RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM

K021194 · Hemagen Diagnostics, Inc. · DCK · Jul 29, 2002 · Immunology

Device Facts

• Record ID: K021194
• Device Name: RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: DCK · Immunology
• Decision Date: Jul 29, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5270
• Device Class: Class 2

Intended Use

Reagent: This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders. Calibrator: The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.

Device Story

System performs quantitative in vitro measurement of C-reactive protein (CRP) in human serum or plasma samples; utilizes latex turbidimetric immunoassay principle; requires use of Raichem CRP Serum Calibrators prepared from pooled human serum with purified CRP; intended for clinical laboratory use; provides CRP concentration values to clinicians to assist in diagnosing and monitoring infection, tissue injury, and inflammatory conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Latex turbidimetric immunoassay; reagents include CRP-specific antibodies; calibrators derived from pooled human serum with purified human pleural fluid CRP; preservatives and stabilizers included.

Indications for Use

Indicated for quantitative in vitro measurement of C-reactive protein (CRP) in human serum, heparin plasma, or EDTA plasma to aid in detection and evaluation of infection, tissue injury, and inflammatory disorders.

Regulatory Classification

Identification

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines representing its body and wings. The eagle is encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)". The text is arranged in a circular fashion around the eagle.

Public Health Service

JUL 2 9 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Jose A. Montanez -Official Correspondent Hemagen Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045

Re: k021194

> Trade/Device Name: RAICHEM® CRP High Sensitivity Test System Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system. Regulatory Class: Class II Product Code: DCK; JIS Dated: July 3, 2002 Received: July 9, 2002

Dear Mr. Montanez:

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/dsma/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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| C | | |
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| 510(k) Number (if known): | K021194 |
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| Device Name: | Raichen CRP High Sensitivity Test System |

Indications For Use:

Reagent:

This reagent is intended for the quantitative in vitro measurements of C-reactive protein (CRP) in human serum or heparin and EDTA plasma. Measurement of C-reactive protein is useful in the detection and evaluation of infection, tissue injury and inflammatory disorders.

Calibrator:

The Raichem C-reactive Protein (CRP) Serum Calibrators are prepared from pooled human serum with added CRP purified from human pleural fluid, and are for use as calibrators in the measurement of CRP by latex turbidimetric immunoassays. Preservatives and stabilizers have been added.

Jaan

(Division Sign-Off)

Division of Clinical Laboratory Devices

510(k) Number K021194

(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)