NeoLynx Screening Application Manager
510(k) K003584
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003584 | Date19 Mar 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JNB
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1555
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NeoLynx Screening Application Manager is a software application designed for use with mass spectrometry systems to analyze and quantify phenylalanine and tyrosine levels in biological samples. Classified under the Ninhydrin and L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine device type (FDA Product Code: JNB), it supports clinical chemistry applications by enabling automated screening and data processing for amino acid measurements in serum, plasma, and urine samples. This tool aids in the detection and monitoring of metabolic disorders, such as phenylketonuria (PKU), by providing precise analytical results.
The device is supplied as a standalone software application, intended for integration with mass spectrometry instrumentation. It is not classified as single-use or reusable but rather as a reusable analytical tool, requiring installation on a compatible computing platform. The software operates in clinical chemistry laboratories and is regulated under FDA 510(k) clearance (K003584), with no explicit sterility or MRI safety requirements stated. Storage and usage depend on the host system’s specifications, and no additional regulatory markings beyond the FDA clearance are referenced in the device data.
Questions
AI-generated answers, 1 Oct 2026
What is the NeoLynx Screening Application Manager used for?
The NeoLynx Screening Application Manager is a software application designed to analyze and quantify phenylalanine and tyrosine levels in biological samples such as serum, plasma, and urine. It automates screening and data processing for amino acid measurements, which helps clinicians detect and monitor metabolic disorders like phenylketonuria (PKU). By integrating with mass spectrometry systems, it provides precise analytical results to support clinical chemistry workflows.
How is the NeoLynx Screening Application Manager supplied and installed?
The NeoLynx Screening Application Manager is supplied as a standalone software application. It is not a physical device but rather a reusable analytical tool that requires installation on a compatible computing platform. The software is intended for use in clinical chemistry laboratories and must be integrated with mass spectrometry instrumentation to function effectively.
Is the NeoLynx Screening Application Manager single-use or reusable?
The NeoLynx Screening Application Manager is classified as a reusable analytical tool. Unlike single-use devices, it is designed for repeated use within a clinical setting, provided it is installed on a properly maintained and compatible computing platform. The software itself does not require replacement after each use.
Does the NeoLynx Screening Application Manager have sterility or MRI safety requirements?
The NeoLynx Screening Application Manager does not have explicit sterility or MRI safety requirements. As a software application, its functionality depends entirely on the host system’s specifications and environmental conditions. There are no regulatory markings or certifications related to sterility or MRI compatibility for this device.
What regulatory clearance does the NeoLynx Screening Application Manager hold?
The NeoLynx Screening Application Manager holds FDA 510(k) clearance under the classification of Ninhydrin and L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine, with the clearance number K003584. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device and is regulated under FDA guidelines for clinical chemistry applications.