(91 days)
Technicon H-3 RTC
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No
The description focuses on standard hematology analysis techniques and hardware components, with no mention of AI/ML terms or functionalities.
No
The device is an in vitro diagnostic hematology analyzer used for quantitative analysis of blood samples, not for direct treatment or therapy of patients.
Yes
The document states "The ADVIA 120 Hematology System ... provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories."
No
The device description explicitly lists multiple hardware components: an analytical module, an autosampler, a computer workstation, and a printer. This indicates it is a hardware-based system with integrated software, not a software-only device.
Yes, the ADVIA 120 Hematology System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "...for In Vitro diagnostic use in clinical laboratories." This is the most direct indicator.
- Device Function: The device analyzes whole blood samples to provide quantitative hematological parameters. This analysis is performed in vitro (outside of the living body) on biological specimens.
- Parameters Measured: The parameters reported (WBC, RBC, Hgb, Plt, Reticulocyte count, etc.) are standard hematological measurements used for diagnostic purposes in clinical settings.
- Intended User/Care Setting: The device is intended for use in "clinical laboratories," which are the typical settings for performing in vitro diagnostic tests.
All of these points align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.
Product codes
GKL, GKZ
Device Description
The ADVIA 120 Hematology System consists of the following: An analytical module that aspirates, dilutes, and analyzes whole blood samples. An autosampler that automatically mixes, identifies, and presents samples for processing. A computer workstation that controls the instrument, provides the 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.
The ADVIA 120 Hematology System 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)
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
MCHC - mean corpuscular hemoglobin concentration
Platelet Parameters
Plt - platelet count MPV - mean platelet volume
Reticulocyte Count
retic - reticulocyte count (percentage and absolute counts) MCVg - mean corpuscular volume of all gated red ceils 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
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
In Vitro diagnostic use in clinical laboratories.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The test results included in this submission demonstrate that the ADVIA 120 Hematology System and the H-3 RTC have equivalent accuracy, precision, linearity, and carryover.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
accuracy, precision, linearity, and carryover
Predicate Device(s)
Technicon H-3 RTC
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.5200 Automated cell counter.
(a)
Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.(b)
Classification. Class II (performance standards).
0
1-11998
510(k) Summary of Safety and Effectiveness
510(k) Summary of Safety and Effectiveness
The following information provides data supporting a substantially equivalent determination between the ADVIA 120 Hematology System and the Technicon H-3 RTC for the CBC, WBC differential, and reticulocyte parameters.
Intended Use
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count and reticulocyte analysis for In Vitro diagnostic use in clinical laboratories.
Device Description
The ADVIA 120 Hematology System consists of the following: An analytical module that aspirates, dilutes, and analyzes whole blood samples. An autosampler that automatically mixes, identifies, and presents samples for processing. A computer workstation that controls the instrument, provides the 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.
The ADVIA 120 Hematology System 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)
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
MCHC - mean corpuscular hemoglobin concentration
)
1
Platelet Parameters
Plt - platelet count MPV - mean platelet volume
Reticulocyte Count
retic - reticulocyte count (percentage and absolute counts) MCVg - mean corpuscular volume of all gated red ceils 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
Principles of Operation
The principles of operation of the ADVIA 120 Hematology System are similar to those of the H-3 RTC.
The WBC parameters are derived through a combination of laser light scatter, as well as light scatter and absorption from a tungsten light source based on cellular peroxidase activity.
The RBC and platelet parameters are derived through laser light scatter and refractive index.
hemoglobin parameters are based on a modification of the manual The cyanmethemoglobin method developed by the International Committee for Standardization in Hematology.
The reticulocyte parameters are derived through a combination of laser light scatter and absorption of a nucleic acid dye.
Conclusion
The test results included in this submission demonstrate that the ADVIA 120 Hematology System and the H-3 RTC have equivalent accuracy, precision, linearity, and carryover.
Gabriel J. Muraca, Jr.
Gabriel J. Muraca. Manager Regulatory Affairs Bayer Corporation 511Benedict Avenue Tarrytown, New York 10591-5097
5/29/99
Date
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, rendered in black.
Food and Drug Ad ninistration 2098 Gaither Road Rockville MD 20850
AUG 2 9 1997
Gabriel J. Muraca, Jr. .Manager Requlatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591 5097
K971998 Re : ADIVA™ 120 Hematology System Regulatory Class: II Product Code: GKL, GKZ Dated: July 23, 1997 Received: July 28, 1997
Dear Mr. Muraca:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Sitman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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്രവാസ്ത്രവുമായ പ
510(k) Number (if known):_
ADVIA 120 Hematology System Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The ADVIA 120 Hematology System is a quantitative, automated hematology analyzer The ADVIA 120 Homatology Bystein is at and reticulocyte analysis for in vitro diagnostic use in clinical laboratories.
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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number |
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
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