510(k) · Cleared
ClearedGuava EZCD4 System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guava Technologies, Inc. · GKZ Counter, Differential Cell
Cleared on Apr 14, 2006 as substantially equivalent to K974360 (Becton Dickinson Immunocytometry Systems, 1998) and 1 other predicate after a 120-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 14, 2006
- Review
- 120 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K946055 (1996). 8 ancestors in all, the oldest K913192 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 2 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 1 generation backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- This deviceK053497 Guava EZCD4 SystemGuava Technologies, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −2 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −1 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| 0 (this device) | K053497 | Guava EZCD4 System | Guava Technologies, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 3 | 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 |
|---|---|---|---|
| * | K974360 | Multitest CD3/CD8/CD45/CD4Summary page 1…Class II Predicate Devices: The Guava EZCD4 Assay is substantially equivalent to the Becton Dickinson MultiTest CD3 FITC / CD8 PE/CD45 PerCP/CD4 APC Reagent (K974360) and TriTest CD3 FITC/ CD4 PE/ CD45 PerCP Reagent (K965053) when performed on the FACSCalibur. Description of Device: Determina… | 1998 |
| * | K965053 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count TubesSummary page 1…ay is substantially equivalent to the Becton Dickinson MultiTest CD3 FITC / CD8 PE/CD45 PerCP/CD4 APC Reagent (K974360) and TriTest CD3 FITC/ CD4 PE/ CD45 PerCP Reagent (K965053) when performed on the FACSCalibur. Description of Device: Determination of the absolute number of CD4 + T cells circulating in… | 1997 |
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?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 8 ancestors have a recall of any class.
- 6 other devices also cite its predicate K974360.
How does its category compare?
All GKZ devicesGKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 EZCD4 Assay is intended to be performed on a Guava PCA System with CytoSoft 2.3 version software which includes three modules; EZCD4, Guava Check and Clean and Shutdown. The system is intended to identify and quantify the absolute counts of CD4 T-Lymphocytes in EDTA whole blood. The GuavaEZCD4 system is intended for the ongoing monitoring of patients with documented diagnosis of an immunodeficiency disease. The Guava EZCD4 system is intended for use only by trained laboratory professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053497: Guava EZCD4 System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053497
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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