A rapid self-test for the detection of 25-hydroxyvitamin D in fingerstick whole blood to identify vitamin D deficiency.
“Vitamin D helps regulate calcium and phosphate in the body, keeping bones, teeth and muscles healthy. A lack of vitamin D can lead to bone deformities such as rickets in children, and bone pain caused by osteomalcia in adults.” – NHS
| Specimens | Whole Blood |
|---|---|
| Format | Cassette |
| Detection | Deficient: 0-10 Insufficient: 10-30 Sufficient: 30-100 |
| Accuracy | 93.80% |
| Certification | CE professional use | MHRA |
| Result time (minutes) | 10 |
| Pack quantity | 1 |
| Case quantity | 540 |
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An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens derived from the human body.
In vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections. In vitro simply means 'in glass', meaning these tests are typically conducted in test tubes, cassettes and similar equipment, as opposed to in vivo tests, which are conducted in the body itself.
The IVDR is the new regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC). As a European regulation, it will be effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.
The IVDR came into force on 25 May 2017. Several implementing acts/guidance documents are being issued by the EU commission and are stipulated to complete some of the requirements to be met.
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