LP(A) CALIBRATORS, AND LP(A) CONTROLS

K132400 · Biokit, S.A. · JIT · Dec 19, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132400
• Device Name: LP(A) CALIBRATORS, AND LP(A) CONTROLS
• Applicant: Biokit, S.A.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 19, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Lp(a) Calibrators are for use in establishing the calibration curve for the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems. The Lp(a) Control I and Control II are intended for use as assayed quality control materials for the quantitative monitoring of Lipoprotein (a) with the Quantia Lp(a) reagents by turbidimetry on the ARCHITECT c Systems.

Device Story

Lp(a) Calibrators and Controls are liquid reagents derived from human serum; used in clinical laboratory settings on ARCHITECT c Systems. Calibrators establish calibration curves for Quantia Lp(a) reagents; Controls monitor quantitative measurement accuracy of Lipoprotein (a) via immunoturbidimetry. Preservatives include Kanamycin Monosulfate and Gentamicin Sulfate. Healthcare providers use these to ensure assay performance; results assist in clinical assessment of Lipoprotein (a) levels. Human serum input is screened nonreactive for HBsAg, anti-HIV-1/HIV-2, and anti-HCV.

Clinical Evidence

Bench testing only. Stability studies confirmed shelf life (32 months at 2-8°C) and reconstituted stability (14 days at 2-8°C) based on recovery within ±10% of assigned values (±3 mg/dL for level 1). Value assignment performed via 30-replicate comparison against Master lot and previous lots on ARCHITECT c8000 system.

Technological Characteristics

Human serum-based calibrators and controls; immunoturbidimetry principle. Preservatives: Kanamycin Monosulfate and Gentamicin Sulfate. Form factor: multi-level liquid sets (5 levels for calibrators, 2 levels for controls). Connectivity: standalone reagents for use on ARCHITECT c Systems. No software algorithm or energy source integral to the calibrator/control itself.

Indications for Use

Indicated for in vitro diagnostic use to establish calibration curves and monitor quantitative measurement of Lipoprotein (a) in human serum or plasma using immunoturbidimetry on ARCHITECT c Systems.

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

510(k) #: k132400

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.