UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System

K162414 · Beckman Coulter, Inc. · GKZ · Nov 29, 2016 · Hematology

Device Facts

• Record ID: K162414
• Device Name: UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
• Applicant: Beckman Coulter, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Nov 29, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

Device Story

UniCel DxH Slidemaker Stainer (SMS) is an automated hematology laboratory instrument for slide preparation and staining. Modifications address fire safety risks identified in field reports. Hardware changes include pressure relief valves to prevent fluidic line rupture, splash shields to protect PCBs from leaks, neoprene gaskets/insulating tape to prevent ribbon cable damage, and RTV silicone chassis sealing. Software changes implement monitoring of reagent top-off frequency and volume; if predefined thresholds are exceeded (indicating potential siphoning/leaks), the system halts operation, requiring service intervention. Device operates in clinical laboratory settings; managed by laboratory technicians/service personnel. Output is automated slide preparation; modifications ensure containment of reagents and protection of internal electronics to prevent fire hazards.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, design control activities, FMEA, and System Risk Assessment verifying hardware/software modifications.

Technological Characteristics

Automated slide preparation and staining system. Components: slidemaking module, slidestaining module, specimen transport module. Connectivity: Ethernet connection to PC-based System Manager. User interface: touch screen, keyboard, mouse. Complies with CLSI H20-A2 for blood film requirements. No sterilization required.

Indications for Use

Indicated for automated preparation and staining of whole venous blood smears on microscope slides for clinical laboratory analysis.

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

• UniCel® DxH SMS Coulter® Cellular Analysis System (K140911)

Submission Summary (Full Text)

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

November 29, 2016

Beckman Coulter, Inc. Ms. Nancy Nadler Director, Regulatory Affairs 11800 SW 147th Avenue Miami, Florida 33196-2500

Re: K162414

Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: October 31, 2016 Received: November 1, 2016

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

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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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Leonthena R. Carrington -S

Leonthena R. Carrington, MS, MBA, MT(ASCP) 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) K162414

#### Device Name

UniCel DxH Slidemaker Stainer Coulter Cellular Analysis System

Indications for Use (Describe)

The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a wholeblood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear.

Type of Use (Select one or both, as applicable)

| <span style="font-family:Wingdings;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family:Wingdings;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|

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# 510(k) Summary for Special 510(k) for the UniCel DxH Slidemaker Stainer Coulter® Cellular Analysis System

#### 510(k) Owner / Submitter Information

Company Name: Beckman Coulter Inc. Address: 11800 SW 147th Ave., Miami, FL 33196 Phone #: [phone] Fax #: [phone] Contact Person: Nancy Nadler Email Address: [e-mail]

#### Date Submitted:

August 26, 2016

#### Device Information

Trade Name: UniCel® DxH Slidemaker Stainer Coulter® Cellular Analysis System Common Name: DxH SMS Classification Name: Automated differential cell counter (21 CFR 864.5220) Classification: Class II Product Code: GKZ Panel: Hematology and Pathology Devices Panel

#### Predicate Device Information

| Predicate Product | 510(k)<br>Number | Date<br>Cleared | Classification | 21 CFR | Product<br>Code |
|------------------------------------------------------|------------------|----------------------|----------------|----------|-----------------|
| UniCel® DxH SMS Coulter®<br>Cellular Analysis System | K140911 | September<br>5, 2014 | Class II | 864.5220 | GKZ |

#### Device Description

The DxH Slidemaker Stainer (SMS) is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

The DxH SMS consists of a slidemaking module, a slidestaining module, and a specimen transport module precisely integrated to provide process control, slidemaking and staining,

Beckman Coulter, Inc. DxH SMS Design Change Special 510(k) - Corrective Action Being Effected Submission Section 5, Page 1 of 4

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and cassette or single-tube delivery of specimens. The DxH SMS processes patient specimens and sends status data to the System Manager.

The System Manager:

- Controls processes, such as making and staining blood smears, and diagnostic . procedures.
- . Manages data, such as test ordering, LIS interface, and logging.

The System Manager resides on a Personal Computer (PC) based workstation running system application specific software. The PC is connected to the DxH SMS via an Ethernet connection. The System Manager provides data management and storage, provides test order management, quality control functionality, diagnostics and maintenance procedures. User interaction is provided via touch screen, keyboard and mouse.

## Design Change Description:

This modification to the DxH SMS is being implemented as part of the corrective action for a field action initiated by Beckman Coulter (BEC) in early August 2016. The field action was issued on the DxH SMS to notify customers that BEC received and confirmed a report of a fire within the Stainer module of a customer's instrument. BEC instructed customers to immediately discontinue use of the Stainer module.

As part of the corrective actions, BEC had developed additional risk control measures for the device to mitigate the potential failure modes associated with the reported fire on the DxH SMS.

## Intended Use/Indications for Use:

The DxH Slidemaker Stainer is a fully automated slide preparation and staining device that aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, stains, buffers, and rinse solutions to that blood smear.

## Comparison to Predicate:

The design changes applied to the DxH SMS serve as additional risk control measures to mitigate each of the potential failure modes identified in the root cause analysis of the field action that initiated these changes.

These design changes do not impact the intended use or performance claims of the DxH SMS.

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#### Device Comparison Table:

| Characteristic | UniCel DxH Slidemaker Stainer<br>(K140911, Predicate) | Proposed Device |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Indications for use | The DxH Slidemaker Stainer is a fully<br>automated slide preparation and staining<br>device that aspirates a whole blood sample,<br>smears a blood film on a clean microscope<br>slide, and delivers a variety of fixatives,<br>stains, buffers, and rinse solutions to that<br>blood smear. | Same |
| Device<br>Classification &<br>Product Code | 21 CFR 864.5220 Automated Cell Counter,<br>GKZ | Same |
| Manufacturer | Beckman Coulter | Same |
| Specimen<br>Collection | Whole venous blood in EDTA | Same |
| Blood Film<br>Preparation | Automatically prepared by DxH SMS | Same |
| Blood Film<br>Requirements | Section 6.3.1 of CLSI H20-A2 | Same |

#### Summary of DxH SMS Performance Testing:

Performance testing is not required. Testing was limited to design and software verification testing.

#### Design Control Activities

The design development and verification/validation of the device modification have been performed under design control. The design control activities were based on risk analysis, and acceptance criteria were set to maintain the efficiency and safety of the device. Testing included design verification testing, temperature testing, and installation testing.

# Substantial Equivalence Conclusion to Demonstrate Safety, Effectiveness & Equivalent Performance to Predicate:

The updates to the DxH SMS that are the subject of this submission, do not change the intended use, nor add or delete a contraindication for the device. The changes do not alter

Beckman Coulter, Inc. DxH SMS Design Change Special 510(k) – Corrective Action Being Effected Submission Section 5. Page 3 of 4

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the device control mechanism, operating principle, energy type, environmental specification, ergonomics of the user interface, dimensional specifications, nor packaging. The device does not have expiration dating nor is it subject to sterilization.

In summary, the updated DxH SMS, as described in this submission is substantially equivalent in terms of safety and effectiveness to the predicate device.

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.