COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use. For In Vitro Diagnostic Use Only.

COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For In Vitro Diagnostic Use Only.

Device Description

The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

AI/ML Overview

The provided document describes the K130253 510(k) submission for the COULTER TQ-Prep Sample Preparation Workstation and COULTER PrepPlus 2 Workstations. These devices are intended for preparing human whole blood for in vitro diagnostic use with specific Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. The submission focuses on demonstrating substantial equivalence to predicate devices through performance studies.

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Type	Acceptance Criteria (Implied by study design goal)	Reported Device Performance
Accuracy	Comparable results to the predicate device. (Based on CLSI EP09-A2)	TQ-Prep: Demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME Reagents.
		PrepPlus2: Demonstrated comparable results to the predicate device with CYTO-STAT tetraCHROME Reagents.
Precision	Acceptable results. (Based on CLSI EP5-A2)	TQ-Prep and PrepPlus 2: Demonstrated acceptable results with CYTO-STAT tetraCHROME Reagents.
Gravimetrics	Acceptable accuracy and precision for dispensing specified fluids.	TQ-Prep: Demonstrated acceptable accuracy and precision results for dispensing ImmunoPrep reagents.
		PrepPlus2: Demonstrated acceptable accuracy and precision results for delivering blood, reagents, controls, and Flow-Count Fluorospheres.
Carryover	Acceptable carryover performance for specimen and reagent. (Based on CLSI Document: H26-A2)	Complete Systems (TQ-Prep, PrepPlus 2, FC 500 with tetraCXP software): Demonstrated acceptable carryover performance for specimen and reagent.

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

The document does not explicitly state the sample sizes used for the test sets in the accuracy, precision, gravimetrics, or carryover studies.

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the studies were conducted to support the 510(k) submission.

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

This information is not provided in the document. The studies described are performance evaluations of an automated pipetting and diluting system, comparing its dispense accuracy, precision, and carryover to predicate devices or established standards. These types of studies typically do not involve "ground truth" established by human experts in the same way, for example, an image analysis study would. The ground truth here would be the actual dispensed volumes or analytical measurements from the flow cytometers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the nature of a pipetting and diluting system, the "truth" is determined by objective measurements (e.g., gravimetric analysis for dispensed volume, flow cytometer readings for accuracy and precision of sample preparation). Adjudication by human experts is not relevant in this context.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact on diagnostic accuracy. The devices in this submission are automated sample preparation workstations, which do not involve human interpretation of medical images or diagnostic outputs in the manner an MRMC study would evaluate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies conducted are standalone performance evaluations of the devices (TQ-Prep and PrepPlus 2 workstations). The "performance" being evaluated is the accuracy, precision, and carryover of their automated functions (pipetting, diluting, reagent addition, mixing) as compared to predicate devices or established guidelines (CLSI documents). There is no "human-in-the-loop" aspect to the fundamental performance of these automated systems.

7. The Type of Ground Truth Used

The "ground truth" in these studies refers to:

For Accuracy and Precision (with reagents): The actual analytical measurements obtained from flow cytometers after sample preparation, which are then compared to results from predicate devices. The assumption is that the predicate devices produce acceptable analytical results.
For Gravimetrics: The actual weight of dispensed liquids, which directly correlates to the volume dispensed. This is an objective, measurable truth.
For Carryover: Analytical measurements demonstrating the absence or presence of unwanted sample transfer, using established methods to quantify carryover.

It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective technical and analytical measurements.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. These devices are automated workstations, not AI/ML algorithms that typically require a distinct training set for model development. The reported studies are performance validation studies.

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

As these are automated workstations and not AI/ML models in the typical sense, there is no "training set" or "ground truth for the training set" established in the conventional AI/ML context. The devices are programmed with specific operational parameters, and their performance is then validated through the studies described.

Summary

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K130253

Image /page/0/Picture/1 description: The image shows the logo for Beckman Coulter. The logo consists of a circular graphic on the left and the company name on the right. The graphic is a dark circle with two curved lines running through it. The text "BECKMAN" is on the top line and "COULTER" is on the bottom line.

JUL 1 5 2013

510(k) Summary

COULTER TQ Prep Sample Preparation and COULTER PrepPlus 2 Workstations

Submitted By: 1.0

Nancy Nadler Director, Regulatory Affairs 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:

January 28, 2013

3.0 Device Name/Trade Name - Classification

COULTER TQ Prep Sample Preparation Workstation - Pipetting and Diluting System for Clinical Use (21 CFR § 862.2750); product code: PER

COULTER PrepPlus 2 Sample Preparation Workstation - Pipetting and Diluting System for Clinical Use (21 CFR § 862.2750): product code: PER

4.0 Predicate Devices:

Candidate	Predicate	Manufacturer	510(k) Number
TQ-Prep	Q-Prep	Beckman Coulter, Inc.	K874188
PrepPlus 2	Manual Pipette	Various	Not applicable

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5.0 Description:

6.0 Intended Use:

PrepPlus 2

Intended Use:

The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (see list below).

Indications for Use:

Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use.

For In Vitro Diagnostic Use Only

TQPrep

Intended Use:

The COULTER TQ-Prep Workstation is intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers (see list below).

Indication for Use:

Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use.

For In Vitro Diagnostic Use Only

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IVD Applications

The following cleared Beckman Coulter IVD applications can be used with the TQ-Prep and PrepPlus2 Workstations on cleared Beckman Coulter flow cytometers as described in each application's Instructions for Use.

CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/ CD8-ECD/CD3-PC5
· CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5
· CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5
· CYTO-STAT triCHROME CD45-FITC/CD8-RD1/CD3-PC5
· CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5
· CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5
· CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5
· CYTO-STAT / COULTER CLONE CD3(IgG1)-FITC/T4-RD1
· CYTO-STAT / COULTER CLONE CD3(IgG1)-FITC/T8-RD1
· CYTO-STAT CD3-FITC/CD56-RD1
· CYTO-STAT / COULTER CLONE T4-RD1/T8-FITC
· CYTO-STAT / COULTER CLONE T8-FITC (CD8- FITC)
· CYTO-STAT / COULTER CLONE T8-RD1 (CD8-RD1)
· CYTO-STAT / COULTER CLONE T4-FITC (CD4- FITC)
· CYTO-STAT / COULTER CLONE T4-RD1 (CD4-RD1)
· CYTO-STAT / COULTER CLONE CD3(IgG1)-FITC
· CYTO-STAT / COULTER CLONE CD3(IgG1)-RD1

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Similarities and Differences between Q-Prep and TQ-Prep Workstations
Attribute	Q-Prep(Predicate)	TQ-Prep
Intended Use	Q-PREP is used to prepare leukocytes forimmunofluorescence measurements on optical flowcytometers.	Intended Use:The COULTER TQ-Prep Workstation is intendedto prepare leukocytes from whole blood for In VitroDiagnostic (IVD) Use when used with theCOULTER ImmunoPrep Reagent System andcleared Beckman Coulter IVD applications oncleared Beckman Coulter flow cytometers (see listbelow).Indication for Use:Pipetting of ImmunoPrep Reagent System (lyse,stabilizer, and fixative reagents) to samplesprepared either manually or with the COULTERPrepPlus 2 sample preparation device to achievelysis of whole blood samples. Use of COULTERTQ-Prep with cleared Beckman Coulter flowInstructions for Use.For In Vitro Diagnostic Use OnlyIVD ApplicationsThe following cleared Beckman Coulter IVDapplications can be used with the TQ-Prep and
Q-Prep(Predicate)	TQ-Prep
	PrepPlus2 Workstations on cleared Beckman Coulterflow cytometers as described in each application'sInstructions for Use.CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5 CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5 CYTO-STAT triCHROME CD45-FITC/CD8-RD1/CD3-PC5 CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5 CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5 CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5 CYTO-STAT/ COULTER CLONE CD3(IgG1)-FITC/T4-RDI CYTO-STAT/COULTER CLONE CD3(IgG1)-FITC/T8-RDI CYTO-STAT CD3-FITC/CD56-RD1 CYTO-STAT/ COULTER CLONE T4-RD1/T8-FITC CYTO-STAT / COULTER CLONE T8-FITC (CD8-FITC) CYTO-STAT/COULTER CLONE T8-RD1 (CD8-
Attribute	Q-Prep(Predicate)	TQ-Prep
Device Classificationand Product Code	862.2750, Pipetting and diluting system for clinicaluse, JQW	862.2750, Pipetting and diluting system for clinicaluse, PER
Manufacturer	Beckman Coulter, Inc.	Same
Controlling software	The timing electronics are on a single circuit board.They control the syringe delivery order, individualsyringe priming cycles, continuous mix cycle, cyclereagent addition and mixing, and stop cycle.	The system microprocessor (386) assembly controls thetouch screen, disk drive, power indicator, beepingdevice, and an internal communication link to theControl Interface card.A microcontroller, located on the Control Interface card,controls the motors, sensors, syringes, the cover/lidinterlock switches, reagent level sense probes and aninternal communication link to the systemmicroprocessor assembly.
		CYTO-STAT / COULTER CLONE T4-FITC (CD4-RDI) CYTO-STAT / COULTER CLONE T4-FITC (CD4-FITC) CYTO-STAT / COULTER CLONE T4-RD1 (CD4-RD1) CYTO-STAT / COULTER CLONE CD3(IgG1)-FITC CYTO-STAT / COULTER CLONE CD3(IgG1)-RD1
Attribute	Q-Prep(Predicate)	TQ-Prep
Lyse Reagents	ImmunoPrep A: Erythrocyte Lysing ReagentImmunoPrep B: Stabilizing ReagentImmunoPrep C: Cell Membrane Fixative	Same
Lyse ReagentVolume Range	ImmunoPrep A: 0.600 mL ± 5%ImmunoPrep B: 0.265 mL ± 5%ImmunoPrep C: 0.100 mL ± 5%	Same
Timing	Premix: $2 \pm 1$ secLysing: $8 \pm 1$ secStabilizing: $10 \pm 1$ secFixative: $10 \pm 1$ sec	Same
Syringe Type	CAM-driven displacement syringes	Stepper Motor Tri-Continent Syringes
Mixing	The mixer has a rotating arm that turns the bottom of the 12 x 75 mm test tube while a clip holds the top of the test tube in a fixed position. A circular rubber grommet holds the test tube in the arm. The arm rotates at a rate of 1400 to 1800 rpm.	The tube lifter/vortex mixer uniformly first lifts the tube up into the dispensing head, then mixes reagents in the sample. The mixer rotates at 1400-1800 rpm.
Sample Introduction	Manual presentation into a tube location on front of instrument via tube access door. Single 12 x 75 mm tube only.	Automated presentation to sample processing area with Multi-tube Carousel Loader (MCL) from 32 test tube (12 x 75 mm) capacity carousel
Sample Identification	Manual, controlled by operator.	Same
Quality ControlTechniques	Gravimetric calibration	Same

and TO-Pren Worksta Similarities and Differences between O-Prep

omparison to Predicates

7.0

Beckman Coulter, Inc.
Coulter PrepPlus 2 and TQ Prep
Sample Preparation Workstations 510(k) Submission

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Similarities and Differences between Manual Pipette and PrepPlus 2 Workstation
Attribute	Manual Pipette(Predicate)	PrepPlus 2
Intended Use	Delivery of a specified volume of liquid.• In the tetraCHROME reagent application, itdelivers whole blood, Immuno Trol andImmuno Trol Low Cells, tetraCHROMEreagents, and Flow-Count Fluorospheres.	Intended Use:The COULTER PrepPlus 2, when used incombinations with the COULTER TQ-PrepWorkstation, is intended to prepare human wholeblood for In Vitro Diagnostic (IVD) Use withcleared Beckman Coulter IVD applications oncleared Beckman Coulter flow cytometers (see listbelow).Indications for Use:Pipetting blood, cleared Beckman Coulter IVDreagents and Flow-Count Fluorospheres to preparesamples for flow cytometric analysis. Use of thePrepPlus 2 with cleared Beckman Coulter flowcytometers is described in each applicationInstructions for Use.For In Vitro Diagnostic Use OnlyIVD ApplicationsThe following cleared Beckman Coulter IVDapplications can be used with the TQ-Prep and PrepPlus2Workstations on cleared Beckman Coulter flowcytometers as described in each application's Instructionsfor Use.• CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/

Beckman Coulter, Inc.
Coulter PrepPlus 2 and TQ Prep
Sample Preparation Workstations 510(k) Submission

Volume 005, Page 8 of 12

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Attribute	Manual Pipette(Predicate)	PrepPlus 2
		CD8-ECD/CD3-PC5• CYTO-STAT tetraCHROME CD45-FITC/CD56-RD1/CD19-ECD/CD3-PC5• CYTO-STAT triCHROME CD45-FITC/CD4-RD1/CD3-PC5• CYTO-STAT triCHROME CD45-FITC/CD8-RD1/CD3-PC5• CYTO-STAT triCHROME CD45-FITC/CD56-RD1/CD3-PC5• CYTO-STAT triCHROME CD45-FITC/CD19-RD1/CD3-PC5• CYTO-STAT triCHROME CD8-FITC/CD4-RD1/CD3-PC5• CYTO-STAT/ COULTER CLONE CD3(IgG1)-FITC/T4-RDI• CYTO-STAT/ COULTER CLONE CD3(IgG1)-FITC/T8-RDI• CYTO-STAT CD3-FITC/CD56-RD1• CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC• CYTO-STAT/COULTER CLONE T8-FITC (CD8-FITC)• CYTO-STAT/COULTER CLONE T8-RD1 (CD8-RD1)• CYTO-STAT/COULTER CLONE T4-FITC (CD4-FITC)• CYTO-STAT/COULTER CLONE T4-RD1 (CD4-
Attribute	Manual Pipette(Predicate)	PrepPlus 2
Device Classificationand Product Code	Not applicable	RDI)• CYTO-STAT/ COULTER CLONE CD3(IgG1)- FITC• CYTO-STAT / COULTER CLONE CD3(IgG1)-RD1862.2750, Pipetting and diluting system for clinical use,PER
Manufacturer	Various	Beckman Coulter, Inc. is the manufacturer of record.
Controlling software	None	Operating System – Loaded into the COULTER TQ-Prep Workstation. The user runs both the PrepPlus 2 and the TQ-Prep Workstation from the TQ-PrepWorkstation touch screen commands.Panel Definition software – This software allows the definition of panels, reagent racks, and control/calibrator racks. Standalone Panel Definitionsoftware also available.
Sample Identification	Manual, controlled by operator.	Same
Sample Introduction	Manual presentation.	Automated presentation with Multi-tube Carousel Loader(MCL) from 32 test tube (12 x 75 mm) capacity carouselTeflon-coated sample probe
Sample ContactMaterial	Polypropylene disposable tip
Cleaning CycleBetween Samples	Pipette tip replaced between samples	Executed with IsoFlow Sheath Fluid in wash station aftereach liquid-handling function. Once daily COULTERCLENZ cleaning agent cleans and rinses the sample probeto prevent protein build-up.
Attribute	Manual Pipette(Predicate)	PrepPlus 2
Volume Range	Manual, controlled by operator.	5 µL to 1,000 µL. (Volumes over 500 µL are delivered in multiple aliquots. Maximum aliquot volume is 500 μL.)
Syringe Size	Not applicable	1.0 mL.
Specimen Tube Size	Variable	Based on the specimen tube's diameter:◦ 13-mm specimen cassetteWith Adaptor:◦ 75 mm specimen tubes◦ 2 mL specimen tubes (with 2 mL tube adaptor)◦ 3 mL specimen tubes (with 3 mL tube adaptor)◦ IMMUNO-TROL control tubes
Specimen Cassette Sizes	Not applicable	12 specimens per cassette for 13-mm specimen tubes
Prepared Sample Tubes (Daughter Tubes)	12 x 75 mm straight polypropylene test tube, round bottom.	Same

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Beckman Coulter, Inc.
Coulter PrepPlus 2 and TQ Prep
Sample Preparation Workstations 510(k) Submission

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Beckman Coulter, Inc.
Coulter PrepPlus 2 and TQ Prep
Sample Preparation Workstations 510(k) Submission

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8.0Study	Summary of Performance Data:Study Design	Study Results
Accuracy	Based on CLSI EP09-A2,Method Comparison and BiasEstimation Using PatientSamples; Approved Guideline--Second Edition (InterimRevision)	The TQ-Prep demonstrated comparableresults to the predicate device with CYTO-STAT tetraCHROME Reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 andCD45-FITC/CD56-RD1/CD19/ECD/CD3-PC5).
Accuracy	Based on CLSI EP09-A2,Method Comparison and BiasEstimation Using PatientSamples; Approved Guideline--Second Edition (InterimRevision)	The PrepPlus2 demonstrated comparableresults to the predicate device with CYTO-STAT tetraCHROME Reagents (CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 andCD45-FITC/CD56-RD1/CD19/ECD/CD3-PC5).
Precision	Based on CLSI EP5-A2,Evaluation of PrecisionPerformance of QuantitativeMeasurement Methods;Approved Guideline - SecondEdition.	The TQ-Prep and PrepPlus 2 demonstratedacceptable results with CYTO-STATtetraCHROME Reagents.
Gravimetrics	Evaluate accuracy and precisionof dispensing ImmunoPrepreagents.	The TQ-Prep demonstrated acceptableaccuracy and precision results fordispensing ImmunoPrep reagents.
Gravimetrics	Evaluate accuracy and precisionof dispensing blood, reagents,controls, and Flow-CountFluorospheres.	The PrepPlus2 demonstrated acceptableaccuracy and precision results fordelivering blood, reagents, controls, andFlow-Count Fluorospheres.
Carryover	Based on CLSI Document: H26-A2, Validation, Verification, andQuality Assurance of AutomatedHematology Analyzers;Approved Standard - SecondEdition, Section 5.7: Carryover	The complete systems, composed of the TQ-Prep, PrepPlus 2, and FC 500 with tetraCXPsoftware, for specimen and reagentdemonstrated acceptable carryoverperformance.

Summary of Performance Data: ጸ በ

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/12/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center is a stylized graphic of an eagle or bird-like figure, which is a common symbol associated with the U.S. government.

Public Health Service

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

July 15, 2013

BECKMAN COULTER, INC. C/O MS. NANCY NADLER DIRECTOR, REGULATORY AFFAIRS 11800 S.W. 147 AVENUE M/S 31-B06 MIAMI FL 33196-2500

Re: K130253

Trade/Device Name: COULTER TQ-Prep Workstation COULTER PrepPlus2 Regulation Number: 21 CFR 862.2750 Regulation Name: Pipetting and diluting system for clinical use Regulatory Class: I Product Code: PER Dated: July 05, 2013 Received: July 08, 2013

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. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements modical device rolated and vester or (QS) regulation (21 CFR Part 820); and if applicable, the

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Page 2-Ms. Nancy Nadler

electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/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/McdicalDcvices/Safety/ReportalProblem/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/MedicalDevices/ResourcesforYou/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

510(k) Number (if known): K130253

Device Name: COULTER® TQ-Prep Workstation

Indications For Use:

Intended Use:

Indication for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 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

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K130253 510(k):

Beckman Coulter, Inc. Coulter PrepPlus 2 and TQ-Prep Sample Preparation Workstations Volume 003, Page 1 of 2

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Indications for Use

510(k) Number (if known): K130253

Device Name: COULTER® PrepPlus 2

Indications For Use:

Intended Use:

Indications for Use:

For In Vitro Diagnostic Use Only

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 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 (OlR)

Maria M. Chan -S

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K130253 510(k):

Beckman Coulter, Inc. Coulter PrepPlus 2 and TQ-Prep Sample Preparation Workslations Volume 003, Page 2 of 2

Regulation Number and Section

§ 862.2750 Pipetting and diluting system for clinical use.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.