Accuscreen TSH

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843281 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Neometrics, Inc. →

• What clinical specialty is the Accuscreen TSH intended for use in, and why is this relevant?

  The Accuscreen TSH is intended for use in clinical chemistry laboratories, as specified by its advisory committee designation. This is relevant because it ensures the device is designed and validated for the precise diagnostic needs of thyroid hormone analysis, which falls under the purview of clinical chemistry. Clinicians and labs specializing in endocrinology or general chemistry will rely on this device for accurate TSH measurements, aiding in the diagnosis and monitoring of thyroid disorders like hypothyroidism and hyperthyroidism.

• Is the Accuscreen TSH a single-use or reusable device, and what does this mean for my lab’s workflow?

  The Accuscreen TSH is supplied as a single-use reagent kit, meaning each kit is intended for one test cycle only. This design eliminates the need for sterilization beyond the manufacturer-provided packaging, simplifying workflows by reducing contamination risks and ensuring consistent performance. Labs should account for this in inventory management, as each kit must be replaced after use.

• How do I know the device meets regulatory standards, and what does the FDA 510(k) clearance (K843281) indicate?

  The Accuscreen TSH holds an FDA 510(k) clearance (K843281), which means it has been determined to be substantially equivalent to a legally marketed device already on the market. This clearance indicates that the device’s design, performance, and safety have been reviewed and approved by the FDA for its intended use in measuring TSH levels in serum or plasma. While it doesn’t imply ongoing approval for specific clinical indications, it confirms the device adheres to regulatory requirements for in vitro diagnostic use.

• Where should I store the Accuscreen TSH kits, and what precautions should I take?

  Storage conditions for the Accuscreen TSH kits are detailed in the accompanying documentation provided by Neometrics, Inc. While the specifics aren’t listed here, typical radioimmunoassay reagents require protection from extreme temperatures, light, and moisture. Since it’s a single-use kit, ensure it remains unopened and sealed until use to maintain sterility and accuracy. Always follow the manufacturer’s instructions to preserve the device’s integrity and performance.

• What type of immunologic technique does the Accuscreen TSH use, and how does this affect its accuracy?

  The Accuscreen TSH employs radioimmunoassay (RIA) techniques to quantify thyroid-stimulating hormone (TSH) levels in serum or plasma. RIA is a highly sensitive method that relies on competitive binding between labeled and unlabeled TSH to measure concentrations accurately. This technique is well-established for thyroid diagnostics, ensuring reliable results for diagnosing and monitoring thyroid disorders like hypothyroidism or hyperthyroidism. The device’s design leverages this method to provide precise measurements within its intended clinical chemistry context.