PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM

K130200 · Abaxis, Inc. · CHH · Feb 15, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130200
• Device Name: PICCOLO TOTAL CHOLESTEROL - CAPILLARY TEST SYSTEM
• Applicant: Abaxis, Inc.
• Product Code: CHH · Clinical Chemistry
• Decision Date: Feb 15, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1175
• Device Class: Class 1

Indications for Use

The Piccolo Total Cholesterol - Capillary Test System used with the Piccolo xpress Chemistry Analyzer is intended for the in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood in a clinical laboratory setting or point-of-care location. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipoprotein disorders.

Device Story

Piccolo Total Cholesterol - Capillary Test System uses reagent discs to process lithium heparinized capillary whole blood samples. Device separates plasma from blood cells; meters plasma and diluent; mixes with dry reagent beads; performs enzymatic endpoint reaction. Analyzer monitors chemical reactions at 37°C. Used in clinical labs or point-of-care locations by professionals. Provides quantitative total cholesterol results to assist clinicians in diagnosing and treating cholesterol and lipoprotein disorders. System utilizes factory-calibrated, lot-specific data via barcode.

Clinical Evidence

Bench testing only. Linearity established across 20-520 mg/dL range (r=0.999). Precision studies (n=160) showed CVs of 1.3-1.5% (within-run) and 2.2-2.6% (total). Method comparison against Roche Cholesterol assay (n=639) demonstrated strong correlation (R2=0.989) with a slope of 0.97 and intercept of 1.23 in Deming regression. Accuracy confirmed via CRMLN certification.

Technological Characteristics

Enzymatic endpoint reaction; 37°C reaction temperature; dry reagent beads with liquid diluent; factory calibration via barcode; lithium heparinized capillary whole blood sample; 20-520 mg/dL assay range; professional use environment.

Indications for Use

Indicated for in vitro quantitative determination of total cholesterol in capillary (fingerstick) heparinized whole blood. Used for diagnosis and treatment of disorders involving excess cholesterol and lipid/lipoprotein disorders in clinical laboratory or point-of-care settings.

Regulatory Classification

Identification

A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.

Submission Summary (Full Text)

{0}

# Decision Summary

Statement for the Record, k130200

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.