(289 days)
Not Found
No
The document describes a standard hematology analyzer and its modifications for compliance and component obsolescence. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic hematology analyzer used in clinical laboratories to provide information for a complete blood count and other cell enumerations. It does not exert a therapeutic effect on a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device provides information "for in vitro diagnostic use in clinical laboratories," indicating its purpose is to aid in diagnosis.
No
The device is described as a modification of existing automated hematology analyzers (ADVIA 2120 and ADVIA 2120i) and performs quantitative measurements on blood and body fluid specimens, including automatic slide preparation and staining. This indicates it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states:
"...for in vitro diagnostic use in clinical laboratories..."
N/A
Intended Use / Indications for Use
The ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:
- A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
- A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
- A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
- A nucleated red blood cell count consisting of NRBC (%/#).
- Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants. - Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#).
In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide.
Product codes
GKZ
Device Description
The ADVIA 2120i (RoHS/REACH compliant) is a modification of the ADVIA 2120i Hematology System designed to address the following business needs:
- To achieve RoHS & Reach compliance
- To address component obsolescence
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
in vitro diagnostic use in clinical laboratories
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)
The following internal studies were completed for the Basophil/Lobularity Method, CSF Method, Hemoglobin Method, Peroxidase Method, RBC/Platelet Method, Reticulocyte Method, and Body Fluids Method:
- Carryover
- Linearity
- Imprecision (within run)
- Accuracy
- Commercial Controls Repeatability and within device Imprecision
- Limit of Quantitation/Detection/Blank
These studies show performance equivalence of the ADVIA®2120i (RoHS/REACH compliant) against the ADVIA®2120 and 2120i. The protocols were tested using CBC, CBC/DIFF/RETIC and Retic only selectivities in each of the sampling modes; opened tube sampling, manual closed tube sampling and automated closed-tube sampling. No non-conformances were observed.
External clinical site studies were completed for Body Fluid and CSF Accuracy, System Flagging, and Method Validation at:
- "University of California-San Francisco"
- "Siemens Healthcare Diagnostics"
- "Memorial Sloan-Kettering Cancer Center"
These studies show performance equivalence of the ADVIA®2120i (RoHS/REACH compliant) against the ADVIA®2120 and 2120i as tested at these External Sites. No non-conformances were observed.
Overall conclusion: The ADVIA 2120i Hematology RoHS/REACH analyzer is safe and effective and performs clinically equivalent to the predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three overlapping profiles facing to the right. The profiles are black and are arranged in a way that suggests depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 11, 2017
Siemens Healthcare Diagnostics Gerard Sadrakula Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
Re: K162977
Trade/Device Name: ADVIA® 2120 ADVIA® 2120i Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: Class II Product Code: GKZ Dated: August 9, 2017 Received: August 11, 2017
Dear Mr. Sadrakula:
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
1
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.
Leonthena R. Carrington -S
Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known) | K162977 |
| Device Name | ADVIA 2120/2120i Hematology auto-analyzers |
| Indications for Use (Describe) | The ADVIA 2120 and ADVIA 2120i with auto slide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories:
• A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
• A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
• A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
• A nucleated red blood cell count consisting of NRBC (%/#).
• Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants.
• Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#).
In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide. |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
г до габед
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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The image appears to be a logo or branding element for the company Siemens.
1.10A 510k Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
510(k) Number: K162977
Date of Preparation: October 19th, 2016. Updated: July 13th 2017
Proprietary and Established Names:
ADVIA®120, ADVIA®2120, ADVIA®2120i,
Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591 Gerard Sadrakula, Regulatory Affairs Specialist Office: (914) 524-2582 Fax: (914) 524-3579)
Regulatory Information:
The ADVIA®2120i is a class 2 analyzer that produces no PMA results.
Predicate Devices:
ADVIA®2120 cleared in K102644 ADVIA®2120i cleared in K102644
Device Description:
The ADVIA 2120i (RoHS/REACH compliant) is a modification of the ADVIA 2120i Hematology System designed to address the following business needs:
- To achieve RoHS & Reach compliance
- To address component obsolescence
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Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The background is plain white.
Intended Use / Indications for Use:
The ADVIA 2120 and 2120i with autoslide are quantitative, automated hematology analyzers that provide the following information for in vitro diagnostic use in clinical laboratories
- A complete blood count (CBC) consisting of WBC, RBC, Hgb, CN-Free Hgb, Calculated Hgb, MCV, Hct, MCH, MCHC, CHCM, RDW, HDW, CH, Plt, MPV.
- A leukocyte differential count consisting of: Neut (%/#), Lymph (%/#), Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
- A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
- A nucleated red blood cell count consisting of NRBC (%/#).
- Enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens.
Note: Above measurands are determined (in whole blood, pleural, peritoneal, or peritoneal dialysis specimens) with K2 and/or K3 EDTA anti-coagulants.
- Quantitative determination of blood cells in Cerebrospinal Fluid (CSF) consisting of WBC, RBC, Neut (%/#), Lymph (%/#), Mono (%/#), MN (%/#), PMN (%/#).
In addition, the system provides the added capability to automatically prepare and stain high quality blood smears on a glass microscope slide.
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Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a teal color. The font is sans-serif and appears to be bold. The word is horizontally oriented and centered in the image.
Technology Features Comparison Table:
| Technological and Features Comparison Table | ||
|---|---|---|
| Feature | ADVIA 2120i | ADVIA 2120i (RoHS/REACH Compliant) |
| Image: ADVIA 2120i | Image: ADVIA 2120i (RoHS/REACH Compliant) | |
| Type of System | Stand-alone, mid-high volume | |
| hematology analyzer | Same | |
| Throughput Rate | 120 samples/hour | Same |
| Intended Use | Quantitative, automated hematology | |
| analyzers that provide information | ||
| for in vitro diagnostic use in clinical | ||
| laboratories | Same | |
| Sample Type | whole blood, pleural, peritoneal, or | |
| peritoneal dialysis specimens with | ||
| K2 and/or K3 EDTA anti-coagulants | Same | |
| Sample volume | 175ul | Same |
| Reagents | Reagents to support Complete | |
| Blood Count, White Blood Cell | ||
| differential and Reticulocyte analysis | Same | |
| Modes of | ||
| sampling | 3 sampling modes: Manual open | |
| tube sampler, manual closed tube | ||
| sampler and automated closed tube | ||
| sampler (autosampler). | Same | |
| Data Entry | Keyboard and Touch Screen | |
| Monitor | Same | |
| Bar code reading | ||
| capability | Fixed and Handheld bar code | |
| readers | Same | |
| Operating | ||
| Principals | Flow cytometry, RBC lysing, | |
| myeloperoxidase staining of the | ||
| WBCs and oxazine staining of the | ||
| reticulocytes, using five channels to | ||
| analyze blood samples. | Same | |
| Controls | ADVIA 3 in 1 with retics (Normal, | |
| Abnormal 1, Abnormal 2) or CBC | ||
| only (L,N,H) and reticulocytes (L, H) | Same | |
| Calibrator | Commercially available calibrator | Same |
| Automation | ||
| Interface | Interface software to allow | |
| connection to LabCell or Aptio | ||
| automation | Same | |
| Software | Clinical- V6.2.4 | Same |
| CPU Module | ARM 9 CPU Module | Same |
| Differences | ||
| Feature | ADVIA 2120i | ADVIA 2120i (RoHS/REACH Compliant) |
| Signal Processor PCB | Existing non-RoHS compliant Signal Processing PCB. No onboard software | New VHDL implementation of signal processing and monitor/keyboard interface design, to achieve RoHS compliance. No onboard software. |
| Autosampler Control PCB DAA | Dropped in SMC4 motor controller. Onboard motion control software for 80186 (CPU). | New VHDL implementation of former used discrete components and includes SMC4 motor control. No change to predicate software |
| Autosampler Control PCB SAA | Dropped in SMC4 motor controller. Onboard motion control software for 80186 (CPU). | New VHDL implementation of former used discrete components and includes SMC4 motor control. No change to predicate software |
| Reference preAmplifier | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Uses the predicate sensors |
| PreAmp Power Supply | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Uses the predicate sensors |
| Laser Diode Driver 1 | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Contains some minor RoHS component changes. |
| Dual Servo Pump | Uses original Software | New VHDL implementation of former used discrete components. Uses original Software |
| Valve Driver Board | Uses original Software | New VHDL implementation of former used discrete components. Uses original Software |
| Parallel Node | Uses original Software | New VHDL implementation of former used discrete components. Uses original Software |
| HGB Interface | Uses original Software | New VHDL implementation of former used discrete components. Uses original Software |
| Perox Optics Scrambler | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Contains some minor RoHS component changes. |
| Sensor Amplifier | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Contains some minor RoHS component changes. |
| Rack Sensor LED | No onboard software or firmware. Contains some non-RoHS compliant components. | No onboard software or firmware. Contains some minor RoHS component changes. |
6
SIEMENS
7
| - IVE | |||
|---|---|---|---|
| Indicator Assy
DAA | No onboard software or firmware.
Contains some non-RoHS compliant
components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|
| Indicator Assy
SAA | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| Input/Output Q
I/O PCBA | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| CAN Scrambler | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| Baso Optics
Scrambler
o Optics
Scrambler | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| Pneu Valve
Scrambler Board
Valve Scrambler
Board | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| UFC Illumination
Board
Illumination Board | Provides cosmetic lighting. No
onboard software or firmware.
Contains some non-RoHS compliant
components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| Switch Panel
Interface
h Panel Interface | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| ID Reader
Interface
Interface | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
| UFC Valve
Scrambler PCB | Interconnect board. No onboard
software or firmware. Contains some
non-RoHS compliant components. | No onboard software or firmware.
Contains some minor RoHS
component changes. |
8
Standard/Guidance Document Referenced:
- CLSI EP15-A3: User Verification of Precision and Estimation of bias: Approved Guidelines Third ● edition
- CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures Approved ● Guidelines Third edition
- CLSI-EP09-A3: Method comparison and bias estimation using patient samples: Approved . Guidelines Third edition
- CLSI-EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement . Procedures :Approved Guidelines Second edition.
- . EN 61010-1:2010 - Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General Requirements
- EN 61010-1:2010, Safety requirements for electrical equipment for measurement, control, and . laboratory use - Parts 2- 6: Particular Requirements – In vitro diagnostic (IVD) medical equipment
- . ISO 14971:2009 - Medical devices - Application of risk management to medical devices. Including European Deviation in EN ISO 14971:2012.
- IEC 62366:2008 Medical devices Application of usability engineering to medical devices .
Note: Regarding Standards IEC 62366:2008 no summary report is being supplied. As detailed in section 1.10 Technology Features Comparison Table, "There are no usability changes to the ADVIA 2120i and the ADVIA 2120i(RoHS/REACH compliant system . Therefore the usability file was updated however no separate report has been created. Existing ADVIA 2120i usability has already been approved as part of the prior 510(K102644) submission.
- EN 62304:2006/AC:2008 Medical device software Software life-cycle processes .
- . EN ISO 15223-1:2012 Medical devices - symbols to be used with medical device labels, labeling and information to be supplied
Note: Regarding Standard EN. ISO 15223-1:2012 no summary report is being supplied. As stated in the Operator guide section 2.7, "There are no Major changes to the ADVIA 120/2120/2120i Operators Guide and the Supplemental Information Research Use Only (RUO) Guide, just some minor formatting and administrative changes to these guides". Therefore as the original Guides have already been approved as part of the prior 510(K102644) submission.
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Image /page/9/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light teal. The letters are evenly spaced and the word is horizontally oriented.
1.12 Performance Characteristics:
The methods listed below:
- a. Basophil/Lobularity Method
- b. CSF Method
- c. Hemoglobin Method
- d. Peroxidase Method
- e. RBC/Platelet Method
- f. Reticulocyte Method
- g. Body Fluids Method
Had the following studies completed internally via the following sections of this submission:
- 7.1 Carryover
- 7.2 Linearity
- 7.3 Imprecision (within run)
- 7.4 Accuracy
- 7.5 Commercial Controls Repeatability and within device Imprecision
- 7.6 Limit of Quantitation/Detection/Blank
These studies show performance equivalence of the ADVIA®2120i (RoHS/REACH compliant) against the ADVIA®2120 and 2120i. The protocols were tested using CBC, CBC/DIFF/RETIC and Retic only selectivities in each of the sampling modes; opened tube sampling, manual closed tube sampling and automated closed-tube sampling. No non -conformances were observed.
The methods listed below:
- a. Body Fluid
- b. CSF Accuracy
Had the following studies completed at external Clinical sites via sections 8.1 of this submission: CSF and Body Fluid Accuracy System Flagging and Method Validation
These studies show performance equivalence of the ADVIA®2120i (RoHS/REACH compliant) against the ADVIA®2120 and 2120i as tested at these External Sites:
- · "University of California-San Francisco",
- · "Siemens Healthcare Diagnostics"
- · "Memorial Sloan-Kettering Cancer Center"
No non -conformances were observed.
There is no change for user needs and intended use in this project.
Our overall conclusion is that:
As a result the ADVIA 2120i Hematology RoHS/REACH analyzer is safe and effective and performs clinically equivalent to the predicate device