Coated Tube High Sensitivity Tsh 100 Uiu/Ml Stan.

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

510(k) Number

K895648 ↗

FDA Product Code

JIT

Device Class

Class II

Regulation

21 CFR Part 862.1150

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Ventrex Laboratories, Inc. →

• What is the Coated Tube High Sensitivity TSH 100 UIU/ml Standard used for?

  This device is a secondary calibrator designed specifically for measuring thyroid-stimulating hormone (TSH) levels in clinical chemistry laboratories. It provides a standardized reference to ensure high-sensitivity TSH assays deliver accurate and consistent results, which is critical for diagnosing thyroid disorders like hypothyroidism or hyperthyroidism.

• How is the Coated Tube High Sensitivity TSH 100 UIU/ml Standard supplied, and is it reusable?

  The calibrator is supplied as a single-use item, meaning each tube is intended for one measurement cycle. This design minimizes contamination risk and ensures the integrity of results, as reusing calibrators could compromise accuracy due to potential degradation or cross-contamination.

• What concentration of TSH does this calibrator provide, and why is this important?

  This calibrator provides a standardized TSH concentration of 100 UIU/ml, which is essential for calibrating assay systems to a known reference. High-sensitivity TSH assays require precise calibration to detect even low TSH levels, which is vital for early diagnosis of thyroid dysfunction in patients.

• Are there any specific storage requirements for this calibrator?

  While the provided data does not specify exact storage conditions, standard laboratory protocols for calibrators should be followed to maintain stability and accuracy. This typically includes storing the device in a clean, dry environment away from direct light, extreme temperatures, and contaminants until use. Always refer to manufacturer guidelines for optimal handling.

• What regulatory pathway was followed for this device’s clearance?

  The Coated Tube High Sensitivity TSH 100 UIU/ml Standard received FDA 510(k) clearance under the Traditional pathway, classified as a Class II device (regulation number 862.1150). This pathway confirms the device is substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for clinical chemistry calibrators.