# K041408: Polymedco OC Auto Micro 80 Fob Test

- Pathway: 510(k) (Traditional)
- Applicant: Polymedco, Inc.
- Decided: Oct 21, 2004 after 147 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
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K132167: I-Chroma Ifob with I-Chroma Reader (2014), 1 descendant of its own
- K200754: Hemosure Accu-Reader A100 (2022), 0 descendants of its own
- K163225: AFIAS iFOB with AFIAS-50 (2017), 0 descendants of its own

## Indications for use
The Polymedco OC Auto Micro 80 Analyzer and OC Auto Micro FOB Test are designed to be used together as an immunological test system intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is useful for the determination of gastrointestinal (Gl) bieeding, found in a number of gastrointestinal (Gl) disorders, e.g., colitis, polyps, and colorectal cancer. The OC Auto Micro FOB Test is recommended for use in 1. Routine physical examinations 2. Monitoring for bleeding in patients 3. Screening for colorectal cancer or gastrointestinal bleeding

Source page: https://510kreport.com/device/K041408
Methodology: https://510kreport.com/methodology