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.

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 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 / nowash 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.

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.

AI/ML Overview

The provided text describes the BD FACS Sample Prep Assistant III (SPA III) device and its performance studies. However, it does not contain detailed acceptance criteria, specific reported device performance metrics with numerical values, sample sizes for test sets, data provenance, information about experts for ground truth, adjudication methods, details of comparative effectiveness studies (MRMC), or specifics about training sets.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (BD FACS Sample Prep Assistant II) through high-level study results.

Here's an attempt to answer the questions based only on the provided text, with clear indications of what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Missing - Not explicitly stated in the document)

The document states that the SPA III demonstrated performance "within specification" or "equivalent performance" in various studies, implying that there were pre-defined acceptance criteria. However, the specific numerical or qualitative criteria themselves are not provided.

Reported Device Performance

Study Type	General Result of Performance	Specific Performance Metrics / Acceptance Criteria Met (Numerical/Qualitative)
Accuracy	The SPA III with the BD FACSCanto system demonstrated equivalent performance.	Missing (No numerical accuracy data or specific equivalence criteria provided)
Precision	The SPA III with the BD FACSCanto system demonstrated system precision within specification.	Missing (No numerical precision data or specific "specification" details provided)
Carryover	The SPA III with the BD FACSCanto system demonstrated system carryover within specification.	Missing (No numerical carryover data or specific "specification" details provided)

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The "Accuracy" study mentions "Using Patient Samples," but the number of samples is not given.
Data Provenance (Country of Origin, Retrospective/Prospective): Not specified.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is an automated sample preparation system for flow cytometry, not an AI/CADe device that interprets images or diagnoses conditions which would typically require expert ground truth.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The studies relate to the automated preparation process's accuracy, precision, and carryover, not diagnostic interpretation.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic aids where human readers interpret cases. The SPA III is a sample preparation accessory.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance studies (Accuracy, Precision, Carryover) evaluated the standalone device (SPA III with the BD FACSCanto system) without explicit human intervention in the preparation process itself. The "human-in-the-loop" concept is not directly applicable here as it's an automated lab instrument, not a diagnostic interpretation tool.

7. The Type of Ground Truth Used

For the Accuracy study, the ground truth was based on "Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, CLSI document EP9-A2." This implies comparison against an established reference method or the predicate device's performance. The specific nature of this "ground truth" (e.g., gold standard manual method, results from the predicate device) is not explicitly detailed beyond citing the CLSI guideline.
For Precision and Carryover, the ground truth implicitly refers to pre-defined "specifications" for these performance characteristics, as outlined in the cited CLSI and FDA guidelines.

8. The Sample Size for the Training Set

Not specified. This device is a hardware and software system for automated sample preparation. It is unlikely to involve a "training set" in the machine learning sense for building a diagnostic algorithm. Its function relies on programmed protocols, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no indication of a "training set" for an AI/ML algorithm.

Summary

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510(k) SUMMARY

MAR - 7 2011

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 K102064.

Submitter Information (21 CFR 807.92(a)(1))

Submitter: BD Biosciences 2350 Qume Drive San Jose, CA 95131 USA

Contact: Marc Glazer Manager, US Regulatory Affairs (408) 954-2355 (408) 954-2495 (FAX)

Summary Date: February 25, 2011

Device Name / Classification (21 CFR 807.92(a)(2))

Name: BD FACSTM Sample Prep Assistant III accessory to the BD FACSCanto™ system with BD FACSCanto™ clinical software Class II (21 CFR 864.5220) – Automated Differential Cell Counter Classification:

Substantially Equivalent/Predicate Device (21 CFR 807.92(a)(3))

The BD FACS Sample Prep Assistant III (SPA III) is substantially equivalent to the BD FACS™ Sample Prep Assistant II (SPA II), both of which are used with the BD FACSCanto system with BD FACSCanto Clinical Software. The SPA III and SPA II are used for the same assay preparation, and result in equivalent performance characteristics.

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Device Description (21 CFR 807.92(a)(4))

Intended Use (21 CFR 807.92(a)(5))

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.

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

For in vitro diagnostic use.

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Technological Characteristics (21 CFR 807.92(a)(6))

The following summary table describes the similarities and differences between the SPA II and SPA III when used with the BD FACSCanto system with BD FACSCanto clinical software.

Characteristic	BD FACS Sample PrepAssistant II	BD FACS Sample PrepAssistant III
	(predicate)	(modification)
Intended Use	When used as a pre-analyticalcomponent of the BDFACSCanto system, the SPA IIbecomes an accessory to the BDFACSCanto system but does notchange the BD FACSCantosystem's intended use.	The BD FACS™ Sample PrepAssistant III is intended toprepare human wholeblood for flow cytometricanalysis on BD FACSCanto IIflow cytometry systems.
Sample Type	Whole blood	Same
DeviceClassification andProduct Code asa Stand-aloneDevice	Automated Differential CellCounter21 CFR 864.5220Product Code: GKZClass II	Same
PreparationMethod	Automated	Same
Pipetting Syringe	500 µL sample/reagent syringe2.5 mL lyse syringe	1 mL sample/reagent syringe10 mL lyse syringe
Supportedprimary bloodsample tubes	Vacutainer	VacutainerSarstedt
Probe rinse	One 30 second wash	3 pulses of approximately 1second
Single-dispenseexcess drawnreagent (waste)	5 µL	4 µL

Table 1: Similarities and Differences

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The SPA III has modifications over the previous generation. These include reduced sample processing time through the use of larger syringes and reduced wash time; reduced reagent waste; and software upgrades to provide usability enhancements.

Study	Study Design	Results
Accuracy	Based on Method Comparison andBias Estimation Using PatientSamples; Approved Guideline, CLSIdocument EP9-A2.	The SPA III with the BDFACSCanto system demonstratedequivalent performance.
Precision	Based on Evaluation of PrecisionPerformance of Clinical ChemistryDevices; Approved Guideline, CLSIdocument EP5-A2.	The SPA III with the BDFACSCanto system demonstratedsystem precision withinspecification.
Carryover	Based on recommendationscontained in Class II SpecialControls Guidance Document:Premarket Notifications forAutomated Differential CellCounters for Immature or AbnormalBlood Cells; Final Guidance forIndustry and FDA,December 4, 2001.	The SPA III with the BDFACSCanto system demonstratedsystem carryover withinspecification.

Table 2: Performance Data (21 CFR 807.92(b)(1)and (2))

Conclusions from Performance Data (21 CFR 807.92(b)(3))

The BD FACS Sample Prep Assistant III with the BD FACSCanto system with BD FACSCanto clinical software demonstrates substantial equivalence to the predicate method.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

BD Biosciences c/o Marc Glazer, Ph.D. Manager, US Regulatory Affairs 2350 Qume Drive San Jose, CA 95131 USA

MAR 0 7 2011

Re: K102064

Trade/Device Name: BD FACSTM Sample Prep Assistant III Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: February 17, 2011 ( Received: February 18, 2011

Dear Dr. Glazer:

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice

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Page 2 - Marc Glazer, Ph.D.

requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria Mchon

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

Enclosure

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Indications for Use Statement

510(k) Number (if known): K102064

Device Name: BD FACSTM Sample Prep Assistant III

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

For in vitro diagnostic use.

Prescription Use X (Part.21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

fice of in Vitro Dlagnostic Device Evaluation and Safety

510(k) K102064

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
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.(b)
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.”