(92 days)
Not Found
No
The description focuses on automation of physical processes (slidemaking, staining, transport) and data management, with no mention of AI/ML for analysis or decision-making.
No
This device is for preparing and staining blood samples for diagnostic procedures, not for treating patients.
No
The device is described as a "slide preparation and staining device" that prepares blood smears for analysis. While the "System Manager" mentioned in the description controls "diagnostic procedures," the device itself is a preparatory tool, not a diagnostic one.
No
The device description clearly outlines physical hardware components (slidemaking module, slidestaining module, specimen transport module, PC workstation) that perform physical actions (aspirating blood, smearing, delivering solutions). While it includes software for control and data management, it is not solely software.
Based on the provided information, the DxH Slidemaker Stainer (SMS) is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device "aspirates a whole-blood sample, smears a blood film on a clean microscope slide, and delivers a variety of fixatives, and rinse solutions to that blood smear." This process is a crucial step in preparing biological samples (blood) for microscopic examination and subsequent diagnostic procedures.
- Device Description: The description further clarifies that it processes "patient specimens" and is integrated with a "System Manager" that "Controls processes, such as making and staining blood smears, and diagnostic procedures." This directly relates to preparing samples for diagnostic purposes.
- Predicate Device: The predicate device listed, K140911; UniCel® DxH SMS Coulter® Cellular Analysis System, is also an IVD device used in cellular analysis, which involves preparing and analyzing blood samples.
IVD devices are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The DxH SMS fits this definition by preparing blood samples for diagnostic analysis.
N/A
Intended Use / Indications for 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, and rinse solutions to that blood smear.
Product codes
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, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing is not required. Testing was limited to design and software verification testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name, "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA," arranged in a circular pattern around the edge. At the center of the seal is a stylized emblem consisting of three human profiles facing to the right, stacked on top of each other, representing the department's focus on health and human well-being.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
| Prescription Use (Part 21 CFR 801 Subpart D) | 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 #: (305) 380-4191 Fax #: (786) 639-4191 Contact Person: Nancy Nadler Email Address: nancy.nadler@beckmancoulter.com
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)
Number | Date
Cleared | Classification | 21 CFR | Product
Code |
|------------------------------------------------------|------------------|----------------------|----------------|----------|-----------------|
| UniCel® DxH SMS Coulter®
Cellular Analysis System | K140911 | September
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
(K140911, Predicate) | Proposed Device |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| 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. | Same |
| Device
Classification &
Product Code | 21 CFR 864.5220 Automated Cell Counter,
GKZ | Same |
| Manufacturer | Beckman Coulter | Same |
| Specimen
Collection | Whole venous blood in EDTA | Same |
| Blood Film
Preparation | Automatically prepared by DxH SMS | Same |
| Blood Film
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.