RDI HS CRP CALIBRATOR SET

K021607 · Reference Diagnostics, Inc. · JIT · Jun 27, 2002 · Clinical Chemistry

Device Facts

• Record ID: K021607
• Device Name: RDI HS CRP CALIBRATOR SET
• Applicant: Reference Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 27, 2002
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

Device Story

The RDI hs CRP Calibrator Set consists of reference materials used to calibrate immunoturbidimetric assays for C-reactive protein (CRP). The calibrators are traceable to the international reference preparation (CRM470). The device is used in clinical laboratory settings by trained personnel to ensure the accuracy of quantitative CRP measurements. By establishing a standard curve, the calibrators allow the assay to translate optical measurements from patient serum or plasma samples into clinically relevant CRP concentration values. This supports the diagnosis and monitoring of inflammatory conditions, infections, and tissue injury.

Clinical Evidence

No clinical data; bench testing only. Accuracy is ensured via traceability to the international reference preparation (CRM470).

Technological Characteristics

In vitro diagnostic calibrator set; liquid or lyophilized reference material; traceable to CRM470 international reference preparation; used for immunoturbidimetric assay calibration.

Indications for Use

Indicated for use as a calibrator set to establish reference points for the quantitative determination of C-reactive protein (CRP) in human serum or plasma samples, aiding in the detection and evaluation of infection, tissue injury, and inflammatory disorders.

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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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 2 7 2002

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

Re: k021607

> Trade/Device Name: RDI hs CRP(C-reactive protein) Calibrator Set Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: May 15, 2002 Received: May 16, 2002

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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (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 predicate device results in a classification 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 ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [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 Manufacturers International and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsmamain.html".

Sincerely yours,

Steven Butman

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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# REFERENCE DIAGNOSTICS, INC.

Abbreviated 510(k): RDI hs CRP Calibrator Set

19 Crosby Drive, Suite 30 Bedford, Massachusetts 01730 Tel [phone] Fax [phone]

Statement of Intended Use

Page 1 of 1

510(k) Number (if known): K021607

RDI hs CRP (C-reactive protein) Calibrator Set Device Name:

#### Indications For Use:

The RDI hs CRP Calibrator Set is intended for medical purposes for use with the RDI hs CRP Kit to establish points of reference that are used in the quantitative determination of C-reactive protein (CRP) in human serum or plasma, by immunoturbidimetric measurement.

#### Summary and Explanation of the Test:

Measurement of CRP helps in detecting and evaluating infection, tissue injury, inflammatory disorders, and associated diseases. The accuracy of the CRP measurements is insured by using calibrators that are traceable to the international reference preparation (CRM470).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The Counter Use

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