Technicon Star System

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K791549 ↗

FDA Product Code

DON

Device Class

Class II

Regulation

21 CFR Part 862.3320

Advisory Committee

Clinical Toxicology

FDA Decision

SESE Substantially Equivalent

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See all devices from Technicon Instruments Corp. →

• What type of assay does the Technicon Star System perform?

  It conducts a radioimmunoassay for digoxin using iodine‑125 labeled antigen, rabbit‑derived antibody, and solid‑phase separation. This combination provides quantitative measurement of digoxin levels in clinical toxicology specimens.

• How was the Technicon Star System cleared for market?

  The device received FDA 510(k) clearance (K791549) through the traditional pathway, with a substantially equivalent decision (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device.

• Is the Technicon Star System a single‑use or reusable instrument?

  The system is a reusable laboratory instrument; however, the assay reagents such as the rabbit antibody and 125‑I labeled digoxin are supplied as consumables that must be replaced according to the manufacturer’s protocol to maintain assay performance.

• What clinical specialty is the Technicon Star System intended for?

  It is intended for use in clinical toxicology, specifically for measuring digoxin concentrations in patients where toxicity or therapeutic monitoring is a concern.

• What regulatory classification does the Technicon Star System have?

  The device is classified as a Class 2 medical device, reflecting moderate risk and requiring special controls. Its classification aligns with its function as a radioimmunoassay instrument for digoxin.