ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR

K123372 · Abbott Laboratories · JIX · Jan 14, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123372
• Device Name: ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
• Applicant: Abbott Laboratories
• Product Code: JIX · Clinical Chemistry
• Decision Date: Jan 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Abbott Lipid Multiconstituent Calibrator is an in vitro diagnostic product intended for the calibration of Abbott Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer.

Device Story

LipidMCC is a lyophilized, human serum-based calibrator containing Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol, and LDL-Cholesterol. Used in clinical laboratories to calibrate the Abbott ARCHITECT c8000 analyzer. The device ensures assay accuracy by providing known concentrations of analytes traceable to CDC/WHO/IFCC reference materials. Laboratory technicians reconstitute the lyophilized material and load it onto the analyzer; the system uses the calibrator to establish a standard curve for patient sample testing. This calibration process minimizes bias in lipid profile measurements, supporting accurate clinical assessment of cardiovascular risk.

Clinical Evidence

Bench testing only. Standardization validated against CDC reference methods for HDL/LDL and WHO/IFCC/CDC reference materials for ApoA1/ApoB. Value assignment verified via method comparison studies using 40 serum samples. Stability testing (shelf-life and open-vial) confirmed performance within ±5% deviation criteria.

Technological Characteristics

Lyophilized human serum-based matrix; contains Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol, and LDL-Cholesterol. Designed for use on the ARCHITECT c8000 clinical chemistry analyzer. Traceable to CDC/WHO/IFCC reference materials. Stability: 36 months shelf-life at 2-8°C; 7 days open-vial stability at 2-8°C.

Indications for Use

Indicated for use as a calibrator for Apolipoprotein A1, Apolipoprotein B, HDL-Cholesterol, and LDL-Cholesterol assays on the ARCHITECT c8000 clinical chemistry analyzer in a clinical laboratory setting.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k123372

This 510(k) was reviewed under OIR'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.