# K132167: I-Chroma Ifob with I-Chroma Reader

- Pathway: 510(k) (Traditional)
- Applicant: Boditech Med, Inc.
- Decided: May 2, 2014 after 294 days
- Product code: OOX (Automated Occult Blood Analyzer)
- 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 K041408 (2004). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041408: Polymedco OC Auto Micro 80 Fob Test, Polymedco, Inc. (2004) Summary page 1.

## Most influential descendants
- K163225: AFIAS iFOB with AFIAS-50 (2017), 0 descendants of its own

## Indications for use
i-CH-ROMA IFOB Controls are external quality control reagents intended for monitoring and ensuring acceptable performance of i-CHROMA iFOB test system which is a qualitative in-vitro diagnostic test for detection of focal occult blood having an analytical cut-off of 100 ng/mL which is equivalent to 8ptg i.e. 0.008 mg hemoglobin per gram of stool. i-CHROMA IFOB in conjunction with i-CH-ROMA Reader is a fluorescence inimuno-chromatographic assay system for qualitative detection of fecal occult blood (FOB) in human focal samples. i-CHROMA iFOB is an in vitro diagnostic test used by laboratories and physician offices for routine physical examination when gastrointestinal bleeding may be suspected.

Source page: https://510kreport.com/device/K132167
Methodology: https://510kreport.com/methodology