510(k) · Cleared

Cleared

Tri T-Stat Reagent Assay (Dried Form) Model 25107-00

K082091510(k) TraditionalCleared Apr 15, 2009265-day reviewClass II21 CFR 864.5220

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Reametrix, Inc. · GKZ Counter, Differential Cell

Cleared on Apr 15, 2009 as substantially equivalent to K971205 (Becton Dickinson Immunocytometry Systems, 1997) and 1 other predicate after a 265-day review. Its family tree reaches back 4 generations to 1993. 2 of the 10 devices in its family, counting itself, have a Class I recall.

Decided: Apr 15, 2009
Review: 265 days
Class: Class II
Product code: GKZ
Recalls: None
Predicates: 2

Its longest line of descent runs back 4 generations to K922745 (1993). 9 ancestors in all. No later device cites it as a predicate yet. 2 of the 10 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 4 generations backK922745 Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1Coulter Immunology · 1993
3 generations backK963263 Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat…Coulter Corp. · 1997 · Recalled (Class I)
2 generations backK990172 Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat…Coulter Corp. · 1999 · Recalled (Class I)
1 generation backK030408 Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody…Beckman Coulter, Inc. · 2003 · Recalled
This deviceK082091 Tri T-Stat Reagent Assay (Dried Form) Model 25107-00Reametrix, Inc. · 2009

Class I recalls in this family

K990172 Tetraone System for Epics XL Flow Cytometry…2 generations back · 1999
K963263 Tetraone System for Epics XL Flow Cytometry…3 generations back · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K922745	Cyto-Stat/Coulter Clone CD3(IGG1)-Fitc/T4-RD1	Coulter Immunology	1993	—
−3	K963263	Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…	Coulter Corp.	1997	Class I
−2	K990172	Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…	Coulter Corp.	1999	Class I
−1	K030408	Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent…	Beckman Coulter, Inc.	2003	4
0 (this device)	K082091	Tri T-Stat Reagent Assay (Dried Form) Model 25107-00	Reametrix, Inc.	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	2	0
1994	1	0
1997	1	0
1998	1	0

FIG. 1 — Lineage of K082091, 1993–2009Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

2 devices in this family have 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

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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	Applicant	Decided	Recalls
*	K971205	Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count Tubes Summary page 1 …FR 864.5220, Panel code: GKZ) Predicate devices Becton Dickinson TriTESTTM reagent CD4 FITC/CD8 PE /CD3 PerCP; TruCOUNTTM Absolute counting tubes (K971205) Beckman Coulter CYTO-STAT® CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 tetraCHROMETM (K030408) Device Description Th…	Becton Dickinson Immunocytometry Systems	1997	—
*	K030408	Cyto-Stat Tetrachrome CD45-Fit/CD4-PE/CD3-PC5 Monoclonal Antibody Reagent, Cyto-Stat… Summary page 1 …PerCP; TruCOUNTTM Absolute counting tubes (K971205) Beckman Coulter CYTO-STAT® CD45-FITC/CD4-PE/CD8-ECD/CD3-PC5 tetraCHROMETM (K030408) Device Description The Dry Tri T-STAT (CD3/CD4/CD8) reagent contains Atto488 - labeled CD4 monoclonal antibody (clone RPA-T4);…	Beckman Coulter, Inc.	2003	4

Also cleared against K971205: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 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.

K990172Tetraone System for Epics XL Flow Cytometry Systems with Cyto-Stat Tetrachrome…Coulter Corp. · 1999 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
K963263Tetraone System for Epics XL Flow Cytometry Systems and Cyto-Stat Tertrachrome…Coulter Corp. · 1997 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
4 of the 9 ancestors have a recall of any class; 2 have a Class I recall.
2 other devices also cite its predicate K971205.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · GKZ

4in 2025

2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007high 638 (2022) · low 99 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GKZ

1in 2025

2007high 37 (2007) · low 0 (2014)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · GKZ

77in 2025

2007high 3,338 (2016) · low 77 (2025)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 Dry Tri T-STAT (CD3/CD4/CD8) reagent, intended for in vitro diagnostic use, is a three color immunofluorescence stain for the labeling, identification, and enumeration of helper/inducer (CD3+CD4+) and cytotoxic/suppressor (CD3+CD8+) T lymphocytes combined with a precise number of fluorescent counting beads to provide absolute CD4+ and CD8+ T-Cell counts on a single platform. This reagent is intended to be used for flow cytometric analysis of erythrocyte-lysed human whole blood. The Tri T-STAT Reagent can be used to monitor forms of immunodeficiency.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K082091 · printed Nov 6, 2026

Cite this page

510(k) Report. “K082091: Tri T-Stat Reagent Assay (Dried Form) Model 25107-00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082091

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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