ACE CALIBRATOR

K141728 · SENTINEL CH. SpA · JIT · Jul 28, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141728
• Device Name: ACE CALIBRATOR
• Applicant: SENTINEL CH. SpA
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 28, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

ACE Calibrator is intended to be used with the Sentinel ACE Liquid Reagent for the preparation of the calibration curve for the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma. The product is for in-vitro diagnostic use only.

Device Story

ACE Calibrator is a single-level, lyophilized human serum-based product containing porcine-derived ACE, preservatives, and stabilizers. It is used in clinical laboratories to establish a calibration curve for the kinetic determination of ACE activity in human serum or plasma when used with the Sentinel ACE Liquid Reagent. The calibrator is reconstituted with deionized water and used on automated clinical chemistry analyzers. By providing a reference point for the assay, it enables the accurate quantification of ACE levels in patient samples, assisting clinicians in diagnostic assessments. The device is intended for professional in-vitro diagnostic use.

Clinical Evidence

Bench testing only. Stability testing confirmed 36-month shelf life for lyophilized product and 7-day stability for reconstituted product at 2-8°C. Value assignment was performed using CAP proficiency survey material and verified against commercial control sera and CAP/WEQAS proficiency material. Recovery testing demonstrated ± 5.0% difference between fresh and 7-day stored reconstituted calibrator.

Technological Characteristics

Lyophilized human serum matrix containing porcine ACE, preservatives, and stabilizers. Single-level calibrator. Reconstituted with 1.0 mL deionized water. Stable at 2-8°C. No electronic components or software algorithms.

Indications for Use

Indicated for use as a calibrator for the kinetic determination of angiotensin converting enzyme (ACE) in human serum or plasma samples in a clinical laboratory setting.

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) #: k141728

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.