# K974779: Abbott Alcyon (TM) 300 (Without Ise Module) and 300I (with Ise Module) Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Feb 13, 1998 after 53 days
- Product code: JJE (Analyzer, Chemistry (Photometric, Discrete), For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2160
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K861087 (1986). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935662: Synermed IR 500 Chemistry Analyzer, Synermed, Inc. (1994) Summary page 2.
- K823480: IL 943 Flame Photometer, Instrumentation Laboratory CO (1983) Summary page 3.
- K791312: Catalog #4-2520 Chloridometer Chloride, Buchler Instruments, Inc. (1979) Summary page 3.
- K972673: Avl 9181 Electrolyte Analyzer, Avl Scientific Corp. (1997) Summary page 3.

## Cited in the summary but kept off the family tree
- K972040: Roche Cobas Mira Plus. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 2.

## Indications for use
The ALCYON Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. The analyzer with the optional Ion-Selective Electrode (ISE) Module measures the concentration of the electrolytes, sodium, potassium, and chloride, in samples using indirect potentiometry.

Source page: https://510kreport.com/device/K974779
Methodology: https://510kreport.com/methodology