(48 days)
The 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 CRP (latex) HS Test System is a latex particle-enhanced immunoturbidimetric test for the quantitative measurement of C-reactive protein in human serum or plasma. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically. The calibrator is the Calibrator for automated systems (C.f.a.s). Proteins; and the recommended control materials are CRP T Control N and Precinorm Protein.
Here's a breakdown of the acceptance criteria and study information for the C-Reactive Protein (Latex) High Sensitive Test System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary presents a comparison study to predicate devices rather than explicit acceptance criteria with pre-defined thresholds. The device aims to demonstrate "substantial equivalence" to the predicate devices. Therefore, the "acceptance criteria" here are implied to be performance characteristics that are comparable to or better than the predicate devices.
| Characteristic | Predicate Device (Tina-Quant® CRP (Latex) HS (K042485)) Reported Performance | Predicate Device (Dade-Behring N High Sensitivity CRP (K033908)) Reported Performance | New Device (CRP (Latex) HS for COBAS Integra instruments) Reported Performance | Implied Acceptance Criteria (Demonstrate equivalence/comparability) |
|---|---|---|---|---|
| Intended Use | Quantitative determination of CRP in human serum/plasma for inflammatory/infection/tissue injury, and aid in CHD risk assessment. | Quantitative determination of CRP in human serum/heparin/EDTA plasma using immunonephelometry for infection/tissue injury/inflammatory disorders, and aid in CVD risk assessment. Also independent marker for recurrent events in stable CAD or ACS. | Same as K042485 | Same intended use as predicate devices. |
| Assay Principle | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection | Same as K042485 (Latex particle-enhanced immunoturbidimetric test) | Consistent assay principle with a predicate (K042485 in this case). |
| Instrument | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nephelometric systems) | COBAS Integra family of analyzers (Integra 400/ 700/ 800) | Compatible with specified COBAS Integra instruments. |
| Reagent Stability | Unopened: up to expiration date at 2-8 °C. On board: 90 days. | Unopened: up to expiration date at 2-8 °C. Opened: 4 weeks in closed vial. | Unopened: up to expiration date at 2-8 °C. On board: 12 weeks. | Comparable or improved reagent stability. |
| Reagent Composition | R1: TRIS buffer, BSA, immunoglobulins (mouse), preservative, stabilizers. R2: Latex particles coated with anti-CRP (mouse) in glycine buffer, preservatives, stabilizers. | Suspension of polystyrene particles coated with mouse monoclonal antibodies to CRP; preservatives. | Same active ingredients and antibody as K042485 | Similar reagent components to a predicate. |
| Sample Type | Human serum and plasma | Human serum, and heparin and EDTA plasma | Same as K042485 (Human serum and plasma) | Compatible with human serum and plasma. |
| Traceability/Standardization | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | Standardized to Tina-Quant® CRP (Latex) HS which is standardized to reference prep CRM 470 (RPPHS 91/0619) | Standardized to recognized reference material. |
| Measuring Range | 0.1 – 20 mg/L without dilution. 0.1 – 300 mg/L with dilution and rerun. | 0.175 – 1100 mg/L with dilution | 0-20 mg/L without dilution. 0-300 mg/L with postdilution. | Comparable or improved measuring range. |
| Lower Detection Limit | 0.03 mg/L | 0.175 mg/L | 0.1 mg/L | Comparable or improved lower detection limit. |
| Within-run Precision (%CV) | Control: 0.43% at 4.27 mg/L, 0.41% at 11.62 mg/L. Serum: 1.34% at 0.55 mg/L, 0.28% at 12.36 mg/L. | Control: 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. | Control: 0.9% at 3.3 mg/L, 0.7% at 8.0 mg/L. Serum: 1.3% at 1.6 mg/L, 0.6% at 11.4 mg/L. | Comparable or improved within-run precision. |
| Between-run Precision (%CV) | Control: 2.70% at 4.34 mg/L, 3.45% at 11.90 mg/L. Serum: 5.70% at 0.52 mg/L, 2.51% at 10.98 mg/L. | Control: 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. | Control: 3.5% at 3.3 mg/L, 2.2% at 8.0 mg/L. Serum: 3.1% at 1.5 mg/L, 2.3% at 11.4 mg/L. | Comparable or improved between-run precision. |
| Functional Sensitivity (CV <10%) | 0.11 mg/L | Not available. | 0.3 mg/L | Comparable functional sensitivity. |
| Limitations: Interferences | Bilirubin (I index 60), Hemoglobin (H index 1000), Lipemia (L index 1000 at CRP > 5mg/L), Rheumatoid factors < 1200 IU/mL, no high dose hook effect up to 1000 mg/L. Rare cases of gammopathy. | Bilirubin up to 230 mg/L, Hemoglobin up to 36 g/L, Triglycerides up to 7.4 g/L. No highly lipemic samples that cannot be clarified. | Bilirubin 10 g/L, Hemoglobin 0.6 g/L, Triglyceride 5 g/L at 2 mg/L CRP, Rheumatoid factors < 1200 IU/mL. No high dose hook effect up to 1000 mg/L CRP. Rare cases of monoclonal gammopathy. Erroneous results may be obtained in samples from patients treated with monoclonal mouse. | Similar or improved interference profiles to predicate devices. |
| Method Comparison | (Predicate vs. Predicate) | (Predicate vs. Predicate) | y = Integra CRP (Latex) hs vs. x = Tina-Quant® CRP (latex) hs. Passing-Bablok results: y=1.0548x + 0.0424. T = 0.956; r = 0.996. | Strong correlation and close agreement with predicate device (Tina-Quant®). |
Study Proving Device Meets Acceptance Criteria:
The study conducted is a method comparison study with a focus on analytical validation experiments.
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Description of Study: The submission states that "analytical validation experiments were performed in order to establish the performance characteristics" and that "method comparison was performed between this method and the predicate device." The primary predicate for comparison was the Roche Tina-quant® CRP (latex) HS Test System (K042485) and for cardiac risk assessment, the Dade Behring N High Sensitivity CRP (K033908).
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Key Findings: The new device (CRP (Latex) HS for COBAS Integra instruments) demonstrated:
- Substantially equivalent intended use, assay principle, reagent composition, sample type, and traceability/standardization to the Tina-Quant® predicate device.
- Comparable or improved performance characteristics in terms of measuring range, lower detection limit, precision (within-run and between-run), and non-interference levels compared to the predicate devices.
- A strong correlation in a method comparison against the Tina-Quant® CRP (latex) HS predicate, with Passing-Bablok results showing
y = 1.0548x + 0.0424,T = 0.956, andr = 0.996. This indicates excellent agreement and substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact number of individual patient samples used in the method comparison and analytical validation studies is not explicitly stated in the provided summary. However, for precision studies, control materials and human serum samples were used.
- Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. It is implied to be laboratory-based analytical validation data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The ground truth for this type of in vitro diagnostic device (quantitative measurement of C-reactive protein) is established by the measured values from the predicate device(s) or recognized reference materials/methods, not through expert visual interpretation. Therefore, a specific number of experts for ground truth establishment is not applicable in the context of this 510(k) summary. The comparison is against established commercial assays.
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth is based on quantitative measurements from predicate devices/reference methods, an adjudication method for reconciling expert opinions is not relevant.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No. This is an in-vitro diagnostic device for quantitative measurement, not an imaging device or a diagnostic aid requiring human interpretation of cases. Therefore, an MRMC study is not relevant or performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Yes, implicitly. The device is a fully automated test system (immunoturbidimetric assay on automated clinical chemistry analyzers). Its performance characteristics (precision, measuring range, detection limit, interference) and method comparison results are indicative of its standalone performance without human intervention in the measurement process itself. Human involvement is limited to sample loading, result interpretation in a clinical context, and maintenance, not in the determination of the CRP value by the device.
7. The Type of Ground Truth Used
- The ground truth is established by quantitative measurements obtained from legally marketed predicate devices (Roche Tina-quant® CRP (latex) HS (K042485) and Dade Behring N High Sensitivity CRP (K033908)), which are themselves standardized to international reference preparation CRM 470 (RPPHS 91/0619).
8. The Sample Size for the Training Set
- The document describes a 510(k) submission for a new device, which focuses on demonstrating substantial equivalence to pre-existing predicate devices. It does not explicitly mention a "training set" in the context of machine learning. For an IVD like this, development typically involves internal analytical studies, not a "training set" in the AI sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As noted above, the concept of a "training set" for AI models is not directly relevant to this type of IVD device submission, which relies on analytical performance validation against established methods and standards.
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K 053603
FEB 9 2006
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| Submittername, address,contact | Roche Diagnostics9115 Hague RoadIndianapolis, IN 46250317-521-3723 |
| Contact Person: Theresa M. AmbroseDate Prepared: January 18, 2006 | |
| Device Name | Proprietary name: C-Reactive Protein (Latex) High Sensitive test system forCOBAS Integra instruments [CRP (latex) HS]Common name: hsCRP test system |
| Classification name: Cardiac C-reactive Protein, Antigen, Antiserum, andControl | |
| Predicatedevices | The CRP (latex) HS Test System for COBAS Integra instruments issubstantially equivalent to the currently marketed Roche Tina-quant® CRP(latex) HS Test System cleared under K042485. For purposes of cardiac riskassessment, the CRP (latex) HS system is also equivalent to the Dade BehringN High Sensitivity CRP (K033908) |
| DeviceDescription | The CRP (latex) HS Test System is a latex particle-enhancedimmunoturbidimetric test for the quantitative measurement of C-reactiveprotein in human serum or plasma. Human CRP agglutinates with latexparticles coated with monoclonal anti-CRP antibodies. The precipitate isdetermined turbidimetrically. The calibrator is the Calibrator for automatedsystems (C.f.a.s). Proteins; and the recommended control materials are CRP TControl N and Precinorm Protein. |
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510(k) Summary, Continued
| Intended use | The 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. |
|---|---|
| Comparison to predicate device | The below table compares the CRP (Latex) HS for COBAS Integra instruments with the predicate device, Tina-Quant® CRP (Latex) HS (K042485) |
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510(k) Summary, Continued
Substantial eq
| Substantial equivalence: comparison table | |||
|---|---|---|---|
| Characteristic | CRP (Latex) HS for COBASIntegra instruments | Predicate deviceTina-Quant® CRP (Latex) HS(K042485) | Predicate device |
| Intended Use/Indications forUse | Same as K042485 | The Tina-quant® CRP (Latex) HighSensitive Immmunoturbidimetric assay isfor the in vitro quantitative determinationof C-reactive protein (CRP) in humanserum and plasma on Roche automatedclinical chemistry analyzers. Highlysensitive measurement of CRP is of usefor the detection and evaluation ofinflammatory disorders and associateddiseases, infection and tissue injury.Measurement of CRP may also be usedas an aid in the assessment of the risk offuture coronary heart disease. When usedas an adjunct to other laboratoryevaluation methods of acute coronarysyndromes, it may also be an additionalindependent indicator of recurrent eventprognosis in patients with stablecoronary disease or acute coronarysyndrome.. | N High Sensitivity CRP is an in vitrodiagnostic reagent for the quantitativedetermination of C-reactive protein(CRP) in human serum, and heparin andEDTA plasma by means of particle-enhanced immunonephelometry usingBN Systems. In acute phase response,increased levels of a number of plasmaproteins, including C-reactive protein,are observed. Measurement of CRP isuseful for the detection and evaluation ofinfection, tissue injury, inflammatorydisorders, and associated diseases.Measurements may also be used as an aidin the identification of individuals at riskfor future cardiovascular disease. Highsensitivity CRP (hsCRP) measurements,when used in conjunction with traditionalclinical laboratory evaluation of acutecoronary syndromes, may be useful as anindependent marker of prognosis forrecurrent events, in patients with stablecoronary disease or acute coronarysyndromes |
| Characteristic | CRP (Latex) HS for COBAS Integra instruments | Predicate deviceTina-Quant® CRP (Latex) HS (K042485) | Predicate deviceDade-Behring N High Sensitivity CRP (K033908) |
| Assay principle | Same as K042485 | Latex particle-enhanced immunoturbidimetric test | Particle-enhanced agglutination with nephelometric detection |
| Instrument | COBAS Integra family of analyzers (Integra 400/ 700/ 800) | Roche/Hitachi family of analyzers | Dade-Behring BN Systems (nepholometric systems) |
| ReagentStability | Unopened kit: up to the stated expiration date at 2-8 °C On board the analyzer (opened and refrigerated): 12 weeks | 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 |
| Reagentcomposition | Same active ingredients and antibody as K042485 | R1: TRIS buffer with bovine serum albumin, immunoglobulins (mouse), preservative, stabilizersR2: Latex particles coated with anti-CRP (mouse) in glycine buffer; preservatives; stabilizers | Suspension of polystyrene particles coated with mouse monoclonal antibodies to CRP; preservatives |
| Sample type | Same as K042485 | Human serum and plasma | Human serum, and heparin and EDTA plasma |
| Traceability/standardization | Standardized to Tina-Quant® CRP (Latex) HS which is standardized to reference preparation CRM 470 (RPPHS 91/0619) (same as both predicates) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) | IFCC/BCR/CAP reference preparation CRM 470 (RPPHS 91/0619) |
| Characteristic | CRP (Latex) HS for COBASIntegra instruments | Predicate deviceTina-Quant® CRP (Latex) HS(K042485) | Predicate deviceDade-Behring N High SensitivityCRP (K033908) |
| Measuringrange | 0-20 mg/L without dilution0-300 mg/L with postdilution | 0.1 – 20 mg/L without dilution0.1 – 300 mg/L extended range withdilution and rerun | 0.175 – 1100 mg/L with dilution |
| LowerDetection Limit | 0.1 mg/L | 0.03 mg/L | 0.175 mg/L |
| Within-runprecision(%CV) | Control material• 0.9% at 3.3 mg/L• 0.7% at 8.0 mg/LHuman serum• 1.3% at 1.6 mg/L• 0.6% at 11.4 mg/L | Control material• 0.43% at 4.27 mg/L• 0.41% at 11.62 mg/LHuman serum• 1.34% at 0.55 mg/L• 0.28% at 12.36 mg/L | Control material• 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-runprecision(%CV) | Control material• 3.5% at 3.3 mg/L• 2.2% at 8.0 mg/LHuman serum• 3.1% at 1.5 mg/L• 2.3% at 11.4 mg/L | Control material• 2.70% at 4.34 mg/L• 3.45% at 11.90 mg/LHuman serum• 5.70% at 0.52 mg/L• 2.51% at 10.98 mg/L | Control material• 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 |
| Characteristic | CRP (Latex) HS for COBAS Integra instruments | Predicate device Tina-Quant® CRP (Latex) HS (K042485) | Predicate device Dade-Behring N High Sensitivity CRP (K033908) |
| Functional Sensitivity (CV <10%) | 0.3 mg/L | 0.11 mg/L | Not available. |
| Limitations: interferences | No significant interference up to:• 10 g/L bilirubin• 0.6 g/L hemoglobin• 5 g/L triglyceride at 2 mg/L CRP• Rheumatoid factors < 1200 IU/mL | 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 | No interference from:• Bilirubin up to 230 mg/L• Hemoglobin up to 36 g/L• Triglycerides up to 7.4 g/LHighly lipemic samples that cannot be clarified by centrifugation (10 min at 15000 X G) must not be tested. |
| No high dose hook effect up to 1000 mg/L CRP | No high dose hook effect up to 1000 mg/L | Particles that are formed in incompletely clotted serum or plasma or due to protein denaturation must be removed by centrifugation prior to testing. | |
| In rare cases, monoclonal gammopathy may lead to false CRP values. | In rare cases, gammopathy, in particular IgM Waldenstrom's macroglobinemia may cause unreliable results | ||
| Erroneous results may be obtained in samples taked from patients who have been treated with monoclonoal mouse | |||
| Predicate devices (continued) | |||
| Characteristic | Predicate deviceCRP (Latex) HS for COBASIntegra instruments | Predicate deviceTina-Quant® CRP (Latex) HS(K042485) | Predicate deviceDade-Behring N High SensitivityCRP (K033908) |
| Result Interpretation | Same as K042485 | For diagnostic purposes, results shouldalways be assessed in conjunction withthe patient's medical history and otherfindings.Increases in CRP values are non-specific and should not be interpretedwithout a complete clinical history.When using CRP to assess the risk ofcoronary heart disease, measurementsshould be made on metabolically stablepatients and compared to previousvalues. Optimally, the average ofhsCRP results repeated two weeksapart should be used for riskassessment. Measurements should becompared to previous values. For riskassessment persistently unexplainedvalues about 10 mg/L should beevaluated for non-cardiovascularorigins. Testing for risk assessmentshould not be performed while there isindications of infection, systemicinflammation, or trauma | Increases in CRP values are non-specific and should not be interpretedwithout a complete clinical history. |
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510(k) Summary, Continued
Predicate devices (continued
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510(k) Summary, Continued, Continue
Predicate devices (continued
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510(k) Summary, Continued, Continue
Predicate devices (continued
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510(k) Summary, Continued, Continue
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| Continued1400 |
|---|
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| 1110 11 244-48 11-12-15 |
| 11510 |
redicate devices (continue
| Characteristic | CRP (Latex) HS for COBASIntegra instruments | Predicate deviceTina-Quant® CRP (Latex) HS(K042485) | Predicate deviceDade-Behring N High SensitivityCRP (K033908) |
|---|---|---|---|
| Expected values | Same as K042485 | Adults: < 5.0 mg/LNeonates 0-3 weeks: 0.1 – 4.1 mg/LChildren (2 months-15 years) 0.1 – 2.8 mg/L | Relative risk/average hsCRP:Low < 1 mg/LAverage 1.0-3.0 mg/LHigh >3.0 mg/L |
| For CVD risk assessment: relative riskLow < 1 mg/LAverage 1.0-3.0 mg/LHigh >3.0 mg/L | |||
| Comparison | y = Integra CRP (Latex) hsx = Tina-Quant® CRP (latex) hs | y= Integra CRP (latex) hsx= Dade-Behring N High Sensitivity CRP | |
| Passing-Bablok results: y=1.0548x + 0.0424. T = 0.956; r = 0.996 |
he new test system has imilar interferes, comparable standards and alibrators, an
comparable in absolute values, which are cleared for indications including cariat
sk assess nalytical validation experiments were performed in order to establish the performance characteristics
ethod comparison was performed between this method and the predicate dev Performance
evaluation
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
Ms. Theresa M. Ambrose Regulatory Principal Roche Diagnostics Corporation 9115 Hague Rd. Indianapolis, IN 46250
FEB & 2006
Re: K053603
Trade/Device Name: C-Reactive Protein (Latex) High Sensitive Test System For Cobas Integra Instruments Regulation Number: 21 CFR8866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD Dated: December 22, 2005
Received: December 23, 2005
Dear Ms. 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 (OS) regulation (21 CFR Part 820).
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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 (240) 276-0484. 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/industry/support/index.html.
Sincerely yours,
Alberto Gutierrez
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053603
Device Name: C-Reactive Protein (Latex) High Sensitive Test System For Cobas Integra Instruments
Indications For Use:
The 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 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)
Ann Chappell
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of 1
510(k)_ lc 053603
§ 866.5270 C-reactive protein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).