ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)

K181082 · Siemens Healthcare Diagnostics, Inc. · NDY · May 25, 2018 · Clinical Chemistry

Device Facts

• Record ID: K181082
• Device Name: ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: NDY · Clinical Chemistry
• Decision Date: May 25, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

The ADVIA® Chemistry Cystatin C 2 (CYSC 2) assay is for the in vitro diagnostic use in the quantitative determination of cystatin C in human serum and plasma (lithium heparin, potassium EDTA) on ADVIA Chemistry systems. Measurement of cystatin C aids in the diagnosis and treatment of renal disease.

Device Story

The ADVIA Chemistry Cystatin C 2 (CYSC 2) assay is an in vitro diagnostic kit for quantitative cystatin C measurement in human serum and plasma. The device uses particle-enhanced turbidimetry; latex particles coated with anti-cystatin-C antibodies agglutinate in the presence of cystatin C, increasing sample turbidity. Turbidity is measured at 571 and 805 nm on ADVIA Chemistry systems. Concentration is determined via a 5-level calibration curve. Used in clinical laboratories by technicians to assist physicians in diagnosing and treating renal disease; results are interpreted alongside other clinical and laboratory findings.

Clinical Evidence

Bench testing only. Method comparison study (n=158) against the predicate showed high correlation (r=1.000) with Passing-Bablok slope 1.008 and intercept 0.101 mg/L. Precision testing (n=80 replicates) demonstrated repeatability CVs of 0.9-2.0% and within-lab CVs of 1.2-3.7%. Linearity confirmed across 0.25-8.93 mg/L range. LoB/LoD/LoQ established at 0.10 mg/L, 0.25 mg/L, and 0.25 mg/L respectively. Interference testing showed no significant interference from bilirubin, lipemia, hemolysis, or rheumatoid factor.

Technological Characteristics

Particle-enhanced turbidimetry assay. Reagents consist of latex particles coated with rabbit anti-cystatin-C antibodies. Measures turbidity at 571 and 805 nm. Calibrators are traceable to IFCC ERM-DA471/IFCC. Compatible with ADVIA Chemistry systems. Measuring range 0.25-8.93 mg/L (up to 26.79 mg/L with dilution).

Indications for Use

Indicated for the quantitative determination of cystatin C in human serum and plasma (lithium heparin, potassium EDTA) to aid in the diagnosis and treatment of renal disease.

Regulatory Classification

Identification

A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k181082

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.