(435 days)
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 (%/#), 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 microscope slide.
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 provided text is a 510(k) Summary for the ADVIA® 2120/2120i Hematology auto-analyzers. This document focuses on demonstrating substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. It does not describe a study that proves the device meets specific acceptance criteria in the way you might expect for a novel AI device with a defined set of performance metrics.
Instead, the submission shows the new device with an ARM9 CPU board performs similarly or identically to the predicate device (the ADVIA 2120/2120i with the current CPU board) across various specifications. The "acceptance criteria" here are essentially the established performance characteristics of the predicate device, and the "study" is the comparison data presented to support substantial equivalence.
Here's an attempt to answer your questions based on the provided text, acknowledging that some information you requested (like AI-specific details, ground truth establishment for a training set, and expert adjudication for a test set) are not relevant or present in this type of FDA submission for a hardware/firmware upgrade to an existing analyzer.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implied to be the performance characteristics of the predicate device. The "reported device performance" is the expectation that the new device (AVIA 2120/2120i with ARM9 CPU) will exhibit identical performance.
| Parameter Category | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (ADVIA 2120/2120i with ARM9 CPU) |
|---|---|---|
| Differential Results | NEUT, LYMPH, MONO, EOS, BASO, LUC, NRBC (% and absolute) | Same |
| Platelet Results | PLT, MPV | Same |
| Reticulocyte Results | %RETIC, #RETIC, MCVr, CHCMr, CHr, MCVg, MCVr, CHCMg, Chg | Same |
| CSF Results | CSF RBC, CSF WBC, CSF MN, CSF PMN, CSF NEUT, CSF LYMPH, CSF MONO | Same |
| BF Results | TNC, RBC | Same |
| Morphology Results | WBC: Left Shift, Atypical Lymph, Blasts, Immature Granulocytes, Myeloperoxidase DeficiencyRBC and PLT: NRBC, ANISO, MICRO, MACRO, HC VAR, HYPO, HYPER, RBC Fragments, RBC Ghosts, Platelet Clumps, Large Platelets | Same |
| Linearity | - WBC (10³/μL): 0.02 to 400 (Max Deviation: 0.5 or 5.0%)- RBC (10⁶/μL): 0.0 to 7.0 (Max Deviation: 0.1)- HGB (g/dL): 0 to 22.5 (Max Deviation: 0.2 or 2.0%)- PLT (10³/μL): 5.0 to 3500 (Max Deviation: 5.0 or 5.0%)- %RETIC: 0.2 to 24.5 (Max Deviation: 5.0%)- CN-free HGB (g/dL): 1 to 22.5 (Max Deviation: 0.3 or 3.0%)- CSF WBC (cells/µL): 0 to 50 (Max Deviation: 5)- CSF RBC (cells/µL): 50 to 5000 (Max Deviation: 10%)- BF TNC (10³/µL): 0 to 50 (Max Deviation: 5)- BF RBC (10⁶/µL): 50 to 1500 (Max Deviation: 10%) | Same |
| Within-Run Precision | (See detailed table in original text; e.g., WBC: Nominal 7.5, SD 0.2, CV 2.66%) | Same |
| Carryover | Less than or equal to 1% | Same |
| Physical/Electrical | (Various detailed specifications for Temperature, Humidity, Noise, Weight, Dimensions, Vacuum/Pressure, Reaction Chamber Temp, Power Pack Temp, Light Intensities, Power Supply Voltages, Sample Mode Volumes, Throughput, Sample Capacity, Tube Sizes/Types, Barcode Reader functionality) | Same |
| Data Management | TDC version 9 or higher, Database storage, Review/edit, User-defined reports/ranges, Bi-directional communication, QC features, ILQC programs, User assistance | Same |
| Consumables/Reagents | CBC TIMEPAC Baso HGB RBC/PLT Defoamer CN-Free CBC TIMEPAC; DIFF TIMEPAC, Perox 1, 2, 3, Perox Sheath, autoRetic, EZ KLEEN, Sheath/Rinse, CSF | Same |
| Calibrators | ADVIA OPTIpoint, ADVIA SETpoint | Same |
| Controls | ADVIA TESTpoint Low/Normal/High, Retic Low/High, 3-in-1 Abnormal1/Normal/Abnormal2 | Same |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document lists performance specifications (linearity, precision) but does not specify the sample sizes or data provenance (country, retrospective/prospective) used to establish these predicate device performance characteristics. The context is that the new device's performance is expected to be identical to the established predicate performance, implying that these performance metrics have been previously validated and are being maintained.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This is not applicable to this submission. The "ground truth" for hematology analyzers is typically established through reference methods, calibrated controls, and comparison to established, validated manual methods, not through expert consensus in the way an imaging AI algorithm's ground truth might be. The document focuses on the technical specifications and equivalence of a hardware component change.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This type of submission does not involve adjudication of diagnostic decisions as would be relevant for an AI algorithm.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is for a hematology auto-analyzer, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone automated hematology analyzer. The submission is not for a new algorithm, but for a hardware (CPU board) and associated software upgrade to an existing analyzer. The performance characteristics presented are those of the entire automated system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for the predicate device's original validation. However, for hematology analyzers, "ground truth" for parameters like cell counts, hemoglobin, etc., is typically established using:
- Reference methods: Highly accurate and precise laboratory methods.
- Calibrated materials: Use of control materials with known values traceable to international standards.
- Manual microscopy or other established techniques: For differential counts or specific cell morphology, comparison to manual review by highly trained laboratorians.
8. The sample size for the training set
Not applicable. This device does not use a "training set" in the context of machine learning. It's a change to a pre-programmed analytical instrument.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the AI sense.
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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)
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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
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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.
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- . 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)
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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:
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| 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% |
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| 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% | |||||
| NominalLevel | StandardDeviation | CoefficientVariation% | ||||
| 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% |
:
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| Similarities: | ||
|---|---|---|
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| #CSF PMN | 100 | 20 |
| %NRBC | n/a | <6 |
| BF TNC (cells/µL) | 500 | n/a |
| BF RBC (10³ cells/µL) | 50 | n/a |
| Carryover | Less than or equal to 1% | Same |
| Computers & Operating Systems | ||
| Real-time Control | multiple distributed real-time microcontrollers | Same |
| User Interfacepersonal computer | Intel based processor Windows 2000 Floppy drive Network card Modem | Same |
| User Interface externalperipherals | Keyboard Mouse Hand-held barcode scanner Printer | Same |
| Physical Specifications | ||
| Electrical Power | Voltage selectable for single-phase: 100 Vac (6 Amps) - 240 Vac (3 Amps)Frequency: 50/60Hz | Same |
| Temperature | Operating: 18℃ to 32℃Storage:-29℃ to 60℃ | Same |
| Relative Humidity | Operating: 15%-80% (noncondensing) | Same |
| Audible Noise Level | 65 decibels | Same |
| Weight (with | 193 kg | Same |
| Similarities: | ||
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| Autosampler and reagents) | ||
| Height | 86cm | Same |
| Width | 141 cm | Same |
| Depth | 68 cm | Same |
| Vacuum/Pressure | 40 psi line: 38 to 42 psi 20 psi line: 19 to 21 psi 5 psi line: 4.5 to 5.5 psi 20" Hg line: 19 to 21" HG | Same |
| Reaction Chamber Temperature | Perox chamber: 58 to 72 ℃ Baso chamber: 32 to 34℃ | Same |
| Power Pack Temperature | Ambient: 18 to 35 °C Fuse side: 18 to 40 °C Filter side: 18 to 40 °C | Same |
| Light Intensities | Tungsten Lamp: 90 to 125 Laser: 150 to 205 | Same |
| Power Supply Voltages | +5 volts Switched: 4.92 to 5.27 V +5 volts Unswitched: 4.87 to 5.33 V +12 volts Switched: 11.2 to 13.01 V -12 volts: -11.2 to -13.01 V +15 volts Switched: 14.56 to 15.63 V -15 volts: -14.56 to -15.63 V +24 volts: 22.46 to 25.58 V Perox Lamp +5 volts: 4.82 to 5.176 V | Same |
| Sample Mode Volumes | Automatic Closed-Tube: 175µL Manual Closed-Tube: 175µL Manual Open-Tube: 175µL | Same |
| Test Selectivity/ CBC | 120 Samples/hr | Same |
| Similarities: | ||
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| Throughput | CBC/Diff120 Samples/hrCBC/Diff/Retic 74 Samples/hrCBC/Retic 74 Samples/hrRetic 74 Samples/hr | |
| Autosampler | With Autoslide slide making enabled:CBC 108 Samples/hrCBC/Diff 108 Samples/hr | |
| Autosampler | ||
| Sample Capacity | 150 samples15 racks of 10 tubes | Same |
| Tube Sizes | 10-13 mm diameter50-100 mm height | Same |
| Tube Types | Some of the allowable tube types:Standard VACUTAINER ®HEMOGARD ®Center puncture Monovette ®Venoject ® II | Same |
| Barcode reader | Reads up to 14 digitsAutomatic label code discriminationCompatible barcode types:1. Codabar2. Interleaved 2 of 53. Code 394. Code 1285. EAN and JAN (8 and 13) | Same |
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| Similarities: | ||
|---|---|---|
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| Data Management | TDC version 9 or higher Database storage capacity of 10,000 records, including graphics Review and edit capability User-defined windows User-defined reports User-defined ranges based on age and sex for Normal, Rerun, Panic, and Delta Check criteria Bi-directional and host query communication protocols Quality control 3D bar graph Levey-Jennings plot SDI graph Table format Remote QC ILQC programs Patient moving average User assistance Context sensitive help Operator's guide Procedure wizards Problem solving diagnostics Remote diagnostics | Same |
| ConsumablesReagents | CBC TIMEPAC Baso HGB RBC/PLT Defoamer CN-Free CBC TIMEPAC | Same |
| Similarities: | ||
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| o Basoo CN-Free HGBo RBC/PLTo Defoamero DIFF TIMEPACo Perox 1o Perox 2o Perox 3o Perox Sheatho autoRetico EZ KLEENo Sheath/Rinseo CSF | ||
| Calibrators | o ADVIA OPTIpointo ADVIA SETpoint | Same |
| Controls | o ADVIA TESTpoint Lowo ADVIA TESTpoint Normalo ADVIA TESTpoint Higho ADVIA TESTpoint Retic Lowo ADVIA TESTpoint Retic Higho ADVIA TESTpoint 3-in-1 Abnormal1o ADVIA TESTpoint 3-in-1 Normalo ADVIA TESTpoint 3-in-1 Abnormal2 | Same |
| Differences: | ||
| Specification | ADVIA 2120 and 2120i with current CPU (predicate) | ADVIA 2120/2120i with ARM9 CPU |
| Computers & Operating Systems | Intel 386ex CPU running Nucleus OS | ARM9 CPU running Nucleus OS |
| Real-time Control | ||
| User Interface software | ADVIA 2120/2120i user interface software (v5.8) | ADVIA 2120/2120i user interface software (v6.0) |
| Communication Interface | BNC Ethernet cable (10Base-2) | RJ-45 Ethernet Cable (100Base-TX) |
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Conclusion I
There ar no wa c funcioniity, or capabilites associates with ADVIA 210/201 anders anders
system ther the molication of the polication of the mores on arter and and and and an
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Image /page/14/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the three branches of government. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center-WO66-G609 Silver Spring, MD 20993-0002
Siemens Healthcare Diagnostics c/o Mr. Gerry Sadrakula Regulatory Affairs Specialist 511 Benedict Avenue Tarrytown, NY 10591
NOV 2 3 2011
Re: K102644
Trade/Device Name: ADVIA® 2120 Hematology Auto analyzer ADVIA® 2120i Hematology Auto analyzer with Auto slide Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: September 29, 2011 Received: September 30, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 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); and good manufacturing practice
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Page 2 – Mr. Gerry Sadrakula
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Th. Vanie m. Chen
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use Form
510(k) Number (if known) K102644
Device Name: ADVIA® 2120/2120i Hematology auto-analyzers
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.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Senek R. Ski
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K102644 Page 1 of 1
§ 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.”