Hangzhou QuickStrip Diagnostics

# Client C — Hangzhou QuickStrip Diagnostics (codename)

> Demo / mock data.

## 1. Company

- HQ: Hangzhou, Binjiang district
- Founded: 2011, A-share listed (2021)
- Existing markets: NMPA (2012), India, Brazil, Middle East (12 markets)
- EU strategy: legacy IVDD certificate transition to IVDR

## 2. Product

| Field | Value |
|-------|-------|
| Trade name | QuickStrip hCG-Q |
| Intended Purpose | Home-use quantitative hCG in urine for pregnancy monitoring |
| IVDR classification | **Class B** (Rule 4(a) — self-test, pregnancy carve-out) |
| Software | None (pure chemistry strip) |

## 3. Regulatory route

- **Conformity assessment**: Annex IX (self-test devices require an NB)
- **NB**: DEKRA NB 0344 — existing IVDD-era partner
- **CPS required**: yes (Class B but self-test triggers usability + clinical study)

## 4. Current progress

- Phases 0–4 complete, all 4 GREEN LIGHTs passed
- Phase 5 — FOLLOW UP (**current**)
  - 3 sites activated (Milan / Rome / Turin)
  - Enrolment: Milan 102/100, Rome 98/100, Turin **64/75**
  - Mid-study data cleaning complete
  - Database date freeze planned 2026-08-30
- Phase 6 — CONCLUSION (CPSR) planned 2026-10

## 5. Risks

| # | Issue | Severity | Mitigation |
|---|-------|----------|------------|
| R1 | Turin site enrolment 15% behind plan | Medium | CRA additional visits; in July assess whether to activate a backup site |

## 6. Recent communications

- 2026-05-17 — Milan PI monthly telecon, data quality good
- 2026-05-10 — Internal data-cleaning review
- 2026-04-20 — DEKRA interim communication (no deficiencies)

## 7. Next actions

- [ ] 2026-06-30 — Turin site enrolment review
- [ ] 2026-08-30 — Database date freeze
- [ ] 2026-09-15 — Statistical analysis begins
- [ ] 2026-10-15 — CPSR v0 draft

## 8. File index

- Project log: `projects/client-c-cps-2025/`
- Monitoring reports: `raw/clients/client-c/monitoring-reports/` (to be uploaded by client)