The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodics in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ lymphocyte percentage in combination with a White Blood Ccll (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count™ Fluorospheres as a single platform measurement.

Device Description

The FlowCARE™ TLG Reagent consists of a four-color antibody reagent composed of CD45-FITC, CD4-PE, CD8-ECD, and CD3-PC5. The assay is performed on the EPICS XL or suitably equipped flow cytometer using appropriate quality control reagents in combination with an optional absolute count reagent, Flow-Count™ Fluorospheres, for determination of CD3+, CD3+CD4+, and CD3+CD8+ absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.

AI/ML Overview

The provided text is a 510(k) summary for the FlowCARE™ TLG Reagent. It outlines the device's intended use, comparison to a predicate device, and a brief statement about performance data. However, it does not contain detailed information about specific acceptance criteria or the study data that proves the device meets those criteria.

The document states: "Accuracy, precision, and linearity studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution." This is a general statement and lacks the specific details required to complete your request.

Therefore, I cannot fill in the table or provide detailed answers to most of your questions based only on the provided text.

Here's an analysis of what information can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the provided text. The document only mentions "acceptable performance per the manufacturer specifications."
Reported Device Performance: Not explicitly stated in the provided text.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not mentioned.
Data Provenance: Not mentioned (country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as this seems to be an in vitro diagnostic reagent for automated cell counting, not an imaging device requiring expert interpretation for ground truth. The ground truth would typically be established by established laboratory methods or reference standards. The document does not specify how ground truth was established for the performance studies mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool requiring human reader studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is a reagent for flow cytometry, which is an automated process. The "analysis software" difference highlighted (predicate uses automated software, subject device uses "Manual analysis using customer created protocols according to package insert") suggests that the interpretation might involve manual steps, but the primary function is reagent-based cell counting. The performance studies would be for the reagent's analytical accuracy, precision, and linearity, which are inherently "standalone" in terms of the reagent's performance on the instrument. However, the details of these studies are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not specified. For this type of device (cell counting reagent), ground truth would typically come from a well-established reference method, potentially manual microscopy counts, or a predicate device.

8. The sample size for the training set

Not applicable/mentioned. This is not an AI/machine learning device that typically involves a training set in the conventional sense. The "training" here would be related to establishing the assay protocol parameters.

9. How the ground truth for the training set was established

Not applicable/mentioned.

Summary of what can be extracted from the text:

Device Name: FlowCARE™ TLG Reagent
Intended Use: Enumeration of CD3+, CD3+CD4+, and CD3+CD8+ absolute cell count and lymphocyte percentage, either as a dual platform measurement (with a hematology instrument's WBC count) or a single platform measurement (with Flow-Count™ Fluorospheres).
Studies Conducted (mentioned, but no details): Accuracy, precision, and linearity studies.
Conclusion of Studies (general statement): "demonstrated acceptable performance per the manufacturer specifications."
Predicate Device: tetraONE™ SYSTEM for EPICS XL Flow Cytometry SYSTEM with CYTO-STAT© tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 Monoclonal Antibody Reagent (Beckman Coulter, Inc., K990172)

Summary

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K081526

510(k) Summary FlowCARE™ TLG Reagent

AUG 1 4 2008

Submitted By: Nancy Nadler Staff Regulatory Affairs Specialist Beckman Coulter, Inc. 11800 SW 147 Avenue, M/C: 31-B06 Miami, Florida 33196-2500 Telephone: (305) 380-4191 FAX: (305) 380-3618

2.0 Date Submitted: May 30, 2008
1.0

3.0 Device Name(s):

3.1 Proprietary Names FlowCARE™ TLG Reagent

3.2 Classification Name Automated differential cell counter (21 CFR § 864.5220)

4.0 Predicate Devices:

Candidate	Predicates	Manufacturer	DocketNumber
FlowCARE™ TLGReagent	tetraONE™ SYSTEMfor EPICS XL FlowCytometry SYSTEMwith CYTO-STAT©tetraCHROMETM CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5Monoclonal AntibodyReagent	Beckman Coulter, Inc.	K990172

રે () Description:

FlowCARE™ TLG Reagent Abbreviated 510(k) Notification

Page 18 of 59

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count reagent, Flow-Count™ Fluorospheres, for determination of CD3+, CD3+CD4+, and CD3+CD8+ absolute counts as a single platform measurement, or in combination with a White Blood Cell Count from a hematology analyzer as a dual platform measurement.

6.0 Intended Use:

The FlowCARE TLG Reagent kit combines four fluorescent labeled monoclonal antibodies in a single reagent formulation. It is intended "For In Vitro Diagnostic Use" for the enumeration of CD3+, CD3+CD4+ and CD3+CD8+ absolute cell count and CD3+, CD3+CD4+ and CD3+CD8+ lymphocyte percentage in combination with a White Blood Cell (WBC) Count from a hematology instrument as a dual platform measurement, or independently when used in combination with Flow-Count™ Fluorospheres as a single platform measurement.

The FlowCARE TLG Reagent is designed for use on the COULTER® EPICS™ XLTM/XL-MCL™ or a suitably equipped flow cytometer with a 488 nm laser capable of detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 -590 nm, 610 - 635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.

Comparison	Characteristic	tetraONE System forEPICS XL FlowCytometry System(Predicate)	FlowCARE TLG Reagent
Similarities	Intended Use	Enumeration of threemajor T-lymphocytesubset populations(CD3+, CD3+CD4+,CD3+CD8+)	Same
	AnalyticalInstrumentation	Deployed on EPICS®XL-MCL™ flowcytometer	Deployed on EPICS® XL-MCL™ flow cytometer orsuitably equipped flowcytometer
	AnalysisReagents	Uses CYTO-STAT®tetraCHROME™ CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5	CD45-FITC, CD4-PE(RD1), CD8-ECD, andCD3-PC5 monoclonal dyeconjugates are identical toCD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5tetraCHROME™ reagentcomponents

7.0 Comparison to Predicate(s):

FlowCARE™ TLG Reagent Abbreviated 510(k) Notification

Page 19 of 59

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Comparison	Characteristic	tetraONE System forEPICS XL Flow CytometrySystem (Predicate)	FlowCARE TLGReagent
	Analysis Reagents	Uses Flow-Count™Fluorospheres absolute countreagent	Same
	Setup Reagents	• Flow-Set™ Fluorospheres• CYTO-COMP™ Cell Kit• CYTO-COMP™ ReagentKit	Same or equivalentreagents
	QC Reagents	• IMMUNO-TROL™Control Cells• IMMUNO-TROL™ LowControl Cells	Same or equivalentreagents
Differences
	Analysis Software	System II™ Automatedanalysis using cellSTAT3D™ algorithm	Manual analysis usingcustomer createdprotocols according topackage insert
	Specimen Age	• ≤ 6 hours (withautomated software)• ≤ 72 hours (withoutautomated software,tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5)	≤ 120 hours (5 days) The specimen agelimit for dual platformmeasurement isdependent upon theclaims for thehematology analyzer but

8.0 Summary of Performance Data:

Accuracy, precision, and linearity studies were conducted and demonstrated acceptable performance per the manufacturer specifications. The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to products already in commercial distribution.

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and the implementing regulation 21 CFR 807.92.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with a snake winding around it, topped with a pair of wings.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 1 4 2008

Beckman Coulter, Inc. c/o Ms. Nancy Nadler Staff Regulatory Affairs Specialist 11800 SW 147 Ave, M/C: 31-B06 Miami, FL. 33196-2500

Re: K081526

Trade/Device Name: FlowCARE™ TLG Reagent Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: May 30, 2008 Received: June 02, 2008

Dear Ms. Nadler:

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 either class II (Special Controls) or class III (PMA), 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); and good manufacturing practice requirements as set forth in the quality systems (QS) 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.

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Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Maria M Chan

Maria M. Chan, Ph.D. Acting Division 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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Indication for Use

510(k) Number (if known):

Device Name: FlowCARE™ TLG Reagent

Indication For Use:

The FlowCARE TLG Reagent is designed for use on the COULTER® EPICSTM XL™/XL=MCL=M or a suitably equipped flow cytometer with a 488 mm laser capable of detecting light scatter (forward and side) and a minimum of four-color fluorescence emission detectable in the following ranges: 504 - 541 nm, 568 - 590 nm, 610 - 635 nm, and 660 - 680 nm. Users should refer to the manufacturer's instrument manuals for specific instructions for setting PMT voltages and fluorescence compensation prior to analysis.

Prescription Use X (21 CFR Part 801 Subpart D)

And/Or

Over the Counter Use _ _ _ _ _ (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 Diagnostic Device Evaluation and Safety (OVD)

Mava Inclos

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K081526

FlowCARE™ TLG Reagent Abbreviated 510(k) Notification

Page 16 of 59

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.”