510(k) · Cleared
ClearedImmune Cell Function Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cylex, Inc. · NID Assay, Proliferation, In Vitro, T Lymphocyte
Cleared on Apr 2, 2002 as substantially equivalent to K971205 (Becton Dickinson Immunocytometry Systems, 1997) and 1 other predicate after a 193-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Apr 2, 2002
- Review
- 193 days
- Class
- Class II
- Product code
- NID
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K946055 (1996). 9 ancestors in all, the oldest K913192 (1992). No later device cites it as a predicate yet.
- Root · 3 generations backK946055 Tritest Reagent CD3 Fitc/CD4 PE/CD45 PercpBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 2 generations backK963963 Multiset Software for Automated Flow Cytometric Data AnalysisBecton Dickinson Immunocytometry Systems · 1996 · Recalled
- 1 generation backK974360 Multitest CD3/CD8/CD45/CD4Becton Dickinson Immunocytometry Systems · 1998
- This deviceK013169 Immune Cell Function AssayCylex, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K946055 | Tritest Reagent CD3 Fitc/CD4 PE/CD45 Percp | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −2 | K963963 | Multiset Software for Automated Flow Cytometric Data Analysis | Becton Dickinson Immunocytometry Systems | 1996 | 1 |
| −1 | K974360 | Multitest CD3/CD8/CD45/CD4 | Becton Dickinson Immunocytometry Systems | 1998 | — |
| 0 (this device) | K013169 | Immune Cell Function Assay | Cylex, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 4 | 0 |
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 NID? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971205 | Tri Test Reagent CD4 Fit C/CD8 PE/CD3 Percp with Trucount Absolute Count TubesSummary page 2…Equivalence: The Cylex Inc. Immune Cell Function Assay has been found to be substantially equivalent to the Becton Dickinson TriTest™ CD4 FITC/CD8 PE/CD3 PerCP Reagent (K971205) and MultiTest™ CD3 FITC/CD8 PE/CD45 PerCP/CD4 ACP Reagent (K974360). All assays differentiate CD4 cells; the Cylex assay determi… | 1997 |
| * | K974360 | Multitest CD3/CD8/CD45/CD4Summary page 2…d to be substantially equivalent to the Becton Dickinson TriTest™ CD4 FITC/CD8 PE/CD3 PerCP Reagent (K971205) and MultiTest™ CD3 FITC/CD8 PE/CD45 PerCP/CD4 ACP Reagent (K974360). All assays differentiate CD4 cells; the Cylex assay determines the responsiveness of those cells and the Becton Dickinson assay… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K971205.
How does its category compare?
All NID devicesNID Assay, Proliferation, In Vitro, T Lymphocyte: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NID
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · NID
Too few NID 510(k)s in any year since 2007 to give a median.
Recalls per year · NID
No recall names NID since 2007.
Adverse event reports per year · NID
No MAUDE report names NID since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant. The…
Read the full statement (112 words)
The Cylex Immune Cell Function Assay measures the concentration of ATP from circulating CD4 cells following in vitro stimulation with phytohemagglutinin (PHA) as an indicator of immune cell function. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell mediated immune response in populations undergoing immunosuppressive therapy for organ transplant.
The Cylex Immune Cell Function Assay detects cell-mediated immunity (CMI) by measuring the concentration of ATP from CD4 cells following stimulation. This measurement is made on heparin anti-coagulated whole blood using a luminometer and luciferin/luciferase. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population.
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/K013169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013169: Immune Cell Function Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013169
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026