510(k) · Cleared

Recalled · Class II · 2016

Trucount Absolute Count Tubes/Counting Control Beads

K970836510(k) TraditionalCleared Aug 26, 1997183-day reviewClass II21 CFR 864.5220Recalls 2

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 Aug 26, 1997 as substantially equivalent to K913192 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 1992. 11 later devices descend from it. It has been recalled 2 times.

Decided: Aug 26, 1997
Review: 183 days
Class: Class II
Product code: GKZ
Recalls: 2
Predicates: 2

Its longest line of descent runs back 1 generation to K913192 (1992). 2 ancestors in all. 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK913192 Simultest (TM) Imk-LymphocyteBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
This deviceK970836 Trucount Absolute Count Tubes/Counting Control BeadsBecton Dickinson Immunocytometry Systems · 1997
Descendant · cites it directly · 10 of its ownK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
Descendant · cites it directly · 5 of its ownK980858 Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing…Becton Dickinson Immunocytometry Systems · 1998 · Recalled
Descendant · 2 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
Descendant · 3 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
Descendant · cites it directly · 1 of its ownK170974 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company · 2017 · Recalled

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

1998high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 11 · 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 · cites it directly5descendants
K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences · 2006 · 2 generations on3descendants
K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · 3 generations on2descendants
K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company · 2017 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K913192	Simultest (TM) Imk-Lymphocyte	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992	—
0 (this device)	K970836	Trucount Absolute Count Tubes/Counting Control Beads	Becton Dickinson Immunocytometry Systems	1997	—
+1	K974360	Multitest CD3/CD8/CD45/CD4	Becton Dickinson Immunocytometry Systems	1998	—
+1	K980858	Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution	Becton Dickinson Immunocytometry Systems	1998	1
+2	K060375	BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166	Bd Biosciences	2006	—
+3	K090967	BD Multitest 6-Color TBNK Reagent, Model 644611	Bd Biosciences	2009	3
+1	K170974	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…	Becton, Dickinson and Company	2017	17

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0

Descendants by year cleared

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

FIG. 1 — Lineage of K970836, 1992–2020Source: 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? (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
*	K913192	Simultest (TM) Imk-Lymphocyte Summary page 1 …Lymphocyre immunophenortyping reagents, when used for absolute counts are substantially equivalent to Simulcest™ reagents, cleared in the Simulcese IMK-Lymphocyte Kic, (K913192), plus ADCC, or, in the case of THITEST™ reagents CD3/CD4/CD45 and CD3/CD8/CD4S, o FACSCounr, K933486. The absolure count applica…	Bd Becton Dickinson Vacutainer Systems Preanalytic	1992	—
*	K933486	Fascount Systme Summary page 1 …Simulcest™ reagents, cleared in the Simulcese IMK-Lymphocyte Kic, (K913192), plus ADCC, or, in the case of THITEST™ reagents CD3/CD4/CD45 and CD3/CD8/CD4S, o FACSCounr, K933486. The absolure count application is the subject of cutrear lymphocyte immunophenotyping reagent submissions. escripcion of the De…	Becton Dickinson Immunocytometry Systems	1994	1

Also cleared against K913192: 4 other devices →

What descends from it? (11)

See all 11

3 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
K980858	Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing Solution	Becton Dickinson Immunocytometry Systems	1998	5
K170974	BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…	Becton, Dickinson and Company	2017	1

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 24, 2016	Class II	Z-2252-2016	Packaging process control	One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.
Mar 31, 2016	Class II	Z-1570-2016	Packaging	One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this…

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K974360 (Becton Dickinson Immunocytometry Systems, 1998) has gone furthest, with 10 descendants of its own.
4 other devices also cite its predicate K913192.

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 FACS Loader

For use with in vitro diagnostic immunophenotyping reagents

For use in erythrocyte lysed whole blood

For use to obtain absolute counts by flow cytometry

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/K970836 · printed Nov 5, 2026

Cite this page

510(k) Report. “K970836: Trucount Absolute Count Tubes/Counting Control Beads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970836

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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