# K032677: Sysmex Poch-100I

- Pathway: 510(k) (Traditional)
- Applicant: Sysmex America, Inc.
- Decided: Feb 11, 2004 after 166 days
- Product code: GKL (Counter, Cell, Automated (Particle Counter))
- Device class: 2
- Regulation: 21 CFR 864.5200
- Recalls of this device: 1 (0 Class I)
- 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) Sysmex KX-21: named in the summary without a submission number

## Recalls of this device
- May 15, 2013 · Class II · Z-0100-2014: The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.

## Indications for use
The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in a CLIA non-waived clinical laboratory (not for Point of Care Use in a CLIA waived laboratory). This instrument provides results for the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, MXD%, NEUT%, LYM#, MXD#, NEUT#, RDW-SD, RDW-CV, MPV.

Source page: https://510kreport.com/device/K032677
Methodology: https://510kreport.com/methodology