AIA-PACK C-Peptide Control Set

K143296 · Tosoh Bioscience, Inc. · JJX · Dec 16, 2014 · Clinical Chemistry

Device Facts

• Record ID: K143296
• Device Name: AIA-PACK C-Peptide Control Set
• Applicant: Tosoh Bioscience, Inc.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The AIA-PACK C-Peptide Control Set is intended for In Vitro Diagnostic Use Only for performing quality control procedures with the ST AIA-PACK C-Peptide II assay.

Device Story

AIA-PACK C-Peptide Control Set consists of two levels of lyophilized buffered bovine serum albumin containing C-peptide (approx. 2 ng/mL and 20 ng/mL). Used by laboratory technicians to perform daily quality control procedures for the ST AIA-PACK C-Peptide II assay on Tosoh AIA-2000 analyzers. Controls are reconstituted and refrigerated; stability is maintained for 14 days post-reconstitution. Output is a measured concentration value compared against assigned ranges to verify assay performance. Ensures accuracy and precision of patient sample testing; helps clinicians rely on C-peptide results for diagnostic decision-making.

Clinical Evidence

Bench testing only. Stability studies confirmed 12-month shelf life at 2-8°C and 14-day in-use stability post-reconstitution. Recovery criteria (100 +/- 10%) and reproducibility (CV <= 10%) were met. Value assignment verified using AIA-2000 analyzers against secondary reference materials traceable to WHO International Reference Reagents.

Technological Characteristics

Lyophilized buffered bovine serum albumin matrix. Two levels of C-peptide concentration (approx. 2 and 20 ng/mL). Designed for use with Tosoh AIA-2000 automated immunoassay analyzers. Storage at 2-8°C.

Indications for Use

Indicated for use as a quality control material for the ST AIA-PACK C-Peptide II assay in a clinical laboratory setting. No specific patient population is targeted as this is an in vitro diagnostic control product.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k143296

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.