(43 days)
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, 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.
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. 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. The WBC differential parameters are derived through a volumetric study of leukocytes after the use of a diluent and lysing reagent.
The provided text is a 510(k) Summary of Safety and Effectiveness for the ADVIA 60 Hematology System. It aims to demonstrate substantial equivalence to the ABX MICROS Hematology System based on accuracy, precision, linearity, and carryover. However, the document does not explicitly state acceptance criteria in a table format and the specific studies that prove the device meets these criteria in the way requested. It generally asserts equivalence to the predicate device.
Given the information provided, I cannot fully complete the table as requested, nor can I provide details on sample sizes, ground truth establishment methods, or multi-reader studies. The document describes the device's function and parameter reporting but lacks detailed study protocols and results in the format requested.
Here's an attempt to extract the closest available information to your requested points, highlighting what is not available from the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with explicit acceptance criteria (e.g., specific ranges for accuracy, precision) or quantitative reported device performance values. It only states a conclusion of equivalence in accuracy, precision, linearity, and carryover to the predicate device.
| Performance Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| Accuracy | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Precision | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Linearity | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
| Carryover | Implied to be equivalent to ABX MICROS Hematology System | Concluded as equivalent to ABX MICROS Hematology System |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not mentioned.
- Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective).
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)
Not applicable. This device is a hematology analyzer, not an imaging device requiring expert interpretation for ground truth. Its ground truth would typically be established by established reference methods (e.g., manual microscopy, highly accurate reference instruments).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of a hematology analyzer.
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 not an AI-assisted diagnostic device. It is a standalone automated hematology analyzer.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this appears to be a standalone performance study. The device is a quantitative, automated analyzer, implying its performance is assessed independently against reference methods or another predicate device. The submission explicitly states: "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." This suggests a direct comparison of the ADVIA 60's results to the ABX MICROS.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the "ground truth" method for the test set. However, for hematology analyzers, ground truth usually involves:
- Reference methods: Such as manual differential counts by trained technologists (for WBC differentials), or established reference instruments/methods for CBC parameters (e.g., conductivity for Hct, cyanide-free methods for Hgb).
- Predicate device comparison: In this specific submission, the "ground truth" performance for equivalence is the performance of the ABX MICROS Hematology System, since the study aims to show "equivalent accuracy, precision, linearity, and carryover" to that predicate device. The document also mentions for hemoglobin parameters that "a modification of the manual International Committee cyanmethemoglobin method developed by the for Standardization in Hematology" is used, implying this as a reference.
8. The sample size for the training set
Not mentioned. This device is from 1998, predating the widespread use of machine learning models requiring explicit "training sets" in the modern sense. Its development would likely have involved engineering and calibration using blood samples, but these wouldn't typically be referred to as a "training set" in a 510(k) submission from this era.
9. How the ground truth for the training set was established
Not applicable, as a distinct "training set" with established ground truth as understood in modern AI development is not specified. Device calibration and development would have relied on established hematology standards and comparison to reference methods.
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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.
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| 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 |
§ 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.”