GSP Instrument and GSP Neonatal hTSH Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K090846 FDA 510(k)
- FDA Product Code
- JLW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1690 FDA 510(k)
- Regulation Number
- 862.1690 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The GSP Neonatal hTSH Kit is a radioimmunoassay device designed for the quantitative measurement of human thyroid-stimulating hormone (hTSH) in dried blood spots from newborns. It functions as a screening tool to detect congenital hypothyroidism by analyzing blood specimens collected on filter paper.
This kit is intended for use with the GSP Instrument, a Class II medical device cleared by the FDA under 510(k) K090846. Supplied as a single-use diagnostic aid, it requires no sterilization beyond manufacturer-provided packaging. The device operates in clinical chemistry settings and complies with FDA regulatory requirements for neonatal screening assays.
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: GSP Neonatal hTSH kit - Revvity, GSP INSTRUMENT AND GSP NEONATAL HTSH KIT (K090846) — FDA 510 (k ..., GSP Neonatal hTSH kit - Revvity, PDF The assigned 5 10 (k) number is K090846 SP 320
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K090846 | Class II | Active |
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Manufacturer
- Manufacturer
- Perkinelmer, Inc.
Sources (1)
- FDA 510(k) K090846 24 fields · synced Sep 19, 2026