Who is the manufacturer of ROCHE-CREACTIVE PROTEIN (LATEX)?

Roche Diagnostics Corp. filed the 510(k) submission for ROCHE-CREACTIVE PROTEIN (LATEX) (K073277).

What is the FDA product code for ROCHE-CREACTIVE PROTEIN (LATEX)?

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

What is the regulatory pathway for ROCHE-CREACTIVE PROTEIN (LATEX)?

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

Who can help prepare an FDA 510(k) submission like ROCHE-CREACTIVE PROTEIN (LATEX)?

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.

ROCHE-CREACTIVE PROTEIN (LATEX)

Q: What are the predicate devices for ROCHE-CREACTIVE PROTEIN (LATEX)?

Roche C-Reactive Protein (Latex).

K073277 · Roche Diagnostics Corp. · DCN · Mar 6, 2008 · Immunology

Device Facts

Record ID	K073277
Device Name	ROCHE-CREACTIVE PROTEIN (LATEX)
Applicant	Roche Diagnostics Corp.
Product Code	DCN · Immunology
Decision Date	Mar 6, 2008
Decision	SESE
Submission Type	Special
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended Use

The intended use has been modified to include new members of the instrument family as is allowed by the Replacement Reagent Policy.

Device Story

Particle-enhanced turbidimetric assay for quantitative C-reactive protein (CRP) measurement in human serum/plasma. Human CRP agglutinates with latex particles coated with mouse monoclonal anti-CRP antibodies; precipitate measured turbidimetrically at 552 nm (Integra) or 546 nm (cobas c 501/311). Used in clinical laboratory settings on COBAS INTEGRA and Roche/Hitachi cobas c analyzer platforms. Automated system performs sample processing, reagent mixing, and optical measurement. Output is a quantitative CRP concentration value (mg/L) provided to clinicians to assist in assessing tissue injury. Modifications include expanded measuring ranges (up to 200-250 mg/L), updated calibrators/controls, and refined lipemia interference data.

Clinical Evidence

Bench testing only. Method comparison study (n=150) between modified device and predicate showed high correlation (r=0.999; linear regression y=0.996x - 0.60 mg/L). Precision studies reported CVs of 1.5-1.8% (within-run) and 2.7-2.9% (total). Interference testing performed for lipemia (L-index) and common drugs.

Technological Characteristics

Particle-enhanced turbidimetric assay. Reagents: R1 (TRIS buffer, BSA, mouse immunoglobulins, 0.09% sodium azide); R2 (anti-CRP coated latex particles in glycine buffer, 0.09% sodium azide). Optical measurement at 546/552 nm. Automated analyzer platform (COBAS INTEGRA/cobas c). Measuring range: 1-250 mg/L depending on platform. Traceable to IFCC/BCR/CAP reference preparation CRM 470.

Indications for Use

Indicated for the quantitative determination of C-reactive protein in human serum and plasma to aid in the evaluation of the amount of injury to body tissues.

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 C-Reactive Protein (Latex)

Reference Devices

CRP T Standard (K011226)
Cfas calibrator (K003400, K012371)

Related Devices

K053603 — C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS · Roche Diagnostics Corp. · Feb 9, 2006
K030545 — CRP-LATEX (II)X2 SEIKEN ASSAY KIT · Denka Seiken Co., Ltd. · Jun 2, 2003

Submission Summary (Full Text)

{0}------------------------------------------------ K073277 MAR – 6 2008 # 510(k) Summary -- C-Reactive Protein (Latex) | 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 9115 Hague Rd Indianapolis IN 46250 (317) 521-7637 | | | Contact person: Kerwin Kaufman | | | Date prepared: November 21, 2007 | | Submission Purpose | Roche Diagnostics hereby submits this Special 510(k): Device Modification to provide notification of modifications to our C-Reactive Protein (Latex) assay. This assay was originally cleared for use in K981897 on the COBAS Integra 700 (analyzer cleared in K951595). Submission history for additional applications to the COBAS Integra family and to Roche/Hitachi cobas c systems are summarized in the following Submission History section. | | | Since the K981897 filing, several modifications to the C-Reactive Protein (Latex) application on the COBAS Integra platform include: | | | • change of calibrator and controls, | | | • validation of the high end of the measuring range of the assay up to 200 mg/L, and | | | • more specific Lipemia interference (L-Index) data provided based on testing with Intralipid instead of triglycerides. | | | The Limitations-interference section of the COBAS Integra labeling was also modified to include information about HAMA, monoclonal gammopathy, and additional testing of a common drug panel. This information is not a device modification but was provided for more safe and effective use of the assay. | | | A further device modification was validated in C-Reactive Protein (Latex) applications to the Roche/Hitachi cobas c 501 and cobas c 311: • The high end of the measuring range was validated up to 250 mg/L | | | Continued on next page | | Submission History | Applications of the K981897 CRP Latex modified reagent were applied to additional analyzers within the COBAS Integra family including Integra 400- 800, 400 Plus and cobas c 111, as well as Roche/Hitachi family cobas c 501 and c 311 analyzers via Letters to File or Internal Documentation per the Reagent Replacement policy: ■ Integra 400, K951595/A003 ■ Integra 800, K951595/A008 ■ Integra 400 plus, K951595/A009 ■ cobas c 111, Internal Documentation, K981897/A003 ■ cobas c 501, Internal Documentation, K060373/A001 (referencing K981897) ■ cobas c 311, Internal Documentation, K981897/A005 | | Device Name | Proprietary name: C-Reactive Protein (Latex) Common name: C-Reactive Protein Classification name: C-reactive protein immunological test system | | Establishment Registration | The establishment registration number for Roche Diagnostics GmbH Penzberg is 9610126. | | Classification | The FDA has classified the C-reactive protein immunological test system in Class II. | : {1}------------------------------------------------ # 510(k) Summary – C-Reactive Protein (Latex), Continued | Panel | Classification Number | Classification Name | Regulation Citation | |---------------|--------------------------|----------------------------------------------------|------------------------| | 82 Immunology | DCN | C-reactive protein immunological test system | 21 CFR 866.5270 | {2}------------------------------------------------ # 510(k) Summary – C-Reactive Protein (Latex), Continued : | Device Description | The C-Reactive Protein (Latex) assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particle coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 552 nm (546 nm on cobas c 501 and c 311 analyzers). | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended use | In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS INTEGRA systems. In vitro test for the quantitative determination of C-reactive protein in human | | Predicate Device | We claim substantial equivalence to the COBAS INTEGRA C-Reactive Protein (Latex) cleared as K981897. | | Substantial equivalency – Similarities | The table below indicates the similarities between the modified C-Reactive Protein (Latex) test and its predicate device (original COBAS INTEGRA C- Reactive Protein (Latex), K981897). | | Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General | | | | Intended Use | The cassette COBAS INTEGRA C- Reactive Protein (Latex), (CRPLX) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human C-reactive protein in serum and plasma. | In vitro test for the quantitative immunological determination of C- reactive protein in human serum and plasma on COBAS INTEGRA systems. In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems. | | Indications for Use | Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. | Same | | Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) | | Specimen type | Serum and Plasma. Acceptable anticoagulants include heparin, EDTA, fluoride and citrate. | Same | | Instrument platform | Integra 700 analyzer. | Integra family including Integra 700, 800, 400, 400 plus, and cobas c111. Also Roche/Hitachi family of cobas c systems including cobas c501 and cobas c311. | | Test principle | | | | Determination of C-reactive protein | Particle enhanced turbidimetric assay. Human CRP agglutinates with latex particle coated with monoclonal anti- CRP antibodies. The precipitate is determined turbidimetrically at 552 nm. | Same Determined turbidimetrically at 546 nm on Roche/Hitachi cobas c systems | | Reagent information | | | | Antibody | Mouse monoclonal anti-CRP antibodies | Same | | Traceability | Traceable to the IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) for 14 serum proteins | Same | | R1 | TRIS buffer with bovine serum albumin and immunoglobulins (mouse) stabilized with 0.09% sodium azide (liquid) | Same | | R2 = SR | Latex particles coated with anti-CRP (mouse) in glycine buffer stabilized with 0.09% sodium azide (liquid) | Same | | Reagent stability | 2-8 °C until expiration date On-board: 12 weeks | Same Note: On-board stability on cobas c 111, 5 weeks | | Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) | | Performance characteristics | | | | Precision | Level 1, 6.2 mg/L CV within-run, 1.8% CV Total, 2.9% Level 2, 142 mg/L CV within-run, 1.5% CV Total, 2.7% | Same | | Lower detection limit | 0.25 mg/L | 1.00 mg/L* * Performance has not changed. The specification is now stated as the claim | | Method Comparison | COBAS Integra 700 CRP Latex (with CRP T Standard) versus COBAS Integra 700 with non-latex CRP (K951595): n=244 r=0.993 $Lin. Regression, y = 1.07x - 6.2 mg/L$ $P/B Regression, y = 1.00x - 2.7 mg/L$ Values ranged from 0.62 to 421 mg/L | COBAS Integra 700 CRP Latex (with CRP T Standard) versus COBAS Integra 700 CRP Latex (with Cfas Protein) n=150 r=0.999 $Lin. Regression, y = 0.996x - 0.60 mg/L$ $P/B Regression, y = 0.992x - 0.16 mg/L$ Values ranged from 0.62 to 362 mg/L | Continued on next page . {3}------------------------------------------------ #### Substantial equivalency -- Similarities (continued) 、 {4}------------------------------------------------ ## 510(k) Summary -- C-Reactive Protein (Latex), Continued : Substantial equivalency – Similarities (continued) {5}------------------------------------------------ ## 510(k) Summary -- C-Reactive Protein (Latex), Continued The table below indicates the differences between the modified C-Reactive Substantial equivalency -Protein (Latex) test and its predicate device (original COBAS INTEGRA C-Differences Reactive Protein (Latex), K981897). | Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | | | | Calibrator | CRP T Standard (K954992) | Cfas Proteins (K012393) | | Quality control | CRP T Control (K954992) CRP T Control N (K003400) | CRP T Control N Precinorm Protein (K012371) Precipath Protein (K012371) | | Lipemia (L-index) Interference | Lipemia: Triglyceride levels higher than 7.5 g/L decrease the apparent CRP value significantly. Turbid samples exceeding 0.1 Absorbance are recognized by the "High Activity" check. Correct results can be obtained after post-dilution. | Lipemia: (Intralipid) COBAS INTEGRA 400/400 plus analyzers: No significant interference up to an L index of 1500 in the lower concentration range (3 mg/L or 28.6 nmol/L). No significant interference up to an L index of 623 in the higher concentration range (80 mg/L or 762 nmol/L). COBAS INTEGRA 700/800 analyzers: No significant interference up to an L index of 1094 in the lower concentration range (3 mg/L or 28.6 nmol/L). No significant interference up to an L index of 797 in the higher concentration range (80 mg/L or 762 nmol/L). There is poor correlation between the L index (corresponds to turbidity) and triglycerides concentration. Turbid samples exceeding 0.1 Absorbance are recognized by the "High Activity" check. Correct results can be obtained after postdilution. | {6}------------------------------------------------ | Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) | |--------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Measuring Range | 0-160 mg/L 0-1600 mg/L with postdilution Postdilution factor of 10 recommended | Integra 700, 800, 400, 400 plus, and cobas c 111: 1-200 mg/L Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:10 dilution. Results from samples diluted by the rerun function are automatically multiplied by a factor of 10. cobas c 501 / c 311: 1-250 mg/L Determine samples having higher concentrations via the rerun function. Dilution of samples via the rerun function is a 1:3 dilution. Results from samples diluted by the rerun function are automatically multiplied by a factor of 3. | : : #### Substantial equivalency - Differences (continued) {7}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three horizontal lines extending from its back, all in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the graphic. Public Health Service Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Roche Diagnostics Corp. c/o Mr. Kerwin L. Kaufman Regulatory Affairs Principal 9115 Hague Rd. Indianapolis, IN 46250 Re: k073277 Trade/Device Name: Roche C-Reactive Protein (Latex) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: February 13, 2008 Received: February 19, 2008 Dear Mr. Kaufman: 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. MAR - 6 2008 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 (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The {8}------------------------------------------------ Page 2 – 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 (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Robert Becker/ Robert L. Becker, Jr., M.D., PH.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ ### Indications for Use 510(k) Number (if known): (013277 Device Name: Roche C-Reactive Protein (Latex) Indications For Use: In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS INTEGRA systems. In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems. Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues. Prescription Use XXX (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) Maria M. Han Page 1 of ____________________________________________________________________________________________________________________________________________________________________ Division Slan-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K073277