---
schema_version: "secwatch.filing_event.v1"
accession: "0001079973-23-000500"
form_type: "8-K"
ticker: "CFOR"
cik: "0001293818"
company_name: "CapForce Inc."
filed_at: "2023-04-18T23:59:59+00:00"
generated_at: "2026-06-17T00:32:41.871960+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# OpGen files De Novo FDA request for Unyvero UTI panel; sensitivity 96.8%

## Summary
- Submitted De Novo classification request to FDA for Unyvero UTI panel after clinical trial.
- Primary endpoint met: weighted avg sensitivity 96.8%, specificity 97.4% across 1,800+ samples.
- Panel detects bacterial/fungal pathogens and antimicrobial resistance markers from urine.
- OpGen will present study data at ASM Microbe 2023 on June 17.
- Unyvero UTI aims to be first high multiplex molecular diagnostic IVD for urine cleared by FDA.

## SEC filing metadata
- accession: 0001079973-23-000500
- form_type: 8-K
- ticker: CFOR
- cik: 0001293818
- company_name: CapForce Inc.
- filed_at: 2023-04-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1293818/000107997323000500/0001079973-23-000500-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1293818/000107997323000500/opgen_8k-041823.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001079973-23-000500
- JSON: https://secwatch.observer/filing/0001079973-23-000500.json
- Plain text: https://secwatch.observer/filing/0001079973-23-000500.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.