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# 3 De Novo Device Classifications
- URL: https://www.fdaweb.com/3-de-novo-device-classifications/
- Published: 2024-09-16T12:00:00.000Z
- Updated: 2026-09-14T14:41:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157779

*Federal Register* notices: FDA has classified the following three devices into Class 2 (special controls) based on *de novo* classification requests:

- Clozapine test systems — Saladax Biomedical *de novo* classification request for MyCare Psychiatry Clozapine Assay Kit. The device is intended to measure clozapine in human specimens, and the results are used in monitoring levels of clozapine to ensure appropriate therapy in patients with treatment-resistant schizophrenia. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20895.pdf?ref=fdaweb.com).
- Device to detect or measure nucleic acid from viruses associated with head and neck cancers — Advance Sentry *de novo* classification request for the NP Screen. The in vitro diagnostic test is intended for prescription use in detecting viral nucleic acid in nasopharyngeal or oropharyngeal cellular specimens from patients with signs and symptoms of head and neck cancer. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20896.pdf?ref=fdaweb.com).
- Pediatric continuous renal replacement therapy system — Medtronic *de novo* classification of the Carpediem System. The device is intended for use as an artificial kidney system for the management of pediatric patients with acute kidney injury or fluid overload by performing such therapies as hemodialysis, hemofiltration, hemodiafiltration, and isolated ultrafiltration. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-16/pdf/2024-20999.pdf?ref=fdaweb.com).