(122 days)
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No
The document describes a standard automated hematology analyzer using established techniques like impedance, spectrophotometry, and cytochemistry. There is no mention of AI, ML, or related concepts in the device description, performance studies, or key metrics.
No
The device is an in vitro diagnostic analyzer that quantifies hematological parameters. It is used for diagnosis, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is an "automated in vitro diagnostic analyzer" and lists parameters "available for diagnostic use".
No
The device description explicitly states it is an "automated in vitro diagnostic analyzer" that utilizes reagents and counting principles based on impedance variation and spectrophotometry, which are hardware-based methods.
Yes, this device is an IVD (In Vitro Diagnostic).
The intended use explicitly states that the VEGA™ Hematology Analyzer is a "quantitative, automated in vitro diagnostic analyzer". This statement directly identifies the device as an IVD.
Furthermore, the device performs measurements on biological samples (blood) to provide information about hematological parameters, which are used in the diagnosis and monitoring of various medical conditions. This aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing the following twenty six (26) hematological parameters:
white blood cells (leukocytes) -WBC
red blood cells (erythrocytes) -RBC
hemoglobin -HGB
hematocrit -HCT
mean corpuscular volume -MCV
mean corpuscular hemoglobin -MCH
mean corpuscular hemoglobin concentration -MCHC
red blood cell distribution width -RDW
platelets -PLT
plateletcrit -PCT
platelet distribution width -PDW
mean platelet volume -MPV
lymphocyte (number) -LYM#
lymphocyte (percent of WBC) -LYM%
monocyte (number) -MON#
monocyte (percent of WBC) -MON%
basophil (number) -BAS#
basophil (percent of WBC) -BAS%
neutrophil (number) -NEU#
neutrophil (percent of WBC) -NEU%
eosinophil (number) -EOS#
eosinophil (percent of WBC) -EOS%
Atypical Lymphocyte (number) -ALY#
Atypical Lymphocyte (percent of lymphocyte number) -ALY%
Large Immature cell (number) -LIC#
Large Immature cell (percent of WBC) -LIC%
The VEGA Hematology Analyzer can be programmed to printout any of the parameters here above independently.
Only twenty (20) parameter printout will be made available for diagnostic use in the United States (eliminating PCT, PDW, ALY%, ALY#, LIC%, LIC#).
Product codes (comma separated list FDA assigned to the subject device)
864.5200, 864.5220
Device Description
The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing twenty six (26) hematological parameters. The device utilizes five (5) different reagents: VEGADIL™, VEGALYSE™, VEGACLEAN™, EOSINOFIX™, and BASOLYSE™.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Clinical studies were performed at three hospital university sites. The clinical study was designed to demonstrate the precision and accuracy of the VEGA Analyzer in a typical setting with operators of various levels of experience and educational backgrounds.
Each site used different reference instrument: Site 1 used a TECHNICON H2 ® Hematology Analyzer; Site 2 used the ABBOT CELL-DYN ® 3500 Hematology Analyzer; and Site 3 used the COULTER STKS ® Hematology Analyzer.
Manual differential count were performed for the samples at all three sites to reflect the widest distribution of normal and abnormal specimens. The cell counts were performed according to NCCLS guidelines H20-A, at all three hospital laboratories.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical studies for precision and accuracy.
Sample Size:
Site 1: 190
Site 2: 238
Site 3: 216
Key Results:
Reproducibility (within run):
- WBC:
§ 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.”
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Image /page/0/Picture/2 description: The image shows a sequence of handwritten characters. The sequence starts with the letter 'K', followed by the number '9', and then the letter 'X'. The sequence continues with the number '6', another letter 'X', and ends with the number '33'.
Nov - 4 1996
510(k) SUMMARY
VEGA ™Hematology Analyzer
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
I. Identification of the Sponsor and Objective:
ABX
Parc Euromédecine,
rue du Caducée - BP 7290,
34184 MONTPELLIER Cédex 4 - FRANCE.
| 510(k) Submission dated | 2/7 , 1996. |
|---|---|
| Contact: | Mr. Brice Prouvé |
| Business Development Manager. | |
| phone: (33) 6714-1516/59/72 | |
| fax: (33) 6714-1517 |
II. Device Name:
Trade/Proprietary Name -VEGA™ Hematology Analyzer
| Common or Usual Name/ | Automated cell counter [864.5200] and |
|---|---|
| Classification Name - | Automated Differential Cell Counter [864.5220] |
Identification of the legally marketed device to which the 510(k) & III. sponsor claims equivalence:
TheVEGA™ Hematology Analyzer is substantially equivalent to the TECHNICON H2 ® Hematology Analyzer, the ABBOT CELL-DYN ® 3500 Hematology Analyzer and the COULTER STKS ® Hematology Analyzer.
1
Description of the Device/Statement of Intended Use: IV.
The VEGA™ Hematology Analyzer is a quantitative, automated in vitro diagnostic analyzer capable of performing the following twenty six (26) hematological parameters:
| white blood cells (leukocytes) | -WBC |
|---|---|
| red blood cells (erythrocytes) | -RBC |
| hemoglobin | -HGB |
| hematocrit | -HCT |
| mean corpuscular volume | -MCV |
| mean corpuscular hemoglobin | -MCH |
| mean corpuscular hemoglobin concentration | -MCHC |
| red blood cell distribution width | -RDW |
| platelets | -PLT |
| plateletcrit | -PCT |
| platelet distribution width | -PDW |
| mean platelet volume | -MPV |
| lymphocyte (number) | -LYM# |
| lymphocyte (percent of WBC) | -LYM% |
| monocyte (number) | -MON# |
| monocyte (percent of WBC) | -MON% |
| basophil (number) | -BAS# |
| basophil (percent of WBC) | -BAS% |
| neutrophil (number) | -NEU# |
| neutrophil (percent of WBC) | -NEU% |
| eosinophil (number) | -EOS# |
| eosinophil (percent of WBC) | -EOS% |
| Atypical Lymphocyte (number) | -ALY# |
| Atypical Lymphocyte (percent of lymphocyte number) | -ALY% |
| Large Immature cell (number) | -LIC# |
| Large Immature cell (percent of WBC) | -LIC% |
The VEGA Hematology Analyzer can be programmed to printout any of the parameters here above independently.
Only twenty (20) parameter printout will be made available for diagnostic use in the United States (eliminating PCT, PDW, ALY%, ALY#, LIC%, LIC#).
The VEGA Hematology Analyzer utilizes five (5) different reagents.
| - | VEGADILTM | : | Diluant |
|---|---|---|---|
| - | VEGALYSETM | : | Lysing Agent |
| - | VEGACLEANTM | : | Cleaner |
| - | EOSINOFIXTM | : | Staining Agen |
| - | BASOLYSETM | : | Lysing Agent |
2
VEGA Measurement Principles:
WBC, RBC, PLT: The counting principle is based on an impedance variation generated by the passage of cells through the calibrated micro-aperture.
HGB: A cyanmethemoglobin compound is measured by spectrophotometry through the optical part of the WBC chamber at a wavelength of 550 nanometers.
HCT: The height of the impulse generated by the passage of the cell through the micro-aperture is directly proportional to the volume of analyzed red blood cell. The HCT measurement is performed by a specialized electronic device which adds all the pulse heights.
MCH, MCHC, MCV are red blood cell indices calculated from the measured parameters.
RDW is a coefficient of variation of the RBC distribution and is expressed as a percent of the average RBC size.
MPV is a platelet indice derived from the accumulation of platelet data within the platelet population distribution.
Leukocyte Differential Counts:
The VEGA Hematology Analyzer uses the similar method counting as the Roche COBAS Argos 5 DIFF Hematology Analyzer. The VEGA Hematology Analyzer combines the use of histochemical stains, measurement of blood cell volume via optical transmission from a tungsten halogen light source to provide leukocyte differentiation. On each individual cell, three methods are aplied:
-
- Cytochemistry with the action of Eosinofix ™ reagent.
-
- Impedance to measure the volume.
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- Optical transmission measurement to obtain information on the internal structure of the cells.
V. Summary of the technological characteristics of the new device in comparison to those of the predicate:
The intended use and measurement principles are the same for each analyzer. There are differences in operation, configuration and capabilities of each device. Algorithms and threshold discrimination of each instrument are slightly different.
3
Brief discussion of the clinical and non-clinical tests relied on for a VI. determination of substantial equivalence:
Clinical studies were performed at three hospital university sites. The clinical study was designed to demonstrate the precision and accuracy of the VEGA Analyzer in a typical setting with operators of various levels of experience and educational backgrounds.
Each site used different reference instrument: Site 1 used a TECHNICON H2 ® Hematology Analyzer; Site 2 used the ABBOT CELL-DYN ® 3500 Hematology Analyzer; and Site 3 used the COULTER STKS ® Hematology Analyzer.
Manual differential count were performed for the samples at all three sites to reflect the widest distribution of normal and abnormal specimens. The cell counts were performed according to NCCLS guidelines H20-A, at all three hospital laboratories. A summary of performance data follows:
Reproducibility (within run):
Reproducibility of an instrument is measured by the coefficient of variation (CV) obtained from the calculation of 20 results of the same sample.
| Parameters | %CV | Reference Values |
|---|---|---|
| - WBC: |