# K952719: Biocircuits Ios (in-Office System)

- Pathway: 510(k) (Traditional)
- Applicant: Biocircuits Corp.
- Decided: Nov 22, 1995 after 160 days
- Product code: KHO (Fluorometer, For Clinical Use)
- Device class: 1
- Regulation: 21 CFR 862.2560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K890908: Stratus (R) II Fluorometric Analyzer & Accessories, Baxter Healthcare Corp (1989). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The IOS™ system is intended for use with specific IOS™ test cartridges in clinical laboratories, physicians’ office laboratories, and other alternate sites to perform immunoassay testing close to the point of patient care.

Source page: https://510kreport.com/device/K952719
Methodology: https://510kreport.com/methodology