Anti-SARS-CoV-2 IgM Antibody Detection

Date of reception of the dossier

24.11.2021

Notified Body number

0123

Internal PECP dossier #

In vitro diagnostic medical device

Chemiluminescent microparticle immunoassay (CMIA) used
for the qualitative detection of IgM antibodies to SARS-CoV-
2 in human serum and plasma

Intended purpose

P1

what is detected and/or measured
please specify the analyte(s) or marker(s), e.g. SARS-CoV-2 spike protein, Kel1 (K)

P2

function of the device
e.g. diagnosis, aid to diagnosis, monitoring, determining the infectious load, tissue typing etc

Aid in the diagnosis of SARS CoV-2
infection

P3

the specific disorder, condition or risk factor of
interest that it is intended to detect, define or
differentiate e.g. hepatitis C infection, exposure to SARS-CoV-2, risk of HIV transmission in blood transfusion etc.

Exposure to SARS-CoV-2

P4

whether it is automated or not

Automated

P5

whether it is qualitative, semi-quantitative or
quantitative

Qualitative

P6

type of specimen(s)
e.g. whole blood, serum, saliva etc

Human serum and plasma

P7

where applicable, the testing population
e.g. persons with specific health conditions,
persons with specific symptoms, children in a
certain age range

Individuals who are suspected to have had coronavirus disease (COVID-19) or individuals that may have been infected by SARSCoV-2

P8

intended user

For Laboratory Professional Use
Only

Technology

T1

principle of the assay method or principles of operation of the instrument e.g. real-time PCR, qualitative PCR, digital PCR, sandwich immunoassay, competitive immunoassay, immunoturbidimetric assay etc.

Chemiluminescent microparticle
immunoassay (CMIA) technology

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