(435 days)
No
The summary describes a standard automated hematology analyzer with an autoslide feature. There is no mention of AI or ML in the intended use, device description, or any other section. The performance studies focus on traditional metrics like linearity and precision, not AI/ML-specific metrics.
No
This device is for in vitro diagnostic use, providing information about blood and fluid sample composition, not for treating any condition.
Yes
The device is described as providing "information for in vitro diagnostic use in clinical laboratories" and performs measurements like complete blood counts (CBC), leukocyte differential counts, and reticulocyte analysis, which are used to diagnose and monitor various medical conditions.
No
The device description clearly outlines multiple hardware components including an analytical module, auto sampler, computer workstation, printer, and auto slide module. This is not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states that the device provides information "for in vitro diagnostic use in clinical laboratories." It then lists numerous hematological parameters measured from biological samples (whole blood, pleural, peritoneal, peritoneal dialysis, and cerebrospinal fluid specimens). This directly aligns with the definition of an IVD, which is a medical device intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic purposes.
- Device Description: The description details an "analytical module that aspirates, dilutes, and analyzes whole blood samples," further confirming its use with biological specimens outside of the body.
- Intended User / Care Setting: The intended user is specified as "clinical laboratories," which is a typical setting for performing in vitro diagnostic tests.
The information provided clearly indicates that the device is used to analyze biological samples in a laboratory setting to provide diagnostic information, which is the core function of an IVD.
N/A
Intended Use / Indications for Use
The ADVIA 2120 and ADVIA 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 (%/#), t 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).
- Ouantitative 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 microscope slide.
Product codes
GKZ
Device Description
The ADVIA 2120/210i Hematology systems with Auto slide are an integrated option of a Hematology analyzers with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability, nucleated red blood cell count, quantitative determination of blood cells in Cerebrospinal Fluid (CSF), enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120/210i Hematology systems with Auto slide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an auto sampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides primary user interface with the instrument and manages the data produced by the instrument; a printer that optionally generates reports based on the instrument results and an auto slide module that prepares a wedge smear from a drop of blood, places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grnwald Giemsa Staining techniques.
The ADVIA 2120/210i with Auto slide reports the following hematological parameters:
White Blood Cell Parameters
WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) Eos- eosinophil count (percentage and absolute counts) Baso- basophil count (percentage and absolute counts) LUC- large unstained cell count (percentage and absolute counts) NRBC- Nucleated Red cell count (percentage and absolute counts)
Red Blood Cell Parameters RBC- red blood cell count Hct- hematocrit MCV- mean corpuscular volume RDW- red cell volume distribution width CHCM- hemoglobin concentration mean HDW- hemoglobin concentration distribution width
Hemoglobin Parameters Hgb- hemoglobin concentration MCH- mean corpuscular hemoglobin
Platelet Parameters Plt- platelet count MPV- mean platelet volume
Reticulocvte Count
Retic- reticulocyte count (percentage and absolute counts) MCVg- mean corpuscular volume of all gated red cells MCVr- mean corpuscular volume of reticulocytes CHCMg- hemoglobin concentration mean of all gated red cells CHCMr- hemoglobin concentration mean of reticulocytes CHg- mean hemoglobin content of all gated red cells CHr- mean hemoglobin content of reticulocytes
In addition the ADVIA 2120 with Autoslide reports the following parameters with Cerebrospinal Fluid samples using the CSF method cleared for use on the ADVIA 120 under K022331:
White Blood Cell Parameters
WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) MN- mononuclear count (percentage and absolute counts) PMN- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters RBC- red blood cell count
Body Fluids (pleural, peritoneal, and peritoneal dialysis) Parameters: RBC - red blood cell count TNC - Total nucleated cell count (including WBC count)
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 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 document provides linearity and within-run precision data for various parameters for both the predicate device and the subject device with ARM9 CPU, indicating that the performance characteristics are similar.
Linearity Parameter Range Maximum Deviation (whichever is greater)
WBC (10³/μL) 0.02 to 400 0.5 or 5.0%
RBC (10⁶/μL) 0.0 to 7.0 0.1
HGB (g/dL) 0 to 22.5 0.2 or 2.0%
PLT (10³/μL) 5.0 to 3500 5.0 or 5.0%
%RETIC 0.2 to 24.5 5.0%
CN-free HGB (g/dL) 1 to 22.5 0.3 or 3.0%
CSF WBC (cells/µL) 0 to 50 5
CSF RBC (cells/µL) 50 to 5000 10%
BF TNC (10³/µL) 0 to 50 5
BF RBC (10⁶/µL) 50 to 1500 10%
Carryover Less than or equal to 1%
Within-Run Precision:
Parameter Nominal Level Standard Deviation Coefficient Variation%
WBC (10³/μL) 7.5 0.2 2.66
RBC (10⁶/μL) 5.0 0.06 1.2
HGB (g/dL) 15.0 0.14 0.93
MCV (fL) 90.0 0.7 0.78
CHCM (g/dL) 32.0 0.25 0.8
RDW (%) 13.0 0.25 1.92
HDW (g/dL) 2.8 0.1 3.57
PLT (10³/μL) 300 8.8 2.93
MPV (fL) 8 0.2 2.5
%NEUT 65 1.4 2.15
%LYMPH 25 1.1 4.4
%MONO 6 0.9 15
%EOS 2 0.5 25
%BASO 1 0.5 50
%LUC 2 0.5 25
%RETIC 2 0.25 12.5
CN-free HGB (g/dL) 15.0 0.20 1.33
CSF WBC 100 15 15.0
CSF RBC 100 15 15.0
#CSF MN 100 20 20%
#CSF PMN 100 20
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K930148, K954954, K971998, K003796, K012904, K022668, K022331, K042251, K051693, K090346
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.”
0
NOV 2 3 2011
Traditional 510(k) Summary of Safety and Effectiveness for the
ADVIA® 2120/2120i Hematology auto-analyzers
This summary of Traditional 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
A. Date of Preparation: February 23, 2011
B. Proprietary and Established Names:
ADVIA® Hematology Auto analyzers
C. Applicant:
Siemens Healthcare Diagnostics Inc., 511 Benedict Ave, Tarrytown, NY 10591
Ernest Joseph, Senior Manager, Regulatory Affairs
Office: (914) 524-2431 Fax: (914) 524-2101
D. Regulatory Information:
Proprietary Name: ADVIA® Hematology Auto analyzers
Common name: Automated Hematology analyzer
- Classification number: 21 CFR § 864.5200, 864.5220 Automated Differential Cell Counter
-
- Classification: Class II
-
- Product Code: GKZ
-
- Panel: Hematology
E. Predicate Device:
ADVIA 2120 and 2120i Hematology Auto analyzers with current CPU board which was cleared on 9/17/2004(K042251)
1
F. Device Description:
The ADVIA 2120/210i Hematology systems with Auto slide are an integrated option of a Hematology analyzers with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability, nucleated red blood cell count, quantitative determination of blood cells in Cerebrospinal Fluid (CSF), enumeration of the total nucleated cell (TNC) count and RBC count for pleural, peritoneal, and peritoneal dialysis (PD) specimens and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120/210i Hematology systems with Auto slide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an auto sampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides primary user interface with the instrument and manages the data produced by the instrument; a printer that optionally generates reports based on the instrument results and an auto slide module that prepares a wedge smear from a drop of blood, places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grnwald Giemsa Staining techniques.
The ADVIA 2120/210i with Auto slide reports the following hematological parameters:
White Blood Cell Parameters
WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) Eos- eosinophil count (percentage and absolute counts) Baso- basophil count (percentage and absolute counts) LUC- large unstained cell count (percentage and absolute counts) NRBC- Nucleated Red cell count (percentage and absolute counts)
Red Blood Cell Parameters RBC- red blood cell count Hct- hematocrit MCV- mean corpuscular volume RDW- red cell volume distribution width CHCM- hemoglobin concentration mean HDW- hemoglobin concentration distribution width
Hemoglobin Parameters Hgb- hemoglobin concentration MCH- mean corpuscular hemoglobin
2
MCHC- mean corpuscular hemoglobin concentration CH- cellaur hemoglobin
Platelet Parameters Plt- platelet count MPV- mean platelet volume
Reticulocvte Count
Retic- reticulocyte count (percentage and absolute counts) MCVg- mean corpuscular volume of all gated red cells MCVr- mean corpuscular volume of reticulocytes CHCMg- hemoglobin concentration mean of all gated red cells CHCMr- hemoglobin concentration mean of reticulocytes CHg- mean hemoglobin content of all gated red cells CHr- mean hemoglobin content of reticulocytes
In addition the ADVIA 2120 with Autoslide reports the following parameters with Cerebrospinal Fluid samples using the CSF method cleared for use on the ADVIA 120 under K022331:
White Blood Cell Parameters
WBC- white blood cell count Neut- neutrophil count (percentage and absolute counts) Lymph- lymphocyte count (percentage and absolute counts) Mono- monocyte count (percentage and absolute counts) MN- mononuclear count (percentage and absolute counts) PMN- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters RBC- red blood cell count
Body Fluids (pleural, peritoneal, and peritoneal dialysis) Parameters: RBC - red blood cell count TNC - Total nucleated cell count (including WBC count)
G. Intended Use:
The ADVIA 2120 and ADVIA 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.
3
- . A leukocyte differential count consisting of Neut (%/#). Lymph (%/#). Mono (%/#), Eos (%/#) Baso (%/#), LUC (%/#).
- A reticulocyte analysis consisting of Retic (%/#), MCVg, MCVr, CHCMz. . 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 microscope slide.
H. Substantial Equivalence Information:
This traditional 510(k) is submitted for a replacement of the Analytical Module (AM) CPU board in the ADVIA 2120/2120i Hematology Autoanalyzers -
Prior 510k Clearances:
K930148 (H*3)( Reticulocyte) measurands/parameters cleared on, (Retic, MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
K954954 ( Reticulocyte) measurands/parameters cleared, (Retic, MCVg, MCVr, CHCMg, CHCMr, CHg, CHr.
K971998 (ADVIA 120) (cleared all parameters under device description except body fluids and CSF).
K003796 (ADVIA 120)(CSF) measurands/parameters cleared (CSF WBC, Neuts, Lymphs Mono's MN's,PMN's)
K012904 (ADVIA 120) measurands/parameters cleared (CN-free Hgb)
K022668 (ADVIA 120) measurands/parameters cleared (Calculated Hgb)
K022331 (ADVIA 120) revised measurands/parameters cleared (CSF WBC, Neuts, Lymphs Mono's MN's,PMN's)
K042251 (ADVIA 2120), (cleared all parameters under device description except body fluids)
4
K051693 (ADVIA 2120 with Auto slide and NRBC), (cleared all parameters under device description except body fluids)
K090346 - ADVIA 2120/2120i Body fluids Application) measurands/parameters cleared RBC, TNC).
Please note that ADVIA 2120i with auto slide was cleared in accordance with replacement Reagent and Instrument family policy guidance provided by FDA.
The AM CPU board utilized in the ADVIA 2120 / 2120i Hematology devices is nearing technology obsolescence. In order to address this obsolescence issue, the following device technology obsolescence changes were performed:
-Implement new device component (CPU board for the analytical subsystem)
Upgrade the Nucleus Operating System version to a newer version that supports the new CPU board.
Modify / compile the device application software to function with the new CPU board.
A comparison of the important similarities and differences between ADVIA 2120/2120i analyzers with the ARM9 CPU board and current CPU board (predicate) are shown in the following tables:
5
| ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120i hematology system is a fully automated diagnostic instrument. The analyzer uses whole blood samples to provide complete blood counts (CBC), white cell differential counts (Diff), and reticulocyte absolute, percent and indices counts (Retic). | ADVIA 2120/2120i with ARM9 CPU | |
|---|---|---|---|
| Same | |||
| Similarities: | Specification | ||
| ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU | ||
| Differential Results | NEUT, LYMPH, MONO, EOS, BASO, LUC, NRBC (% and absolute) | ||
| Platelet Results | PLT, MPV | ||
| Reticulocyte Results | %RETIC, #RETIC, MCVr, CHCMr, CHr, MCVg, MCVr, CHCMg, Chg | ||
| CSF Results | CSF RBC, CSF WBC, CSF MN, CSF PMN, CSF NEUT, CSF LYMPH, CSF MONO | ||
| BF Results | TNC, RBC | ||
| Morphology Results | WBC: | Left Shift, Atypical Lymph, Blasts, Immature Granulocytes, Myeloperoxidase Deficiency | Same |
| RBC and PLT: | NRBC, ANISO, MICRO, MACRO, HC VAR, HYPO, HYPER, RBC Fragments, RBC Ghosts, Platelet Clumps, Large Platelets | ||
| Performance | Linearity Parameter | Range | Maximum Deviation (whichever is greater) |
| WBC (10³/μL) | 0.02 to 400 | 0.5 or 5.0% | |
| RBC (10⁶/μL) | 0.0 to 7.0 | 0.1 | |
| HGB (g/dL) | 0 to 22.5 | 0.2 or 2.0% | |
| PLT (10³/μL) | 5.0 to 3500 | 5.0 or 5.0% | |
| %RETIC | 0.2 to 24.5 | 5.0% |
6
7
| larities: | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU | ||||
|---|---|---|---|---|---|---|
| cification | CN-free HGB (g/dL) | 1 to 22.5 | 0.3 or 3.0% | Same | ||
| CSF WBC (cells/ µL) | 0 to 50 | 5 | ||||
| CSF RBC (cells/ µL) | 50 to 5000 | 10% | ||||
| BF TNC (10³/µL) | 0 to 50 | 5 | ||||
| BF RBC (10⁶/µL) | 50 to 1500 | 10% | ||||
| 0.02 to 400 | 10 x 10³ cells or ≤10.0% | |||||
| 0.01 to 6.76 | 10 x 10⁶ cells or ≤10.0% | |||||
| Nominal | ||||||
| Level | Standard | |||||
| Deviation | Coefficient | |||||
| Variation% | ||||||
| Within-Run Precision | Parameter | |||||
| WBC (10³/μL) | 7.5 | 0.2 | 2.66 | |||
| RBC (10⁶/μL) | 5.0 | 0.06 | 1.2 | |||
| HGB (g/dL) | 15.0 | 0.14 | 0.93 | |||
| MCV (fL) | 90.0 | 0.7 | 0.78 | |||
| CHCM (g/dL) | 32.0 | 0.25 | 0.8 | |||
| RDW (%) | 13.0 | 0.25 | 1.92 | |||
| HDW (g/dL) | 2.8 | 0.1 | 3.57 | |||
| PLT (10³/μL) | 300 | 8.8 | 2.93 | |||
| MPV (fL) | 8 | 0.2 | 2.5 | |||
| %NEUT | 65 | 1.4 | 2.15 | |||
| %LYMPH | 25 | 1.1 | 4.4 | |||
| %MONO | 6 | 0.9 | 15 | |||
| %EOS | 2 | 0.5 | 25 | |||
| %BASO | 1 | 0.5 | 50 | |||
| %LUC | 2 | 0.5 | 25 | |||
| %RETIC | 2 | 0.25 | 12.5 | |||
| CN-free HGB (g/dL) | 15.0 | 0.20 | 1.33 | |||
| CSF WBC | 100 | 15 | 15.0 | |||
| CSF RBC | 100 | 15 | 15.0 | |||
| #CSF MN | 100 | 20 | 20% |
:
.
8
| Similarities: | ||
|---|---|---|
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| #CSF PMN | 100 | 20 |
| %NRBC | n/a |