# K220763: ALPCO Calprotectin Immunoturbidimetric Assay

- Pathway: 510(k) (Traditional)
- Applicant: ALPCO
- Decided: Apr 13, 2023 after 393 days
- Product code: NXO (Calprotectin, Fecal)
- Device class: 2
- Regulation: 21 CFR 866.5180
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ALPCO Calprotectin Immunoturbidimetric Assay is an in-vitro diagnostic assay used for the quantitative measurement of human fecal calprotectin in human stool. The ALPCO Calprotectin Immunoturbidimetric Assay is intended for in-vitro diagnostic use as an aid in diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings.

Source page: https://510kreport.com/device/K220763
Methodology: https://510kreport.com/methodology