# K181599: Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Coulter
- Decided: Mar 18, 2019 after 273 days
- Product code: QFS (Monocyte Distribution Width Quantitative Measurement For Sepsis Risk Assessment)
- Device class: 2
- Regulation: 21 CFR 866.3215
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K912133 (1991). 8 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162827: Vidas B.R.a.H.M.S. PCT (PCT), bioMerieux, Inc. (2017) Summary page 5.
- K081822: Coulter 6C Cell Control, Models 628027 & A59925, Beckman Coulter, Inc. (2009) Summary page 8.
- K885028: Coulter 5P Control, Coulter Electronics, Inc. (1989) Summary page 9.

## Most influential descendants
- K193124: Unicel DxH 800 Coulter Cellular Analysis System (2020), 1 descendant of its own
- K240252: UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System (2024), 0 descendants of its own

## Indications for use
The Unicel DxH 800 Coulter Cellular Analysis System with Early Sepsis Indicator Application is the quantitative measurement of Monocyte Distribution Width (MDW). The Early Sepsis Indicator is intended for use with adult patients presenting to the emergency department, on whom a white cell differential test has been ordered. MDW is measured from a (K2EDTA) whole-blood venous sample within 2 hours of collection. MDW values greater than 20.0 together with other laboratory findings and clinical information, aids in identifying patients with sepsis or at increased risk of developing sepsis within the first 12 hours of hospital admission. MDW values greater than 20.0 should be interpreted in association with other clinical information and diagnostic testing, as a proportion of patients without sepsis may have an elevated MDW value at baseline. MDW values less than or equal to 20.0 cannot rule out sepsis or the development of sepsis within 12 hours of hospital admission. The Early Sepsis Indicator should not be used as the sole basis to determine the absence of sepsis. The predictive value of the Early Sepsis Indicator for identifying sepsis in patients with hematological abnormalities has not been established.

Source page: https://510kreport.com/device/K181599
Methodology: https://510kreport.com/methodology