SeekInClarity® Cancer Treatment Response Monitoring Kit

Dénomination commerciale

SeekInClarity® Cancer Treatment Response Monitoring Kit

Code d'IUD-ID

ID primaire

L'ID primaire est l'IUD-ID principal qu'un fabricant désigne comme identifiant de référence d'un dispositif dans EUDAMED.

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D-SQ-04XV

IUD-ID de base

IUD-ID de base

L'IUD-ID de base est l'identifiant principal qui regroupe toutes les variantes d'un même modèle de dispositif — la clé de la « famille » réglementaire.

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B-SQ-04XV

Numéro de référence/catalogue

67319

Entité d'attribution

Entités d'attribution IUD

Les entités d'attribution sont les organismes que la Commission européenne a désignés pour attribuer les identifiants uniques des dispositifs au titre du système IUD de l'UE.

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EUDAMED

Catégorie de risque

Classes de risque RDIV

Les classes de risque du RDIV classent les dispositifs de diagnostic in vitro du risque le plus faible (classe A) au plus élevé (classe D), selon le risque pour le patient et la santé publique d'un résultat erroné.

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IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

SeekInClarityTM Cancer Treatment Response Monitoring Kit utilizes circulating cell-free DNA (cfDNA) isolated from plasma derived from peripheral whole blood (about 10 ml) of subjects and analyzes the copy number aberrations (CNAs) patterns of pre- and post- therapy samples. Peripheral blood is collected at baseline and at the beginning of every one/two cycle during treatment. At each collection time point, 10 ml of peripheral blood is collected in STRECK cfDNA blood collection tubes or EDTA blood collection tubes. Plasma is separated from the cell pellet, and cfDNA is purified from clarified plasma. Extracted cfDNA undergoes whole-genome library construction, and then sequences on Illumina’s sequencing systems by shallow whole genome sequencing (sWGS). The curative effect can be predicted according to the change trend of CNAs before and after treatment. Clinicians should make a comprehensive judgment of the test results in combination with other clinical and laboratory test indicators. This kit is only used to construct cfDNA library.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W01010201ALBUMIN (CC)

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW999

  1. Please read this instruction carefully before experiments, and implement them in strict accordance with the requirements. 2. The results of this kit will be affected by many factors, such as the source of the sample, sample collection, sample quality, sample transportation conditions, sample processing and other factors, as well as the limitations of DNA extraction quality, operating environment and current molecular biology technology, which may lead to false positive or false negative test results. Users must comprehend the potential errors in the test process and the limitation of accuracy. 3. In order to avoid any potential biological hazards in the sample, the test sample shall be regarded as a substance with infectious risk, and corresponding protective measures shall be taken during the operation to avoid contact with skin and mucous membrane. The waste shall be treated according to the biological pollutant treatment procedure. 4. Do not use reagents with damaged package, unclear labels and expiration date. 5. All components of this kit have been strictly prepared. Changing or replacing the components will lead to invalid results. Components of kits with different batch shall not be mixed with each other. 6. Laboratory management shall be carried out in strict accordance with the national management specifications for molecular biology laboratories and clinical gene amplification laboratories. Laboratory personnel must receive professional training. 7. The experimental process shall be carried out in different areas (reagent preparation area, sample preparation area, sample amplification and product analysis area). Special instruments and equipment shall be used in each stage of experimental operation, and supplies in each stage of each area shall not be used interchangeably. 8. This kit is only used for in vitro diagnosis and is not used for other clinical purposes. 9. This kit is only applicable to blood samples and designated device.

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.