DC-UIBC-CAL

K163078 · Sekisui Diagnostics P.E.I., Inc. · JIT · Dec 8, 2016 · Clinical Chemistry

Device Facts

• Record ID: K163078
• Device Name: DC-UIBC-CAL
• Applicant: Sekisui Diagnostics P.E.I., Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 8, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For IN VITRO diagnostic use as a calibrator in clinical chemistry assays for UIBC (Unsaturated Iron Binding Capacity). DC-UIBC-CAL may be used to check the linearity over the reportable patient range of UIBC assays.

Device Story

DC-UIBC-CAL is a human-serum-based, lyophilized calibrator used in clinical chemistry analyzers to calibrate UIBC (Unsaturated Iron Binding Capacity) assays. It is intended for professional use in clinical laboratories. The device is reconstituted and placed on automated analyzers (e.g., Beckman Coulter AU, Roche/Hitachi, Cobas Mira) to establish a reference point for patient sample testing. By providing a known concentration of UIBC, the calibrator allows the analyzer to adjust its measurement parameters, ensuring accurate quantification of patient UIBC levels. This calibration process is essential for clinical decision-making regarding iron metabolism and related disorders. The device benefits patients by ensuring the accuracy and reliability of diagnostic test results used by physicians to diagnose and monitor iron-related conditions.

Clinical Evidence

Bench testing only. No clinical data. Stability studies (accelerated and real-time) were conducted to support shelf-life and open-vial claims. Value assignment was performed using Sekisui protocols on specified clinical chemistry instruments, with traceability to NIST SRM 937.

Technological Characteristics

Lyophilized human serum calibrator; 1-level format; 6 x 10mL packaging. Traceable to NIST SRM 937 per ISO 17511:2003. Reconstituted stability: 14 days at 2-8°C. Storage: 2-8°C. Compatible with automated clinical chemistry systems (Beckman Coulter AU, Roche/Hitachi, Cobas Mira).

Indications for Use

Indicated for use in automated clinical chemistry analyzers to calibrate UIBC assays and verify linearity across the reportable patient range.

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) #: k163078

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.