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N Latex Cystatin C: N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and lithium-heparinized plasma by means of particle-enhanced immunonephelometry using the BN Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. N Protein Standard UY: N Protein Standard UY is used for preparing reference curves for the immunonephelometric determination of a1microglobulin and Cystatin C using the BN Systems.

The N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and lithium heparinized plasma by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec® Systems. Used in conjunction with other clinical and laboratory findings, N Latex Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. Used in conjunction with the assay reagents, N Protein Standard UY is for use in the establishment of reference curves for the determination of cystatin C on the BN II and BN ProSpec Systems. N Cystatin C Control 1 and 2 are included with N Latex Cystatin C kit and are for use as assayed accuracy controls and precision controls in the determination of cystatin C by immunonephelometry with the BN II and BN ProSpec Systems. The N Latex Cystatin C test system is based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Acceptance Criteria and Device Performance for N Latex Cystatin C

This document summarizes the acceptance criteria and performance study results for the N Latex Cystatin C device, as described in the provided FDA 510(k) summary (K171072).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details performance studies but does not explicitly define a "table of acceptance criteria". Instead, it describes established methodologies and states that "Results met the pre-established acceptance criteria." for the method comparison study. Based on the reported data, the following can be inferred as performance metrics that met the sponsor's internal acceptance criteria for substantial equivalence:

• CysC Control 1: Repeatability CV 1.78%, Within-device/lab CV 1.78%
• CysC Control 2: Repeatability CV 1.00%, Within-device/lab CV 1.01%
• Serum Pool 1: Repeatability CV 3.85%, Within-device/lab CV 3.85%
• Serum Pool 2: Repeatability CV 1.39%, Within-device/lab CV 1.41%
• Serum Pool 3: Repeatability CV 1.62%, Within-device/lab CV 1.62%
• Plasma Pool 1: Repeatability CV 2.38%, Within-device/lab CV 2.65%
• Plasma Pool 2: Repeatability CV 2.09%, Within-device/lab CV 2.09%
• Plasma Pool 3: Repeatability CV 1.07%, Within-device/lab CV 1.26%

BN II:

• CysC Control 1: Repeatability CV 1.93%, Within-device/lab CV 2.24%
• CysC Control 2: Repeatability CV 1.42%, Within-device/lab CV 1.54%
• Serum Pool 1: Repeatability CV 2.54%, Within-device/lab CV 2.62%
• Serum Pool 2: Repeatability CV 1.34%, Within-device/lab CV 1.55%
• Serum Pool 3: Repeatability CV 1.69%, Within-device/lab CV 1.80%
• Plasma Pool 1: Repeatability CV 2.59%, Within-device/lab CV 2.59%
• Plasma Pool 2: Repeatability CV 1.62%, Within-device/lab CV 1.75%
• Plasma Pool 3: Repeatability CV 1.98%, Within-device/lab CV 2.42% |
  | Measuring Range (Linearity) | Acceptable linearity over the specified range. | Demonstrated linearity over the range of 0.27 to 10.3 mg/L. |
  | Limit of Quantitation (LoQ) | LoQ at a specified %CV (e.g.,

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