Vitalab Amylase Reagent

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

510(k) Number

K040534 ↗

FDA Product Code

JFJ

Device Class

Class II

Regulation

21 CFR Part 862.1070

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• In-Vitro Test Determination Total Bilirubin

  Class II

  FDA 510(k) K854180 Active Cleared 25 Nov 1985

• Centurion-II, Model 3103 Apnea/Brady Cardia Trachy

  Class II

  FDA 510(k) K851889 Active Cleared 23 Oct 1985

• Vitalab Uric Acid Reagent

  Class I

  FDA 510(k) K040467 Active Cleared 8 Mar 2004

• Envoy 500 Hdl; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)

  Class I

  FDA 510(k) K071706 Active Cleared 20 Dec 2007

• Full-Disclosure Ambulatory ECG System

  Class II

  FDA 510(k) K823529 Active Cleared 15 Dec 1982

• Vitalab Direct Bilirubin Reagent

  Class II

  FDA 510(k) K040631 Active Cleared 18 Mar 2004

See all devices from Clinical Data →

• What is the Vitalab Amylase Reagent used for?

  The Vitalab Amylase Reagent is a catalytic method reagent specifically designed for measuring amylase levels in clinical chemistry. It works by catalyzing the breakdown of 2-chloro-4-nitrophenyl-α-D-maltotrioside, producing 2-chloro-4-nitrophenol to enable quantitative determination of amylase in serum or plasma samples. This makes it essential for diagnosing conditions related to amylase activity, such as pancreatitis or other pancreatic disorders.

• Is the Vitalab Amylase Reagent compatible with other analyzers?

  No, the Vitalab Amylase Reagent is exclusively intended for use with the Vitalab Selectra Analyzer. It is not designed or validated for compatibility with other clinical chemistry analyzers, so using it with alternative systems could compromise accuracy or functionality.

• How is the Vitalab Amylase Reagent supplied, and what are its handling requirements?

  The reagent is supplied as a single-part solution, with no explicit sterility or single-use designation noted. Handling and storage must adhere to standard laboratory protocols for reagent stability and contamination control. This includes protecting it from light, extreme temperatures, and physical contamination to preserve its catalytic activity and measurement reliability.

• Is the Vitalab Amylase Reagent reusable or single-use?

  The Vitalab Amylase Reagent is not explicitly labeled as single-use or reusable in the provided data. However, since it is a liquid reagent used in enzymatic assays, it is typically intended for single-use per batch to maintain accuracy and prevent cross-contamination. Laboratories should follow their internal protocols for reagent usage and disposal to ensure compliance with clinical chemistry best practices.

• What regulatory pathway does the Vitalab Amylase Reagent follow?

  The Vitalab Amylase Reagent is classified as a Class II device under FDA regulation 862.1070 and holds a 510(k) clearance (K040534) for substantial equivalence. This means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and performance requirements for in vitro diagnostic use in clinical chemistry.