# K992799: Sangui Biotech, Inc. Epo (Erythropoietin) Elisa Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sangui Biotech, Inc.
- Decided: Jun 7, 2000 after 293 days
- Product code: GGT (Assay, Erythropoietin)
- Device class: 2
- Regulation: 21 CFR 864.7250
- 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; 1 cites 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. The FDA summary names its predicate without a number.
- (no number) Nichols Institute Diagnostics EPO [Erythropoietin] Assay Chemiluminescent Assay (Coated Bead Technology): named in the summary without a submission number

## Most influential descendants
- K052223: Access Epo Assay (2006), 2 descendants of its own
- K240182: Access EPO (2024), 0 descendants of its own
- K183088: ADVIA Centaur Erythropoietin (EPO) assay (2019), 0 descendants of its own

## Indications for use
The intended use of this product is the quantitative determination of erythropoietin levels in human serum. This assay is intended as an aid in the diagnosis of anemias and polycythemias. With the advent of the administration of recombinant erythropoietin as a biologic therapy to increase red blood cell mass, an erythropoietin assay may be used also to aid in the prediction and monitoring of response to recombinant erythropoietin treatment in persons with anemias.

Source page: https://510kreport.com/device/K992799
Methodology: https://510kreport.com/methodology