510(k) · Cleared

Cleared

Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes

K965053510(k) TraditionalCleared Nov 21, 1997338-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

Becton Dickinson Immunocytometry Systems · GKZ Counter, Differential Cell

Cleared on Nov 21, 1997 as substantially equivalent to K933486 (Becton Dickinson Immunocytometry Systems, 1994) after a 338-day review. Its family tree reaches back 1 generation to 1994. 15 later devices descend from it.

Decided: Nov 21, 1997
Review: 338 days
Class: Class II
Product code: GKZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K933486 (1994). 15 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK933486 Fascount SystmeBecton Dickinson Immunocytometry Systems · 1994 · Recalled
This deviceK965053 Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count…Becton Dickinson Immunocytometry Systems · 1997
Descendant · cites it directly · 10 of its ownK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
Descendant · 2 generations on · 5 of its ownK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
Descendant · 3 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
Descendant · 4 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
Descendant · cites it directly · 2 of its ownK071141 BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model…Bd Biosciences · 2007

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1998high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 15 · See all

K974360Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998 · cites it directly10descendants
K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems · 1998 · 2 generations on5descendants
K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · 3 generations on3descendants
K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · 4 generations on2descendants
K071141BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402Bd Biosciences · 2007 · cites it directly2descendants

View 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)	K965053	Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes	Becton Dickinson Immunocytometry Systems	1997	—
+1	K974360	Multitest CD3/CD8/CD45/CD4	Becton Dickinson Immunocytometry Systems	1998	—
+2	K980858	Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution	Becton Dickinson Immunocytometry Systems	1998	1
+3	K060375	BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166	Bd Biosciences	2006	—
+4	K090967	BD Multitest 6-Color TBNK Reagent, Model 644611	Bd Biosciences	2009	3
+1	K071141	BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402	Bd Biosciences	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1998	2	0
2002	1	0
2006	3	0
2007	1	0
2008	1	0
2009	2	0
2010	1	0
2015	2	0
2017	1	0
2020	1	0

FIG. 1 — Lineage of K965053, 1994–2020Source: 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.

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

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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	Applicant	Decided	Recalls
*	K933486	Fascount Systme Summary page 1 …Device (21 CER 807.92()(3) The BDIS TriTEST™ CD3/CD4/CD4S5 reagent with TRUCOUNT Absolute Count Tubes is substantially equivalent to the BDIS FACSCount system cleared in K933486. Desaintion of the Device (21 CFR 807.92(a)(4) The BDIS TxTEST CD3 fluaescein isothioganate (FITC)/CD4 phycoerythtin (PE)/CD45…	Becton Dickinson Immunocytometry Systems	1994	1

Also cleared against K933486: 3 other devices →

What descends from it? (15)

See all 15

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K974360	Multitest CD3/CD8/CD45/CD4	Becton Dickinson Immunocytometry Systems	1998	10
K071141	BD Tritest CD3/CD4/CD45 with BD Trucount Absolute Count Tubes, Model 340402	Bd Biosciences	2007	2
K090810	Thermo Scientific Cyto-Cal Count Tubes	Microgenics Corp.	2009	0
K053497	Guava EZCD4 System	Guava Technologies, Inc.	2006	0

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 a recall.
Of its descendants, K974360 (Becton Dickinson Immunocytometry Systems, 1998) has gone furthest, with 10 descendants of its own.
3 other devices also cite its predicate K933486.

How does its category compare?

All GKZ devices

GKZ Counter, Differential Cell: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

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 peripheral whole blood

For use with or without an isotype control

To characterize and monitor some forms of autoimmune disease

To characterize and monitor some forms of immunodeficiency disease, such as in HIV-infected individuals

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/K965053 · printed Nov 4, 2026

Cite this page

510(k) Report. “K965053: Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K965053

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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