BD FACS 7-COLOR SETUP BEADS

K040026 · Becton Dickinson Immunocytometry Systems · GKZ · Sep 10, 2004 · Hematology

Device Facts

• Record ID: K040026
• Device Name: BD FACS 7-COLOR SETUP BEADS
• Applicant: Becton Dickinson Immunocytometry Systems
• Product Code: GKZ · Hematology
• Decision Date: Sep 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use on a BD FACSCanto flow cytometer with BD FACSCanto software. The beads are used to adjust fluorescent detector voltages, to set fluorescence compensation, and to monitor daily instrument performance.

Device Story

Kit containing lyophilized 4-um and 6-um beads (unlabeled or labeled with fluorophores: FITC, PE, PerCP, APC, PerCP-Cy5.5, PE-Cy7, APC-Cy7); used in clinical laboratory settings by trained personnel to calibrate BD FACSCanto flow cytometers. Beads rehydrated with diluent; processed by flow cytometer to adjust forward scatter (FSC) photodiode, side scatter (SSC) photomultiplier tube (PMT) voltages, and fluorescence detectors. Output used to ensure instrument performance and compensation accuracy prior to immunophenotyping assays. Benefits include standardized instrument setup and consistent data acquisition for clinical flow cytometry.

Clinical Evidence

Bench testing only. Studies included stability testing (7 months at 2-8°C) and reproducibility testing across three lots, which demonstrated performance equivalent to the predicate device.

Technological Characteristics

Lyophilized beads in single-use pouches; rehydrated with provided diluent. Used for calibration of flow cytometers with 488-nm blue and 633-nm red lasers. Class II device (Product Code GKZ).

Indications for Use

Indicated for in-vitro use on the BD FACSCanto flow cytometer to adjust detector voltages, set fluorescence compensation, and monitor daily instrument performance.

Regulatory Classification

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

• CaliBRITE beads (K000897)
• CaliBRITE beads (K973483)
• CaliBRITE beads (K961623)
• CaliBRITE beads (K925274)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K040026

B. Purpose for Submission:
New device

C. Analyte:
CD3⁺CD8⁺, CD3⁺CD4⁺, CD3⁻CD16⁺ and/or CD56⁺, CD3⁻CD19⁺, and CD3⁺.

D. Type of Test:
Semi-quantitative, optical

E. Applicant:
Becton Dickinson Immunocytometry Systems

F. Proprietary and Established Names:
BD FACSTM 7-Color Setup Beads

G. Regulatory Information:
1. Regulation section:
21 CFR 864.5220, Automated differential cell counter
2. Classification:
Class II
3. Product Code:
GKZ, Counter, differential cell
4. Panel:
Hematology (81)

H. Intended Use:
1. Intended use(s):
BD FACS 7-color setup beads are for in-vitro use on the BD FACSCanto flow cytometer with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation, and to monitor daily instrument performance.
2. Indication(s) for use:
BD FACS 7-color setup beads are for in-vitro use on the BD FACSCanto flow cytometer with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation, and to monitor daily instrument performance.
3. Special condition for use statement(s):
For use on the BD FACSCanto flow cytometer with BD FACSCanto software.
4. Special instrument Requirements:
Not Applicable.

I. Device Description:
BD FACS 7-color setup beads are supplied as a kit containing 25 individually packaged setup bead tubes, a bottle of bead diluent, target values, and spectral overlap factors. The beads are used to set up a flow cytometry before running

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immunophenotyping assays on stained cells. Each setup bead tube contains a lyophilized pellet that is rehydrated with bead diluent. Each pellet contains a mixture of 4um and 6-um beads that are either unlabeled or individually labeled with fluorophores; fluorescein, R-phycoerythrin (PE), Peridinin chlorophyll protein (PerCP), allophycocyanin (APC), PerCP cyanine 5.5 tandem (PerCP-Cy5.5), PE cyanine 7 tandem (PE-Cy7), APC cyanine 7 tandem (APC-Cy7).

J. Substantial Equivalence Information:

1. Predicate device name(s): BD CaliBRITE Beads
2. Predicate K number(s): K973483
3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | BD FACS 7-color Setup Beads | BD CaliBRITE Beads |
| Intended Use | To adjust detector voltages, to set fluorescence compensation, and to monitor daily instrument performance. | Same |
| Storage | 2-8° C, 7 months | Same |
| Fluorophores | | |
| R-phycoerythrin (PE) | Same | Same |
| Peridinin Chlorophyll protein (PerCP-Cy5.5) | Same | Same |
| PerCP cyanine 5.5 tandem (PerCP-Cyb5.5) | Same | Same |
| Allophycocyanin (ACP) | Same | Same |
| Differences | | |
| Item | Device | Predicate |
| Form | Lyophilized | Liquid |
| Fluorophores | | |
| Fluorescein. | Fluorescein isothiocyanate (FITC) derivative used for starting material for conjugation resulting in fluorescein surface-coupled | Fluorescein EX derivative used as starting material for conjugation resulting in fluorescein surface-coupled PMMA beads. |

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| | PMMA beads. | |
| --- | --- | --- |
| PE-Cy7 | PE cyanine 7 tandem (PE-Cy7) same as predicate with the exception that PE is derivatized with cyanine7 | NA |
| APC-Cy7 | APC cyanine 7 tandem (APC-Cy7); same as predicate with the exception that APC is derivatized with cyanine 7 | NA |

K. Standard/Guidance Document Referenced (if applicable):
Not Applicable

L. Test Principle:
The dual laser FACS-brand flow cytometer is set up for data acquisition and analysis each day using BD FACS 7-color setup beads and BD flow cytometry system software to adjust the forward scatter (FSC) photodiode, the photomultiplier tube (PMT) voltages for side scatter (SSC) and the fluorescence detectors.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
MFI Specification: The study was set up so that all tubes were hydrated at different times with BD FACS setup bead diluent, incubated at 2-8C, and then all read together on the flow cytometer after the last time point. Each time point is the average of 6 acquisitions-3 acquisitions of each of the two duplicate bead tubes.
Results: All beads were stable and within specification.
Spectral Overlap: Spectral overlap was calculated from the same Data set which determined little or no change and within specification
b. Linearity/assay reportable range:
Not applicable
c. Traceability (controls, calibrators, or method):
Not applicable
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable
b. Matrix comparison:

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Not applicable

3. Clinical studies:
a. Clinical sensitivity:
Not applicable
b. Clinical specificity:
Not applicable
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
Not applicable

5. Expected values/Reference range:
Not applicable

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.