SeekInClarity® Cancer Treatment Response Monitoring Kit

Trade name

SeekInClarity® Cancer Treatment Response Monitoring Kit

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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D-SQ-04XV

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

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B-SQ-04XV

Reference / catalog number

67319

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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EUDAMED

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01010201ALBUMIN (CC)

1 warning recorded — scroll inside the panel to see all entries.

• 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.

No certificate specifically references this device's Basic UDI-DI.