C-Terminal/Mid-Molecule Parathyroid -

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K843685 ↗

FDA Product Code

CEW

Device Class

Class II

Regulation

21 CFR Part 862.1545

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Quest Diagnostics Nichols Institute →

• What clinical conditions is this device designed to help diagnose or monitor using C-terminal and mid-molecule PTH measurements?

  This radioimmunoassay (RIA) kit quantifies both intact and fragmented forms of parathyroid hormone (PTH), which aids in diagnosing and monitoring parathyroid disorders such as hyperparathyroidism and renal failure. By detecting C-terminal and mid-molecule PTH, it provides broader insights into PTH levels beyond just intact PTH, helping clinicians assess parathyroid function more comprehensively.

• Is this device intended for use in all clinical laboratory settings, or are there specific requirements?

  The kit is explicitly intended for use in clinical laboratories and is classified as a Class II device under FDA regulation 862.1545. While no additional laboratory-specific requirements are detailed beyond standard reagent handling, it is designed for professional diagnostic use by trained personnel in accredited laboratory environments.

• How is this device supplied, and is it reusable or single-use?

  The device is supplied as a single-use diagnostic reagent kit, meaning each kit is intended for one-time use only. This design ensures consistency in results and reduces the risk of contamination or cross-reactivity between tests, which is critical for accurate PTH measurement in clinical chemistry.

• What regulatory pathway was followed for this device’s clearance, and how does that affect its use?

  This device received FDA clearance through a 510(k) submission (K843685) under the Traditional clearance type, determined to be Substantially Equivalent to a predicate device. The clearance was reviewed by the Clinical Chemistry (CH) Advisory Committee, confirming its classification as a Class II device for use in clinical laboratories. This pathway ensures compliance with FDA standards for diagnostic reagents.

• Are there any special storage instructions provided for this kit beyond standard reagent handling?

  The provided data does not specify any unique storage conditions beyond what is typical for reagent kits. As a standard diagnostic reagent, it should be stored according to manufacturer guidelines (e.g., refrigeration, protection from light) to maintain stability and accuracy. Always refer to the included instructions for precise storage recommendations.