# DEN160047: ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

- Pathway: De Novo (Direct)
- Applicant: Beckman Coulter
- Decided: Jun 29, 2017 after 269 days
- Product code: PWD (Flow Cytometric Test System For Hematopoietic Neoplasms)
- Device class: 2
- Regulation: 21 CFR 864.7010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K183592: ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer (2019), 1 descendant of its own
- K232600: DxFLEX Flow Cytometer; ClearLLab 10C Panels (2023), 0 descendants of its own

## Indications for use
The ClearLLab reagents are intended for in vitro diagnostic use as a panel for qualitative identification of cell populations by multiparameter immunophenotyping on an FC 500 flow cytometer. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having the following hematopoietic neoplasms: chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS), and/or myeloproliferative neoplasms (MPN). The reagents can be used with peripheral whole blood collected in EDTA (K2 and K3EDTA), Acid Citrate Dextrose or Heparin, bone marrow collected in K2EDTA, ACD, or Heparin, and lymph node specimens. Interpretation of the results should be confirmed by a pathologist or equivalent professional in conjunction with other clinical and laboratory findings. These reagents provide multiparameter, qualitative results for the Cluster of Differentiation (CD) parameters listed below: - ClearLLab T1: CD2, CD56, CD7, CD5, CD45 - ClearLLab T2: CD8, CD4, CD3, CD45 - ClearLLab B1: Kappa, Lambda, CD19, CD5, CD45 - ClearLLab B2: CD20, CD10, CD19, CD38, CD45 - ClearLLab M: CD7, CD13, CD34, CD33, CD45

Source page: https://510kreport.com/device/DEN160047
Methodology: https://510kreport.com/methodology