Aqualite Free T Assay

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

Full name

Sealite Sciences, Inc. Aqualite Free T, Assay

510(k) Number

K974551 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Sealite Sciences Inc.

  Class II

  FDA 510(k) K941983 Active Cleared 18 Aug 1994

• Aqualite Intact Pth

  Class II

  FDA 510(k) K970483 Active Cleared 14 Apr 1997

• Sealite Sciences, Inc. Aqualite Lh

  Class I

  FDA 510(k) K964925 Active Cleared 22 Jan 1997

• Sealite Science, Inc. Aqualite(R) Lh

  Class I

  FDA 510(k) K943188 Active Cleared 20 Oct 1994

• Sealite Sciences, Inc. Aqualite Prolactin

  Class I

  FDA 510(k) K970188 Active Cleared 20 Feb 1997

• Aqualite Fsh

  Class I

  FDA 510(k) K943437 Active Cleared 28 Dec 1994

See all devices from Sealite Sciences, Inc. →

• What is the Aqualite Free T Assay used for?

  The Aqualite Free T Assay is a single-site competitive inhibition bioluminescent immunoassay (BIA) designed specifically for the quantitative measurement of free thyroxine (T4) levels in human serum. It provides precise detection of free T4, which is critical for diagnosing and monitoring thyroid function disorders, such as hyperthyroidism or hypothyroidism. The assay’s solid-phase technique ensures accuracy by immobilizing a T4 carrier complex on polystyrene tubes, enabling reliable results.

• How is the Aqualite Free T Assay supplied, and is it single-use?

  The Aqualite Free T Assay is supplied as a single-use kit, meaning each kit is intended for one-time use only. This design ensures sterility and consistency in results, as reuse could compromise accuracy or introduce contamination. The kit includes all necessary components for testing, including calibrators, controls, and reagents, eliminating the need for additional supplies beyond the 50 µL human serum sample required per assay.

• What are the key steps involved in performing the Aqualite Free T Assay?

  The assay process begins with adding 50 µL of human serum, calibrator, or control to the polystyrene tube. Next, a mouse monoclonal anti-T4 antibody linked to AquaLite® is introduced, followed by a 90-minute incubation on an orbital shaker. This step allows the antibody to bind to free T4 in the sample, enabling precise detection through bioluminescent signaling. The solid-phase technique ensures that unbound components are washed away, leaving only the T4-antibody complex for measurement.

• Is the Aqualite Free T Assay suitable for use in all clinical chemistry laboratories?

  Yes, the Aqualite Free T Assay is explicitly intended for use in clinical chemistry laboratories equipped to perform bioluminescent immunoassays. Its design—including the requirement for an orbital shaker and specific incubation conditions—ensures compatibility with standard laboratory workflows. The assay’s FDA 510(k) clearance (K974551) and classification under device class II for in vitro diagnostic use further validate its suitability for regulated clinical settings.

• How should the Aqualite Free T Assay be stored, and what precautions should be taken?

  The Aqualite Free T Assay should be stored according to the manufacturer’s instructions provided in the kit documentation. Typically, single-use assay kits are stored in a cool, dry place, protected from direct light and extreme temperatures. Since it is a single-use product, it is important to avoid exposure to contaminants or moisture before use. Always check the expiration date on the packaging, as expired reagents may yield inaccurate results. Proper handling ensures the integrity of the assay components and maintains the reliability of the test.