DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE

K133728 · Siemens Healthcare Diagnostics, Inc. · CGX · Jan 24, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133728
• Device Name: DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CGX · Clinical Chemistry
• Decision Date: Jan 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1225
• Device Class: Class 2

Intended Use

The CRE2 method is an in vitro diagnostic test for the quantitative measurement of creatinine in human serum, plasma, and urine on the Dimension Vista® System. Creatinine measurements are used in the diagnosis and treatment of certain renal disease, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

Device Story

The Dimension Vista® Creatinine (CRE2) Flex® reagent cartridge is an in vitro diagnostic test used on the Dimension Vista® System. It utilizes a modified kinetic Jaffe technique where creatinine reacts with picrate in a strong base (sodium hydroxide) to form a red chromophore. The system measures the rate of increasing absorbance at 510 nm (bichromatic 510/577 nm) to determine creatinine concentration. The device is intended for use in clinical laboratory settings by trained technicians. The system provides quantitative results that assist healthcare providers in diagnosing and treating renal disease and monitoring dialysis. It also supports autodilution protocols for samples exceeding the measuring range (up to 40 mg/dL for serum/plasma and 900 mg/dL for urine).

Clinical Evidence

Bench testing only. Method comparison study (n=140 serum, n=112 urine) against the predicate showed good agreement (serum slope 1.02, r=1.000; urine slope 1.05, r=0.999). Comparison against IDMS reference method (n=48 serum) showed slope 1.06, r=0.997. Precision testing (CLSI EP05-A2) over 20 days demonstrated within-lab CVs ranging from 0.7% to 4.0%. LoB/LoD/LoQ were established per CLSI EP17-A2. Interference testing (CLSI EP07-A2) evaluated various substances; bias >10% was observed for specific concentrations of acetone, cefoxitin, cephalothin, glucose, pyruvate, triglycerides, and HIL components.

Technological Characteristics

Modified kinetic Jaffe technique; photometric detection (bichromatic 510/577 nm). Reagents: Lithium Picrate (125 mM) and Sodium Hydroxide (1000 mM). Form factor: Prepackaged Flex® reagent cartridge for automated clinical chemistry system. Traceability: NIST SRM 914a (IDMS). Connectivity: Integrated with Dimension Vista® System.

Indications for Use

Indicated for quantitative measurement of creatinine in human serum, plasma, and urine for diagnosis and treatment of renal disease, monitoring renal dialysis, and as a calculation basis for other urine analytes.

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) #: k133728

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.