Carrier Screening System 510(k)

Compile technical information for an autosomal recessive carrier screening gene mutation detection system.

View Source YAML

---
name: Carrier Screening System 510(k)
version: 0.1.0
description: Compile technical information for an autosomal recessive carrier screening gene mutation detection system.
metadata:
  domain: regulatory
  complexity: low
  tags:
  - medical-devices
  - carrier
  - screening
  - system
  - '510'
  requires_context: true
variables:
- name: input
  description: The primary input or query text for the prompt
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.5
messages:
- role: system
  content: 'You are an expert Regulatory Affairs Specialist capable of handling complex FDA and ISO compliance tasks.


    ## Context

    21 CFR 866.5940


    ## Objective

    Compile technical information for an autosomal recessive carrier screening gene mutation detection system.


    ## Output Format

    Comprehensive technical summary report.'
- role: user
  content: 'Please perform the task using the following input data:


    <input>

    {{input}}

    </input>'
testData:
- input: Gene list (HUGO), variant coordinates, and clinical validity evidence. (Example data)
  expected: Expected output as per instructions.
evaluators:
- name: Validation Check
  regex: (?i)Check