Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard automated hematology analyzer using established technologies (focused flow impedance and light transmission) for cell counting and differentiation. There is no mention of AI, ML, image processing, or any training/test data sets typically associated with AI/ML development. The performance studies focus on traditional analytical and clinical metrics.

Therapeutic

No
The device is described as an "in vitro diagnostic device" used to identify and enumerate hematology parameters from blood samples, not to treat or alleviate a disease or condition.

Diagnostic

Yes.
The "Intended Use / Indications for Use" section explicitly states that it is "for in vitro diagnostic use in clinical laboratories". The "Device Description" also reiterates that it is "for in vitro diagnostic use in clinical laboratories" and that it is "used for the in vitro diagnostic testing of whole blood specimens."

SaMD (Software as a Medical Device)

No

The device description explicitly states the system is comprised of an analyzer and reagents, and operates using focused flow impedance and light transmission technologies, indicating it is a hardware-based device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The very first sentence explicitly states "for in vitro diagnostic use in clinical laboratories".
Device Description: The description also reiterates "for in vitro diagnostic use in clinical laboratories" and "used for the in vitro diagnostic testing of whole blood specimens".
Function: The device analyzes blood samples to identify and enumerate various hematology parameters, which is a core function of in vitro diagnostics.
Setting: It is intended for use in "clinical laboratories," the typical setting for IVD devices.
Sample Type: It analyzes "venous whole blood samples," which are biological specimens used in IVD testing.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

Product codes

GKZ

Device Description

The ABX MICROS ES 60 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting, quality control, calibration, and cleaning. The system is a microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. It operates in complete blood count (CBC) and Differential (DIFF) mode using a combination of focused flow impedance and light transmission technologies. It is available in Closed (CT) or Open Tube (OT) sampling versions.

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

Adult patient population. It is not intended to be used for pediatric subjects.

Intended User / Care Setting

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

Comparability with Predicate Device:

Sample size: 179 whole blood specimens from adult patients
Data source: Analyzed at four test sites in the US
Annotation protocol: Each sample was analyzed in duplicate on the ABX Micros ES 60 (CT model) and on the predicate ABX Micros 60.

Comparability between Sampling methods:

Sample size: 237 whole blood specimens from adult patients
Data source: Analyzed at one test site in France
Annotation protocol: Each of the samples was analyzed in duplicate on the ABX Micros ES 60 CT (Close Tube model) and on the ABX Micros ES 60 OT (Open Tube model).

Comparability between Anticoagulant types:

Sample size: 52 normal and pathological blood specimens
Data source: Analyzed on the ABX Micros ES60 (CT model) at three sites in the US. The specimens used in this study were venous blood specimens that were prospectively collected for this study specifically.
Annotation protocol: Each subject provided blood collected in both K2EDTA and K3EDTA. Each of the samples was analyzed in duplicate on the ABX Micros ES 60.

Clinical Sensitivity / Specificity:

Sample size: 100 normal and 100 pathological samples
Data source: Left-over samples from both hospital and private independent clinical laboratories in France.
Annotation protocol: Preserved in K2EDTA covering the full analytic range of the ABX Micros ES60 were analyzed in duplicate on the ABX Micros ES60 (CT model) and ABX Micros ES60 (OT model). Two slides with May Grünwald Giemsa staining were prepared for each sample. Slide reviews were conducted as a gold standard reference and WBC differential counts were conducted using 400-cell reference differential count (200 cells per reader, 2 readers) on each sample following the procedure discussed in CLSI H20-A2. Samples were classified into Normal or Abnormal samples for the ABX Micros ES60 OT, ABX Micros ES60 CT, and the reference method (manual slide microscopy for differential count and morphological appreciation; the predicate ABX Micros 60 for quantitative CBC parameters). Abnormal samples were subdivided into those with abnormal proportions of one or more cell types (quantitative), and those containing abnormal cells (morphological).

Reference Interval:

Sample size: 275 (135 male and 140 female) normal adult samples
Data source: Analyzed in duplicate on the ABX Micros ES60 (OT model) and ABX Micros ES60 (CT model) at one test site in the US.
Annotation protocol: Whole blood samples collected in K2EDTA. The nonparametric data analysis method was used, depending only on the ranks of the reference data arranged in order of increasing size. Per EP28-A3, the reference interval is determined to be between and including the lower and upper reference limits, which enclose 95% of the values from the reference population subjects. Confidence intervals for the reference limit were calculated using a 90% probability (90% CI).

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Analytical Limits at Low Level (LoB, LoD, LoQ):

Study Type: Analytical Performance
Sample Size: For LoB, 60 repeated measurements of 5 different plasma samples. For LoD, 10 runs of 6 low samples on each instrument. For LoQ, at least 40 runs of 4 samples by level.
Key Results:
- LoB: WBC LoB 0.1 x 10^3/mm^3, RBC LoB 0.01 x 10^6/mm^3, HCT LoB 0.1%, PLT LoB 1 x 10^3/mm^3.
- LoD: WBC LoD 0.2 x 10^3/mm^3, RBC LoD 0.01 x 10^6/mm^3, HGB LoD 0.5 g/dL, HCT LoD 0.2%, PLT LoD 4 x 10^3/mm^3.
- LoQ: WBC LoQ 0.8 x 10^3/mm^3, RBC LoQ 0.7 x 10^6/mm^3, HGB LoQ 0.6 g/dL, HCT LoQ 8%, PLT LoQ 42 x 10^3/mm^3.
- Results for Micros ES60 OT and CT were similar and met specifications.

Precision (Repeatability):

Study Type: Imprecision (Repeatability)
Sample Size: 12 normal and 10 abnormal fresh whole blood samples.
Key Results: Results obtained were in the specifications. %CV acceptance criteria: WBC

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.”

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 20, 2014

Horiba ABX SAS/Horiba Medical c/o Ms. Caroline Ferrer, Regulatory Affairs Manager Parc Euromedecine Rue du Caducee - BP7290 34184 Montpellier Cedex 4 - France

Re: K141161

Trade/Device Name: ABX Micros ES 60 OT and ABX Micros ES 60 CT Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: November 14, 2014 Received: November 17, 2014

Dear Ms. Ferrer:

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 Part 801); 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 vours.

Leonthena R. Carrington -A

Maria M. Chan, Ph.D. for Director Division of Immunology and Hematology Devices Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K141161

Device Name

ABX MICROS ES 60 OT (Open Tube model) ABX MICROS ES 60 CT (Close Tube model)

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------------------------------------	----------------------------------------------------------

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Premarket Notification [510(k)] 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.

The assigned 510(k) number is : K141161

1.0 Sumitted by : Company: HORIBA ABX SAS HORIBA MEDICAL Parc Euromédecine Rue du Caducée - BP 7290 34184 Montpellier cedex 4 FRANCE

Contact Person: Caroline Ferrer (caroline.ferrer@horiba.com) Telephone: + (33) 4 67 14 1843 Fax: + (33) 4 67 14 1517

2.0 Date Submitted :

14th November 2014

3.0 Device Name and Classification : Trade/Proprietary Name: ABX MICROS ES 60

Classification:

Device:	Counter, differential cell
Panel:	81 Hematology
Regulation number:	864.5220
Product Code:	GKZ
Class:	2

4.0 System description :

4.1 Device Description

The ABX MICROS ES 60 is a quantitative, automated hematology analyzer and leukocyte differential counter for in vitro diagnostic use in clinical laboratories. The instrument system is comprised of the analyzer and a suite of analytical reagents that allow for simultaneous quantitative determination of hemoglobin measurement, cell counting, quality control, calibration, and cleaning. The system is a microprocessor controlled hematology analyzer used for the in vitro diagnostic testing of whole blood specimens. It operates in complete blood count (CBC) and Differential (DIFF) mode

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using a combination of focused flow impedance and light transmission technologies. It is available in Closed (CT) or Open Tube (OT) sampling versions.

4.2 Principles of Operation

The ABX Micros ES 60 principle of automated cell counting and sizing is used in the analysis of the whole blood. Each cell suspended in a conductive liquid (diluent) acts as an insulator. As each cell goes through the aperture, it momentarily increases the resistance of the electrical path between two submerged electrodes on either side of the aperture. This causes a measurable electronic pulse. While the number of pulses indicates particle count, the amplitude of the electrical pulse is proportional to the cell volume. These pulses are sent to the Signal Conditioner for analog to digital conversion. Pulse counts and digitized pulse measurements are sent to the System Manager for processing by the algorithms where the reported parameter values, flags and histograms are generated.

The diluted sample is processed through two different chambers:

The RBC / PLT chamber, for the Red Blood Cell (RBC) and Platelet (PLT) detection .
The WBC / HGB chamber, for the White Blood Cell (WBC) and Hemoglobin (HGB) counts

Image /page/4/Figure/8 description: This image shows a schematic diagram of a blood analysis system. The diagram includes components such as WBC/HGB, RBC/PLT, and ABX Diluent/Lyse. The diagram also shows the flow of samples and reagents through the system, with arrows indicating the direction of flow. The image includes labels such as CT and OT.

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Red Blood Cells (RBC) and Platelets (PLT) Detection:

The blood specimen is diluted in the electrolytic (current conductor) ABX Minidil LMG and pulled through the 50 um calibrated micro-aperture in the mini flow-cytometer. Two electrodes are placed on either side of the aperture. Electric current passes through the electrodes continuously. When a cell passes through the aperture, the electric resistance between the two electrodes increases proportionately to the cell volume.

The impedance variation is measured and allows for the RBC and PLT quantification.

Hemoglobin Measurement:

The lysing reagent breaks down the RBC cell membrane and releases the hemoglobin contained by the cell. The hemoglobin, released by the lysing reagent, combines with the potassium cyanide from the lysing reagent to form a chromogenous cyanmethemoglobin compound. This compound is then measured through the optical part of the WBC/HGB chamber by spectrophotometry at a wavelength of 550 nm.

Hematocrit Measurement:

All the RBC pulses are grouped into various sizes. Each group pulse height is then averaged. All the pulse height averages are then averaged one final time for a mean average of all the RBC pulse heights. This function is a numeric integration of the MCV. The HCT results are given as a percentage of this integration.

Red Distribution Width (RDW) Calculation:

The RDW is calculated from the RBC histogram. It allows to follow the evolution of the width of the RBC histogram in relation to the number of cells and their average volume.

Mean Cell Volume (MCV), Mean Cell Hemoglobin (MCH) and Mean Corpuscular Hemoglobin Concentration (MCHC) Calculations:

The MCV is calculated directly from the entire RBC histogram. The MCH is calculated from the HGB value and the RBC count. The MCHC is calculated according to the HGB and HCT values.

Mean Platelet Volume (MPV):

The MPV is directly derived from the analysis of the platelet distribution curve.

White Blood Cell (WBC) Count:

The WBC count is carried out in the WBC/HGB chamber. The detection principle is the same as for RBC.

ABX Minidil LMG reagent preserves and prepares the WBC cell membrane for the differential reaction. The lysing reagent has a differential mode of action on the WBC cytoplasmic membranes.

When the lysing reagent reacts with the lymphocytes, the cytoplasm and the . membrane are destroyed. At the end of the lysing action, only the nucleous remains intact and this action results in a smaller volume detected by the instrument.

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When the lysing reagent reacts with the monocyte cytoplasmic membrane, it has an intermediate reaction that empties the cytoplasm from the cell. At the end of the lysing action, the monocyte cells obtained have an intermediate size between the lymphocytes and the granulocytes.
When the lysing reagent reacts with the granulocytes, it has a limited reaction due ● to a molecule in their cytoplasmic structure which protects them from the shrinking action of the lyse. This in turn makes the granulocytes the larger of the WBC sub-populations in the cell differentiation.

The three sub-populations of WBCs are placed according to the number of cells and the size of the cells in each group. The lymphocyte, monocyte and granulocyte results are given as a percentage of the entire WBC count.

The granulocytes subpopulation of the WBC contains three sub-populations that contain cytoplasmic granular material which stain various colors when viewed microscopically. They are as followed:

Neutrophils
Eosinophils
Basophils

The distribution of these cells depends on the pathological and physiological conditions of the individuals analyzed.

Pathological cells are placed in different zones within the WBC distribution curve and trigger alarms.

4.3 Modes of Operation

Two models of ABX Micros ES 60 are available.

. The Closed Tube (CT) instrument: it has a cap-piercing mechanism. The blood collection tube is placed directly in the analyzer without removing the cap.
. The Open Tube (OT) instrument: the cap form the blood collection tube must be removed before analyzing the sample.

4.4 Specimen Identification

Specimen identification is by manual sample identification with the use of a hand held barcode scanner.

4.5 Calibration

Calibration is a procedure that is performed during specific situations such as installation. maintenance or service intervention. It is performed by a HORIBA ABX SAS representative. It ensures that the precision and accuracy of the analyzer are acceptable, so that accurate measurements are performed by the analyzer.

ABX Minocal calibrator (K955925) is used for the ABX Micros ES 60 calibration procedure. Assigned assay values are traceable to reference methods.

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4.6 Quality Control

Quality control allows the user to monitor a set of analyses based on known sample values and ranges over a period of several months. Statistical computation performed on these populations allows the extraction of qualitative information related to the stability of the instrument.

ABX Minotrol 16 Control (K850755) enables monitoring of system performance for all directly measured and calculated CBC and Diff parameters. Assigned assay values are determined on validated instruments using the appropriate reagents.

4.7 Software

HORIBA ABX SAS's Hazard Analysis and Software Development process for this product are included in this submission.

5.0 Intended use

5.1 Indications for Use :

The ABX MICROS ES 60 (OT and CT models) is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in clinical laboratories to identify and enumerate the following parameters: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV, LYM%, LYM#, MON%, MON#, GRA%, GRA#, in K2EDTA and K3EDTA anticoagulated venous whole blood samples of adult patient population. It is not intended to be used for pediatric subjects.

5.2 Special Conditions for Use Statements:

For prescription use only

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6.0 Substantial Equivalence Information :

The following tables show the similarities and differences between the candidate device and its predicate device identified below.

6.1 Predicate Device Name and 510(k) number:

Candidate device	Predicate device	Manufacturer	510(k) number
ABX MICROS ES 60	ABX MICROS 60	HORIBA ABX SAS	K030799

6.2 Comparison with predicate Device : Similarities

| Item | Candidate
(ABX MICROS ES 60) | Predicate K030799
(ABX MICROS 60) |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ABX MICROS ES 60 (OT
and CT models) is a quantitative
multi-parameter, automated
hematology analyzer for in vitro
diagnostic use in clinical
laboratories to identify and
enumerate the following
parameters: WBC, RBC, HGB,
HCT, MCV, MCH, MCHC,
RDW, PLT, MPV, LYM%,
LYM#, MON%, MON#, GRA%,
GRA#, in K2EDTA and K3EDTA
anticoagulated venous whole
blood samples of adult patient
population. It is not intended to be
used for pediatric subjects. | The ABX MICROS 60
Hematology Analyzer is a fully
automated (microprocessor
controlled) hematology analyzer
used for the in vitro diagnostic
testing of whole blood specimens
or blood cell concentrates. It
operates in complete blood count
(CBC) mode. |
| Principles of Measurement | | |
| RBC, PLT, HCT, MPV | Impedance | Same |
| HGB | Spectrophotometry | Same |
| WBC, WBC Differential
(LYM, MON, GRA)) | Impedance | Same |
| RDW, MCV, MCH, MCHC | Calculation | Same |
| Reagents | | |
| Diluent | ABX Minidil LMG | Same |
| Lyse | ABX Minilyse LMG or ABX
Alphalyse 360 | Same |
| Cleaner | ABX Miniclean | Same |
| Reagent Pack | ABX Minipack LMG | Same |
| Concentrated cleaning reagent | ABX Minoclair | Same |
| Quality Controls | ABX Minotrol 16
(3 levels) | Same |
| Calibrator | ABX Minocal | Same |
| System configuration | Bench top | Same |

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| Item | Candidate
(ABX MICROS ES 60) | Predicate K030799
(ABX MICROS 60) |
|-----------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------|
| | Handheld barcode reader
(optional)
Integrated barcode reader (CT
version only)
Printer | |
| Sampling mechanism | Single tube presentation – open
and closed vial sampling | Same |
| Aspiration pathway | Single sampling probe and
common aspiration pathway used
for all sample presentation modes | Same |
| Minimum Sample Volume | 50 μL | Same |
| Specimen sample volume | 10 μL | Same |
| Counting aperture diameters | | |
| RBC/PLT | 50 μm | Same |
| WBC | 80 μm | Same |
| Dilution ratios | | |
| RBC/PLT chamber | 1/15000 | Same |
| Performance claims | | |
| Precision | | |
| WBC | 95% | Same |
| RBC | R2 > 95% | Same |
| HGB | R2 > 95% | Same |
| HCT | R2 > 95% | Same |
| PLT | R2 > 95% | Same |

6.3 Comparison with predicate Device : Differences

| Item | Candidate
(ABX MICROS ES 60) | Predicate K030799
(ABX MICROS 60) |
|------------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| User Interface Display | Automated instrument with 8"
LCD touch screen display | Automated instrument with 3"
LCD display |
| Software application | Linux-based software application | Internally developed software
application |
| Analytical cycle | 1) Draining sequence done by
vacuum
2) No air bubble. | 1) Draining sequence
movement
2) Presence of air bubble at
the end of all cycles |

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| Item (ABX MICROS ES 60) (ABX MICROS 60) |
|-----------------------| | Sample types | Dilution ratios | | WBC chamber | Throughput | Dimensions | Weight CT model: 17 kg CT model: 14 kg |
| Performance claims | | High Linearity limit | | WBC (10³/mm³) | RBC (10⁶/mm³) | HGB (g/dL) | 24 | HCT (%) | 70 | PLT (10³/mm³) | Limit Of Quantitation | | WBC (10³/mm³) | RBC (10⁶/mm³) | HGB (g/dL) | 0.6 | HCT (%) | 8.0 | PLT (10³/mm³) | Carry-over | | WBC | | Candidate
| Predicate K030799
------------------------------------------|-------------------------------------------------|
| Whole blood samples only | Whole blood samples and blood cell concentrates |
| |
| 1/260 | 1/250 |
| OT / CT models: 60 / 50 samples per hour | OT / CT model: approx. 60 / 55 samples per hour |
| OT / CT models: 43 x 36 x 36 cm | OT / CT models:44 x 36 x 33 cm |
| OT model: 14 kg
| OT model: 14 kg
| |
| |
| 100 | Same |
| 8.0 | Same |
| 26 |
| 80 |
| 2200 | Same |
| |
| 0.8 | Not available |
| 0.7 | Not available |
| Not available |
| Not available |
| 42 | Not available |
| |