BD FACS SAMPLE PREP ASSISTANT III (SPA III)

K102064 · Becton, Dickinson & CO · GKZ · Mar 7, 2011 · Hematology

Device Facts

• Record ID: K102064
• Device Name: BD FACS SAMPLE PREP ASSISTANT III (SPA III)
• Applicant: Becton, Dickinson & CO
• Product Code: GKZ · Hematology
• Decision Date: Mar 7, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II flow cytometry systems. Pipetting blood, reagents and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems: - BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes - BD Multitest IMK Kit with or without BD Trucount Tubes - BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or without BD Trucount Tubes - BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes For in vitro diagnostic use.

Device Story

Microprocessor-controlled pipetting/diluting system; automates whole blood sample preparation for flow cytometry. Inputs: human whole blood samples in Vacutainer or Sarstedt tubes; reagents; lysing solution. Operation: robotic pipetting module (X/Y/Z axes) pierces tube caps, aliquots blood/reagents, mixes samples per preprogrammed/custom protocols, adds lysing solution, and performs automated probe cleaning. Output: prepared samples ready for acquisition/analysis on BD FACSCanto II flow cytometer. Used in clinical laboratory settings by trained personnel. Enhances workflow by reducing processing time and reagent waste compared to previous generation. Healthcare providers use resulting flow cytometry data for diagnostic assessment; device ensures standardized, automated sample preparation, reducing manual handling errors and improving throughput.

Clinical Evidence

Bench testing only. Performance evaluated per CLSI guidelines: accuracy (EP9-A2), precision (EP5-A2), and carryover (FDA guidance for automated differential cell counters). Results demonstrated that the SPA III with the BD FACSCanto system achieved equivalent performance and precision within specifications compared to the predicate method.

Technological Characteristics

Microprocessor-controlled robotic pipetting system. Components: enclosure, X/Y/Z robotic module, fluid pumps, barcode reader, 1 mL sample/reagent syringe, 10 mL lyse syringe. Connectivity: accessory to BD FACSCanto II flow cytometer. Software-controlled automation of fluidics and optics. Sterilization: not specified.

Indications for Use

Indicated for preparation of human whole blood samples for flow cytometric analysis on BD FACSCanto II systems using specific BD Multitest reagent kits.

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

• BD FACSCanto system with BD FACSCanto clinical software (k050191)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k102064

B. Purpose for Submission:
Modifications to a previously cleared device (BD FACS Sample Prep Assistant II - k050191):
a. Expanded options for primary sample tubes (in addition to the already available Vacutainer tubes);
b. Increased throughput by using a shorter wash cycle (three 1-second pulses replace one 30-second wash) and increasing syringe sizes (the sample/reagent syringe is increased to 1 mL from 0.5 mL and the lyse syringe is increased to 10 mL from 2.5 mL)
c. Reduced reagent waste for single dispenses (4 µL compared to 5 µL)
d. SPA software version 4.0.2 which supports the above hardware changes and adds pre-programmed reagent panels for BD Multitest 6-Color TBNK Reagent (k090967) based on testing results using the Replacement Reagent and Instrument Family Policy (December 11, 2003).

C. Manufacturer and Instrument Name:
BD Biosciences
BD FACS™ Sample Prep Assistant III accessory to the BD FACSCanto™ system with BD FACSCanto™ clinical software

D. Type of Test or Tests Performed:
Specimen processor.

E. System Descriptions:
1. Device Description:
The BD FACS Sample Prep Assistant III is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer.
2. Principles of Operation:
The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.
3. Modes of Operation:
Automatic, closed mode.
4. Specimen Identification:
To enter the ID, one can scan a primary tube with the barcode scanner, or manually type a unique identification code (Sample ID) into the worklist.
5. Specimen Sampling and Handling:

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The carousel rack holds up to 40 uncapped 12 x 75 mm polystyrene secondary tubes and is compatible with the BD FACS™ Loader. Each rack has an identification code stamped on top. A work list can be generated to enter primary tube identification, tube type, position, panel, and secondary tube positions.

6. Calibration:
Not applicable

7. Quality Control:
Quality control is performed in the context of the FACSCanto System. Manufacturer also recommends verification of accuracy and precision following probe change or replacement.

8. Software:
FDA has reviewed applicant’s Hazard Analysis and Software Development processes for this line of product types:
Yes_X_ or No

F. Regulatory Information:
1. Regulation section:
21 CFR 864.5220 – Automated Differential Cell Counter
2. Classification:
Class II
3. Product code:
GKZ
4. Panel:
81 Hematology

G. Intended Use:
1. Indication(s) for Use:
The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II flow cytometry systems.

Pipetting blood, reagents and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto II flow cytometry systems:
- BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes
- BD Multitest IMK Kit with or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or without BD Trucount Tubes
- BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD Trucount Tubes

For in vitro diagnostic use.

2. Special Conditions for Use Statement(s):
None

H. Substantial Equivalence Information:
1. Predicate Device Name(s) and 510(k) numbers:
BD FACSCanto system with BD FACSCanto clinical software (k050191)
Note: BD FACS Sample Prep Assistant II is a component of the above mentioned system.
2. Comparison with Predicate Device:

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| Similarities | | |
| --- | --- | --- |
| Item | BD FACS Sample Prep Assistant III (k102064) | BD FACS Sample Prep Assistant II (k050191) |
| Intended Use | The BD FACSTM Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto II flow cytometry systems. | To prepare human whole blood for flow cytometry. When used as a pre-analytical component of the BD FACSCanto system, the SPA II becomes an accessory to the BD FACSCanto system but does not change the BD FACSCanto system’s intended use. |
| Sample Type | Whole blood | Same |
| Preparation Method | Automated | Same |
| Differences | | |
| --- | --- | --- |
| Item | BD FACS Sample Prep Assistant III (k102064) | BD FACS Sample Prep Assistant II (k050191) |
| Pipetting Syringe | 1 mL sample/reagent syringe
10 mL lyse syringe | 500 μL sample/reagent syringe
2.5 mL lyse syringe |
| Supported primary blood sample tubes | Vacutainer
Sarstedt | Vacutainer |
| Probe rinse | 3 pulses of approximately 1 second | One 30 second wash |
| Single-dispense excess drawn reagent (waste) | 4 μL | 5 μL |

I. Special Control/Guidance Document Referenced (if applicable):

1. CLSI Document. EP5-A2. Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline - Second Edition". 2004.
2. CLSI Document EP9-A2. Method Comparison and Bias Estimation Using Patient Samples; Approved Guidelines - Second Edition. 2002.
3. 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, December 4, 2001.

J. Performance Characteristics:

1. Analytical Performance:

a. Accuracy:

Accuracy was assessed based on Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, CLSI document EP9-A2.

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The SPA III was compared to the manual pipetting using the BD Multitest 6-Color TBNK Reagent with BD Trucount Tubes in a 3 site external clinical study. Each site analyzed 255 patient specimens. For CD3+CD4+, CD3+CD8+ and CD3+ (percent and absolute values) mean bias was within ±1.0 and met the manufacturer's acceptance criteria of 95% CI on bias ≤ 10%. For CD3-CD19+ and CD3-CD16+CD56+ (percent and absolute values) mean bias was within ±4.0% and met the manufacturer's acceptance criteria of 95% CI on bias ≤ 20%.

The SPA III with the BD FACSCanto system demonstrated equivalent performance.

b. Precision/Reproducibility:

Precision was assessed based on Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, CLSI document EP5-A2. Pipetting precision was assessed gravimetrically for the BD-defined Multitest protocol using normal donor blood, BD Multi-Check process control, reagent buffer (to represent reagent). The performance for pipetting blood was found to be within the manufacturer's specifications of 50 μL ± 3% and the performance for pipetting reagent was found to be within the manufacturer's specifications of 20 μL ± 7%.

Precision of the staining and lysing of samples was also assessed. This was demonstrated by measuring the closeness of agreement between independent test/measurement results obtained under stipulated conditions. These conditions include multiple operators (3), multiple instruments (3 SPA III), and duration of testing (21 days) run twice daily in duplicate. The study samples were CD-Chex normal (CDN) and CD-Chex CD4 low (CDL) stained with BD Multitest 6-Color TBNK Reagent in BD Trucount Tubes.

Measurements for this study were the absolute counts and percentages of the following lymphocyte subsets: CD3+CD4+, CD3+CD8+, CD3+, CD3-CD19+ and CD3-CD16+CD56+. The manufacturer's acceptance criteria were as follows:

Absolute counts:
95% upper CI on the CV ≤ 10% for CD3+, CD4+ and CD8+
95% upper CI on the CV ≤ 20% for CD19+ and CD16+56+

Percent positives:
95% upper CI on the SD ≤ 2.5

Study results indicate that the device performed according to the manufacturer's acceptance criteria.

c. Linearity:

Not applicable

d. Carryover:

Carryover was assessed based on recommendations contained in 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, December 4, 2001.

Sample carryover was tested using three donors (in duplicate) on three SPA III instruments. These studies indicated that the device performed within the

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manufacturer's specification of <0.2%.

Reagent carryover was tested using three donors (in duplicate) on three SPA III instruments. These studies indicated that the device performed with a carry over that was within the manufacturer's specification of <0.01%. The SPA III with the BD FACSCanto system demonstrated system carryover within specification.

e. Interfering Substances:
Not applicable

2. Other Supportive Instrument Performance Data Not Covered Above:
Not applicable

K. Proposed Labeling:
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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