# K955719: Sickle-2000

- Pathway: 510(k) (Traditional)
- Applicant: Medicus Technologies, Inc.
- Decided: Aug 14, 1996 after 240 days
- Product code: GIQ (Hemoglobin S)
- Device class: 2
- Regulation: 21 CFR 864.7415
- 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. The FDA summary names its predicate without a number.
- (no number) Sicklequik: named in the summary without a submission number

## Indications for use
SICKLE-2000 is an in-vitro centrifugal solubility test that detects Hemoglobin S, the abnormal hemoglobin found in sickle cell disease and sickle cell trait.

Source page: https://510kreport.com/device/K955719
Methodology: https://510kreport.com/methodology