PHG · Class II — Moderate Risk (510(k) clearance required) · Clinical Chemistry · 21 CFR 862.2570
Classification
FDA Product Code
PHG
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 862.2570
Review panel
CH
Medical specialty
Clinical Chemistry
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
A droplet digital PCR system is an in vitro diagnostic amplification and detection test system that is intended for the amplification, detection (qualitative and quantitative), and analysis of nucleic acid samples, isolated from clinical specimens, which have been partitioned into nanoliter or smaller droplets using a water oil emulsion technique. A droplet digital PCR system is intended for use with cleared or approved in vitro diagnostic assays which specify its use.