secwatch.observer — SEC 8-K summary
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Issuer:     CapForce Inc. (CFOR)
CIK:        0001293818
Form:       8-K
Filed at:   2023-04-18T23:59:59+00:00
Accession:  0001079973-23-000500
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1293818/000107997323000500/0001079973-23-000500-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1293818/000107997323000500/opgen_8k-041823.htm
  HTML page:      https://secwatch.observer/filing/0001079973-23-000500

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer