# K163215: AnemoCheck

- Pathway: 510(k) (Traditional)
- Applicant: Sanguina, LLC
- Decided: Sep 13, 2017 after 301 days
- Product code: KHG (Whole Blood Hemoglobin Determination)
- Device class: 2
- Regulation: 21 CFR 864.7500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971998 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032203: Hemocue Hemoglobin 201 + System Article 121704, Hemocue, Inc. (2003) Summary page 4.
- K042251: Bayer Advia 2120 Hematology Analyzer with Autoslide System, Bayer Healthcare, LLC (2004) Summary page 4.

## Indications for use
The AnemoCheck is an in vitro diagnostic semi-quantitative assay for use in point-of-care, clinical and doctor office laboratories for the determination of hemoglobin level and estimation of hematocrit percentage (within normal hemoglobin range) in anticoagulated (K2EDTA, heparin or citrate) whole blood (capillary or venous). AnemoCheck should not be used to evaluate neonatal samples (birth - 1 month).

Source page: https://510kreport.com/device/K163215
Methodology: https://510kreport.com/methodology