HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)

K130870 · Hitachi Chemical Diagnostics, Inc. · CIC · May 2, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130870
• Device Name: HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
• Applicant: Hitachi Chemical Diagnostics, Inc.
• Product Code: CIC · Clinical Chemistry
• Decision Date: May 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

The S TEST Reagent Cartridge Calcium (CA) is intended for the quantitative determination of calcium in serum, lithium heparinized plasma, and sodium citrate plasma using the HITACHI Clinical Analyzer E40. The S TEST Reagent Cartridge Calcium is intended for use in clinical laboratories or physician office laboratories. For in vitro diagnostic use only. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Device Story

The Hitachi Clinical Analyzer is an automated, bench-top, wet chemistry system. It uses single-use plastic reagent cartridges containing two reservoirs (R1, R2) and a reaction cell. The system processes serum or plasma samples by pipetting sample and reagent into the reaction cell, mixing, and incubating. A multi-wavelength photometer measures the absorbance of the purple-red complex formed by calcium and o-cresolphthalein complexone (with 8-hydroxyquinoline to exclude magnesium interference). The analyzer calculates analyte concentration based on absorbance. Results are available in approximately 15 minutes. The device is operated by laboratory personnel or technicians in clinical or physician office laboratories. The output is a quantitative calcium concentration value, which assists clinicians in diagnosing and monitoring parathyroid, bone, and renal diseases.

Clinical Evidence

Bench testing included analytical sensitivity (LOD 0.19 mg/dL), linearity (0.4-17.1 mg/dL), 20-day precision (CVs 0.7-1.9%), and interference testing (bilirubin, lipemia, ascorbic acid, hemoglobin). Method comparison (n=97) showed r=0.976, slope 0.99. Matrix comparison (n=44) validated serum/plasma equivalence. Clinical performance was evaluated at three physician office laboratory (POL) sites (n=55-57 per site), demonstrating accuracy comparable to reference methods with r values ranging from 0.984 to 0.987 and slopes from 0.96 to 0.99.

Technological Characteristics

Bench-top automated wet chemistry analyzer. Reagent cartridges: plastic, 13.5mm x 28mm x 20.2mm. Sensing: multi-wavelength photometer (570/660 nm). Principle: colorimetric (o-cresolphthalein complexone). Connectivity: includes operations screen/printer. Software: embedded control for pipetting, incubation, and absorbance calculation.

Indications for Use

Indicated for quantitative determination of calcium in serum, lithium heparinized plasma, and sodium citrate plasma. Used in clinical/physician office labs for diagnosis/treatment of parathyroid disease, bone diseases, chronic renal disease, and tetany.

Regulatory Classification

Identification

A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Submission Summary (Full Text)

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

510(k) #: k130870

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.