ST AIA-PACK hsE2 Calibrator Set

K160113 · Tosoh Bioscience, Inc. · JIT · Feb 17, 2016 · Clinical Chemistry

Device Facts

• Record ID: K160113
• Device Name: ST AIA-PACK hsE2 Calibrator Set
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ST AIA-PACK hsE2 Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK hsE2 assay.

Device Story

ST AIA-PACK hsE2 Calibrator Set consists of six liquid levels of human serum containing estradiol (0 to 1,100 pg/mL) and sodium azide preservative. Used on Tosoh AIA System Analyzers to calibrate the hsE2 assay. Calibrators are processed by the analyzer to establish a calibration curve, allowing the system to quantify estradiol concentrations in patient serum or heparinized plasma samples. Used by laboratory technicians in clinical settings. Output is a calibration curve used to calculate patient results, aiding clinicians in diagnosing and monitoring conditions related to estradiol levels.

Clinical Evidence

Bench testing only. Stability studies (real-time and open-vial) confirmed 12-month shelf life and 1-day open-vial stability at 2-8°C. Value assignment validation demonstrated grand mean recovery within 10% CV across multiple analyzers and reagent lots.

Technological Characteristics

Liquid calibrator set; human serum matrix with sodium azide preservative. Six levels (0, 25, 50, 100, 500, 1100 pg/mL). Traceable to IRMM CRM577. Designed for use on Tosoh AIA System Analyzers. Refrigerated storage (2-8°C).

Indications for Use

Indicated for the calibration of the ST AIA-PACK hsE2 assay in clinical laboratory settings. No specific patient population or contraindications are defined for the calibrator itself.

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) #: k160113

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.