Lumipulse G Progesterone-N Calibrators

K163546 · Fujirebio Diagnostics,Inc. · JIT · Jan 13, 2017 · Clinical Chemistry

Device Facts

• Record ID: K163546
• Device Name: Lumipulse G Progesterone-N Calibrators
• Applicant: Fujirebio Diagnostics,Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jan 13, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Lumipulse G Progesterone-N Calibrators are for in vitro diagnostic use in the calibration of Lumipulse G Progesterone-N on the LUMIPULSE G System.

Device Story

Lumipulse G Progesterone-N Calibrators are liquid, ready-to-use reagents containing progesterone in a sodium chloride/MES buffer matrix with bovine protein and sodium azide preservative. The kit consists of three levels (0, 0.5, and 40 ng/mL). The device is used in a clinical laboratory setting to calibrate the Lumipulse G Progesterone-N assay on the LUMIPULSE G System. The healthcare provider uses the calibrators to establish a calibration curve on the analyzer, which is then used to quantify progesterone levels in patient serum samples. This calibration process ensures the accuracy and reliability of the assay results, which are used by clinicians to assess patient progesterone levels.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was validated through analytical studies including stability (long-term, real-time, open-vial), transport simulation, and value assignment traceability to ERM-DA347 and BCR-348R reference materials. Accuracy and sensitivity criteria were met.

Technological Characteristics

Liquid, ready-to-use calibrator kit. Matrix: 0.15 M sodium chloride, MES buffer, bovine protein, sodium azide. Traceability: Gravimetric preparation traceable to ERM-DA347 and BCR-348R. Storage: 2-10°C. Shelf life: 9 months. System: LUMIPULSE G.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the Lumipulse G Progesterone-N assay on the LUMIPULSE G System. No specific patient population is described as this is a calibrator device.

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) #: k163546

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.