# K971736: Sysmex Immature Reticulocyte Fraction (Irf) Parameter

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex Corp.
- Decided: Aug 26, 1997 after 106 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 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) reticulocyte count: named in the summary without a submission number

## Most influential descendants
- K991839: Abx Pentra 120 Retic Automated Hematology Analyzer (1999), 3 descendants of its own
- K022200: Pentra 120/Pentra 120 Retic Options SPS, Model Pentra 120 (2002), 2 descendants of its own
- K050719: Abx Pentra DX 120: Option SPS Evolution (2005), 1 descendant of its own
- K151133: Pentra XLR (2015), 0 descendants of its own
- K993356: Coulter Hematology Analyzers with Irf & MRV Analyses (2000), 0 descendants of its own

## Indications for use
The IRF parameter of the R-Series analyzers is intended for in-vitro use in clinical laboratories. Its clinical use is to monitor bone marrow suppression and recovery in terms of erythropoiesis in situations of previous cancer chemotherapeutic bone marrow suppression and bone marrow transplantation. Qualified laboratory personnel are responsible for review of all abnormal results.

Source page: https://510kreport.com/device/K971736
Methodology: https://510kreport.com/methodology