510(k) Report

510(k) · Cleared

Cleared

Multitest CD3/CD8/CD45/CD4

K974360510(k) TraditionalCleared Mar 11, 1998112-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 Mar 11, 1998 as substantially equivalent to K970326 (Becton Dickinson Immunocytometry Systems, 1997) and 3 other predicates after a 112-day review. Its family tree reaches back 2 generations to 1996. 10 later devices descend from it.

Decided
Mar 11, 1998
Review
112 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
4

Its longest line of descent runs back 2 generations to K946055 (1996). 7 ancestors in all, the oldest K913192 (1992). 10 later devices descend from it, 7 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1997: 3 other ancestors1994: 1 other ancestor1992: 1 other ancestor2002: 1 descendant cleared2017: 1 descendant cleared2006: 3 descendants cleared2015: 1 descendant cleared1998: 1 descendant cleared2010: 1 descendant cleared2020: 1 descendant cleared2009: 1 descendant clearedK946055 · Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp · Becton Dickinson Immunocytometry Systems · 1996 · recalledK963963 · Multiset Software for Automated Flow Cytometric Data Analysis · Becton Dickinson Immunocytometry Systems · 1996 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors 1 generation forward: 7 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K963963 · Multiset Software for Automated Flow Cytometric Data Analysis · Becton Dickinson Immunocytometry Systems · 1996 · recalledK946055 · Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp · Becton Dickinson Immunocytometry Systems · 1996 · recalled0
  1. Root · 2 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
  2. 1 generation backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
  3. This deviceK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
  4. 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
  5. Descendant · 2 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
  6. Descendant · 3 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
  7. 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
  8. Descendant · 2 generations on · 0 of its ownK201814 BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5…Becton, Dickinson and Company · 2020 · Recalled

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

1998: 12002: 12006: 32009: 12010: 12015: 12017: 12020: 1
1998high 3 (2006) · low 0 (1999)2026

Most influential descendants

Showing 5 of 10 · See all
  • 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
  • K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations)…Becton, Dickinson and Company · 2020 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K946055Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems19961
−1K963963Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems19961
0 (this device)K974360Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems1998—
+1K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems19981
+2K060375BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models 337 and 166Bd Biosciences2006—
+3K090967BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences20093
+1K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company201717
+2K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical…Becton, Dickinson and Company20205

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199410
199730

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200630
200910
201010
201510
201710
202010
FIG. 1 — Lineage of K974360, 1996–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250943 Sysmex XR-Series (XR-10) Automated Hematology…score 13.2 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K970326Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count Tubes
Cleared while this submission was under review
Summary page 1
…evice Predicate Device (21 CFR 807.92(a)(3)) MultiTEST CD3/CD8/CD45/CD4 reagent and TRUCOUNT absolute count tubes are substantially equivalent” to THTEST CD3/CD8/CD45 (K970326), T TEST CD3/CD4/CD45 (K965053), TRUCOUNT tubes (K970836) and MultiSET software (K963963). Description of the Device (21 CFR 807…
Becton Dickinson Immunocytometry Systems1997—
*K965053Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp; Trucount Absolute Count Tubes
Cleared while this submission was under review
Summary page 1
…807.92(a)(3)) MultiTEST CD3/CD8/CD45/CD4 reagent and TRUCOUNT absolute count tubes are substantially equivalent” to THTEST CD3/CD8/CD45 (K970326), T TEST CD3/CD4/CD45 (K965053), TRUCOUNT tubes (K970836) and MultiSET software (K963963). Description of the Device (21 CFR 807.92(a)(4)) The Becton Dickinso…
Becton Dickinson Immunocytometry Systems1997—
*K970836Trucount Absolute Count Tubes/Counting Control Beads
Summary page 1
…CD3/CD8/CD45/CD4 reagent and TRUCOUNT absolute count tubes are substantially equivalent” to THTEST CD3/CD8/CD45 (K970326), T TEST CD3/CD4/CD45 (K965053), TRUCOUNT tubes (K970836) and MultiSET software (K963963). Description of the Device (21 CFR 807.92(a)(4)) The Becton Dickinson CD3 fluorescein isothioc…
Becton Dickinson Immunocytometry Systems19972
*K963963Multiset Software for Automated Flow Cytometric Data Analysis
Summary page 1
…COUNT absolute count tubes are substantially equivalent” to THTEST CD3/CD8/CD45 (K970326), T TEST CD3/CD4/CD45 (K965053), TRUCOUNT tubes (K970836) and MultiSET software (K963963). Description of the Device (21 CFR 807.92(a)(4)) The Becton Dickinson CD3 fluorescein isothiocyanate (FITC)/CD8 phycoerythrin…
Becton Dickinson Immunocytometry Systems19961

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems19985
K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD…Becton, Dickinson and Company20171
K141932Aquios CL Flow Cytometer, Aquios Tetra-1 Panel,Aquios Tetra-2+Panel, Aquios Immuno-Trol…Beckman Coulter, Inc.20150
K101911Immuknow-the Cylex Immune Cellfunction AssayCylex, Inc.20100
K060423Cyan DXD, Multitest CD8/CD4/CD3, CD3-Fitc, CD3-Rpe, CD3-Apc and FluorospheresDakocytomation California, Inc.20060
K053497Guava EZCD4 SystemGuava Technologies, Inc.20060
K013169Immune Cell Function AssayCylex, Inc.20020

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 2 years and passes through 1 company; a new generation was cleared every 1.2 years on median.
  • 4 of the 7 ancestors have a recall of any class.
  • Of its descendants, K980858 (Becton Dickinson Immunocytometry Systems, 1998) has gone furthest, with 5 descendants of its own.

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

2007: 62008: 62009: 62010: 42011: 32012: 32013: 12014: 32015: 32016: 32017: 42018: 32019: 52020: 12022: 32023: 42024: 32025: 42026 (partial year): 4
2007high 6 (2007) · low 0 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GKZ

108in 2025

2007: 117 days median2008: 99 days median2009: 147 days median2010: 290 days median2011: 315 days median2012: 408 days median2014: 165 days median2015: 273 days median2016: 198 days median2017: 280 days median2018: 270 days median2019: 210 days median2022: 638 days median2023: 329 days median2024: 157 days median2025: 108 days median2026 (partial year): 254 days median
2007high 638 (2022) · low 99 (2008)2026

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

Recalls per year · GKZ

1in 2025

2007: 372008: 52009: 132010: 272011: 282012: 72013: 62015: 32016: 32017: 32018: 2, 2 Class I2019: 22020: 12022: 42023: 12025: 1
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

2007: 2682008: 9252009: 5592010: 8962011: 2,9052012: 2,9592013: 3,0702014: 3,1122015: 1,9722016: 3,3382017: 2292018: 4972019: 9082020: 3422021: 3912022: 1982023: 1552024: 1152025: 77
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007611737268
20086995925
2009614713559
2010429027896
20113315282,905
2012340872,959
20131—63,070
2014316503,112
2015327331,972
2016319833,338
201742803229
201832702 (2)497
201952102908
20201—1342
20210—0391
202236384198
202343291155
202431570115
20254108177
202642540—

What is it indicated for?

For the FACS® family of flow cytometers equipped with a blue (488-nm) and a red diode (635-nm) laser.

A monoclonal antibody reagent for identification and enumeration of matur¢ human T lymphocyte subsets in human peripheral blood.

For use with erythrocyte lysed whole blood.

To characterize and monitor forms of autoimmune diseases, such as lupus.

To characterize and monito or acquired immunodeficiencics, such as SCID or AIDS.

For in vitro diagnostic use.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Becton Dickinson Immunocytometry Systems

21 FDA decisions under this applicant name. See the company

  • K040725BD Facscanto SystemBecton Dickinson Immunocytometry Systems · 20042 recalls
  • K040026BD Facs 7-Color Setup BeadsBecton Dickinson Immunocytometry Systems · 20043 recalls
  • K980858Multitest CD3/CD16+56/CD45/CD19 Reagent and Multitest Imk Kit Lysing SolutionBecton Dickinson Immunocytometry Systems · 19981 recall
  • K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetBecton Dickinson Immunocytometry Systems · 19981 recall
  • K971205Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count TubesBecton Dickinson Immunocytometry Systems · 1997

Recent decisions in GKZ

The GKZ category page

  • K260781Yumizen H550Horiba Abx Sas · 2026
  • K253212XR-Series (XR-10, XR-20) Automated Hematology AnalyzersSysmex America, Inc. · 2026
  • K243348Athelas HomeAthelas, Inc. · 2026
  • K251249Tru Hematology TestTruvian Sciences, Inc. · 2026
  • K250943Sysmex XR-Series (XR-10) Automated Hematology AnalyzerSysmex America, Inc. · 2025

https://510kreport.com/device/K974360 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974360: Multitest CD3/CD8/CD45/CD4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974360

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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