CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

K060140 · Diagnostic Chemicals , Ltd. · JIT · Apr 24, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060140
• Device Name: CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum. The CRP-ADVANCE Multi-Calibrator Set, Cat. No SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be used with the DCL CRP-ADVANCE Assay.

Device Story

CRP-ADVANCE Multi-Calibrator Set (Model SE-250) consists of 5 levels of human C-reactive protein standards (3.0–362 mg/L). Used as calibrators for DCL CRP-ADVANCE immuno-agglutination assays on clinical chemistry analyzers (e.g., Hitachi 911). Liquid, ready-to-use serum matrix. Donor units tested non-reactive for HBsAg, HCV, and HIV-1/2. Used by laboratory professionals to establish calibration curves for quantitative CRP measurement, ensuring accuracy of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human C-reactive protein standards in serum matrix. 5 levels (3.0-362 mg/L). Packaged in 2 mL vials. Ready-to-use liquid. Traceable to ERM 470. Compatible with Hitachi 911 or equivalent analyzers. Storage at 2-8°C.

Indications for Use

Indicated for in vitro diagnostic use as calibrators for the DCL CRP-ADVANCE Assay to quantify C-reactive protein in human serum.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Penny White Regulatory Affairs Coordinator External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE C1E 2A6

APR 2 4 2006

Re: k060140 Trade/Device Name: CRP-ADVANCE Multi-Calibrator Set Regulation Number: 21 CFR§862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: March 14, 2006 Received: March 17, 2006

Dear Ms. White:

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 vours.

Alberto Gutt

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

100140 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CRP-ADVANCE Multi-Calibrator Set

Indications For Use:

For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum.

## Identification.

The CRP-ADVANCE Multi-Calibrator Set, Cat. No. SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be use with the DCL CRP-ADVANCF Assay.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benem
Revision Sign-Off

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Ciffice of In Vitro Diagnostic Device Evaluation and Safety

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