ST AIA-PACK PROG III Calibrator Set

K153417 · Tosoh Bioscience, Inc. · JIT · Dec 18, 2015 · Clinical Chemistry

Device Facts

• Record ID: K153417
• Device Name: ST AIA-PACK PROG III Calibrator Set
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

ST AIA-PACK PROG III Calibrator Set consists of six liquid levels of bovine protein matrix containing progesterone (0 to 45 ng/mL approx.) and sodium azide preservative. Used in clinical laboratories on Tosoh AIA System Analyzers to calibrate the ST AIA-PACK PROG III assay. Calibrator values are assigned gravimetrically using USP reference standards and verified on AIA-2000 instruments. Healthcare providers use the resulting assay calibration to quantify progesterone levels in patient serum or heparinized plasma samples. Accurate calibration ensures the assay provides reliable progesterone measurements, which aids clinicians in assessing reproductive health and endocrine function.

Clinical Evidence

Bench testing only. Stability studies (real-time and open-vial) confirmed recovery within 100 +/- 10% and reproducibility (CV) <= 10%. Value assignment was validated by analyzing 5 replicates on two Tosoh AIA-2000 instruments, demonstrating precision (CV) between 2.0% and 4.8% across calibrator levels.

Technological Characteristics

Liquid calibrator set; bovine protein matrix; sodium azide preservative. Six levels (0, 0.5, 1.5, 5.0, 15, 45 ng/mL). Traceable to USP reference standard (Lot #11J239). Designed for use on Tosoh AIA System Analyzers. Storage: 2-8°C.

Indications for Use

Indicated for in vitro diagnostic calibration of the ST AIA-PACK PROG III assay. No specific patient population, age, or gender restrictions are defined for the calibrator itself, as it is a laboratory reagent used by clinical laboratory professionals.

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) #: k153417

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.