Browse hierarchy: [Microbiology (MI)](/submissions/MI) → [Subpart F — Immunological Test Systems](/submissions/MI/subpart-f%E2%80%94immunological-test-systems) → [21 CFR 866.5910](/submissions/MI/subpart-f%E2%80%94immunological-test-systems/866.5910) → SCU — Dna And Rna Oncology Controls

# SCU · Dna And Rna Oncology Controls

_Microbiology · 21 CFR 866.5910 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/SCU

## Overview

- **Product Code:** SCU
- **Device Name:** Dna And Rna Oncology Controls
- **Regulation:** [21 CFR 866.5910](/submissions/MI/subpart-f%E2%80%94immunological-test-systems/866.5910)
- **Device Class:** 2
- **Review Panel:** [Microbiology](/submissions/MI)

## Identification

Quality control material for cystic fibrosis nucleic acid assays. A quality control material for cystic fibrosis nucleic acid assays is a device intended to help monitor reliability of a test system by detecting analytical deviations such as those that may arise from reagent or instrument variation in genetic testing. This type of device includes recombinant, synthetic, and cell line-based DNA controls.

## Classification Rationale

Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.

## Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays.” See § 866.1(e) for the availability of this guidance document.

The device is classified as Class II under regulation 21 CFR 866.5910 with special controls. The special control guidance document "Class II Special Controls Guidance Document: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays" is available at http://www.fda.gov/cdrh/oivd/guidance/1614.html.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/SCU](https://fda.innolitics.com/submissions/MI/subpart-f%E2%80%94immunological-test-systems/SCU)

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