# K122553: Mission Plus HB Hemoglobin Testing System

- Pathway: 510(k) (Traditional)
- Applicant: ACON Laboratories, Inc.
- Decided: Aug 5, 2013 after 349 days
- Product code: GKR (System, Hemoglobin, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5620
- 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 K032482 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032482: Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System, Stanbio Laboratory (2003) Summary page 4.

## Indications for use
The Mission® Plus Hemoglobin (Hb) Testing System is for the quantitative determination of hemoglobin in non-anticoagulated capillary whole blood or anticoagulated venous whole blood in EDTA (K2, K3, Na2) or sodium heparin. The testing system is designed for point-of-care use in primary care settings. Estimation of hematocrit is only for hemoglobin values from 12.3 to 17.5 g/dL (123 to 175 g/L). The Mission® Pius Hemoglobin (Hb) Control Solution is intended to validate hemoglobin testing using the Mission® Plus Hemoglobin (Hb) Testing System. The Mission® Plus Hemoglobin (Hb) Testing System is for professional in vitro diagnostic use only.

Source page: https://510kreport.com/device/K122553
Methodology: https://510kreport.com/methodology