510(k) · Cleared
ClearedXW-100 Automated Hematology Analyzer, XW QC CHECK
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sysmex America, Inc. · GKZ Counter, Differential Cell
Cleared on Oct 12, 2015 as substantially equivalent to K852992 (Streck Laboratories, Inc., 1985) after a 299-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it.
- Decided
- Oct 12, 2015
- Review
- 299 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K852992 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK852992 Para Check (Aka Eight Check-C)Streck Laboratories, Inc. · 1985
- This deviceK143577 XW-100 Automated Hematology Analyzer, XW QC CHECKSysmex America, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK172604 XW-100 Automated Hematology Analyzer for CLIA Waived UseSysmex America, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK210346 Sysmex XW-100 Automated Hematology AnalyzerSysmex America, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852992 | Para Check (Aka Eight Check-C) | Streck Laboratories, Inc. | 1985 | — |
| 0 (this device) | K143577 | XW-100 Automated Hematology Analyzer, XW QC CHECK | Sysmex America, Inc. | 2015 | — |
| +1 | K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | Sysmex America, Inc. | 2017 | — |
| +2 | K210346 | Sysmex XW-100 Automated Hematology Analyzer | Sysmex America, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
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 GKZ? 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? (2)
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 |
|---|---|---|---|
| * | K852992 | Para Check (Aka Eight Check-C)Summary page 6…(864.8625) Product Code: JPK 3. Predicate device Para® Check (K852992) 4. Device description XW QC CHECK is an in vitro diagnostic product that contains… | 1985 |
| * | — | Sysmex pocH-100i Automated Hematology Analyzer Named without a submission number |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172604 | XW-100 Automated Hematology Analyzer for CLIA Waived Use | 2017 | 1 |
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.
- Of its descendants, K172604 (Sysmex America, Inc., 2017) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Sysmex XW-100™ is a quantitative automated hematology analyzer intended for in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or…
Read the full statement (130 words)
The Sysmex XW-100™ is a quantitative automated hematology analyzer intended for in vitro diagnostic point of care use to classify and enumerate the following parameters for venous whole blood anticoagulated with K2/K3 EDTA: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV. It is not for use in diagnosing or monitoring oncology patients, children under the age of 2, or for chronically or critically ill patients.
XW QC CHECK is a stabilized whole blood matrix designed for statistical process control of the Sysmex XW-100 automated hematology analyzer. It is not intended for calibration of the analyzer. Assayed parameters include WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, LYM%, Other WBC%, NEUT%, LYM#, Other WBC#, NEUT#, RDW-SD, RDW-CV, and MPV.
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/K143577 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143577: XW-100 Automated Hematology Analyzer, XW QC CHECK.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143577
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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