DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR

K121907 · Siemens Healthcare Diagnostics · CJO · Jul 23, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121907
• Device Name: DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CJO · Clinical Chemistry
• Decision Date: Jul 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Indications for Use

The ALPI method is an in vitro diagnostic test for the quantitative measurement of alkaline phosphatase in human serum and plasma on the Dimension® clinical chemistry system. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ALPI CAL is an in vitro diagnostic product for the calibration of alkaline phosphatase (ALPI) method on the Dimension® clinical chemistry system.

Device Story

The Dimension ALPI system is an in vitro diagnostic assay for measuring alkaline phosphatase activity in human serum and plasma. The device uses a reagent cartridge containing p-nitrophenyl phosphate (p-NPP) and 2-amino-2-methyl-1-propanol (AMP) buffer. Alkaline phosphatase catalyzes the transphosphorylation of p-NPP to p-nitrophenol (p-NP) in the presence of magnesium and zinc ions. The system measures the rate of change in absorbance at 405 nm (bichromatic 405/510 nm) to determine enzyme activity. The ALPI CAL is a three-level liquid calibrator used to calibrate the assay. The device is intended for use in clinical laboratory settings by trained personnel. Results are used by clinicians to diagnose and monitor liver, bone, parathyroid, and intestinal conditions. The system provides automated quantitative results, facilitating clinical decision-making regarding patient disease status.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison (n=116, r=0.999), linearity (10-1000 U/L), and precision (within-lab %CV 1.6-4.2%). Interference testing performed per CLSI EP7-A2; no significant interference observed for common substances up to tested concentrations. Reference interval established from 132 healthy adults.

Technological Characteristics

In vitro diagnostic reagent cartridge and liquid calibrator. Principle: Bichromatic rate technique (405/510 nm). Reagents: p-NPP, AMP buffer, Mg/Zn ions. Calibrator: Human serum albumin-based, porcine kidney-derived alkaline phosphatase. Connectivity: Automated clinical chemistry system. Standards: CLSI EP5-A2, EP6-A, EP7-A2, EP9-A2, EP17-A, C28-A3.

Indications for Use

Indicated for quantitative measurement of alkaline phosphatase in human serum and plasma to aid in diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For use on Dimension clinical chemistry systems.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Submission Summary (Full Text)

{0}

Decision Summary, k121907

This 510(k) was reviewed under OIVD’s Pilot Triage 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.