ST AIA-PACK PROG II Calibrator Set

K143144 · Tosoh Bioscience, Inc. · JIT · Dec 3, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143144
• Device Name: ST AIA-PACK PROG II Calibrator Set
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 3, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

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

Device Story

ST AIA-PACK PROG II Calibrator Set consists of six liquid calibrator levels (0 to 45 ng/mL) containing progesterone in a human serum matrix with sodium azide preservative. Designed for use on Tosoh AIA System Analyzers (e.g., AIA-2000) to calibrate the ST AIA-PACK PROG II assay. Calibrator values are assigned via a multi-step traceability process using USP reference standards and verified through replicate testing on Tosoh analyzers. Used by laboratory professionals in clinical settings to ensure accurate quantification of progesterone levels in patient samples. Benefits include standardized assay performance and reliable clinical decision-making for progesterone-related diagnostics.

Clinical Evidence

Bench testing only. Stability studies (real-time and open-vial) confirmed 6-month shelf life and 1-day open-vial stability at 2-8°C. Value assignment validation performed on Tosoh AIA-2000 analyzers using 5 replicates per level; results showed precision (CV) ranging from 1.8% to 5.8%, meeting the <10% acceptance criterion.

Technological Characteristics

Liquid calibrator set; six levels (0, 0.5, 1.5, 5.0, 15, 45 ng/mL approx.); human serum matrix; sodium azide preservative. Traceable to USP reference standards. 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 II assay for the measurement of progesterone in human serum and heparinized plasma.

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 MEMORANDUM

510(k) #: k143144

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.