510(k) · Cleared
ClearedTri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell
Cleared on Dec 1, 1997 as substantially equivalent to K933486 (Becton Dickinson Immunocytometry Systems, 1994) after a 244-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Dec 1, 1997
- Review
- 244 days
- Class
- Class II
- Product code
- GKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933486 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK933486 Fascount SystmeBecton Dickinson Immunocytometry Systems · 1994 · Recalled
- This deviceK971205 Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute…Becton Dickinson Immunocytometry Systems · 1997
- Descendant · cites it directly · 0 of its ownK101911 Immuknow-the Cylex Immune Cellfunction AssayCylex, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK082091 Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK013169 Immune Cell Function AssayCylex, Inc. · 2002
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933486 | Fascount Systme | Becton Dickinson Immunocytometry Systems | 1994 | 1 |
| 0 (this device) | K971205 | Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes | Becton Dickinson Immunocytometry Systems | 1997 | — |
| +1 | K101911 | Immuknow-the Cylex Immune Cellfunction Assay | Cylex, Inc. | 2010 | — |
| +1 | K082091 | Tri T-Stat Reagent Assay (Dried Form) Model 25107-00 | Reametrix, Inc. | 2009 | — |
| +1 | K013169 | Immune Cell Function Assay | Cylex, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K933486 | Fascount SystmeSummary page 1…FR 807.92()(3) The BDIS TriT EST™ CD4 FITC/CD8 PE/CD3 PerCP reagent with TRUCOUNT Absolute Count Tubes is substantially equivalent to FACSCount (cleared to market under K933486). The BDIS TrTEST CD4 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin (PE)/CD3 peridinin chlorophyll protein (PerCP) reagent… | 1994 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
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?
For use with any flow cytometer equipped with a 488 nm laser and capable of detection in the ranges: 515-545 nm, 562-607 nm, and >650 nm
For use with erythrocyte lysed whole blood
For in vitro diagnostic use
To identify and enumerate absolute counts of CD3+ and CD3+CD4 and CD3+CD8+ lymphocytes
To characterize and monitor some forms of immunodeficiency, such as in HIV infected individuals
To characterize and monitor some forms of autoimmune diseases
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/K971205 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971205: Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971205
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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