Lumipulse G E2-III Calibrators

K163053 · Fujirebio Diagnostics,Inc. · JIT · Dec 1, 2016 · Clinical Chemistry

Device Facts

• Record ID: K163053
• Device Name: Lumipulse G E2-III Calibrators
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 1, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Lumipulse G E2-III Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G E2-III on the LUMIPULSE® G System.

Device Story

Lumipulse G E2-III Calibrators are a set of three liquid, ready-to-use calibrators containing estradiol in a Tris buffer with bovine protein stabilizer and sodium azide preservative. The device is used in a clinical laboratory setting by trained personnel to calibrate the Lumipulse G E2-III assay on the LUMIPULSE® G System. The calibrators provide known concentrations of estradiol (19-2000 pg/mL) to establish a calibration curve on the analyzer. This curve allows the system to quantify estradiol levels in patient serum samples. Proper calibration ensures the accuracy and reliability of the assay results, which are used by clinicians to assess patient endocrine status. The calibrator values are lot-specific and provided on an included calibration card.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (shelf-life, transport simulation, and open-vial) confirmed performance criteria for sensitivity, accuracy, and reproducibility over 18 months of storage at 2-10°C.

Technological Characteristics

Liquid, ready-to-use calibrator kit containing 3 levels of estradiol in Tris buffer with bovine protein stabilizer and sodium azide. Traceable to BCR-577 by IRMM and verified against ID-GC/MS. Standardized per ISO 17511:2003. Compatible with LUMIPULSE G System.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the Lumipulse G E2-III assay on the LUMIPULSE® G System.

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) #: k163053

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.