ST AIA-PACK C-PEPTIDE II CALIBRATOR SET

K140648 · Tosoh Bioscience, Inc. · JIT · Apr 10, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140648
• Device Name: ST AIA-PACK C-PEPTIDE II CALIBRATOR SET
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 10, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

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

Device Story

The ST AIA-PACK C-Peptide II Calibrator Set consists of six levels of calibrators (0 to 33 ng/mL) used to calibrate the ST AIA-PACK C-Peptide II assay on Tosoh AIA System analyzers. The set includes one liquid calibrator (0 ng/mL) and five lyophilized calibrators containing C-peptide in a protein matrix with sucrose. The device is used in clinical laboratory settings by trained laboratory personnel. The healthcare provider uses the calibrated assay to measure C-peptide levels in patient samples (urine, serum, EDTA plasma), which aids in clinical decision-making regarding insulin production and diabetes management. The calibrators are standardized against WHO 1st IRP 84/510 to ensure accurate assay performance.

Clinical Evidence

Bench testing only. Stability studies confirmed a 12-month shelf life at 2-8°C and a 1-day in-use stability after reconstitution. Recovery and reproducibility (CV <= 10%) met acceptance criteria (100 +/- 10%) across three lots.

Technological Characteristics

Six-level calibrator set; protein matrix with sucrose; lyophilized (levels 2-6) and liquid (level 1) formats; sodium azide preservative. Standardized against WHO 1st IRP 84/510. 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 C-Peptide II assay. No specific patient population, age, or gender restrictions 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) #: k140648

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.