← Back to catalogue

Total Triiodothyronine (T3) Microplate EIA

FDA 510(k)

Class II (US FDA 510(k))

510(k) K971779

by Monobind, Inc.

Identifiers

510(k) Number
K971779 FDA 510(k)
FDA Product Code
CDP FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1710 FDA 510(k)
Regulation Number
862.1710 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Total Triiodothyronine (T3) Microplate EIA is an enzyme immunoassay (EIA) designed for the quantitative measurement of total triiodothyronine (T3) in serum or plasma samples. As a radioimmunoassay variant, it employs competitive binding between free T3 in the sample and T3-coated microplate wells to detect hormone levels, enabling clinical assessment of thyroid function.

This device is supplied as a 96-well microplate for in vitro diagnostic use in clinical chemistry laboratories. It is intended for single-use and requires no sterilization beyond manufacturer-provided packaging. The assay adheres to FDA 510(k) clearance (K971779) under the Clinical Chemistry advisory committee, classified as a Class II device (CDP) under regulation 862.1710. Storage and handling follow standard laboratory protocols for immunoassay reagents.

Frequently asked questions

What is the Total Triiodothyronine (T3) Microplate EIA used for?

This device is designed for the quantitative measurement of total triiodothyronine (T3) in serum or plasma samples. By employing a competitive enzyme immunoassay (EIA) method, it detects free T3 levels, enabling clinicians to assess thyroid function accurately. The results help diagnose and monitor conditions related to thyroid hormone imbalance.

How is the Total Triiodothyronine (T3) Microplate EIA supplied?

The assay is supplied as a 96-well microplate, which is intended for in vitro diagnostic use in clinical chemistry laboratories. Each microplate is pre-packaged and ready for immediate use, with no additional sterilization required beyond the manufacturer’s sealed packaging.

Is the Total Triiodothyronine (T3) Microplate EIA single-use or reusable?

This device is designed for single-use only. After use, the microplate should be discarded to maintain accuracy and prevent cross-contamination. Single-use ensures consistent performance and reduces the risk of carryover errors in subsequent assays.

What storage and handling instructions apply to this device?

The Total Triiodothyronine (T3) Microplate EIA follows standard laboratory protocols for immunoassay reagents. It should be stored according to the manufacturer’s instructions, typically at refrigerated temperatures (2–8°C) until use. Avoid exposure to extreme temperatures, direct sunlight, or contamination. Always check the packaging for specific storage guidelines before use.

What regulatory pathway does this device follow?

This device is cleared by the FDA under the 510(k) premarket notification process (K971779) and classified as a Class II device under regulation 862.1710. It was determined to be substantially equivalent to a predicate device through the Clinical Chemistry advisory committee, ensuring compliance with U.S. regulatory standards for in vitro diagnostics.

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: Monobind Total Triiodothyronine (T3) Microplate EIA (7973), Monobind.com: T3/ FT3 ELISA Microplate, Monobind Inc. T3/ FT3 Coated Plate - ELISA | Sigma-Aldrich

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Monobind, Inc.
FDA Applicant
Monobind

Sources (1)

  • FDA 510(k) K971779 24 fields · synced Oct 1, 2026