Calcium2

K244042 · Abbott Ireland · CJY · Feb 10, 2025 · Clinical Chemistry

Device Facts

• Record ID: K244042
• Device Name: Calcium2
• Applicant: Abbott Ireland
• Product Code: CJY · Clinical Chemistry
• Decision Date: Feb 10, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1145
• Device Class: Class 2

Indications for Use

The Calcium2 assay is used for the quantitation of calcium in human serum, plasma, or urine on the ARCHITECT c System. 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

Calcium2 is an automated clinical chemistry assay for the ARCHITECT c System; measures calcium concentration in human serum, plasma, or urine. Principle of operation: Arsenazo III dye reacts with calcium in an acid solution to form a blue-purple complex; color intensity measured at 660 nm is proportional to calcium concentration. Used in clinical laboratories by technicians; results are reviewed by physicians to assist in diagnosing and managing parathyroid, bone, and renal diseases, and tetany. Provides quantitative calcium levels to support clinical decision-making.

Clinical Evidence

Bench testing only. Performance validated on ARCHITECT c8000 System. Studies included precision (within-run, within-lab, reproducibility per CLSI EP05-A3), accuracy (bias vs NIST SRM 956d), linearity (CLSI EP06), and interference testing (CLSI EP07). Method comparison (CLSI EP09c) against predicate showed correlation coefficient of 1.00 for both serum (n=120) and urine (n=112). LoB, LoD, and LoQ established per CLSI EP17-A2.

Technological Characteristics

Automated clinical chemistry assay using Arsenazo III dye. Reagent contains Arsenazo III (0.932 g/L) and sodium azide preservative. Operates on ARCHITECT c System. Serum/plasma AMI: 2.0–24.0 mg/dL; Urine AMI: 2.0–24.0 mg/dL with EMI up to 96.0 mg/dL. Traceable to NIST SRM 956. Connectivity via ARCHITECT c8000 platform.

Indications for Use

Indicated for the quantitation of calcium in human serum, plasma, or urine to aid in the diagnosis and 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) Number: K244042

This 510(k) was reviewed under the OHT7/OHT8 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.