# Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry
> **Food and Drug Administration** · Final rule. · Published 2004-11-24 · Effective 2004-12-27 · 69 FR 68254
## Document
- **Document number:** 04-25975
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 68254
- **CFR reference:** 21 CFR 862
- **Publication date:** 2004-11-24
- **Effective date:** 2004-12-27
- **HHS docket:** Docket No. 2004N-0482
## Abstract

The Food and Drug Administration (FDA) is classifying newborn screening test systems for amino acids, free carnitine, and acylcarnitines using tandem mass spectrometry into class II (special controls). The special control that will apply to the device is the guidance document entitled "Class II Special Controls Guidance Document: Newborn Screening Test Systems for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry." The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976, the Safe Medical Devices Act of 1990, the Food and Drug Administration Modernization Act of 1997, and the Medical Device User Fee and Modernization Act of 2002. The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/11/24/04-25975/medical-devices-clinical-chemistry-and-clinical-toxicology-devices-classification-of-newborn)
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