Immuchem Neonatal TSH-MP ELISA

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

510(k) Number

K913963 ↗

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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• What is the Immuchem Neonatal TSH-MP ELISA used for in clinical practice?

  The Immuchem Neonatal TSH-MP ELISA is designed for the quantitative measurement of Thyroid-Stimulating Hormone (TSH) in neonatal blood spots. It aids in early detection of thyroid dysfunction in newborns, helping clinicians identify potential congenital hypothyroidism or other thyroid-related conditions during routine neonatal screening.

• Is the Immuchem Neonatal TSH-MP ELISA intended for single-use or repeated use?

  The device is explicitly supplied as a single-use diagnostic kit, meaning each kit is intended for one-time use in clinical chemistry laboratories. This ensures accuracy and prevents cross-contamination between samples.

• What storage requirements does the Immuchem Neonatal TSH-MP ELISA have?

  The kit does not require special storage conditions beyond those outlined in the accompanying instructions. Standard laboratory storage practices should be followed to maintain its integrity and performance.

• How was the regulatory pathway for this device determined?

  The Immuchem Neonatal TSH-MP ELISA received FDA 510(k) clearance under the classification of Class II medical devices (regulation number 862.1690). The device was determined to be *substantially equivalent* to a predicate product, and the review was conducted by the Clinical Chemistry (CH) advisory committee. The clearance type was traditional, meaning a full submission was reviewed by the FDA.

• What type of laboratory equipment is needed to use the Immuchem Neonatal TSH-MP ELISA?

  The kit is designed for use in clinical chemistry laboratories with standard laboratory equipment. No specialized tools or instruments are required beyond those commonly available for ELISA-based assays.