Vision Calcium
by Abbott Laboratories 510(k)
Active
510(k) K863670
Overview
The Vision Calcium is a Cresolphthalein Complexone, Calcium reagent, classified under the Clinical Chemistry device type. It is designed for use in automated chemistry analyzers to measure serum or plasma calcium levels, providing quantitative results for clinical assessment of calcium metabolism disorders.
This device is supplied as a single-use reagent for in vitro diagnostic use in clinical laboratories. It is regulated under FDA 510(k) clearance (K863670) and falls under Class II – Special Controls (product code CIC). No MRI safety or sterility requirements are specified, and storage conditions are not detailed in the regulatory submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863670 | Date13 Nov 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Vision (Tm) Calcium
- 510(k) Number
- FDA Product Code
- CIC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What clinical chemistry tests does the Vision Calcium reagent support, and how is it used in a lab setting?
The Vision Calcium reagent is specifically designed for automated chemistry analyzers to measure serum or plasma calcium levels. It provides quantitative results, which are essential for assessing calcium metabolism disorders. Since it is classified under Clinical Chemistry devices, it is intended for use in clinical laboratories to aid in diagnosing conditions related to calcium imbalance, such as hypercalcemia or hypocalcemia.
Is the Vision Calcium reagent single-use, and how should it be stored?
The Vision Calcium reagent is supplied as a single-use reagent for in vitro diagnostic use. While the regulatory submission does not specify storage conditions, single-use reagents are typically stored according to manufacturer guidelines—usually at room temperature or refrigerated, protected from light and moisture, until use. Always refer to the accompanying documentation for precise storage instructions.
What regulatory pathway was followed for the Vision Calcium reagent, and what does that mean for its use in clinical settings?
The Vision Calcium reagent was cleared through the FDA’s 510(k) pathway, specifically under Traditional clearance, and is classified as Class II with Special Controls. This means it was determined to be substantially equivalent to a legally marketed predicate device and meets additional FDA requirements to ensure safety and effectiveness. Clinicians can rely on its regulatory clearance as evidence of its compliance with FDA standards for clinical chemistry reagents.
Are there different sizes or models of the Vision Calcium reagent, and how would I identify the correct one for my lab’s analyzer?
The Vision Calcium reagent is described as a single reagent type (Cresolphthalein Complexone) without explicit mention of multiple sizes or models in the provided data. To ensure compatibility, verify that your lab’s automated chemistry analyzer is compatible with single-use reagents and consult Abbott Laboratories’ documentation or technical support to confirm the correct reagent type for your specific analyzer model.