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PerkinElmer EnLite Neonatal TREC Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) DEN140010

by Wallac Oy

Identifiers

510(k) Number
DEN140010 FDA 510(k)
FDA Product Code
PJI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 866.5930 FDA 510(k)
Regulation Number
866.5930 FDA 510(k)
Advisory Committee
Immunology FDA 510(k)
FDA Decision
DENG FDA 510(k)

The PerkinElmer EnLite Neonatal TREC Test System is a Severe Combined Immunodeficiency Disorder (SCID) Newborn Screening Test System, classified under Class II devices. It performs a semiquantitative determination of T-cell receptor excision circle (TREC) DNA in dried blood specimens collected on filter paper, aiding in the detection of SCID in newborns. TRECs are epigenetic markers used to assess T-cell development, enabling early identification of immune system deficiencies.

This system is designed for use with the VICTOR EnLite instrument and operates as an in vitro diagnostic device. Supplied as a kit, it includes reagents for polymerase chain reaction (PCR) assays and is intended for single-use in clinical laboratory settings. The device is FDA-cleared under 510(k) number DEN140010 and adheres to regulatory standards for immunology-based newborn screening. Storage and handling follow manufacturer guidelines to maintain assay integrity.

Frequently asked questions

What clinical condition does this test help identify in newborns and how does it work?

The PerkinElmer EnLite Neonatal TREC Test System is designed to aid in the early detection of Severe Combined Immunodeficiency Disorder (SCID), a rare but life-threatening immune system deficiency. It does this by measuring T-cell receptor excision circles (TRECs), which are epigenetic markers reflecting T-cell development. Low TREC levels in dried blood samples from newborns can indicate impaired immune function, prompting further diagnostic evaluation for SCID.

Is this test intended for use in hospitals, clinics, or only specialized laboratories?

This system is specifically intended for use in clinical laboratory settings, where trained personnel can perform the semiquantitative TREC DNA analysis. While it requires specialized equipment (the VICTOR EnLite instrument) and reagents, it is not designed for point-of-care or home use. Laboratories must follow manufacturer guidelines to ensure proper handling and assay integrity.

How is the test supplied, and is it meant for single-use or repeated testing?

The PerkinElmer EnLite Neonatal TREC Test System is supplied as a kit containing reagents for polymerase chain reaction (PCR) assays. It is explicitly designed for single-use per test cycle, meaning each kit is intended for one analysis of a dried blood specimen on filter paper. This ensures consistency and prevents cross-contamination between samples.

What type of blood sample does this test require, and how should it be stored?

The test uses dried blood specimens collected on filter paper, a common method for newborn screening programs. While the kit itself does not include storage instructions for the blood spots, the manufacturer’s guidelines (referenced in the description) must be followed to maintain assay integrity. Typically, such samples are stored at room temperature in a dry environment until testing, but exact conditions should be confirmed with the provided documentation.

What instrument is required to run this test, and is it compatible with other systems?

This test system is designed exclusively for use with the PerkinElmer VICTOR EnLite instrument. It is not compatible with other luminometers or PCR platforms, as the assay protocols and detection methods are optimized for this specific instrument. Laboratories must ensure they have the correct hardware to perform the TREC analysis accurately.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM (DEN140010) — FDA 510(k ..., PDF Wallac Oy, a Subsidiary of Perkinelmer, Inc., AccessGUDID - DEVICE: EnLite Neonatal TREC kit (06438147331819)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wallac Oy

Sources (1)

  • FDA 510(k) DEN140010 24 fields · synced Sep 20, 2026