(43 days)
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No
The description focuses on standard hematology analysis techniques (impedance, spectrophotometry, volumetric study) and does not mention any AI/ML components or algorithms. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is described as an "in vitro diagnostic hematology analyzer" used for determining various hematological parameters. It analyzes blood samples and generates reports, which are diagnostic activities, not therapeutic ones.
Yes
The document explicitly states its intended use is an "automated in vitro diagnostic hematology analyzer" and that its outputs will be "available for diagnostic use".
No
The device description explicitly states that the system consists of an "analytical module that aspirates, dilutes, and analyzes whole blood samples" and a "printer," indicating the presence of significant hardware components beyond just software.
Yes, based on the provided text, the Bayer ADVIA 60 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states it is an "automated in vitro diagnostic hematology analyzer." It also specifies its use for determining various hematological parameters, which are measurements taken from biological samples (blood) outside of the body.
- Intended User/Care Setting: It is indicated for "in vitro diagnostic use in clinical laboratories." This further reinforces its purpose as a diagnostic tool used in a laboratory setting.
- Device Description: The description details how the device analyzes whole blood samples and reports hematological parameters. This process of analyzing biological samples to provide information about a patient's health is the core function of an IVD.
The text clearly and repeatedly identifies the device as being used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
The ADVIA 60 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In Vitro diagnostic use in clinical laboratories.
The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) 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
mean platelet volume MPV
lymphocyte (number) #LYM
lymphocyte (percent of WBC) %LYM
monocyte (number) #MON
monocyte (percent of WBC) %MON
granulocyte (number) #GRA
granulocyte (percent of WBC) %GRA
The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters:
- ·16 parameters
- · 8 parameters (WBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT)
- · 5 parameters (WBC, RBC, MPV, HGB, HCT)
Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The ADVIA 60 Hematology System consists of an analytical module that aspirates, dilutes, and analyzes whole blood samples along with a printer that optionally generates reports based on the instrument results.
The ADVIA 60 Hematology System reports the following hematological parameters:
White Blood Cell Parameters WBC - white blood cell count GRA - granulocyte count (percentage and absolute counts) LYM - lymphocyte count (percentage and absolute counts) MON - mononuclear 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
Hemoglobin Parameters Hab - hemoglobin concentration MCH - mean corpuscular hemoglobin MCHC - mean corpuscular hemoglobin concentration
Platelet Parameters Pit - platelet count MPV - mean platelet volume
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
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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 60 Hematology System and the ABX MICROS Hematology System have equivalent accuracy, precision, linearity, and carryover.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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SEP 2 2 1998 510(k) Summary of Safety and Effectiveness
information provides data supporting a substantially equivalent The following determination between the ADVIA 60 Hematology System and the ABX MICROS Hematology System for CBC and WBC differential parameters.
Intended Use
The ADVIA 60 Hematology System is a quantitative, automated hematology analyzer that provides a leukocyte differential count for In Vitro diagnostic use in clinical laboratories.
Device Description
The ADVIA 60 Hematology System consists of an analytical module that aspirates, dilutes, and analyzes whole blood samples along with a printer that optionally generates reports based on the instrument results.
The ADVIA 60 Hematology System reports the following hematological parameters:
White Blood Cell Parameters WBC - white blood cell count GRA - granulocyte count (percentage and absolute counts) LYM - lymphocyte count (percentage and absolute counts) MON - mononuclear 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
Hemoglobin Parameters Hab - hemoglobin concentration MCH - mean corpuscular hemoglobin MCHC - mean corpuscular hemoglobin concentration
Platelet Parameters Pit - platelet count MPV - mean platelet volume
Principles of Operation
The principles of operation of the ADVIA 60 Hematology System are similar to those of the ABX MICROS Hematology System.
The RBC/WBC/Plt parameters are counted based on impedance variation generated by the passage of cells through a calibrated micro-aperture.
hemoglobin parameters are based on a modification of the The manual International Committee cyanmethemoglobin method developed by the for Standardization in Hematology.
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The WBC differential parameters are derived through a volumetric study of leukocytes after the use of a diluent and lysing reagent.
Conclusion
The test results included in this submission demonstrate that the ADVIA 60 Hematology System and the ABX MICROS Hematology System have equivalent accuracy, precision, linearity, and carryover.
Gabriel J. Muraca, Jr.
7/31/98
Date
Gabriel Manager Regulatory Aff Bayer Corporation 511Benedict Avenue Tarrytown, New York 10591-5097
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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The eagle is positioned to the right of the text, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
SEP 2 2 1998
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Re: K982802 Trade Name: Bayer ADVIA® 60 Hematology System Regulatory Class: II Product Code: GKZ Dated: July 31, 1998 Received: Auqust 10, 1998
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 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). 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 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. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (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 action. In addition, FDA may publish further announcements 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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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 labelinq regulation (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/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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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Page 1 of 1
510(k) Number (if known): K9826802
Device Name: Bayer ADVIA® 60 Hematology System
Indications For Use:
The Bayer ADVIA 60 is an automated in vitro diagnostic hematology analyzer capable of determining the following eighteen (18) 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 |
| mean platelet volume | MPV |
| lymphocyte (number) | #LYM |
| lymphocyte (percent of WBC) | %LYM |
| monocyte (number) | #MON |
| monocyte (percent of WBC) | %MON |
| granulocyte (number) | #GRA |
| granulocyte (percent of WBC) | %GRA |
The ADVIA 60 Hematology Analyzer can be programmed to printout any of the following groups of parameters:
- ·16 parameters
- · 8 parameters (WBC (WBC, RBC, HGB, HCT, MCV, MCH, MCHC, and PLT)
- · 5 parameters (WBC, RBC, MPV, HGB, HCT)
Only the eight (8) and sixteen (16) parameter printout will be made available for diagnostic use in the United States.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | Optional Format 1-2-96) | |
| (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number |