RIACOAT T-4

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K833745 ↗

FDA Product Code

CDX

Device Class

Class II

Regulation

21 CFR Part 862.1700

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• T4 Ria Kit

  Class II

  FDA 510(k) K810811 Active Cleared 7 Apr 1981

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  Class II

  FDA 510(k) K811213 Active Cleared 29 May 1981

• Tsh (Ria) Kit

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  FDA 510(k) K820089 Active Cleared 28 Jan 1982

• Digoxin (Ria) Kit

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• Tbg Diagnostic Kit

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  FDA 510(k) K811725 Active Cleared 10 Jul 1981

• Combo-Fer Iron Diagnostic

  Class I

  FDA 510(k) K811954 Active Cleared 27 Jul 1981

See all devices from Immuno Assay Corp. →

• What is the RIACOAT T-4 used for?

  The RIACOAT T-4 is a radioimmunoassay kit designed specifically for measuring total thyroxine (T4) levels in plasma or serum samples. It employs a coated-tube method where labeled and unlabeled thyroxine compete for binding sites on thyroxine antibody-coated tubes. This competitive binding allows for precise quantitative measurement of T4 concentrations, which is critical for diagnosing and monitoring thyroid-related conditions.

• How is the RIACOAT T-4 kit supplied and used?

  The RIACOAT T-4 is supplied as a single-use diagnostic kit. To perform the assay, undiluted samples, standards, and controls are incubated with tracer in the thyroxine antibody-coated tubes for 2 hours. This incubation period enables the competitive binding reaction to occur, allowing for the determination of T4 levels. The kit is intended exclusively for in vitro diagnostic use in clinical chemistry laboratories.

• Is the RIACOAT T-4 kit sterile?

  The provided data does not specify any sterility requirements or claims for the RIACOAT T-4 kit. Users should follow standard laboratory protocols for handling and preparing samples to ensure safety and accuracy, particularly since it is intended for in vitro diagnostic use.

• Can the RIACOAT T-4 kit be reused?

  The RIACOAT T-4 is explicitly designed as a single-use diagnostic kit. Reusing components could compromise the accuracy of results and potentially introduce contamination or cross-reactivity, which is why it is not recommended. Each kit is intended for one assay cycle only.

• What regulatory pathway does the RIACOAT T-4 follow?

  The RIACOAT T-4 received FDA clearance under the 510(k) pathway, specifically with clearance number K833745. It is classified under Clinical Chemistry and is substantially equivalent to a predicate device, as determined by the FDA. The product code assigned is CDX, indicating its classification in diagnostic clinical chemistry.