510(k) · Cleared
ClearedQScout Lab; QScout RLD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ad Astra Diagnostics, Inc. · GKZ Counter, Differential Cell
Cleared on Nov 14, 2023 as substantially equivalent to K140911 (Beckman Coulter, Inc., 2014) after a 229-day review. Its family tree reaches back 2 generations to 2013. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 14, 2023
- Review
- 229 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K120771 (2013). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK120771 Unicel DXH 800 Coulter Cellular Analysis SystemBeckman Coulter, Inc. · 2013 · Recalled
- 1 generation backK140911 Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH…Beckman Coulter, Inc. · 2014 · Recalled (Class I)
- This deviceK230878 QScout Lab; QScout RLDAd Astra Diagnostics, Inc. · 2023
Class I recalls in this family
- K140911 Unicel DXH 800 Coulter Cellular Analysis System/…direct predicate · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K120771 | Unicel DXH 800 Coulter Cellular Analysis System | Beckman Coulter, Inc. | 2013 | 11 |
| −1 | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer… | Beckman Coulter, Inc. | 2014 | Class I |
| 0 (this device) | K230878 | QScout Lab; QScout RLD | Ad Astra Diagnostics, Inc. | 2023 | — |
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.
1 device in this family has a Class I recall. 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 GKZ device
- #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K140911 | Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter…Summary page 5…fferential Cell Counter Classification 21 CFR 864.5220, Class II, Product Code: GKZ Predicate Device Beckman Coulter UniCel® DxH 800 Coulter® Cellular Analysis System (K140911) Device Description The QScout™ system is intended for in vitro diagnostic use in screening patient populations 18 years and ol… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K140911Unicel DXH 800 Coulter Cellular Analysis System/ Unicel DXH Slidemaker Stainer Coulter Cellular Analysis…Beckman Coulter, Inc. · 2014 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 2 of the 2 ancestors have a recall of any class; 1 has a Class I recall.
- 4 other devices also cite its predicate K140911.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · GKZ
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GKZ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GKZ
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · GKZ
77in 2025
MAUDE reports naming product code GKZ, 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 | 6 | 117 | 37 | 268 |
| 2008 | 6 | 99 | 5 | 925 |
| 2009 | 6 | 147 | 13 | 559 |
| 2010 | 4 | 290 | 27 | 896 |
| 2011 | 3 | 315 | 28 | 2,905 |
| 2012 | 3 | 408 | 7 | 2,959 |
| 2013 | 1 | — | 6 | 3,070 |
| 2014 | 3 | 165 | 0 | 3,112 |
| 2015 | 3 | 273 | 3 | 1,972 |
| 2016 | 3 | 198 | 3 | 3,338 |
| 2017 | 4 | 280 | 3 | 229 |
| 2018 | 3 | 270 | 2 (2) | 497 |
| 2019 | 5 | 210 | 2 | 908 |
| 2020 | 1 | — | 1 | 342 |
| 2021 | 0 | — | 0 | 391 |
| 2022 | 3 | 638 | 4 | 198 |
| 2023 | 4 | 329 | 1 | 155 |
| 2024 | 3 | 157 | 0 | 115 |
| 2025 | 4 | 108 | 1 | 77 |
| 2026 | 4 | 254 | 0 | — |
What is it indicated for?
The QScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDTA whole blood: • White blood cell count (WBC) • Neutrophils (NEUT#) • Lymphocytes (LYMPH#) • Monocytes…
Read the full statement (110 words)
The QScout™ Lab is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic use in screening patient populations 18 years and older found in clinical laboratories and point-of-care (POC) settings. The QScout Lab is used with the QScout RLD test to enumerate and classify the following parameters in venous K2/K3EDTA whole blood:
• White blood cell count (WBC)
• Neutrophils (NEUT#)
• Lymphocytes (LYMPH#)
• Monocytes (MONO#)
• Eosinophils (EOS#)
• Basophils (BASO#)
• Immature Granulocytes (IG#)
• Percent Neutrophils (NEUT%)
• Percent Lymphocytes (LYMPH%)
• Percent Monocytes (MONO%)
• Percent Eosinophils (EOS%)
• Percent Basophils (BASO%)
• Percent Immature Granulocytes (IG%)
• Neutrophil to Lymphocyte Ratio (NLR)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230878: QScout Lab; QScout RLD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230878
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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