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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.

Device Description

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.

AI/ML Overview

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 5mg/L), Rheumatoid factors

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