Who is the manufacturer of Tina-quant C-Reactive Protein IV?

Roche Diagnostics Operations (Rdo) filed the 510(k) submission for Tina-quant C-Reactive Protein IV (K192072).

What is the FDA product code for Tina-quant C-Reactive Protein IV?

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

What is the regulatory pathway for Tina-quant C-Reactive Protein IV?

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

What are the predicate devices for Tina-quant C-Reactive Protein IV?

Tina-quant C-Reactive Protein Gen. 3 (K083444).

Who can help prepare an FDA 510(k) submission like Tina-quant C-Reactive Protein IV?

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.

Tina-quant C-Reactive Protein IV

K192072 · Roche Diagnostics Operations (Rdo) · DCN · Feb 21, 2020 · Immunology

Device Facts

Record ID	K192072
Device Name	Tina-quant C-Reactive Protein IV
Applicant	Roche Diagnostics Operations (Rdo)
Product Code	DCN · Immunology
Decision Date	Feb 21, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended Use

Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems. 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 plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

Device Story

Tina-quant® C-Reactive Protein IV is a 2-component, liquid, ready-to-use particle-enhanced immunoturbidimetric assay. It utilizes DUREL (dual radius enhanced latex) technology where human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The resulting aggregates are measured turbidimetrically on Roche cobas c systems. The device is intended for use by clinical laboratory professionals. The output is a quantitative CRP concentration (mg/L), which healthcare providers use to evaluate the extent of tissue injury. The assay is standardized against ERM-DA474/IFCC reference material.

Clinical Evidence

Bench testing only. Precision evaluated over 21 days (total CV 1.6-2.4%). Linearity confirmed 3.0-350 mg/L (R²=0.9976). Interference testing showed no significant impact from endogenous substances or common drugs (except ticarcillin 300-750 mg/L). Method comparison with predicate (N=110) yielded Passing/Bablok slope 0.985, intercept 0.278, Pearson r=0.999. Reference interval verified with 500 healthy donors.

Technological Characteristics

Liquid, 2-component particle-enhanced immunoturbidimetric assay. Reagents: TRIS buffer with BSA (R1); latex particles coated with mouse anti-CRP antibodies in glycine buffer (R2). Sensing principle: turbidimetric measurement of latex agglutination. Platform: cobas c 501 analyzer. Standardization: ERM-DA474/IFCC. Measuring range: 3-350 mg/L. Storage: 2-8 °C.

Indications for Use

Indicated for the in vitro quantitative determination of C-reactive protein (CRP) 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

Tina-quant C-Reactive Protein Gen. 3 (K083444)

Related Devices

K083444 — C-REACTIVE PROTEIN (LATEX) · Roche Diagnostics Corp. · Mar 18, 2009
K032336 — TINA-QUANT CRP (LATEX) · Roche Diagnostics Corp. · Aug 5, 2003
K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET · Good Biotech Corp. · Jul 29, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. February 21, 2020 Roche Diagnostics Operations (RDO) Barbara McWhorter Regulatory Affairs Program Manager 9115 Hague Road Indianapolis, Indiana 46250 Re: K192072 Trade/Device Name: Tina-quant C-Reactive Protein IV Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: August 20, 2019 Received: August 22, 2019 Dear Barbara McWhorter: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {1}------------------------------------------------ 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Carolina Kagan Acting Chief, IMFB Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192072 Device Name Tina-quant® C-Reactive Protein IV Indications for Use (Describe) Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems. 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 plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # Tina-quant® C-Reactive Protein IV 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics Act of our intention to market the device described in this Premarket Notification 510(k). The purpose of this Traditional 510(k) Premarket Notification is to obtain FDA review and clearance for the Tina-quant® C-Reactive Protein IV. {4}------------------------------------------------ | Submitter Name | Roche Diagnostics | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Address | 9115 Hague Road P.O. Box 50416 Indianapolis, IN 46250-0457 | | Contact | Barbara Ann McWhorter Phone: (317) 521-2336 FAX: (317) 521-2324 Email: barbara.mcwhorter@roche.com | | Date Prepared | January 10, 2020 | | Proprietary Name | Tina-quant® C-Reactive Protein IV | | Common Name | C-Reactive Protein | | Classification Name | C-reactive protein immunological test system | | Product Codes, Regulation Numbers | DCN, 21 CFR § 866.5270 | | Predicate Devices | Roche Diagnostics C-Reactive Protein Gen.3 | | Establishment Registration | Roche Diagnostics GmbH Mannheim, Germany: 9610126 Roche Diagnostics GmbH in Penzberg, Germany: 9610529 Roche Diagnostics Indianapolis IN, United States: 1823260 | {5}------------------------------------------------ ## 1. DEVICE DESCRIPTION The Tina-quant® C-Reactive Protein IV reagent will be a liquid ready to use 2 component particle enhanced immunoturbidimetric assay. Reagents - working solutions R1: TRIS* buffer with bovine serum albumin; preservatives R2 Latex particles coated with anti-CRP (mouse) in glycine buffer; immunoglobulins (mouse); preservative * TRIS= Tris(hydroxymethyl)-aminomethane The Tina-quant® C-Reactive Protein IV assay will be based on the DUREL technology (dual radius enhanced latex - technology) which is also used in C-Reactive Protein Gen.3 predicate method. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The aggregates are determined turbidimetrically. ### 2. INDICATIONS FOR USE Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems. 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 plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. ### 3. TECHNOLOGICAL CHARACTERISTICS | | | Table 1: Tina-quant® C-Reactive Protein IV Technical Characteristics | | | |--|--|---------------------------------------------------------------------------|--|--| |--|--|---------------------------------------------------------------------------|--|--| | Feature | Predicate C-Reactive Protein Gen.3 k083444 | Candidate Device Tina-quant® C-Reactive Protein IV k192072 | |------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. | Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems. | | Feature | Predicate C-Reactive Protein Gen.3 k083444 | Candidate Device Tina-quant® C-Reactive Protein IV k192072 | | Indications for Use | Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. | 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 plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. | | Assay Method | Particle enhanced immunoturbidimetric assay | Same | | Detection Method | turbidimetric | Same | | Instrument Platform | Roche automated clinical chemistry analyzers | cobas c 501 analyzer | | Sample Type/Matrix | Serum Plasma: K2- or K3-EDTA, lithium heparin | Same | | Calibrator | Calibrator f.a.s. Proteins | Same | | Calibration Method | 6-point spline | Same | | Calibration Interval | After reagent lot change As required following quality control procedures | - after reagent lot change - after 3 weeks on-board the analyzer - after 6 months when using a single reagent lot - as required following quality control procedures | | Controls | Precinorm Protein Precipath Protein PreciControl ClinChem Multi 1 PreciControl ClinChem Multi 2 | Precinorm Protein Precipath Protein PreciControl ClinChem Multi 1 PreciControl ClinChem Multi 2 | | Traceability/Standardization | Standardized against an internal method traceable to CRM 470 (RPPHS - Reference Preparation for Proteins in Human Serum). | Standardized against the certified reference material in human serum of the IRMM (Institute for Reference Materials and Measurements) ERM-DA474/IFCC. | | Reagent Stability | Shelf life at 2-8 °C: See expiration date on cobas c pack label. On-board in use and refrigerated on the analyzer: 12 weeks | Same | | Measuring Range | 0.3 to 350 mg/L | 3 to 350 mg/L | {6}------------------------------------------------ {7}------------------------------------------------ | Feature | Predicate C-Reactive Protein Gen.3 k083444 | | | Candidate Device Tina-quant® C-Reactive Protein IV k192072 | | | | | |-----------|--------------------------------------------------|----------------|--------------|------------------------------------------------------------------|------------------------|--------------|--------|-----| | | Repeatability | | | Repeatability | | | | | | | | Mean (mg/L) | SD (mg/L) | CV% | Mean (mg/L) | SD (mg/L) | CV% | | | | CRP T Control N | 3.35 | 0.04 | 1.2 | Precinorm Protein | 9.69 | 0.128 | 1.3 | | | Precipath Protein | 44.4 | 0.6 | 1.3 | Precipath Protein | 55.2 | 0.859 | 1.6 | | | Human Serum 1 | 0.57 | 0.02 | 3.6 | Human Serum 2 | 4.55 | 0.0702 | 1.5 | | | Human Serum 2 | 1.56 | 0.03 | 1.6 | Human Serum 3 | 10.6 | 0.167 | 1.6 | | | Human Serum 3 | 43.2 | 0.5 | 1.2 | Human Serum 4 | 82.4 | 1.82 | 2.2 | | | | | | | Human Serum 5 | 186 | 3.76 | 2.0 | | Precision | | | | | Human Serum 6 | 331 | 4.40 | 1.3 | | | Intermediate Precision | | | | Intermediate Precision | | | | | | | Mean (mg/L) | SD (mg/L) | CV% | Mean (mg/L) | SD (mg/L) | CV% | | | | CRP T Control N | 3.06 | 0.09 | 2.9 | Precinorm Protein | 9.69 | 0.142 | 1.5 | | | Precipath Protein | 43.6 | 0.8 | 1.9 | Precipath Protein | 55.2 | 1.04 | 1.9 | | | Human Serum 1 | 0.51 | 0.06 | 11.1 | Human Serum 2 | 4.55 | 0.0735 | 1.6 | | | Human Serum 2 | 1.44 | 0.06 | 3.9 | Human Serum 3 | 10.6 | 0.206 | 1.9 | | | Human Serum 3 | 41.3 | 0.7 | 1.7 | Human Serum 4 | 82.4 | 1.97 | 2.4 | | | | | | | Human Serum 5 | 186 | 4.39 | 2.4 | | | | | | | Human Serum 6 | 331 | 5.80 | 1.8 | | LoB | 0.2 mg/L | | | Same | | | | | | LoD | 0.3 mg/L | | | Same | | | | | | LoQ | 0.6 mg/L | | | 3 mg/L | | | | | {8}------------------------------------------------ | Feature | Predicate C-Reactive Protein Gen.3 k083444 | Candidate Device Tina-quant® C-Reactive Protein IV k192072 | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------| | Method Comparison: Predicate vs Candidate | Passing Bablok: | | | | $Y=0.985x+0.278$ | | | | $R=0.999$ | | | | N=110 Min=3.06/Max=347 mg/L | | | Interferences: | Serum Index: I=60 mg/dL H=1000 mg/dL L=1000 RH: no interference up to 1200 IU/mL Immunoglobulins: no interference up to 50 g/L | Same | # 4. NON-CLINICAL PERFORMANCE EVALUATION The following performance data were provided in support of the substantial equivalence determination: Precision according to CLSI EP5-A3 Detection Limit: LoB, LoD and LoQ according to CLSI EP17-A2 Linearity according to CLSI EP6-A Interferences- L, H and I Indices Interferences – Albumin, Immunoglobulin (IgG) and Rheumatoid Factors Interference - Drugs Matrix Comparison - Anticoagulants Method Comparison to Predicate ### All performance specifications were met. #### 4.1. Precision: Repeatability and Intermediate Precision (CLSI EP05-A3) Precision measurements were conducted to evaluate repeatability (within-run precision) and the intermediate precision (within-laboratory precision) according the CLSI guideline EP05-A3. {9}------------------------------------------------ The Tina-quant® C-Reactive Protein IV reagent was evaluated on a single cobas c 501 analyzer according to CLSI guideline EP05-A3. The protocol consisted of 4 human serum samples along with 2 controls (Precinorm Protein and Precipath Protein) which were analyzed in 2 parts for 21 days. Two aliquots of each sample were randomized and then analyzed on 3 lots of reagents. One operator performed all analysis along with utilizing 1 calibration throughout the 21-day study period. | Specimen | Mean (mg/L) | SD (mg/L) | CV % | |-------------------|-------------|-----------|------| | Precinorm Protein | 9.69 | 0.128 | 1.3 | | Precipath Protein | 55.2 | 0.859 | 1.6 | | Serum 2 | 4.55 | 0.0702 | 1.5 | | Serum 3 | 10.6 | 0.167 | 1.6 | | Serum 4 | 82.4 | 1.82 | 2.2 | | Serum 5 | 186 | 3.76 | 2.0 | | Serum 6 | 331 | 4.40 | 1.3 | ### Table 2: Repeatability Summary ### Table 3: Intermediate/Within Lab Precision Summary | Specimen | Mean (mg/L) | SD (mg/L) | CV % | |-------------------|-------------|-----------|------| | Precinorm Protein | 9.69 | 0.142 | 1.5 | | Precipath Protein | 55.2 | 1.04 | 1.9 | | Serum 2 | 4.55 | 0.0735 | 1.6 | | Serum 3 | 10.6 | 0.206 | 1.9 | | Serum 4 | 82.4 | 1.97 | 2.4 | | Serum 5 | 186 | 4.39 | 2.4 | | Serum 6 | 331 | 5.80 | 1.8 | #### 4.2. Analytical Sensitivity (CLSI EP17-A2) #### 4.2.1. Limit of Blank (LoB) LoB of the Tina-quant® C-Reactive Protein IV assay was tested on 3 reagent lots. Ten aliquots of analyte free saline were analyzed on 1 Roche cobas c 501 analyzer in 6 runs over 3 days, for a total of N=60 determinations per lot. {10}------------------------------------------------ ### Table 4: LoB | Claimed LoB [mg/L] | Observed LoB [mg/L] | |--------------------|---------------------| | 0.2 | 0.0700 | #### 4.2.2. Limit of Detection (LoD) LoD of the Tina-quant® C-Reactive Protein IV assay was tested on 3 reagent lots. Five samples of low analyte level human serum were analyzed, each with 2 aliquots, on 1 Roche cobas c 501 analyzer, in 6 runs, over 3 days, for a total of N=60 determinations per lot. ### Table 5: LoD | Claimed LoD [mg/L] | Observed LoD [mg/L] | |--------------------|---------------------| | 0.3 | 0.137 | #### Limit of Quantitation (LoQ) 4.2.3. The LoQ of Tina-quant® C-Reactive Protein IV assay was tested on 3 reagent lots. Nine low concentration human serum samples (in the range from LoB up to approximately 2 times the specified LoQ) were analyzed on 1 Roche cobas c 501 analyzer, in 5 runs, with 5 aliquots of each sample for a total of N=25 determinations per sample per lot. ### Table 6: LoQ | Claimed LoQ [mg/L] | Observed LoQ [mg/L] | |--------------------|---------------------| | 3 | 0.313 | #### Linearity/Assay Reportable Range (CLSI EP06-A) 4.3. The dilution series was prepared from native unmodified human serum sample pools and then analyzed on using Tina-quant® C-Reactive Protein IV reagent. The dilution series was prepared resulting in 15 levels (including the high and low concentration pools). The diluted samples spanned the measuring range including a non-zero sample below the low end of measuring range and a sample over the high end of measuring range. Each dilution level was measured in triplicate (n ≥ 3). {11}------------------------------------------------ ### Table 7: Linearity | Sample type / | Linear Regression | Claimed Measuring Range | |---------------|------------------------------------------------------------------|-------------------------| | Serum | y=1.002x-0.0169 Pearson correlation coefficient (R)=0.9994 | 3 to 350 mg/L | #### 4.4. Endogenous Interference #### 4.4.1. L, H, and I Indices The effect on quantitation of Tina-quant® C-Reactive Protein IV in the presence of lipemia, hemolysis and bilirubin were determined at 2 levels, 5-10 mg/L and 35-100 mg/L c-reactive protein, utilizing a dilution set of the added interfering substances. Eleven level serial dilution sets were prepared. Each of the 11 interferent levels were measured in triplicate from low to high concentration. All dilution levels for each interferent were measured in 1 run. The mean concentration of the 3 replicates at each level was used to calculate recovery to the known creactive protein concentration. ### Table 8: Interference - L, H and I Indices | Interferent | Claim No interference up to | |-------------------|--------------------------------| | Lipemia | 1000 L Index | | Hemolysis | 1000 H Index | | Bilirubin | 60 I Index | | Ditauro Bilirubin | 60 I Index | #### Albumin, Immunoglobulin (IgG) and Rheumatoid Factors Interference 4.4.2. The effect on quantitation of Tina-quant® C-Reactive Protein IV in the presence of albumin, IgG and rheumatoid factors were determined at 2 levels, 5-10 mg/L and 35-100 mg/L c-reactive protein, utilizing a dilution set of the added interfering substances. Eleven level serial dilution sets were prepared. Each of the eleven interferent levels were measured in triplicate from low to high concentration. All dilution levels for each interferent were measured in 1 run. The median {12}------------------------------------------------ concentration of the 3 replicates at each level was used to calculate recovery to the known creactive protein concentration. | Interferent | Claim No interference up to | |-------------|--------------------------------| | Albumin | 60 g/L | | IgG | 50 g/L | | RF Factor | 1200 IU/mL | | Table 9: Interference - Albumin, Immunoglobulin (IgG) and Rheumatoid Factors | | | | | | |------------------------------------------------------------------------------|--|--|--|--|--| |------------------------------------------------------------------------------|--|--|--|--|--| #### 4.5. Exogenous Interferences - Drugs The effect on quantitation of Tina-quant® C-Reactive Protein IV in the presence of potentially interfering drugs were determined at 2 levels, 5-10 mg/L and 35-100 mg/L c-reactive protein. One portion of each pool was spiked with the respective amount of drug and the other portion of the pool with solvent used to dissolve the drug, which was used for the baseline reference creactive protein concentration. The c-reactive protein mean concentration of both portions was determined in N=5 results. The mean % Recovery was calculated when comparing the drug spiked portions to the c-reactive protein baseline reference mean concentration. | Drug | Tested Up To With No Interference (mg/L) | |----------------------|---------------------------------------------| | N-Acetylcysteine | 1660 | | Ampicillin-Na | 1000 | | Ascorbic acid | 300 | | Cefoxitin | 6600 | | Heparin | 5000 IU/L | | Levodopa | 20 | | Methyldopa + 1.5 | 22.5 | | Metronidazole | 200 | | Doxycyclin | 50 | | Acetylsalicylic acid | 1000 | | Rifampicin | 60 | | Ticarcillin | 225 | | Penicillamin | 24 | | | | Table 10: Exogenous Interference - Drugs | | |--|--|------------------------------------------|--| | | | | | {13}------------------------------------------------ | Phenylbutazone | 400 | |----------------|-----| | Cyclosporine | 5 | | Acetaminophen | 200 | | Ibuprofen | 500 | | Theophylline | 100 | #### Sample Matrix Comparison 4.6. The effect on quantitation of c-reactive protein in the presence of anticoagulants with the Tinaquant® C-Reactive Protein IV reagent was determined on the cobas c 501 analyzer by comparing values obtained from native samples (single donors) drawn into serum, Li-Heparin, K2- and K3-EDTA plasma primary tubes. Table 11: Sample Matrix Comparison | Anticoagulant | Linear Regression | Range Tested [mg/L] | |----------------------|---------------------------------|---------------------| | Serum vs. Li-Heparin | $y = 1.029x - 0.192, r = 0.999$ | 3.34 to 344 | | Serum vs. K2-EDTA | $y = 1.024x - 0.201, r = 0.999$ | 3.34 to 344 | | Serum vs. K3-EDTA | $y = 1.024x - 0.258, r = 0.999$ | 3.34 to 344 | #### Method Comparison to Predicate 4.7. A method comparison of the Tina-quant® C-Reactive Protein IV on the cobas c 501 analyzer versus the predicate device, Roche Diagnostics C-Reactive Protein Gen.3 was completed. One hundred ten native, unaltered serum samples, were tested in 1 run on 1 cobas c 501 analyzer in singlet using 1 lot of reagent. All samples were also testing for icteric, lipemic and hemolytic interference via analyzer serum indices. Statistics were created using Passing/Bablok and weighted Deming regression analysis. | | Passing/Bablok Regression | Weighted Deming Regression | |-----------------------|------------------------------|-------------------------------| | Slope | 0.985 | 0.979 | | Intercept | +0.278 | +0.296 | | Correlation (Pearson) | 0.999 | 0.999 | {14}------------------------------------------------ #### 4.8. Stability The stability studies and acceptance criteria have been reviewed and found to be acceptable. The stability data supports Roche Diagnostic's claims as reported on the package labeling. ### 5. FDA GUIDANCE FDA Guidance for Industry and FDA Staff: Review Criteria for Assessment of C-Reactive Protein (CRP), High Sensitivity C-Reactive Protein (hsCRP) and Cardiac C-Reactive Protein (cCRP) Assays was followed in this 510(k) submission. ### 6. ADDITIONAL INFORMATION Other Devices Required But Not Provided: - Calibrator f.a.s Proteins, k133330 ● - . Precinorm Protein, k133330 - . Precipath Protein, k133330 - . PreciControl ClinChem Multi 1, k133330 - . PreciControl ClinChem Multi 2, k133330 There have been no changes to these items marketed with the new Tina-quant® C-Reactive Protein IV.