DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS

K133751 · Diamond Diagnostics, Inc. · JIT · Aug 8, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133751
• Device Name: DIAMOND DIAGNOSTICS ISE SERUM STANDARDS, DIAMOND DIAGNOSTICS ISE URINE STANDARDS
• Applicant: Diamond Diagnostics, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 8, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Diamond Diagnostics ISE Serum Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Serum mode. Diamond Diagnostics ISE Urine Standards are intended for in-vitro diagnostics to provide calibration points for the sodium, potassium, and chloride electrodes on ADVIA Chemistry systems in Human Urine mode.

Device Story

Diamond Diagnostics ISE Serum and Urine Standards are aqueous buffered electrolyte solutions used to calibrate sodium, potassium, and chloride electrodes on ADVIA Chemistry systems. The device consists of low and high concentration standards packaged in 100mL HDPE dropper bottles. It is intended for professional use in clinical laboratory settings. The standards are used by laboratory technicians to establish calibration points for the analyzer's ion-selective electrodes (ISE). By providing known analyte concentrations, the device ensures the accuracy of the ADVIA system's measurements of patient serum or urine samples, facilitating clinical decision-making regarding electrolyte balance.

Clinical Evidence

Bench testing only. Stability was validated via accelerated stress testing and open-vial stability studies (30 days at 18-25°C). Analyte values were determined using reference methods (Flame Photometry for Na+/K+ and Silver/Silver Chloride Titration for Cl-) and traced to NIST standard materials (NIST 919b, 918b).

Technological Characteristics

Aqueous buffered solution of electrolytes and preservatives in deionized water. Packaged in 100mL HDPE dropper bottles. No human or animal components. Shelf life: 24 months. Storage: 18-25°C. Traceability to NIST 919b and 918b standards.

Indications for Use

Indicated for in-vitro diagnostic calibration of sodium, potassium, and chloride electrodes on ADVIA Chemistry systems using human serum or urine samples.

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) #: k133751

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.