient serum or plasma samples. Benefits include standardized measurement of ferritin, aiding in the diagnosis and monitoring of iron-related conditions.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Calibrator set for immunoturbidimetric assay; liquid or lyophilized form; intended for use with RDI Ferritin Kit. Class II device, product code JIT.

Indications for Use

Indicated for use as a reference standard in the quantitative determination of Ferritin in human serum or plasma samples using the RDI Ferritin Kit.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administrat 2098 Gaither Road Rockville MD 20850

MAR 1 3 2006

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 19 Crosby Drive, Suite 30 Bedford MA, 01730

Re: k053291 Trade/Device Name: RDI Ferritin Calibrator Set Regulation Number: 21 CFR§ 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: February 23, 2006 Received: February 24, 2006

Dear Dr. Lawlor:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Alberto G. A.

Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K053291

Device Name:

RDI Ferritin Calibrator Set

Indications For Usc:

The RDI Ferritin Calibrator Set is intended for medical purposes for use with the RDI Ferritin Kit to establish points of reference that are used in the quantitative determination of Ferritin in human serum or plasma by immunoturbidimetric measurement.

Prescription Use (Per 21 CFR 801.109)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

CA

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

10(k) KOS3291