Dupont Dimension Amylase Method

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

510(k) Number

K942640 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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See all devices from Dupont Medical Products →

• What is the Dupont Dimension Amylase Method used for?

  The Dupont Dimension Amylase Method is a catalytic method used to measure amylase activity in biological specimens as part of clinical chemistry testing. It is intended for in vitro diagnostic use in clinical laboratory settings to support the assessment of pancreatic or salivary function based on amylase levels.

• How is the Dupont Dimension Amylase Method supplied and is it single-use?

  The device is supplied as a reagent system for in vitro diagnostic use. It is intended for use in clinical laboratory settings, and like most clinical chemistry reagents, it is designed for single-use per test run to ensure accuracy and prevent cross-contamination, though the exact number of tests per kit is not specified in the provided data.

• What regulatory pathway was used for the Dupont Dimension Amylase Method?

  The Dupont Dimension Amylase Method was cleared through the FDA 510(k) process under submission number K942640, which determined it to be substantially equivalent to a legally marketed predicate device. It is classified as a Class II medical device under regulation 862.1070 with product code JFJ.