What is the FDA product code for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

NQD. 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 CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

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

What are the predicate devices for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

Tina-quant® CRP (latex) HS Test System (K003400); Dade Behring N High Sensitivity CRP (K033908).

Who can help prepare an FDA 510(k) submission like TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

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 CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)

Q: Who is the manufacturer of TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)?

Roche Diagnostics Corp. filed the 510(k) submission for TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485).

K042485 · Roche Diagnostics Corp. · NQD · Oct 29, 2004 · Immunology

Device Facts

Record ID	K042485
Device Name	TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE)
Applicant	Roche Diagnostics Corp.
Product Code	NQD · Immunology
Decision Date	Oct 29, 2004
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5270
Device Class	Class 2

Intended Use

The Tina-quant® CRP (Latex) High Sensitive Immunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome.

Device Story

The Tina-quant CRP (Latex) HS is a latex particle-enhanced immunoturbidimetric assay used on Roche automated clinical chemistry analyzers. It measures C-reactive protein (CRP) levels in human serum or plasma samples. The device operates by measuring the turbidity resulting from the agglutination of latex particles coated with anti-CRP antibodies when exposed to CRP in the patient sample. The resulting optical signal is proportional to the CRP concentration. Used in clinical laboratory settings by trained technicians, the output is a quantitative CRP value (mg/L). Healthcare providers use these results to evaluate inflammatory states, assess cardiovascular disease risk, and provide prognostic information for patients with acute coronary syndromes. The device benefits patients by providing high-sensitivity CRP measurements that assist in clinical decision-making regarding cardiovascular risk and disease management.

Clinical Evidence

No new clinical studies performed. Evidence relies on analytical equivalence to the predicate device (k003400) and an analytical bridge to the Dade Behring N High Sensitivity CRP (k033908), which previously established clinical utility for cardiovascular risk assessment. Supporting literature provided.

Technological Characteristics

Particle-enhanced immunoturbidimetric assay. Reagents: buffer (R1) and anti-CRP antibody-latex microparticles (R2). Analyzers: Roche/Hitachi 904, 911, 912, 917, MOD P. Quantitative measurement of CRP antigen-antibody complex agglutination via turbidity.

Indications for Use

Indicated for in vitro quantitative determination of CRP in human serum and plasma to detect/evaluate inflammatory disorders, infection, and tissue injury. Also indicated as an aid in assessing future coronary heart disease risk and as an independent prognostic indicator for recurrent events in patients with stable coronary disease or acute coronary syndromes.

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® CRP (latex) HS Test System (K003400)
Dade Behring N High Sensitivity CRP (K033908)

Related Devices

K083444 — C-REACTIVE PROTEIN (LATEX) · Roche Diagnostics Corp. · Mar 18, 2009
K180099 — Optilite High Sensitivity C-Reactive Protein Kit · The Binding Site Group , Ltd. · Oct 12, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ K042485 OCT 2 9 2004 | 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 Road Indianapolis, IN 46250 317-521-3723 | | | Contact Person: Theresa M. Ambrose | | | Date Prepared: September 9, 2004 | | Device Name | Proprietary name: Tina-Quant CRP (Latex) HS Test System (C-reactive protein (latex) high sensitive) | | | Common name: hsCRP test system | | | Classification name: Cardiac C-reactive Protein, Antigen, Antiserum, and Control | | Predicate device | The Tina-quant® CRP (latex) HS Test System is substantially equivalent to the currently marketed Roche Tina-quant® CRP (latex) HS Test System cleared under K003400. For purposes of the extended intended use, we claim equivalence to the currently marketed Dade Behring N High Sensitivity CRP (K033908) | | Device Description | The Tina-quant® CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the measurement of C-reactive protein in human serum or plasma. | {1}------------------------------------------------ ## 510(k) Summary, Continued Intended use The Tina-quant® CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome. The below table compares Tina-Quant® CRP (Latex) HS with the predicate Comparison to predicate device devices, Tina-Quant® CRP (Latex) HS (K003400), and Dade-Behring N High Sensitivity CRP (K033908). {2}------------------------------------------------ 510(k) Summary, Continue Substantial equivalence, comparison table. | Substantial equivalence: comparison table Characteristic | Tina-Quant® CRP (Latex) HS (modified intended use) | Predicate device Tina-Quant® CRP (Latex) HS (K003400) | Predicate device Dade-Behring N High Sensitivity CRP (K033908) | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------| | Intended Use | The Tina-quant® CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Highly sensitive measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome. | Immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on automated clinical chemistry analyzers. | N High Sensitivity CRP is an in vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle-enhanced immunonephelometry using BN Systems. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes | | | Characteristic | Indications for Use | Predicate device Tina-Quant® CRP (Latex) HS (modified intended use) | Predicate device Tina-Quant® CRP (Latex) HS (K003400) | Predicate device Dade-Behring N High Sensitivity CRP (K033908) | | Indications for Use | Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome. | For the quantitative determination of C-reactive protein in human serum and plasma. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. | In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, are observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders, and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes | | | Assay principle | Same as K003400 | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection | | | Instrument | Same as K003400 | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nepholometric systems) | | | Reagent Stability | | | | | | Same as K003400 | | Unopened kit: up to the stated expiration date at 2-8 °C On board the analyzer (opened and refrigerated): 90 days | Unopened kit: up to the stated expiration date at 2-8 °C Opened: 4 weeks at stored in closed vial. Do not freeze | | | Sample type | Same as K003400 | Human serum and plasma | Human serum, and heparin and EDTA plasma | | | Traceability/ standardization | Same as both predicates | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | | | Measuring range | Same as K003400 | 0.1 – 20 mg/l without dilution 0.1 -300 mg/l extended range with dilution and rerun | 0.175 – 1100 mg/L with dilution | | | Lower Detection Limit | Same as K003400 | 0.03 mg/L | 0.175 mg/L | | | Within-run precision (%CV) | Same as K003400 | Control material 0.43% at 4.27 mg/L 0.41% at 11.62 mg/L Human serum 1.34% at 0.55 mg/L 0.28% at 12.36 mg/L | 2.5% at 0.5 mg/L 3.8% at 1.3 mg/L 2.1% at 2.1 mg/L 2.6% at 14 mg/L 3.9% at 24 mg/L 5.7% at 56 mg/L | | | Between-run precision (%CV) | Same as K003400 | Control material 2.70% at 4.34 mg/L 3.45% at 11.90 mg/L Human serum 5.70% at 0.52 mg/L 2.51% at 10.98 mg/L | 3.1% at 0.5 mg/L 3.8% at 1.1 mg/L 3.4% at 2.1 mg/L 4.0% at 15 mg/L 2.3% at 26 mg/L 4.4% at 62 mg/L | | | Functional Sensitivity (CV < 10%) | Same as K003400 | 0.11 mg/L | Not available. | | | Limitations: interferences | | Limitations: Result Interpretation | Expected values | | | Same as K003400 | No interference from Bilirubin up to 230 mg/L Hemoglobin up to 36 g/L Triglycerides up to 7.4 g/L Highly lipemic samples that cannot be clarified by centrifugation (10 min at 15000 X G) must not be tested. | Same as K003400 | Same as both predicates (both sets of information are provided) | | | No significant interference up to I index of 60 (60 mg/dL bilirubin) H index of 1000 (1000 mg/dL hemoglobin) L index of 1000 at CRP > 5mg/L (lipemia; intralipid) L index of 800 at CRP > 4mg/L L index of 500 at CRP > 2 mg/L Rheumatoid factors < 1200 IU/mL | Particles that are formed in incompletely clotted serum or plasma or due to protein denaturation must be removed by centrifugation prior to testing. | Increases in CRP values are non- specific and should not be interpreted without a complete clinical history. When using CRP to assess the risk of coronary heart disease results should be compared to previous values. For diagnostic purposes, results should always be assessed in conjunction with the patient's medical history and other findings. | Adults: < 5.0 mg/L Neonates 0-3 weeks: 0.1 – 4.1 mg/L Children (2 months-15 years) 0.1 – 2.8 mg/L | | | | No high dose hook effect up to 1000 mg/L In rare cases, gammopathy, in particular IgM Waldenstrom's macroglobinemia may cause unreliable results | | Relative risk/average hsCRP: Low < 1 mg/L Average 1.0-3.0 mg/L High >3.0 mg/L | | Continued on next page 28 {3}------------------------------------------------ 510(k) Summary, Continued Predicate device (continued {4}------------------------------------------------ 30 : {5}------------------------------------------------ : 31 {6}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white. Public Health Service ## OCT 2 9 2004 Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Theresa M. Ambrose, Ph.D., DABCC, FACB, RAC Regulatory Principal Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250 Re: k042485 > Trade/Device Name: Tina-Ouant® CRP (Latex) HS Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: September 10, 2004 Received: September 13, 2004 Dear Dr. Ambrose: 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). {7}------------------------------------------------ Page 2 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 (301) 594-3084. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Jean M. Cooper, US, DVM. Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ ## Indications for Use 510(k) Number (if known): N/A K042485 510(k) Number (if known): N/A Device Name: Tina-Quant® CRP (Latex) HS Indications For Use: The Tina-quant® CRP (Latex) High Sensitive Immmunoturbidimetric assay is for the in vitro quantitative determination of C-reactive protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of CRP is of use for the detection and evaluation of inflammatory disorders and associated diseases, infection and tissue injury. Highly sensitive measurement of CRP may also be used as an aid in the assessment of the risk of future coronary heart disease. When used as an adjunct to other laboratory evaluation methods of acute coronary syndromes, it may also be an additional independent indicator of recurrent event prognosis in patients with stable coronary disease or acute coronary syndrome. 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) Page 1 of Carol Benson **Division Sign-Off** of in Vitro Diaar 510(k). K02485 24