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Microplate Neonatal GALT Assay

FDA 510(k)

Class II (US FDA 510(k))

510(k) K990827

by Bio-Rad

Identifiers

510(k) Number
K990827 FDA 510(k)
FDA Product Code
KQP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1315 FDA 510(k)
Regulation Number
862.1315 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Microplate Neonatal GALT Assay is a fluorescent enzymatic assay designed to measure galactose-1-phosphate uridyl transferase (GALT) activity. This enzyme deficiency is associated with classical galactosemia, a rare metabolic disorder. The assay quantifies GALT levels in neonatal dried blood spot samples, supporting early detection and diagnosis of galactosemia in newborns.

This assay is supplied as a fluorescent procedure for qualitative analysis and is classified as a Class II medical device under FDA regulations. It is intended for single-use in clinical chemistry laboratories and requires automated microplate readers for processing. The kit includes all necessary reagents and is regulated under FDA 510(k) clearance (K990827), with no third-party distribution. Storage conditions and sterility are not specified but follow standard laboratory protocols for enzymatic assays.

Frequently asked questions

What is the Microplate Neonatal GALT Assay used for?

The Microplate Neonatal GALT Assay is designed to measure galactose-1-phosphate uridyl transferase (GALT) enzyme activity in neonatal dried blood spot samples. GALT deficiency is linked to classical galactosemia, a rare metabolic disorder, so this assay supports early detection and diagnosis in newborns, enabling timely medical intervention.

How is the assay supplied and what equipment is required?

The assay is supplied as a complete fluorescent enzymatic procedure kit, including all necessary reagents for qualitative analysis. It is intended for single-use in clinical chemistry laboratories and requires automated microplate readers for processing. The kit is not designed for third-party distribution and must be used directly by authorized facilities.

Is the Microplate Neonatal GALT Assay sterile and how should it be stored?

The device data does not specify sterility requirements, but standard laboratory protocols for enzymatic assays should be followed. Storage conditions are also not explicitly detailed, so facilities should adhere to general guidelines for maintaining reagent stability, typically at controlled room temperature or as indicated on the kit packaging, away from direct light and moisture.

Can this assay be reused or is it intended for single-use?

The Microplate Neonatal GALT Assay is explicitly intended for single-use only. Each kit is designed for one analysis cycle, ensuring accuracy and preventing cross-contamination. Reuse is not supported and could compromise diagnostic reliability.

What regulatory pathway does this device follow?

The Microplate Neonatal GALT Assay is classified as a Class II medical device under FDA regulations and has obtained 510(k) clearance (K990827). It was reviewed by the FDA’s Clinical Chemistry (CH) advisory committee and is substantially equivalent to a predicate device, enabling its use in clinical chemistry laboratories for neonatal screening.

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: Microplate Neonatal Total Galactose (TGAL) Assay (S&S 2992 paper) - Bio-Rad, MICROPLATE NEONATAL GALT ASSAY (K990827) — FDA 510 (k) | Innolitics, Microplate Neonatal Total Galactose (TGAL) Assay (S&S 2992 paper) - Bio-Rad

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bio-Rad

Sources (1)

  • FDA 510(k) K990827 24 fields · synced Oct 1, 2026