Devices & IVD

IVD Performance Study for a Molecular Diagnostic

Focus Area

Devices & IVD

Duration

9 months

Footprint

6 tertiary hospital labs

Key Outcome

CDSCO approval on first submission

Overview

A performance-evaluation study for a molecular IVD delivered CDSCO-ready evidence and a clean first-cycle submission.

The Challenge

What we were asked to solve

An emerging molecular-diagnostics sponsor needed real-world performance evidence for an infectious-disease IVD across diverse patient populations to satisfy CDSCO requirements.

Our Approach

How we delivered it

16-site multi-lab study using tertiary NABH-accredited hospital partners
2Head-to-head comparator design against a validated reference method
3Central data-quality monitoring via AI-native CTMS
4Dedicated regulatory affairs support for CDSCO submission dossier

Outcomes

CDSCO approval on first submission

1,240 clinical samples analyzed across 6 sites in 9 months

Sensitivity 96.4%, specificity 98.1% vs comparator (per sponsor SAP)

CDSCO submission approved in first cycle

Sponsor secured downstream US FDA 510(k) pre-submission meeting

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