510(k) · Cleared
ClearedMission Plus HB Hemoglobin Testing System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
ACON Laboratories, Inc. · GKR System, Hemoglobin, Automated
Cleared on Aug 5, 2013 as substantially equivalent to K032482 (Stanbio Laboratory, 2003) after a 349-day review. Its family tree reaches back 1 generation to 2003.
- Decided
- Aug 5, 2013
- Review
- 349 days
- Class
- Class II
- Product code
- GKR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032482 (2003). No later device cites it as a predicate yet.
- Root · 1 generation backK032482 Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemStanbio Laboratory · 2003
- This deviceK122553 Mission Plus HB Hemoglobin Testing SystemACON Laboratories, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement System | Stanbio Laboratory | 2003 | — |
| 0 (this device) | K122553 | Mission Plus HB Hemoglobin Testing System | ACON Laboratories, Inc. | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GKR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GKR device
- #1 K201217 HemoCue Hb 301 Systemscore 0.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032482 | Stanbio Laboratory Hemopoint H2 Hemoglobin Measurement SystemSummary page 4…Panel: Hematology (81) Predicate Device(s): Hemopoint H2 Hemoglobin Measurement System, Stanbio Laboratory 1261 North Main Street, Boerne, Texas 78006 510(k) Number: K032482 Device Name: Mission® Plus Hemoglobin (Hb) Testing System Proprietary Name | Classification Pg);lduect Descripti… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All GKR devicesGKR System, Hemoglobin, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GKR
2in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · GKR
Too few GKR 510(k)s in any year since 2007 to give a median.
Recalls per year · GKR
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GKR
1in 2024
MAUDE reports naming product code GKR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 16 |
| 2010 | 0 | — | 1 | 9 |
| 2011 | 1 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 25 |
| 2013 | 2 | — | 1 | 43 |
| 2014 | 0 | — | 0 | 31 |
| 2015 | 0 | — | 0 | 19 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 9 |
| 2020 | 2 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122553: Mission Plus HB Hemoglobin Testing System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026