← Product Code [OYE](/productcode/OYE) · BK230835 # BD Leucocount™ Kit; BD FACSuite™ Clinical BD Leucocount™ Assay Module; BD FACSLyric™ Flow Cytometer (BK230835) _Becton, Dickinson & Company San Jose, CA · OYE · Jul 24, 2023 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/BK230835 ## Device Facts - **Applicant:** Becton, Dickinson & Company San Jose, CA - **Product Code:** [OYE](/productcode/OYE.md) - **Decision Date:** Jul 24, 2023 - **Decision:** SESE - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The BD Leucocount™ Kit consists of BD Leucocount™ Reagent (propidium iodide fluorescent dye) and BD Trucount™ Tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, BD FACSVia™, and BD FACSLyric™ flow cytometer systems, or for a flow cytometer equipped with a 488-nm laser able to threshold on propidium iodide fluorescence, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use. The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for the following: Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. Enumeration of residual white blood cells (rWBCs) in leucoreduced blood products. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. ## Device Story BD Leucocount™ Kit uses propidium iodide fluorescent dye to stain DNA in nucleated white blood cells; BD Trucount™ tubes with internal reference beads enable absolute cell counting. Samples are prepared manually and acquired on BD FACSLyric™ flow cytometer. BD Leucocount™ Assay Module for BD FACSuite™ Clinical software automates data processing; identifies rWBC and bead populations via gating; calculates absolute rWBC counts based on bead events and sample volume. Used in clinical laboratories by trained personnel. Output includes lab reports with rWBC counts (cells/μL) and total counts per pack. Assists clinicians in verifying leucoreduction quality in blood products; ensures patient safety by minimizing residual WBCs in transfusions. ## Clinical Evidence Bench testing and clinical method comparison performed. Method comparison study (n=502 evaluable specimens) across four sites compared BD Leucocount™ on BD FACSLyric™ vs. BD FACSVia™; acceptance criteria met. Precision, repeatability, linearity, LoB (0 cells/μL), LoQ (0.7 cells/μL), carryover, and inter-site reproducibility studies conducted per CLSI standards (EP05-A3, EP06-Ed2, EP17-A2, EP09c). ## Technological Characteristics Flow cytometric assay using propidium iodide (nucleic acid dye) and Trucount™ beads. BD FACSLyric™ system uses blue (488-nm) and red (640-nm) lasers. Detection: 586/42 filter (blue laser) for reagent, 660/10 filter (red laser) for beads. Software: BD FACSuite™ Clinical with BD Leucocount™ Assay Module. Manual sample preparation. Connectivity: Standalone or networked clinical system. ## Regulatory Identification An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers. ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.” ## Predicate Devices - BD FACSVia™ System with BD Leucocount™ Reagent Assay ([BK150307](/device/BK150307.md)) - BD FACSLyric™ Flow Cytometer ([K201814](/device/K201814.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} ## ATTACHMENT 36 – 510(k) SUMMARY This 510(k) summary is being provided in accordance with the requirements of 21 CFR 807.92. Date of Summary: April 24, 2023 ### 1. Submitted By Becton, Dickinson and Company BD Biosciences 2350 Qume Drive San Jose, CA 95131-1807 USA Contact: Jonathan Lee Senior Regulatory Affairs Specialist Telephone: (415) 680-5626 Email: (b) (6) @bd.com ### 2. Device Trade Name/Device Name: BD Leucocount™ Kit; BD FACSuite™ Clinical BD Leucocount™ Assay Module; BD FACSLyric™ Flow Cytometer Classification: Class II Device Classification: Flow Cytometric Reagents and Accessories Regulation Description: Automated Differential Cell Counter Regulation Medical Specialty: Hematology Product Code: OYE Regulation Number: 21 CFR 864.5220 ### 3. Predicate Device Predicate Trade Name/Device Name: BD FACSVia™ System with BD Leucocount™ Reagent Assay 510(k) Number: BK150307 Classification: Class II Device Classification: Flow Cytometric Reagents and Accessories Regulation Description: Automated Differential Cell Counter Regulation Medical Specialty: Hematology Product Code: OYE Regulation Number: 21 CFR 864.5220 BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 1 of 10 {1} Predicate | Trade Name/Device Name: | BD FACSLyric™ Flow Cytometer | | --- | --- | | 510(k) Number: | K201814 | | Classification: | Class II | | Device Classification: | Flow Cytometric Reagents and Accessories | | Regulation Description: | Automated Differential Cell Counter | | Regulation Medical Specialty: | Hematology | | Product Code: | OYE | | Regulation Number: | 21 CFR 864.5220 | #### 4. Device Description BD Leucocount™ Kit is a flow cytometric in vitro diagnostic assay based on a nucleic acid fluorescent dye. The purpose of this 510(k) is to add use of the cleared BD Leucocount™ Kit with the BD FACSLyric™ flow cytometer system. In addition, the intended use statement of the BD FACSLyric™ Flow Cytometer will be updated to support use with the BD Leucocount™ Kit. To use the BD Leucocount™ Kit on the BD FACSLyric™ flow cytometer system, the following system components are required: - BD Leucocount™ Kit - BD Leucocount™ Assay Module for BD FACSuite™ Clinical application - BD FACSLyric™ flow cytometer system - BD Leucocount™ RBC Control, BD Leucocount™ PLT Control, or BD Leucocount™ Combo Control - BD FACSLink™ (optional) To enable use of the BD Leucocount™ Kit with the BD FACSLyric™ flow cytometer system, BD Leucocount™ Assay Module has been developed. #### 5. Indications for Use ##### **BD Leucocount™ Kit** The BD Leucocount™ Kit consists of BD Leucocount™ Reagent (propidium iodide fluorescent dye) and BD Trucount™ Tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, BD FACSVia™, and BD FACSLyric™ flow cytometer systems, or for a flow cytometer equipped with a 488-nm laser able to threshold on propidium iodide fluorescence, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use. BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 2 of 10 {2} ### **BD FACSLyric™ Flow Cytometer** The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for the following: - Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. - Enumeration of residual white blood cells (rWBCs) in leucoreduced blood products. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. ## **6. Substantial Equivalence Comparison between Subject and Predicate Devices** Table 1 provides a summary list of the subject devices and their corresponding predicate device. **Table 1. Subject and Predicate Devices** | Subject Device | Predicate Device | | --- | --- | | BD Leucocount™ Kit (with BD FACSuite™ Clinical BD Leucocount™ Assay Module) | BD FACSVia™ System with BD Leucocount™ Reagent Assay (BK150307) | | Subject Device | Predicate Device | | BD FACSLyric™ Flow Cytometer | BD FACSLyric™ Flow Cytometer (K201814) | ### **BD Leucocount™ Kit – Summary of Device Comparison** Table 2 provides a comparison between the subject BD Leucocount™ Kit and its predicate device. The subject BD Leucocount™ Kit is the same as its predicate device, as follows: - Same indications for use: for enumerating residual white blood cells in leucoreduced blood products. - Same components in the BD Leucocount™ Kit (BD Leucocount™ Reagent and BD Trucount™ Tubes). - Same assay principle. - Same specimen types, specimen stability, cell population for analysis, and sample preparation method. The subject BD Leucocount™ Kit differs from its predicate device, as follows: - BD FACSLyric™ Flow Cytometer has been added for use with the subject device. - An assay module (BD Leucocount™ Assay Module) has been developed to enable BD Leucocount™ Kit to be used with BD FACSuite™ Clinical application on BD FACSLyric™ Flow Cytometer. BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 3 of 10 {3} ### BD FACSLyric™ Flow Cytometer – Summary of Device Comparison Table 3 provides a comparison between the subject BD FACSLyric™ Flow Cytometer and its predicate device. The only difference between the subject BD FACSLyric™ Flow Cytometer and its predicate is that the intended use statement will be updated to support use with the BD Leucocount™ Kit. All other aspects of the BD FACSLyric™ Flow Cytometer remain the same as described in the most recent BD FACSLyric™ Flow Cytometer 510(k) clearance K201814 (predicate). **Table 2. Comparison Between BD Leucocount™ Kit and its Predicate** | Feature/Attribute | Subject Device | Predicate Device | | --- | --- | --- | | | **BD Leucocount™ Kit (with BD Leucocount™ Assay Module, for use with BD FACSLyric™ Flow Cytometer)** | **BD Leucocount™ Reagent Assay (BD Leucocount™ Kit) for use with BD FACSVia™ System (BK150307)** | | **Device Classification and Product Code** | Regulation Description: Flow Cytometric Reagents and Accessories Regulatory Class: II Regulation Number: 21 CFR 864.5220 Product Code: OYE | | | **Intended Use / Indications for Use** | The BD Leucocount™ Kit consists of BD Leucocount™ Reagent (propidium iodide fluorescent dye) and BD Trucount™ Tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, BD FACSVia™, **and BD FACSLyric™ flow cytometer systems**, or for a flow cytometer equipped with a 488-nm laser able to threshold on propidium iodide fluorescence, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use. | BD Leucocount™ Kit consists of BD Leucocount™ reagent (propidium iodide fluorescent dye) and BD Trucount™ tubes and is intended for use with the BD FACSCalibur™, BD FACSort™, BD FACScan™, and BD FACSVia™ flow cytometer systems, or for a flow cytometer equipped with a 488-nm argon ion laser able to threshold on FL2, for enumerating residual white blood cells (rWBCs) in leucoreduced blood products. For in vitro diagnostic use. | | **Reagents** | BD Leucocount™ Kit • BD Leucocount™ Reagent • BD Trucount™ Tubes | | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 4 of 10 {4} | Feature/Attribute | Subject Device BD Leucocount™ Kit (with BD Leucocount™ Assay Module, for use with BD FACSLyric™ Flow Cytometer) | Predicate Device BD Leucocount™ Reagent Assay (BD Leucocount™ Kit) for use with BD FACSVia™ System (BK150307) | | --- | --- | --- | | Detection/Assay Principle | The BD Leucocount™ Reagent contains propidium iodide fluorescent dye. Propidium iodide is a nucleic acid dye which, when used with RNAse, stains only cellular DNA. White blood cells are nucleated cells that contain DNA and are therefore stained with the dye. Non-nucleated particles (including platelets and red blood cells) do not stain with this reagent. BD Trucount™ Tubes contain beads that act as an internal reference to accurately determine the absolute count of residual white blood cells (rWBCs). Appropriate samples are combined with the lyophilized bead pellet in the BD Trucount™ Tube before staining. After staining rWBCs, samples are acquired on a flow cytometer. Absolute rWBC counts are determined by using a simple calculation based on bead number and sample volume. | | | Specimen Type | Leucoreduced blood products, including: - Leucoreduced red blood cells - Leucoreduced platelets | | | Sample Volume | 100 μL | | | Sample Preparation | Manual | | | Instrument and Software Platform | **For BD FACSLyric™ Flow Cytometer:** - BD FACSLyric™ Flow Cytometer using BD FACSuite™ Clinical application with BD Leucocount™ Assay Module - System adjusts/optimizes photomultiplier tube (PMT) voltages | **For BD FACSVia™ Flow Cytometer:** - BD FACSVia™ Flow Cytometer using BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file - Fixed PMT voltages | | Software - Inputs | **For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module:** - Flow cytometry data. - Lot and expiry information for BD Trucount™ beads and setup beads. - **Lot and expiry information for reagents.** - Sample tube ID. - May also input the pack volume. | **For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file:** - Flow cytometry data. - Lot and expiry information for BD Trucount™ beads and setup beads. - Sample tube ID. - May also input the pack volume. | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 5 of 10 {5} | Feature/Attribute | Subject Device BD Leucocount™ Kit (with BD Leucocount™ Assay Module, for use with BD FACSLyric™ Flow Cytometer) | Predicate Device BD Leucocount™ Reagent Assay (BD Leucocount™ Kit) for use with BD FACSVia™ System (BK150307) | | --- | --- | --- | | **Software - Outputs** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: • BD Leucocount™ Lab Report • Assay Setup Report • Instrument QC Report | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: • BD Leucocount™ Lab Report • Instrument QC Report | | **Software – Operator/User** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: • Clinical laboratory personnel. | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: • Clinical laboratory personnel. | | **Software – Operator/User Actions** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: • Analysis gates/regions are automatically applied to the flow cytometry dot plots. The user inspects the dot plots, and the gates/regions may be adjusted by the user as needed. • Reports generated by the software with BD Leucocount™ Assay Module are reviewed by the user. | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: • Analysis gates/regions are automatically applied to the flow cytometry dot plots. The user inspects the dot plots, and the gates/regions may be adjusted by the user as needed. • Reports generated by the software with BD Leucocount™ assay test definition file are reviewed by the user. | | **Software – Acquisition Stopping Criteria** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: • 10,000 BD Trucount™ beads events collected. • Acquisition time limit: 5 minutes. | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: • 10,000 BD Trucount™ beads events collected. • Acquisition time limit: 5 minutes. | | **Software – Gated Analysis Events/ Populations** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: • Residual white blood cells (rWBCs) • BD Trucount™ Beads | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: • Residual white blood cells (rWBCs) • BD Trucount™ Beads | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 6 of 10 {6} | Feature/Attribute | Subject Device | Predicate Device | | --- | --- | --- | | | **BD Leucocount™ Kit (with BD Leucocount™ Assay Module, for use with BD FACSLyric™ Flow Cytometer)** | **BD Leucocount™ Reagent Assay (BD Leucocount™ Kit) for use with BD FACSVia™ System (BK150307)** | | **Software – rWBC Analysis Gate Type** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: - The rWBC population is identified by a default pre-defined gate template/region that is automatically set. The gate may be adjusted by the user as needed. | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: - The rWBC population is identified by a default pre-defined gate template/region that is automatically set. The gate may be adjusted by the user as needed. | | **Software – BD Trucount™ Beads Analysis Gate Type** | For BD FACSuite™ Clinical Application with BD Leucocount™ Assay Module: - The BD Trucount™ Beads population is identified **with an algorithm gate** that is automatically set and adjusted. The gate may be adjusted further by the user as needed. | For BD FACSVia™ Clinical software with BD Leucocount™ assay test definition file: - The BD Trucount™ Beads population is identified by a default pre-defined gate template/region that is automatically set. The gate may be adjusted by the user as needed. | | **Instrument Configuration** | For BD FACSLyric™ Flow Cytometer: - Equipped to detect forward scatter, side scatter and up to six fluorescence channels for IVD use. - BD Leucocount™ reagent (propidium iodide) uses the blue laser's detector with the 586/42 filter. - BD Trucount™ absolute counting beads use the red laser's detector with the 660/10 filter. | For BD FACSVia™ Flow Cytometer: - Equipped to detect forward scatter, side scatter and up to two fluorescence channels for IVD use. - BD Leucocount™ reagent (propidium iodide) uses the blue laser's detector with the 585/40 filter. - BD Trucount™ absolute counting beads use the blue laser's detector with the 533/30 filter. | | **Specimen Stability Age of Blood (AOB) Age of Stain (AOS)** | Prepare and run the samples within 48 hours following leucoreduction. For specimens stained within 24 hours of leucoreduction, acquire the samples within 24 hours of staining. For specimens stained within 48 hours of leucoreduction, acquire the samples within 60 minutes of staining. | | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 7 of 10 {7} | Feature/Attribute | Subject Device BD Leucocount™ Kit (with BD Leucocount™ Assay Module, for use with BD FACSLyric™ Flow Cytometer) | Predicate Device BD Leucocount™ Reagent Assay (BD Leucocount™ Kit) for use with BD FACSVia™ System (BK150307) | | --- | --- | --- | | Number of Tubes per Assay | 1 Tube | | | Measurement Range | For BD FACSLyric™ Flow Cytometer: 0.7 – 350 rWBCs/μL | For BD FACSVia™ Flow Cytometer: 0 – 350 rWBCs/μL | | Results Reporting | Software-assisted report generation. The lab report provides the rWBC count in cells/μL. The lab report also provides the total rWBC count per pack, if the pack volume is entered. | | Table 3. Comparison Between BD FACSLyric™ Flow Cytometer and its Predicate | Feature/Attribute | Subject Device BD FACSLyric™ Flow Cytometer | Predicate Device BD FACSLyric™ Flow Cytometer (K201814) | | --- | --- | --- | | Intended Use / Indications for Use | The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for the following: • Immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. • Enumeration of residual white blood cells (rWBCs) in leucoreduced blood products. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. | The BD FACSLyric™ flow cytometer is intended for use as an in vitro diagnostic device for immunophenotyping using up to six fluorescence detection channels and two light scatter channels using a blue (488-nm) and a red (640-nm) laser. It is intended for use with in vitro diagnostic (IVD) assays and software that are indicated for use with the instrument. | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 8 of 10 {8} ## 7. Performance Data The following performance studies were conducted to support the substantial equivalency determination. **Table 4. BD Leucocount™ Kit Bench Performance Studies** | Study | Standard | Objective | Results | | --- | --- | --- | --- | | Within-Site Precision Using Control Materials | CLSI EP05-A3 | To evaluate the precision performance of BD Leucocount™ Kit on the BD FACSLyric™ Flow Cytometer. | All acceptance criteria were met. | | Repeatability Evaluation Using Clinical Specimens | CLSI EP05-A3 | To verify repeatability performance of BD Leucocount™ Kit on the BD FACSLyric™ Flow Cytometer through testing clinical specimens. | All acceptance criteria were met. | | Linearity | CLSI EP06-Ed2 | To evaluate the linear range of the BD Leucocount™ Kit using BD FACSLyric™ Flow Cytometer, for measuring residual White Blood Cell (rWBC) absolute counts. | The linear range for rWBC absolute counts using BD Leucocount™ Kit on BD FACSLyric™ Flow Cytometer was established based on the acceptance criteria. | | Limit of Blank | CLSI EP17-A2 | To evaluate Limit of Blank of BD Leucocount™ Kit with BD FACSLyric™ Flow Cytometer. | The Limit of Blank (LoB) is 0 cells/μL for rWBC absolute counts. | | Limit of Quantitation | CLSI EP17-A2 | To evaluate Limit of Quantitation of BD Leucocount™ Kit with BD FACSLyric™ Flow Cytometer. | The Limit of Quantitation (LoQ) is 0.7 cells/μL for rWBC absolute counts. | | Interfering Substances | CLSI EP07-Ed3 CLSI EP37-Ed1 | To assess the performance of BD Leucocount™ Kit for use with BD FACSLyric™ Flow Cytometer in the presence of potential endogenous and exogenous interfering substances. | There was no detectable interference for all the tested substances, with the exception of triglycerides, a known interferent that causes light scattering changes. This interfering condition caused by lipemic specimens will be reflected in the instructions for use. | | Sample and Reagent Carryover | CLSI H26-A2 | To evaluate sample and reagent carryover using BD Leucocount™ Kit with BD FACSLyric™ Flow Cytometer. | All acceptance criteria were met. | BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 9 of 10 {9} | Study | Standard | Objective | Results | | --- | --- | --- | --- | | BD FACSLyric™ Manual Versus Loader Acquisition Equivalency | CLSI EP09c | To determine the method bias of the BD Leucocount™ Kit for samples acquired on the BD FACSLyric™ Flow Cytometer using BD FACS™ Universal Loader, versus samples that are acquired manually. | All acceptance criteria were met. | | Anticoagulants | CLSI EP07-Ed3 | To assess the compatibility of the BD Leucocount™ Kit with various anticoagulants used in blood products collection and storage. | All tested anticoagulants (ACD, CPD, CP2D, CPDA, EDTA, 4% Sodium Citrate, Heparin) met the study acceptance criteria. | **Table 5. BD Leucocount™ Kit Performance Studies Conducted at Clinical Sites** | Study | Standard | Objective | Results | | --- | --- | --- | --- | | Method Comparison | CLSI EP09c | To determine the method bias between the subject device (BD Leucocount™ Kit on BD FACSLyric™ Flow Cytometer) versus the predicate device (BD Leucocount™ Kit on BD FACSVia™ Flow Cytometer). | A total of 520 specimens were enrolled across four testing sites. 502 specimens were evaluable. 18 specimens were non-evaluable. The acceptance criteria were met. | | Inter-Site Reproducibility | CLSI EP05-A3 | To assess inter-site reproducibility of BD Leucocount™ Kit on BD FACSLyric™ Flow Cytometer. | The results of inter-site reproducibility for the BD Leucocount™ Kit on the BD FACSLyric™ Flow Cytometer demonstrated that the variability across three sites met study acceptance criteria. | | Specimen Stability | CLSI EP25-A | To support the sample stability and stained sample stability claims for leucoreduced red blood cells and leucoreduced platelets. | The acceptance criteria were met. The results from the study support the specimen stability claims. | ## 8. Conclusion The subject device, BD Leucocount™ Kit (with BD Leucocount™ Assay Module, to enable use with the BD FACSLyric™ Flow Cytometer), is substantially equivalent to the predicate device, BD Leucocount™ Kit (for use with the BD FACSVia™ Flow Cytometer). BD Biosciences Traditional 510(k) BD Leucocount™ Kit Attachment 36 (510(k) Summary) Page 10 of 10 --- **Source:** [https://fda.innolitics.com/device/BK230835](https://fda.innolitics.com/device/BK230835) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com