DMA Amylase Procedure

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K931559 ↗

FDA Product Code

CIW

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Hemoglobin Controls

  Class II

  FDA 510(k) K790457 Active Cleared 4 Apr 1979

• Gamma Glutamyl Transferase Procedure

  Class I

  FDA 510(k) K863586 Active Cleared 3 Oct 1986

• Direct Bilirubin Procedure

  Class II

  FDA 510(k) K881166 Active Cleared 28 Apr 1988

• Data-Zyme Glucose Hexokinase UV

  Class II

  FDA 510(k) K801052 Active Cleared 23 May 1980

• Data-Zyme Triglyceride Procedure

  Class I

  FDA 510(k) K780379 Active Cleared 12 May 1978

• Magnesium Procedure

  Class I

  FDA 510(k) K861668 Active Cleared 27 May 1986

See all devices from Data Medical Associates, Inc. →

• What is the DMA Amylase Procedure used for?

  The DMA Amylase Procedure is an in vitro diagnostic device designed to measure amylase activity quantitatively in serum or plasma samples. Amylase levels are critical for diagnosing and monitoring conditions like pancreatitis, mumps, or other disorders affecting amylase secretion, such as salivary gland dysfunction or diabetes-related complications. By detecting enzyme activity via a starch-dye bound polymer substrate, it provides objective data to support clinical decision-making in clinical chemistry laboratories.

• How is the DMA Amylase Procedure supplied and intended for use?

  This device is supplied as a reagent kit, specifically formulated for single-use in clinical chemistry laboratories. It adheres to standard laboratory protocols and requires careful handling to ensure accurate results. The kit includes all necessary components for the starch-dye polymer reaction, enabling precise measurement of amylase activity in patient samples. Laboratories must follow the included instructions for proper storage and usage to maintain sterility and performance.

• Is the DMA Amylase Procedure sterile and reusable?

  The DMA Amylase Procedure is intended for single-use only, meaning each kit is designed for one test cycle. Sterility is maintained through controlled manufacturing and packaging, ensuring reliability for clinical applications. Reuse is not recommended or supported, as it could compromise accuracy, sterility, or regulatory compliance. Laboratories should discard unused components after opening to prevent contamination.

• What storage conditions are required for the DMA Amylase Procedure?

  The DMA Amylase Procedure must be stored under controlled conditions as specified in the accompanying instructions to preserve its efficacy. Typically, this includes protection from extreme temperatures, humidity, and light exposure. The reagent kit should be kept in a cool, dry environment (e.g., 2–8°C) until use, and any unused portions should be discarded promptly to avoid degradation. Adhering to these guidelines ensures the polymer substrate remains stable for accurate amylase measurement.

• What regulatory pathway does the DMA Amylase Procedure follow?

  The DMA Amylase Procedure holds FDA 510(k) clearance under the Traditional pathway, classified as a Class 2 device with product code CIW. This classification reflects its role in clinical chemistry, where moderate risk is associated with ensuring accurate diagnostic results. The clearance (K931559) was granted in 1993 after demonstrating substantial equivalence to a predicate device, confirming its safety and performance for measuring amylase activity in serum or plasma.