N Latex Cystatin C; N Protein Standard UY

K171072 · Siemens Healthcare Diagnostics Products GmbH · NDY · May 12, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171072
• Device Name: N Latex Cystatin C; N Protein Standard UY
• Applicant: Siemens Healthcare Diagnostics Products GmbH
• Product Code: NDY · Clinical Chemistry
• Decision Date: May 12, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Indications for Use

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 is used for preparing reference curves for the immunonephelometric determination of α1-microglobulin and Cystatin C using the BN Systems.

Device Story

Device is an in vitro diagnostic kit for quantitative cystatin C measurement in human serum/plasma. Principle: particle-enhanced immunonephelometry. Polystyrene particles coated with anti-human cystatin C antibodies aggregate when mixed with patient samples; aggregates scatter light; scattered light intensity is proportional to cystatin C concentration. Used on BN II and BN ProSpec systems in clinical laboratories by trained technicians. Output is a concentration value (mg/L) compared against a reference curve established by N Protein Standard UY. Healthcare providers use results to assess renal function and guide treatment decisions. Benefits include standardized, accurate monitoring of renal disease status.

Clinical Evidence

Bench testing only. Precision studies (n=80 per sample) showed repeatability CVs 1.00-3.85% and within-lab CVs 1.01-3.85%. Linearity confirmed 0.27-10.3 mg/L; LoQ 0.08 mg/L. No high-dose hook effect up to 42.91 mg/L. Method comparison (n=186) against predicate showed high correlation (r=0.988-0.998) and Passing-Bablok regression slopes of 0.981-0.982. Reference interval study (n=203) established range 0.49-1.19 mg/L.

Technological Characteristics

Reagents: polystyrene particles coated with rabbit anti-human cystatin C antibodies. Measurement: particle-enhanced immunonephelometry. Energy: light scattering. Connectivity: BN II and BN ProSpec systems. Calibrator: N Protein Standard UY (lyophilized polygeline with human proteins). Traceability: ERM-DA471/IFCC. Software: embedded system control for nephelometric analysis.

Indications for Use

Indicated for quantitative determination of cystatin C in human serum and lithium-heparinized plasma to aid in the diagnosis and treatment of renal diseases in adult patients.

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) #: k171072

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.