# K101831: Enterix Insurefit Fob Controls, Model 16800

- Pathway: 510(k) (Traditional)
- Applicant: Bionostics, Inc.
- Decided: Oct 1, 2010 after 92 days
- Product code: OSL (Control, Fecal Occult Blood)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K041297 (2004). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041297: Polymedco OC Light Fobt Test, Polymedco, Inc. (2004) Summary page 2.
- K080812: Hemoccult Ict, Beckman Coulter, Inc. (2008) Summary page 1.

## Indications for use
Enterix InSure FIT FOBT Controls are for in vitro diagnostic use only and include a positive control containing stabilized human hemoglobin and a negative control containing a buffer. This is an assayed positive and negative control and intended for the qualitative test determinations of Enterix Insure FIT product. Enterix InSure FIT FOBT Controls are for exclusive use with Enterix InSure FIT product. These controls can be used to independently verify the functionality and performance of the InSure FIT test by laboratories and other professional medical institutions as part of a comprehensive quality assurance program.

Source page: https://510kreport.com/device/K101831
Methodology: https://510kreport.com/methodology