ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT

K133067 · Siemens Healthcare Diagnostics, Inc. · CDT · Nov 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133067
• Device Name: ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
• Applicant: Siemens Healthcare Diagnostics, Inc.
• Product Code: CDT · Clinical Chemistry
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1705
• Device Class: Class 1

Intended Use

The ADVIA® Chemistry Triglycerides 2 assay (TRIG 2) is intended for in vitro diagnostic use in the quantitative measurement triglycerides in human serum and plasma on the ADVIA® Chemistry systems. Measurements of triglycerides are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Device Story

ADVIA Chemistry Triglycerides 2 (TRIG 2) is a ready-to-use liquid reagent for automated clinical chemistry analyzers (ADVIA 1800). Input: human serum or plasma samples. Principle: Fossati three-step enzymatic reaction; lipase converts triglycerides to glycerol and fatty acids; glycerol kinase and glycerol-3-phosphate-oxidase produce hydrogen peroxide; peroxidase catalyzes formation of colored complex with 4-aminophenazone and 4-chlorophenol. Output: absorbance measured at 505/694 nm, proportional to triglyceride concentration. Used in clinical laboratories by trained personnel. Results assist physicians in diagnosing and monitoring lipid metabolism, diabetes, and endocrine disorders.

Clinical Evidence

Bench testing only. Precision established per CLSI EP5-A2 (N=80 per sample, total CV 0.4-1.0%). Linearity assessed across 10-550 mg/dL range (R²=0.9998). LoB/LoD/LoQ determined per CLSI EP17-A2 (LoQ=10 mg/dL). Method comparison with predicate (N=101) yielded slope 0.94, intercept 4.4 mg/dL. Matrix comparison (N=60) performed for Lithium Heparin and K-EDTA plasma. Interference testing evaluated bilirubin, hemolysis, and ascorbic acid; bias >10% defined as significant interference.

Technological Characteristics

Liquid enzymatic reagent; Fossati three-step method (lipase, glycerol kinase, glycerol-3-phosphate-oxidase, peroxidase). Endpoint measurement at 505/694 nm. Traceable to NIST SRM909c. Packaged in 40 mL wedges. Compatible with ADVIA 1800 Chemistry system. Calibrated using Siemens Set-Point Chemistry calibrator (k030169).

Indications for Use

Indicated for quantitative measurement of triglycerides in human serum and plasma to aid in diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, lipid metabolism disorders, or endocrine disorders.

Regulatory Classification

Identification

A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

Submission Summary (Full Text)

{0}

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

510(k) #: k133067

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.