Neogram Pku Tandem Mass Spectrometry Kit
510(k) K021541
Active
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK021541 | Date28 Oct 2002 | StatusActive |
Recalls
-
- Terminated Z-0686-2013
Truncated V-Bottomed Microplate Wells used in assays contain defective wells.
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- Withdrawn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 NeoGram PKU Tandem Mass Spectrometry Kit is a Phenylalanine test system designed for quantitative screening of phenylalanine, tyrosine, and the phenylalanine-to-tyrosine ratio (Phe/Tyr) in dried blood spot specimens. This device employs tandem mass spectrometry to detect phenylketonuria (PKU) and related metabolic disorders by analyzing amino acid concentrations in neonatal or clinical samples. It operates as a diagnostic aid in clinical chemistry laboratories, providing objective measurements to support early identification of metabolic conditions.
The kit is supplied as a single-use reagent system for use with tandem mass spectrometry instrumentation, requiring no additional sterilization. It is classified under FDA regulation 862.1555 and falls under FDA Class II (Device Class 2) with a traditional 510(k) clearance (K021541). Storage and handling follow manufacturer guidelines to maintain reagent integrity, and its use is restricted to qualified laboratory settings with appropriate mass spectrometry capabilities. No MRI safety considerations apply, as the kit consists of non-magnetic consumables.
Other devices from Perkinelmer Life Sciences
Questions
AI-generated answers, 1 Oct 2026
What is the NeoGram PKU Tandem Mass Spectrometry Kit used for?
The NeoGram PKU Tandem Mass Spectrometry Kit is designed for quantitative screening of phenylalanine, tyrosine, and the phenylalanine-to-tyrosine ratio (Phe/Tyr) in dried blood spot specimens. It helps detect phenylketonuria (PKU) and related metabolic disorders by analyzing amino acid concentrations in neonatal or clinical samples, serving as a diagnostic aid in clinical chemistry laboratories for early identification of these conditions.
How is the NeoGram PKU Tandem Mass Spectrometry Kit supplied and prepared for use?
The kit is supplied as a single-use reagent system specifically for use with tandem mass spectrometry instrumentation. It does not require additional sterilization, as it is designed for one-time use. The system must be used in qualified laboratory settings equipped with appropriate mass spectrometry capabilities to ensure accurate and reliable results.
Is the NeoGram PKU Tandem Mass Spectrometry Kit sterile?
The kit is not intended to be sterilized further by the user, as it is supplied as a single-use reagent system. The manufacturer ensures the integrity of the reagents during production, and no additional sterilization steps are required before use.
Can the NeoGram PKU Tandem Mass Spectrometry Kit be reused?
No, the NeoGram PKU Tandem Mass Spectrometry Kit is explicitly designed for single-use only. Reusing the kit could compromise the accuracy of results and potentially introduce contamination, which is why it is intended for one-time use per sample analysis.
What storage and handling guidelines should be followed for the NeoGram PKU Tandem Mass Spectrometry Kit?
The kit must be stored and handled according to the manufacturer’s guidelines to maintain reagent integrity. Proper storage conditions, such as temperature and humidity control, are critical to preserving the performance and reliability of the reagents. Always follow the instructions provided to ensure optimal results and prevent degradation.