(28 days)
The Bayer ADVIA 2120 Hematology System with Autoslide is a quantitative, automated hematology analyzer that provides a complete blood cell count, leukocyte differential count and reticulocyte analysis for in vitro diagnostic use in clinical laboratories. In addition, the system provides the added capability to automatically prepare and stain high-quality blood smears on a microscope slide.
The ADVIA 2120 Hematology system with Autoslide is an integrated option of a Hematology analyzer with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120 Hematology system with Autoslide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an autosampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides 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 and an autoslide module that prepares a wedge smear from a drop of blood, places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grunwald Giemsa Staining techniques.
The provided text does not contain specific acceptance criteria or a detailed study description for the ADVIA® 2120 with Autoslide. Instead, it focuses on demonstrating that the device is substantially equivalent to a predicate device (ADVIA 120 Hematology Analyzer) through a 510(k) submission.
The core argument for substantial equivalence is that the ADVIA 2120 with Autoslide performs the same functions (hematological analysis and automated slide preparation/staining) using similar technological characteristics as the predicate device, with the added functionality of the Autoslide module.
Therefore, many of the requested details about acceptance criteria, performance metrics, sample sizes, and expert adjudication are not present in this document. The 510(k) process for substantial equivalence often relies on demonstrating that the new device performs similarly to a legally marketed predicate device, rather than requiring extensive new performance studies against predefined acceptance criteria for every parameter.
However, I can extract information related to the device's capabilities and the nature of the submission.
Here's a breakdown of what can be inferred and what is not available from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided. The document states that the new device is "substantially equivalent" to the predicate device. This implies that its performance is considered comparable to the predicate, which would have had its own performance data established. The exact acceptance criteria used to deem it substantially equivalent are not detailed.
Sufficient information is not provided to complete this table.
2. Sample Size Used for the Test Set and Data Provenance
Not explicitly provided. The document does not describe specific test sets, sample sizes, or data provenance used for performance evaluation of the ADVIA 2120 with Autoslide itself. The focus is on demonstrating technological similarity to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/provided. Since no specific performance study against a defined ground truth is detailed for this 510(k) submission, there is no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable/provided. As no detailed test set or ground truth establishment is described, an adjudication method is not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This device is an automated hematology analyzer and slide maker/stainer, not an AI-assisted diagnostic tool for human readers in the typical sense of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Implicitly yes, in the context of the predicate device. The ADVIA 2120 with Autoslide is an automated system. Its performance, like its predicate (ADVIA 120), is inherent to the algorithms and hardware that perform the blood analysis and slide preparation. While not explicitly called a "standalone algorithm performance study" in modern AI terms, the device's measurements and slide quality are its standalone outputs. The 510(k) relies on the predicate device's established standalone performance and demonstrates that the new device performs similarly.
7. The Type of Ground Truth Used
Not explicitly described for this submission. For diagnostic devices like hematology analyzers, typical ground truth for analytical performance includes:
- Reference Methods: Highly accurate and validated laboratory methods for measuring specific analytes (e.g., manual differential counts, reference hemoglobinometry).
- Patient Samples: Using samples with known clinical conditions.
- Control Materials: Calibrated reference materials and controls.
Given the nature of a 510(k) for substantial equivalence, the ground truth would have been established for the predicate device, and the current submission argues the new device operates on the same (or similar) principles to achieve comparable results.
8. The Sample Size for the Training Set
Not applicable/provided. The document does not discuss a training set in the context of machine learning or AI algorithm development. This submission is for a medical device (hematology analyzer and automated slide stainer) that uses established analytical principles (laser light scatter, absorption, impedance, chemical reactions), not a machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable/provided. As there is no "training set" described for an AI algorithm, this information is not relevant to the provided document.
{0}------------------------------------------------
SEP 1 7 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® 2120 with Autoslide
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.
Ko4225 The assigned 510(k) number is: _
1. Intended Use
The Bayer ADVIA 2120 with Autoslide is a quantitative, automated hematology analyzer that The Dayer In 11 11 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 21 provides a leaded to the system provides the added capability to automatically prepare and stain high-quality blood smears on a microscope slide.
2. Predicate Device
Proprietary Name: Bayer ADVIA 120 Hematology Analyzer Common name: Automated Hematology Analyzer Classification name: Automated hematology complete blood cell counter (§ 864.5200), differential cell counter (§ 864.5220) Classification number: 21 CFR Parts 864.5200, 864.5220, Class II 510(k) Number: K971998
3. Device Information
Proprietary Name: Bayer ADVIA 2120 Hematology Analyzer with Autoslide System Common name: Automated Hematology Analyzer and Automated Maker and Stainer Comment in the name: Automated hematology complete blood cell counter (§ 864.5200), differential cell counter (§ 864.5220) and automated slide stainer (§ 864.3800) Classification number: 21 CFR Parts 864.5200, 864.5220, 864.3800 , Class II
4. Device Description
The ADVIA 2120 Hematology system with Autoslide is an integrated option of a Hematology analyzer with complete blood cell count, leukocyte differential cell count, reticulocyte analysis capability and a slide stainer designed to provide reflexive slide making/staining without user intervention based upon pre-selected, user-definable criteria.
The ADVIA 2120 Hematology system with Autoslide consists of the following: an analytical module that aspirates, dilutes, and analyzes whole blood samples; an autosampler that automatically mixes, identifies, and presents the samples for processing; a computer workstation that controls the instrument, provides 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 and an autoslide module that prepares a wedge smear from a drop of blood,
{1}------------------------------------------------
places it on a microscope slide and stains the slide in accordance with Wright, Wright-Giemsa and May-Grunwald Giemsa Staining techniques.
The ADVIA 2120 with Autoslide 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 cells 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
{2}------------------------------------------------
In addition the ADVIA 2120 with Autoslide reports the following parameters with Cerebrospinal Fluid samples using the CSF method cleared for use on the ADVIA 120 under K022331:
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) MN- mononuclear count (percentage and absolute counts) PMN- polymorphonuclear count (percentage and absolute counts)
Red Blood Cell Parameters RBC- red blood cell count
- For Laboratory Use Only (not reportable)
The ADVIA 2120 with Autoslide supports the following staining techniques:
Wright Stain Wright-Giemsa Stain May-Grunwald Stain
5. Summary of Technological Characteristics
The principles of operation of the ADVIA 2120 Hematology System with Autoslide are similar to those of the ADVIA 120, the only difference is the ability of the ADVIA 2120 Hematology System with Autoslide to prepare a wedge smear from a drop of blood, place it on a microscope slide and stain the slide in accordance with Wright, Wright-Giemsa and May-Grunwald Giemsa Staining techniques.
The Autoslide module will dispense a drop of blood from the sample on a slide, the smearing assembly will create a smear using the surface tension of the blood. After smearing, the slide is sent to the printer where information on patient demographics can be printed along with any other necessary information. If staining is required, the slide moves into the stainer, where the slide is stained according to the staining method in use. Once staining is complete, the slide is transferred to a rack and processing is complete.
The hematological parameters supported by the ADVIA 2120 with Autoslide are the same and use the same technology as the predicate device, the ADVIA 120, below is a summary of the technological characteristics for each parameter:
The White Blood Cell 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.
{3}------------------------------------------------
The Red Blood Cell and Platelet parameters are derived through laser light scatter and refractive index.
The Hemoglobin parameters are based on a modification of the manual cyanmethemoglobin The Homogroum parantee 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.
6. Conclusion
Based on all the information provided as part of this submission the ADVIA 2120 Hematology system with Autoslide is substantially equivalent to the ADVIA 120 Hematology System.
Andrea Holle
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
8/17/04
Date
Date
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged around a stylized eagle emblem. The eagle is depicted with three swooping lines forming its body and wings, symbolizing health and human services. The text is arranged in a circular fashion around the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, New York 10591
SEP 1 7 2004
K042251 Re: Trade/Device Name: ADVIA® 2120 with Autoslide Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ, KPA Dated: August 18, 2004 Received: August 20, 2004
Dear Mr. Holle:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
{5}------------------------------------------------
Page 2
If you desire specific information about the application of labeling requirements to your device, or you desire specific missition and advertising of your device, please contact the Office of In of questions on the promotion and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation other general information on your responsibilities under the Act from the Tou may oounly other generational and Consumer 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., PhA Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
Indications for Use
510(k) Number (if known): $(14)255
Device Name: ADVIA® 2120 with Autoslide
Indications For Use:
The Bayer ADVIA 2120 Hematology System with Autoslide is a quantitative, The Bayer ADVIA 2120 Homatology Oyotin's a leukocyte differential count and automated nematology analyzof that promostic use in clinical laboratories. In addition, and stain high reticulocyce analysis for in vitro diagnounce as a stain highquality blood smears on a microscope slide.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Jacqueline Bautista
Division Sign-Off
Page 1 of 1__
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042251
§ 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.”