Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191396 FDA 510(k)
- FDA Product Code
- CJY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1145 FDA 510(k)
- Regulation Number
- 862.1145 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Yumizen C1200 Calcium AS and Yumizen C1200 Creatinine Jaffe are in vitro diagnostic reagents designed for use on the Yumizen C1200 clinical chemistry analyzer. These reagents measure calcium levels using Arsenazo III dye to create a blue complex at neutral pH, while the creatinine assay employs the Jaffé method to assess creatinine concentration in biological samples. Both assays are intended for serum, plasma, and urine analysis, enabling precise biochemical evaluations in clinical settings.
These reagents are supplied as part of a system authorized under FDA 510(k) clearance (K191396) and IVDR compliance, intended for single-use in clinical chemistry workflows. The Yumizen C1200 analyzer supports high-throughput processing of up to 1200 tests per hour, with features such as automated sample handling, clot detection, and quality checks for hemolysis, icterus, and lipemia. Reagents and calibrators are stored refrigerated, ensuring stability and accuracy for routine and STAT testing in laboratory environments.
Frequently asked questions
Are these reagents designed for reuse or single-use in clinical settings, and why does that matter for my lab workflow?
The Yumizen C1200 Calcium AS and Creatinine Jaffe reagents are explicitly intended for single-use in clinical chemistry workflows. This design ensures precision and reduces the risk of cross-contamination or degradation from repeated handling, which is critical for accurate biochemical measurements like calcium and creatinine assays. Single-use also aligns with high-throughput demands, as it minimizes preparation time and streamlines the workflow on the Yumizen C1200 analyzer, which processes up to 1200 tests per hour.
What types of biological samples can these reagents analyze, and how does that impact their clinical utility?
The Yumizen C1200 Calcium AS and Creatinine Jaffe reagents are validated for use with serum, plasma, and urine samples. This versatility makes them suitable for a broad range of clinical evaluations, including routine monitoring of kidney function (creatinine), electrolyte balance (calcium), and diagnostic assessments in emergency or outpatient settings. The ability to analyze urine samples, for example, expands their utility for detecting early signs of metabolic disorders or monitoring chronic conditions like diabetes.
How should these reagents be stored, and what precautions should be taken to maintain their stability and performance?
The reagents and calibrators for the Yumizen C1200 system are stored refrigerated to preserve stability and accuracy. Proper refrigeration (typically between 2°C and 8°C) is essential, as it prevents degradation of the Arsenazo III dye (used for calcium) and the Jaffé reagents (used for creatinine), both of which are sensitive to temperature fluctuations. This storage requirement ensures reliable results for routine and STAT testing, particularly in high-volume labs where consistency is critical.
What regulatory pathways have these reagents undergone, and how does that affect their use in clinical laboratories?
The Yumizen C1200 Calcium AS and Creatinine Jaffe reagents are authorized under FDA 510(k) clearance (K191396) and comply with the In Vitro Diagnostic Regulation (IVDR) in the EU. This dual regulatory approval ensures they meet stringent performance and safety standards for clinical chemistry assays in both U.S. and international markets. Laboratories can rely on these reagents for accurate, traceable results, as they have undergone rigorous validation for precision, sensitivity, and clinical relevance in measuring calcium and creatinine levels.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe (K191396 ..., Yumizen C1200 AL Clinical Chemistry Analyzer - HORIBA, Yumizen C1200 Calcium AS, Yumizen C1200... (K191396) - FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K191396 | Class II | Active |
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Manufacturer
- Manufacturer
- Horiba Abx Sas
Sources (2)
- FDA 510(k) K191396 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026