BD FACS SAMPLE PREP ASSISTANT III

K131301 · Becton, Dickinson & CO · PER · Aug 2, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131301
• Device Name: BD FACS SAMPLE PREP ASSISTANT III
• Applicant: Becton, Dickinson & CO
• Product Code: PER · Clinical Chemistry
• Decision Date: Aug 2, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2750
• Device Class: Class 1

Intended Use

The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

Device Story

Microprocessor-controlled pipetting/diluting system; automates lyse/no-wash sample preparation for flow cytometry. Inputs: whole blood specimens in primary tubes (Vacutainer/Sarstedt), reagents, lysing solution. Operation: robotic pipetting module (X/Y/Z axes) pierces tube caps; syringe pumps volumetrically measure/transfer fluids to daughter tubes; mixes samples; adds lysing solution; automates probe cleaning. Output: prepared samples ready for acquisition on BD FACSCalibur or BD FACSCanto II flow cytometers. Used in clinical laboratories; operated by technicians/lab staff. Automates manual pipetting tasks; ensures consistent sample preparation; reduces manual error; improves workflow efficiency for flow cytometric analysis.

Clinical Evidence

Bench testing only. Accuracy evaluated via method comparison and bias estimation (CLSI EP9-A2); precision evaluated per CLSI EP5-A2; carryover evaluated per FDA guidance for automated differential cell counters. Results demonstrated equivalent performance to manual preparation and system specifications.

Technological Characteristics

Microprocessor-controlled robotic pipetting system; X/Y/Z axis movement; 1 mL sample/reagent syringes and 10 mL lyse syringe; fluidic, optic, robotic, and electronic components; barcode reader; automated probe rinse (3 pulses, ~1 sec each).

Indications for Use

Indicated for in vitro diagnostic use in preparing human whole blood samples for flow cytometric analysis using specific previously cleared BD Multitest and BD Tritest reagent kits on BD FACSCanto II and BD FACSCalibur flow cytometry systems.

Regulatory Classification

Identification

A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

Predicate Devices

• BD FACS™ Sample Prep Assistant III (K131301 - predicate for BD FACSCanto II system usage)

Submission Summary (Full Text)

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## Section 5: 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is K131301

| 1.0 | Submitted By: | BD Biosciences<br>2350 Qume Drive<br>San Jose, CA 95131 USA |
|-----|-----------------|----------------------------------------------------------------------------------------------------------------|
| | Contact: | Kimberly Liedtke<br>Regulatory Affairs Specialist<br>Telephone: [phone]<br>Email: [e-mail] |
| | Date Prepared: | August 1, 2013 |
| 2.0 | Device Name: | BD FACS™ Sample Prep Assistant III |
| | Classification: | Class II (21 CFR 864.5220 - Automated Differential<br>Cell Counter) |

### 3.0 Intended Use: The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

#### 4.() Indications for Use:

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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

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur flow cytometry systems:

- 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
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

Basic Description of the Device: 5.0

> The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow

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cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

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.

- Predicate Device: 6.0
The BD FACSCalibur system, using the BD FACS™ Sample Prep Assistant III (SPA III) is substantially equivalent to the BD FACSCanto II system using the BD FACS™ Sample Prep Assistant III (SPA III). For both systems, the SPA III is used to prepare human whole blood for flow cytometric analysis. When used with the BD FACSCalibur system, the SPA III and manual pipetting are used for the same sample type and result in similar performance characteristics.

- Comparison to the Predicate: 7.0
Similarities and Differences:

| Characteristic | BD SPA III used with the<br>BD FACSCanto II system<br>(predicate) | BD SPA III used with the<br>BD FACSCanto II and<br>BD FACSCalibur systems<br>(modification) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The BD FACS™ Sample<br>Prep Assistant III is<br>intended to prepare human<br>whole blood for flow<br>cytometric analysis on BD<br>FACSCanto II flow<br>cytometry systems. | The BD FACS™ Sample<br>Prep Assistant III is<br>intended to prepare human<br>whole blood for flow<br>cytometric analysis on BD<br>FACSCanto II and BD<br>FACSCalibur flow<br>cytometry systems. |
| Sample Type | Whole blood | Same |

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| Preparation<br>Method | Automated | Same |
|-----------------------------------------------------------|------------------------------------------------------|------|
| Pipetting<br>Syringe | 1 mL sample/reagent<br>syringe<br>10 mL lyse syringe | Same |
| Supported<br>primary<br>blood sample<br>tubes | Vacutainer<br>Sarstedt | Same |
| Probe Rinse | 3 pulses of approximately 1<br>second | Same |
| Single-<br>dispense<br>excess drawn<br>reagent<br>(waste) | 4 µL | Same |

And Children Children

·

### 8.0 Summary of Performance Data

:

| Study | Study Design | Results |
|-----------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Accuracy | Based on Method<br>Comparison and Bias<br>Estimation Using Patient<br>Samples; Approved<br>Guideline, CLSI document<br>EP9-A2 | The SPA III with the BD<br>FACSCalibur system<br>demonstrated equivalent<br>performance in its ability to<br>prepare human whole blood<br>for flow cytometric<br>analysis. |
| Precision | Based on Evaluation of<br>Precision Performance of<br>Clinical Chemistry Devices;<br>Approved Guideline, CLSI<br>document EP5-A2 | The SPA III demonstrated<br>system precision within<br>specification. |
| Carryover | Based on recommendations<br>contained in Class II<br>Special Controls Guidance<br>Document: Premarket<br>Notifications for Automated<br>Differential Cell Counters<br>for Immature or Abnormal<br>Blood Cells; Final<br>Guidance for Industry and<br>FDA, December 4, 2001 | The SPA III demonstrated<br>system carryover within<br>specification. |

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The BD FACS™ Sample Prep Assistant III with the BD FACSCalibur system demonstrates substantial equivalence to the predicate method.

:

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Image /page/5/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a person embracing or supporting another, representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 2, 2013

BD BIOSCIENCES C/O MS. KIMBERLY LIEDTKE REGULATORY AFFAIRS SPECIALIST 2350 QUME DRIVE SAN JOSE, CA 95131

| Re: 510(k) Number: | K131301 |
|--------------------|------------------------------------------------|
| Trade/Device Name: | BD FACS™ Sample Prep Assistant III |
| Regulation Number: | 21 CFR 862.2750 |
| Regulation Name: | Pipetting and Diluting System for Clinical Use |
| Regulatory Class: | Class I |
| Product Code: | PER |
| Dated: | May 2, 2013 |
| Received: | May 7, 2013 |

Dear Ms. Liedtke:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Kimberly Liedtke

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

## Maria M. Chan -S

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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### Indications for Use Statement

510(k) Number (if known): _K131301

Device Name: BD FACSTM Sample Prep Assistant III_

### Intended Use:

The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

### Indications for Use:

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

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:

- 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
- BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
- BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
- BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

| Prescription Use _____________________________________________________________________________________________________________________________________________________________ | And/Or | Over the Counter Use _________________________________________________________________________________________________________________________________________________________ |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| (21 CFR Part 801 Subpart D) | | (21 CFR Part 801 Subpart C) |

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

# Maria M. Chan -S

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