Final guidance for 510k/ de novo submission of nucleic acid based multiplexed IVDs

rangani_rj

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Hi all,

As global market of DNA based IVDs is expected to reach 20 Billion by 2020, this new guideline may help developers of such kind of IVDs.

Guidance provides detailed recommendations (analytical and clinical performance) to be included for 510 (k)/ de novo submission of nucleic acid-based (DNA/RNA) multiplexed IVDs (detecting ≥20 different organisms/targets (drug resistant marker) in a single reaction from single specimen/culture) using polymerase chain reaction (PCR), reverse-transcriptase polymerase chain reaction (RT-PCR), bead-based liquid arrays, microarrays, re-sequencing approaches etc (21 CFR 862.2570).

It is not intended for IVDs that utilize detection mechanisms other than nucleic acid based approaches, like IVDs to screen donors of blood and blood components, and donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for communicable diseases.
 

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  • Nucleic Acid Based IVDs - final guidance.pdf
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Stijloor

Leader
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Re: Final guidance for 510k/ de novo submission of nucleic acid based multiplexed IVD

A Quick Bump!

In case you missed this post + attachment.
 
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