DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI

K122323 · Siemens Healthcare Diagnostics · CJO · Aug 28, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122323
• Device Name: DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI
• Applicant: Siemens Healthcare Diagnostics
• Product Code: CJO · Clinical Chemistry
• Decision Date: Aug 28, 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 Vista® 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 Vista® System.

Device Story

The ALPI method is an in vitro diagnostic assay for quantitative measurement of alkaline phosphatase (ALP) in human serum and plasma. The device uses a Flex® reagent cartridge on the automated Dimension Vista® System. Principle of operation: ALP catalyzes transphosphorylation of p-nitrophenylphosphate (p-NPP) to p-nitrophenol (p-NP) in the presence of 2-amino-2-methyl-1-propanol (AMP) buffer, magnesium, and zinc ions. The system measures the change in absorbance at 405 nm (bichromatic 405/510 nm rate technique), which is directly proportional to ALP activity. The ALPI CAL is a liquid, human serum albumin-based calibrator containing porcine kidney ALP used to calibrate the assay. The system is operated by laboratory personnel in clinical settings. Results are used by physicians to diagnose and monitor liver, bone, parathyroid, and intestinal conditions.

Clinical Evidence

Bench testing only. Method comparison study (n=116) against predicate showed correlation coefficient r=0.999, slope 1.05. Serum vs. plasma comparison (n=50) showed r=0.999, slope 1.02. Precision testing (n=80) per CLSI EP5-A2 showed within-lab CVs ranging from 1.8% to 4.1%. Linearity established from 10–1000 U/L. Interference testing per CLSI EP7-A2 showed bias <10% for hemoglobin, bilirubin, and lipemia (up to 400 mg/dL). LoB, LoD, and LoQ determined per CLSI EP17-A.

Technological Characteristics

Reagent: Flex® cartridge containing p-NPP, AMP buffer, Mg/Zn ions. Calibrator: Liquid, human serum albumin-based, porcine kidney ALP. Measurement: Bichromatic rate (405/510 nm). Connectivity: Automated clinical chemistry analyzer. 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 diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. For use on Dimension Vista® System.

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)

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# Decision Summary

Decision Summary: k122323

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.