# K221508: AnemoCheck Home

- Pathway: 510(k) (Traditional)
- Applicant: Sanguina, Inc.
- Decided: Sep 29, 2023 after 493 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: 1 generation back to K032203 (2003). 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)
- K032203: Hemocue Hemoglobin 201 + System Article 121704, Hemocue, Inc. (2003) Summary page 4.
- K042379: Anemiapro Self-Screener, Biosafe Laboratories, Inc. (2004) Summary page 4.

## Indications for use
AnemoCheck Home is intended for home use for the determination of hemoglobin level in whole blood from a finger stick by people over the age of 18. This device is intended for people with anemia caused by iron deficiency anemia, vitamin B12 deficiency anemia, folate deficiency anemia, or who have chronic anemia due to sickle cell disease or thalassemia. AnemoCheck Home tests are for in vitro diagnostic use only. Prescription Use Only.

Source page: https://510kreport.com/device/K221508
Methodology: https://510kreport.com/methodology