Ra System, Analyte Serum Amylase (30C and 37C)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K871269 ↗

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 Technicon Instruments Corp. →

• What clinical purpose does the RA System, Analyte Serum Amylase (30°C and 37°C) serve in a lab setting?

  This device is designed for the quantitative measurement of serum amylase activity at two specific temperatures—30°C and 37°C—using catalytic assay methods. It falls under clinical chemistry instruments and is used to aid in biochemical analysis for diagnostic purposes, such as assessing pancreatic function or identifying conditions like pancreatitis.

• Is this device intended for single-use or can it be reused in a clinical laboratory?

  The regulatory data does not specify whether the RA System is single-use or reusable. Laboratories must follow their own established protocols for device maintenance, cleaning, and reuse based on manufacturer guidelines and infection control standards.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it belong to?

  The RA System received FDA 510(k) clearance under the Traditional review pathway and is classified as a Class II device under 21 CFR 862.1070. This classification indicates it poses moderate risk and requires special controls to ensure safety and effectiveness.

• Are there any special storage or handling requirements for this device beyond standard laboratory practices?

  The regulatory data does not provide specific storage or handling instructions beyond typical clinical laboratory requirements. Laboratories should follow the manufacturer’s guidelines and general best practices for maintaining instrument performance and sterility.

• What types of facilities or settings is this device authorized for use in?

  This device is authorized for use in clinical laboratory settings, where precise biochemical analysis is conducted. It is not intended for point-of-care or home-use environments, as its design and regulatory classification align with controlled laboratory environments.