(24 days)
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.
The ADVIA 60 with software version 1.6 is a bench top, clinical laboratory instrument that analyzes in-vitro samples of whole blood specimens. The device reports a complete blood count (CBC) and 3-part WBC differential (LMG). The device operates as either a closed tube/closed system or open tube/open system. The ADVIA 60 can evaluate 5, 8, 16, or 18 hematology parameters depending on its internal configuration.
The provided text describes the ADVIA 60 Software Version 1.6 as an in-vitro diagnostic device for quantitative determination of blood cells and hematologic parameters. It aims to demonstrate substantial equivalence to its predicate devices, the ADVIA 60 with software version 1.4 and Abbott Cell-Dyn 4000.
Here's an analysis based on your requested criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The documentation focuses on demonstrating substantial equivalence rather than explicit acceptance criteria with numerical thresholds. However, it implicitly uses accuracy, precision, and linearity as key performance indicators for comparison.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate) | Reported Device Performance (ADVIA 60 v1.6) |
|---|---|---|
| Accuracy | Equivalent to ADVIA 60 v1.4 and Cell-Dyn 4000 | "Equivalent to predicate device." |
| Precision | Equivalent to ADVIA 60 v1.4 | "Equivalent to predicate device." |
| Linearity | As specified in product labeling (v1.4) | "Expanded linearity claims" (supported by results) |
Note: The document does not provide specific numerical ranges or statistical metrics for "equivalent" performance; it relies on a general statement of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "The test results included in this submission demonstrate..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used, their qualifications, or their involvement in establishing ground truth for the test set. Given the nature of a hematology analyzer, ground truth would typically be established by laboratory methods, not expert consensus in the traditional sense of image interpretation.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method. This is expected as the device is an automated hematology analyzer, and its performance is typically evaluated against reference methods or predicate devices, not through expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The device is an automated hematology analyzer, not a diagnostic imaging or interpretation tool that would involve human readers. The study focuses on the device's performance characteristics compared to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies conducted were standalone performance evaluations. The ADVIA 60 Software Version 1.6 is an automated instrument, and its performance is measured directly by comparing its output against predicate devices or reference methods. There is no human interpretation or involvement in the measurement process being evaluated.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation implicitly relies on:
- Established performance of predicate devices: The ADVIA 60 with software version 1.4 and the Abbott Cell-Dyn 4000 are used as benchmarks. Their established accuracy, precision, and linearity serve as the de-facto "ground truth" for comparison.
- Fundamental scientific measurement principles: For parameters like hemoglobin, it refers to a "modification of the manual cyanmethemoglobin method developed by the International Committee for Standardization in Hematology," implying a gold standard reference method for that specific measurement. Similarly, RBC/WBC/Plt counting is based on "impedance variation," a well-established principle for cellular enumeration.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This is typical for device submissions that focus on performance validation rather than detailing the underlying algorithmic development and training data.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth would have been established.
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ADVIA 60 Software Version 1.6
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 60 with software version 1.6 and the predicate device, ADVIA 60 with software version 1.4.
The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the predicate device cleared to market under K982802.
The Abbott Cell-Dyn 4000 (K961439) is also used as a predicate device to establish clinical accuracy of the ADVIA 60 with software version 1.6.
Intended Use
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.
Device Description
The ADVIA 60 with software version 1.6 is a bench top, clinical laboratory instrument that analyzes in-vitro samples of whole blood specimens. The device reports a complete blood count (CBC) and 3-part WBC differential (LMG). The device operates as either a closed tube/closed system or open tube/open system. The ADVIA 60 can evaluate 5, 8, 16, or 18 hematology parameters depending on its internal configuration.
Principles of Operation
The ADVIA 60 with software version 1.6 is based on the same fundamental technology as the ADVIA 60 with software version 1.4.
The RBC/WBC/Plt parameters are counted based on impedance variation qenerated by the passage of cells through a calibrated micro-aperture.
The hemoglobin parameters are based on a modification of the manual cyanmethemoglobin method developed by the International Committee 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.
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Similarities and Differences between the ADVIA 60 with software version 1.6 and ADVIA 60 with software version 1.4 (predicate device K982802)
The following table provides similarities and differences between ADVIA 60 with software version 1.6 and ADVIA 60 with software version 1.4.
| Similarities/Differences | Characteristic | ADVIA 60 with SoftwareVersion 1.4 | ADVIA 60 with SoftwareVersion 1.6 |
|---|---|---|---|
| Similarities | Intended Use | Hematology analyzer forin-vitro diagnostic use | Same as predicate device. |
| Accuracy | As specified in productlabeling. | Equivalent to predicatedevice. | |
| Precision | As specified in productlabeling. | Equivalent to predicatedevice. | |
| Difference | Linearity | As specified in productlabeling. | Expanded linearity claims |
Similarities and Differences between the ADVIA 60 with software version 1.6 and Abbott Cell-Dyn 4000 (predicate device K961439)
The following table provides similarities and differences in the principles of measurement between ADVIA 60 with software version 1.6 and Abbott Cell-Dyn 4000.
| Similarities/Differences | Characteristic | Cell-Dyn 4000 | ADVIA 60 with SoftwareVersion 1.6 |
|---|---|---|---|
| Similarities | RBC/Plt count | Aperture impedance | Aperture impedance |
| Hgb measurement | Spectrophotometer | Spectrophotometer | |
| Differences | WBC Count | Light scattering | Aperture impedance |
| MCV | Light scattering | Calculated from Hct | |
| WBC Differential | Multiple angle polarizedlight scatter separation | Aperture impedance |
Conclusion
The test results included in this submission demonstrate that the ADVIA 60 with software version 1.6 has equivalent accuracy and precision to the ADVIA 60 with software version 1.4. Expanded linearity claims with version 1.6 are supported with the results included in this submission.
Amees B. Taka
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Date August 1, 2003
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
SEP - 8 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Baver HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591-5097
K032524 Re:
Trade/Device Name: ADVIA 60 Hematology Analyzer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 1, 2003 Received: August 15, 2003
Dear Dr. Edds:
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 vour 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).
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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.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International 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.
Steven Gutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number: K032524
Device Name: ADVIA 60 hematology analyzer
Indications for Use:
For in-vitro diagnostic use in the quantitative determination of blood cells and hematologic parameters in whole blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﺎ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K032524
§ 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.”