510(k) Report

510(k) · Cleared

Cleared

Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count Tubes

K971110510(k) TraditionalCleared Nov 25, 1997244-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 25, 1997 as substantially equivalent to K913192 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) after a 244-day review. Its family tree reaches back 1 generation to 1992. 6 later devices descend from it.

Decided
Nov 25, 1997
Review
244 days
Class
Class II
Product code
GKZ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K913192 (1992). 6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared2006: 1 descendant cleared2017: 1 descendant cleared2015: 1 descendant cleared2009: 1 descendant cleared2020: 1 descendant clearedK913192 · Simultest (TM) Imk-Lymphocyte · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19921990200020102020
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants K913192 · Simultest (TM) Imk-Lymphocyte · Bd Becton Dickinson Vacutainer Systems Preanalytic · 19920
  1. Root · 1 generation backK913192 Simultest (TM) Imk-LymphocyteBd Becton Dickinson Vacutainer Systems Preanalytic · 1992
  2. This deviceK971110 Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount…Becton Dickinson Immunocytometry Systems · 1997
  3. 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
  4. Descendant · 2 generations on · 3 of its ownK060375 BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes with Models…Bd Biosciences · 2006
  5. Descendant · 3 generations on · 2 of its ownK090967 BD Multitest 6-Color TBNK Reagent, Model 644611Bd Biosciences · 2009 · Recalled
  6. Descendant · 2 generations on · 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
  7. Descendant · 3 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 6 descendants. See all descendants

Descendants cleared per year

1998: 12006: 12009: 12015: 12017: 12020: 1
1998high 1 (1998) · low 0 (1999)2026

Most influential descendants

Showing 5 of 6 · 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 · 2 generations on1descendant
  • 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 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K913192Simultest (TM) Imk-LymphocyteBd Becton Dickinson Vacutainer Systems Preanalytic1992—
0 (this device)K971110Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 Percp;with Trucount Absolute Count…Becton Dickinson Immunocytometry Systems1997—
+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
+2K170974BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical…Becton, Dickinson and Company201717
+3K201814BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical…Becton, Dickinson and Company20205

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
200610
200910
201510
201710
202010
FIG. 1 — Lineage of K971110, 1992–2020Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K913192Simultest (TM) Imk-Lymphocyte
Summary page 1
…percentages of T lymphocytes and Natural Killer lymphocytes (NK cells), is substantially equivalent to Simultest™ IMK- Lymphocyte Tube F (cleared to market under 510(k) K913192). When used to enumerate absolute counts of T and NK cells, it is substantially equivalent to Simultest IMK- Lymphocyte Tube F pl…
Bd Becton Dickinson Vacutainer Systems Preanalytic1992—
*—automated differential cell counter (ADCC)
Named without a submission number
—

Also cleared against K913192: 4 other devices →

What descends from it? (6)

1 later device cites 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

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 no recall.
  • Of its descendants, K980858 (Becton Dickinson Immunocytometry Systems, 1998) has gone furthest, with 5 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

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 use with any flow cytometer with specified detection ranges

For use with erythrocyte lysed whole blood

For use with or without an isotype control

For in vitro diagnostic use

To identify and enumerate percentages and absolute counts of CD3+ and CD16+CD56+ lymphocytes in normal individuals and patients with certain tumors and viral infections

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

Also cleared against K913192

4 other devices cite the same predicate.

  • K970326Tritest Reagent CD3 Fitc/CD8 PE/CD45 Percp;with Trucount Absolute Count TubesBecton Dickinson Immunocytometry Systems · 1997
  • K970742Tritest CD3 Fitc/CD19 PE/CD45 Percp Reagent with Trucount Absolute Count TubesBecton Dickinson Immunocytometry Systems · 1997
  • K970836Trucount Absolute Count Tubes/Counting Control BeadsBecton Dickinson Immunocytometry Systems · 19972 recalls
  • K953302Facs Loader SystemBecton Dickinson Immunocytometry Systems · 1995

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
  • K974360Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
  • K973483Facscomp Software and Calibrite Beads for Use in Flow Cytometer Instrument SetBecton Dickinson Immunocytometry Systems · 19981 recall

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/K971110 · printed Nov 5, 2026

Cite this page

510(k) Report. “K971110: Tritest Reagent CD3 Fitc/CD16+CD56 PE/CD45 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/K971110

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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