# K990327: Reticone System for Epics XL Flow Cytometry Systems

- Pathway: 510(k) (Traditional)
- Applicant: Coulter Corp.
- Decided: Apr 26, 1999 after 83 days
- Product code: GKZ (Counter, Differential Cell)
- Device class: 2
- Regulation: 21 CFR 864.5220
- 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 K872166 (1987). 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)
- K872166: Facscan Flow Cytometer - Reticcount Reti. Enu. Kit, Bd Becton Dickinson Vacutainer Systems Preanalytic (1987) Summary page 1.
- K880636: Reticcount Software, Bd Becton Dickinson Vacutainer Systems Preanalytic (1988) Summary page 1.

## Indications for use
The reticONE™ SYSTEM for EPICS® XL™ Flow Cytometry Systems combines a reagent Kit consisting of a Coriphosphine-O dye and a Biological Calibrator, and software for automated analysis of reticulocytes in whole blood using EPICS® XL™ Flow Cytometry Systems with SYSTEM II™ Software. The system is intended “For In Vitro Diagnostic Use” and allows identification and enumeration of reticulocyte percentage and absolute count. The reticulocyte count is diagnostically useful in discriminating between normal and abnormal erythropoiesis. It can be useful in the diagnosis or detection of anemias, internal hemorrhaging, hemoglobinopathies and certain nutritional or vitamin deficiencies. Decreased or defective red cell production may result in a lower reticulocyte count such as in aplastic anemias. Elevated reticulocyte counts may be observed in clinical conditions where red cell destruction is increased (for example, hemolytic anemias and hypersplenism) or where there is increased red cell production (for example, erythropoietin drug therapy and a response to treated anemia). Since the kidneys are a primary source of erythropoietin (a hormone that regulates erythroid development), the reticulocyte count is also affected in individuals with renal disease. In cases of renal atrophy, the reticulocyte count will be decreased. In cases of malignancy or hypersplenism, the reticulocyte count will be elevated. Reticulocyte counts are also used as an indicator of bone marrow recovery following intensive cytotoxic chemotherapy or a bone marrow transplantation. Increased reticulocyte counts in these patients are indicative of bone marrow regeneration.

Source page: https://510kreport.com/device/K990327
Methodology: https://510kreport.com/methodology