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.

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

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ADVIA® 2120 / 2120i Hematology auto-analyzer.

Advanced 2120 / 2120i Hematology Auto-Analyzer Performance Study

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on establishing "performance equivalence" between the new ADVIA 2120i (RoHS/REACH Compliant) and its predicate devices (ADVIA 2120 and 2120i). Explicit numerical acceptance criteria are not presented in a generalized table, but rather implied by the successful completion of various performance studies and demonstrating "performance equivalence." The device's performance is reported as meeting this equivalence by showing "No non-conformances were observed" across all tested parameters.

Performance Characteristic	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Carryover	Equivalent to predicate device	No non-conformances observed
Linearity	Equivalent to predicate device	No non-conformances observed
Imprecision (within run)	Equivalent to predicate device	No non-conformances observed
Accuracy	Equivalent to predicate device	No non-conformances observed
Commercial Controls Repeatability and within device Imprecision	Equivalent to predicate device	No non-conformances observed
Limit of Quantitation/Detection/Blank	Equivalent to predicate device	No non-conformances observed
CSF Accuracy	Equivalent to predicate device	No non-conformances observed
Body Fluid Accuracy	Equivalent to predicate device	No non-conformances observed
System Flagging	Equivalent to predicate device	No non-conformances observed
Method Validation	Equivalent to predicate device	No non-conformances observed

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions that studies were completed both internally and at external Clinical sites. However, specific sample sizes for the test set are not provided in the given text.

Data Provenance:
- Internal Studies: Conducted at Siemens Healthcare Diagnostics.
- External Studies: Conducted at:
  - "University of California-San Francisco"
  - "Siemens Healthcare Diagnostics" (also listed as an external site for these specific studies)
  - "Memorial Sloan-Kettering Cancer Center"
- The document does not explicitly state whether the data was retrospective or prospective. Given the nature of performance equivalence studies for a modified device, it is highly likely that these were prospective studies using fresh samples.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. For hematology analyzers, ground truth often involves manual microscopy review by trained medical technologists or pathologists, but this is not detailed here.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

A Multi Reader Multi Case (MRMC) comparative effectiveness study was NOT done (or at least not reported in this document). The studies focus on comparing the device's performance against a predicate device, not on assessing human reader improvement with or without AI assistance. The device is an automated analyzer, not an AI-assisted diagnostic tool for human interpretation.

6. Standalone Performance Study (Algorithm Only):

Yes, the studies described are for the standalone performance of the ADVIA® 2120i (RoHS/REACH compliant) device. These are "algorithm only" studies in the sense that they evaluate the automated analyzer's measurements. There is no human-in-the-loop component being evaluated in these performance studies for the device itself.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for establishing the accuracy of the measurements. For hematology parameters, ground truth often involves:

Reference methods (e.g., manual differential counts, packed cell volume for hematocrit).
Confirmed values from existing, validated predicate devices or established laboratory methods.
Pathology or outcomes data are less likely to be the direct ground truth for quantitative measurements of blood cells but would be relevant for clinical validity.

Given the context of demonstrating "performance equivalence" to a predicate device, it is highly probable that the ground truth for parameters like CBC, differential, and reticulocyte counts would be either reference methods or established predicate device measurements from the ADVIA 2120/2120i systems known to be accurate.

8. Sample Size for the Training Set:

The document does not provide information regarding a "training set" sample size. This device is presented more as a hardware/firmware modification of an existing, already-trained system, rather than a new algorithm requiring a distinct training phase. Therefore, the concept of a separate training set as understood in machine learning might not directly apply or be documented here.

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

As no training set information is provided, how the ground truth for a training set was established is not detailed.

Summary

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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

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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.

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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:

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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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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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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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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 volumehematology analyzer	Same
Throughput Rate	120 samples/hour	Same
Intended Use	Quantitative, automated hematologyanalyzers that provide informationfor in vitro diagnostic use in clinicallaboratories	Same
Sample Type	whole blood, pleural, peritoneal, orperitoneal dialysis specimens withK2 and/or K3 EDTA anti-coagulants	Same
Sample volume	175ul	Same
Reagents	Reagents to support CompleteBlood Count, White Blood Celldifferential and Reticulocyte analysis	Same
Modes ofsampling	3 sampling modes: Manual opentube sampler, manual closed tubesampler and automated closed tubesampler (autosampler).	Same
Data Entry	Keyboard and Touch ScreenMonitor	Same
Bar code readingcapability	Fixed and Handheld bar codereaders	Same
OperatingPrincipals	Flow cytometry, RBC lysing,myeloperoxidase staining of theWBCs and oxazine staining of thereticulocytes, using five channels toanalyze blood samples.	Same
Controls	ADVIA 3 in 1 with retics (Normal,Abnormal 1, Abnormal 2) or CBConly (L,N,H) and reticulocytes (L, H)	Same
Calibrator	Commercially available calibrator	Same
AutomationInterface	Interface software to allowconnection to LabCell or Aptioautomation	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.

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SIEMENS

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	- IVE

Indicator AssyDAA	No onboard software or firmware.Contains some non-RoHS compliantcomponents.	No onboard software or firmware.Contains some minor RoHScomponent changes.
Indicator AssySAA	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
Input/Output QI/O PCBA	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
CAN Scrambler	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
Baso OpticsScramblero OpticsScrambler	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
Pneu ValveScrambler BoardValve ScramblerBoard	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
UFC IlluminationBoardIllumination Board	Provides cosmetic lighting. Noonboard software or firmware.Contains some non-RoHS compliantcomponents.	No onboard software or firmware.Contains some minor RoHScomponent changes.
Switch PanelInterfaceh Panel Interface	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
ID ReaderInterfaceInterface	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.
UFC ValveScrambler PCB	Interconnect board. No onboardsoftware or firmware. Contains somenon-RoHS compliant components.	No onboard software or firmware.Contains some minor RoHScomponent changes.

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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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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

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.”