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K Number
K974607
Device Name
RANDOX CALCIUM
Manufacturer
RANDOX LABORATORIES, LTD.
Date Cleared
1998-02-02

(54 days)

Product Code
CJY
Regulation Number
862.1145
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration. Measurements of calcium are used in the diagnosis and treatment of parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure and a variety of bone diseases.

Device Description

The Randox Laboratories Limited Calcium Test Kit is an in vitro diagnostic reagent for the quantitative determination of calcium in human serum. This method is based on the interaction of calcium with Arsenazo III to form a coloured complex which can be measured at 650nm. The intensity of the final colour is directly proportional to the calcium concentration.

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the "Randox Calcium" device, and an "Indications for Use" statement. This document does not contain the specific details about acceptance criteria, device performance studies, or the methodologies used to establish ground truth as requested in your prompt.

The document states that the Randox Laboratories Limited Calcium Test Kit is:

  • An in vitro diagnostic reagent
  • For the quantitative determination of calcium in human serum
  • Based on the interaction of calcium with Arsenazo III to form a coloured complex
  • Which can be measured at 650nm
  • The intensity of the final colour is directly proportional to the calcium concentration.
  • Measurements of calcium are used in the diagnosis and treatment of conditions such as parathyroid disease, malignant diseases with and without bone involvement, chronic renal failure, and a variety of bone diseases.

It also notes that the test kit must be used by suitably qualified laboratory personnel under appropriate laboratory conditions.

However, it does not include:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and the data provenance.
  3. Number of experts and their qualifications for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study details.
  6. Standalone performance details.
  7. Type of ground truth used.
  8. Training set sample size.
  9. How ground truth for the training set was established.

This document is typically a summary of the FDA's decision regarding substantial equivalence, not the detailed study report itself. To find the specific information you are looking for, you would generally need to refer to the full 510(k) submission document or supporting studies, which are not included in this extract.

§ 862.1145 Calcium test system.

(a)
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).(b)
Classification. Class II.