Who is the manufacturer of CRP HS TEST SYSTEM?

Roche Diagnostics Corp. filed the 510(k) submission for CRP HS TEST SYSTEM (K003400).

What is the FDA product code for CRP HS TEST SYSTEM?

DCN. It is classified under 21 CFR 866.5270 as a Class 2 device in the Immunology panel.

What is the regulatory pathway for CRP HS TEST SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for CRP HS TEST SYSTEM?

Roche Integra C-Reactive Protein test (K981897).

Who can help prepare an FDA 510(k) submission like CRP HS TEST SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CRP HS TEST SYSTEM

K003400 · Roche Diagnostics Corp. · DCN · May 10, 2001 · Immunology

Device Facts

Record ID	K003400
Device Name	CRP HS TEST SYSTEM
Applicant	Roche Diagnostics Corp.
Product Code	DCN · Immunology
Decision Date	May 10, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended Use

For the quantitative determination of C-reactive protein in human serum and plasma. In For the quantitative determilation of Of a number of plasma proteins, including Cacute phase response, increased levels of a number of plasma proteins, and acure protein, are observed. Measuremont of CRP is useful for the detection and reactive protein, are observed. Measuremont of Orders, and associated diseases. evaluation of infection, tissue injury, inflammatory disorders, and associated diseases.

Device Story

CRP US Test System is a latex particle-enhanced immunoturbidimetric assay; designed for use on Roche/Hitachi family of clinical analyzers. Input: human serum or plasma samples. Principle: immunoturbidimetric reaction where latex particles coated with anti-CRP antibodies agglutinate in presence of CRP; turbidity change measured photometrically. Output: quantitative CRP concentration. Used in clinical laboratory settings by trained laboratory personnel. Results assist healthcare providers in evaluating inflammatory states, tissue injury, and infection.

Clinical Evidence

Bench testing only. Performance characteristics evaluated and compared to predicate device; results confirmed substantial equivalence.

Technological Characteristics

Latex particle-enhanced immunoturbidimetric assay. Traceable to IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619). Designed for automated processing on Roche/Hitachi clinical analyzer platforms.

Indications for Use

Indicated for the quantitative determination of C-reactive protein in human serum and plasma to aid in the detection and assessment of infection, tissue injury, inflammatory disorders, and associated diseases.

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.

Predicate Devices

Roche Integra C-Reactive Protein test (K981897)

Related Devices

K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT · Denka Seiken Co., Ltd. · Jun 2, 2003
K023269 — HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS · Instrumentation Laboratory CO · Dec 23, 2002
K011958 — CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT · Denka Seiken'S · Dec 4, 2001
K021194 — RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM · Hemagen Diagnostics, Inc. · Jul 29, 2002
K032663 — QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 · Instrumentation Laboratory CO · Dec 19, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ MAY 1 0 2001 ## 510(k) Summary - CRP US on Roche / Hitachi Family of Clinical Analyzers | Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter name, address, contact | Roche Diagnostics Corporation 9115 Hague Rd Indianapolis IN 46250 (317) 576 3723 Contact person: Priscilla A Hamill Date prepared: October 27, 2000 | | Device Name | Proprietary name: CRP US Test System Common name: C-Reactive Protein test Classification name: System, Test, C-Reactive Protein | | Device description | The C-Reactive Protein US test is a latex particle-enhanced immunoturbidimetric assay packaged for use on the Roche/Hitachi family of analyzers. | | Intended use | For the quantitative determination of C-reactive protein in human serum and plasma. | | Indication for use | The C-reactive protein test is used for the detection and assessment of inflammatory disorders, tissue injury and infection. | | Substantial equivalence | The CRP US test is equivalent to other devices legally marketed in the United States. We claim equivalence to the Roche Integra C-Reactive Protein test (K981897). | {1}------------------------------------------------ ## 510(k) Summary - CRP US on Roche / Hitachi Family of Clinical Analyzers, continued The following table compares CRP US, with the predicate devices. Substantial equivalence similarities | Feature | New Device CRP US | Predicate Device Roche Integra Cassette (K981897) | |--------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Intended use | For the quantitative determination of C-reactive protein | For the quantitative determination of C-reactive protein | | Indication for use | Detection and assessment of inflammatory disorders, tissue injury and infection. | Detection and assessment of inflammatory disorders, tissue injury and infection. | | Sample type | Human serum and plasma | Human serum and plasma | | Traceability | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | The following table compares the CRP US, with the predicate devices. Substantial equivalence differences | Feature | New Device CRP US | Predicate Device Roche Integra Cassette (K981897) | |-----------------|-------------------------------------------------------|---------------------------------------------------------| | Assay principle | Latex particle - enhanced immunoturbidimetric test | Latex particle - enhanced immunoturbidimetric test | | Instrument | Roche/Hitachi family of analyzers | Integra family of analyzers | The performance characteristics of the CRP US were evaluated and found to Substantial equivalence be equivalent to those of the predicate device. performance characteristics {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the wings of a bird. The caduceus is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". MAY 1 0 2001 Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457 510(k) Number: K003400 Re: Trade/Device Name: CRP HS Test System Regulation Number: 866.5270 Regulatory Class: II Product Code: DCN Dated: October 27, 2000 Received: November 1, 2000 Dear Ms. Hamill: We have reviewed your Section 510(k) notification of intent to market the device referenced n o have level have determined the device is substantially equivalent to 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). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include are is 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations ( remarket ripp. V ally in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such perious on. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect reeister. Frease now hight have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 {4}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): Ν/Δ Κορ3400 Device Name: CRP US Test System Indications For Use: For the quantitative determination of C-reactive protein in human seram and plasma. In For the quantitative determilation of Of a number of plasma proteins, including Cacute phase response, increased levels of a number of plasma proteins, and acure protein, are observed. Measurement of CRP is useful for the detection and reactive protein, are observed. Measuremont of Orders, and associated diseases. evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Fred Lacy | (Division Sign-Off) | | |-----------------------------------------|---------| | Division of Clinical Laboratory Devices | | | 510(k) Number | K003400 | (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) | |