(167 days)
The ADVIA® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.
The technological and methodological principles of the ADVIA 2120 with Autoslide used for the quantitative measurement of blood cells in whole blood specimens will be used without change except for the addition of a new methodology to quantitate nucleated red blood cells and correct for white blood cells in peripheral whole blood.
The ADVIA 2120 Nucleated Red Blood Cell (nRBC) method is described below:
a) The ADVIA 2120 nRBC Analysis method uses histogram analysis routines to analyze the unstained region of the Peroxidase channel as well as an arithmetic algorithm that combines counts from the Peroxidase and Basophil/Lobularity channels to enumerate nRBCs.
b) The analysis corrects the White Blood Cell Count for the presence of nRBCs, as well as the WBC Differential. It reports the corrected WBC count and the corrected differential.
The new nRBC method will report the following Red Blood Cell Parameters-
- % nucleated Red Blood Cells (% nRBC)
- absolute nRBC (# of nRBC per microliter)
The provided text describes the ADVIA® 2120 with Autoslide and NRBC Method. However, it does not include detailed acceptance criteria or a study proving the device meets specific performance metrics in the format requested.
The text focuses on explaining the new functionality (nRBC analysis) and its technological characteristics compared to the predicate device. It also includes the FDA's 510(k) clearance letter, which confirms substantial equivalence but does not detail the underlying performance studies or acceptance criteria that led to that determination.
Therefore, I cannot provide the requested table or answer most of the questions because the information is not present in the provided document.
Here's what can be extracted based on the limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in the document.
- Reported Device Performance:
- Reports "% nucleated Red Blood Cells (% nRBC)"
- Reports "absolute nRBC (# of nRBC per microliter)"
- Reports nRBC counts for whole blood samples with either 200 or more nRBC/uL, or with at least 2% nRBCs with a WBC count of at least 3,000/ uL.
- Corrects the White Blood Cell Count for the presence of nRBCs.
- Recalculates the WBC Differential, and recalculates %MN and %PMN.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 a standalone automated analyzer, not an AI-assisted reader system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Yes, the device is described as an "Automated Hematology Analyzer," indicating standalone performance. The document states, "The ADVIA 2120 nRBC method uses histogram analysis routines... as well as an arithmetic algorithm that combines counts... to enumerate nRBCs." This describes the algorithm's standalone operation.
7. The type of ground truth used: The text mentions "nRBC counts are performed by manual methods that are well established as reference methods in clinical laboratories and consistent with NCCLS H-20A." This suggests that manual microscopy (per NCCLS H-20A guidelines) would have been used as the ground truth for validation, likely expert consensus through manual review.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not explicitly stated, but likely through manual methods consistent with NCCLS H-20A, as referenced for "reference methods."
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DEC 7 2005
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ADVIA® 2120 with Autoslide and NRBC Method
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.
The assigned 510(k) number is: K051693
1. Submitted By:
Andres Holle Manager, Regulatory Affairs Bayer HealthCare LLC Diagnostics Division 511 Benedict Avenue Tarrytown, NY 10591 Telephone: (914) 524-3494 FAX: (914) 524-2500 E-mail: andres.holle.b(@bayer.com
2. Intended Use
The ADVIA 2120 nRBC method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.
3. Predicate Device
Proprietary Name: Bayer ADVIA 2120 Hematology Analyzer with Autoslide Common name: Automated Hematology Analyzer with Autoslide 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: K042251
nRBC counts are performed by manual methods that are well established as reference methods in clinical laboratories and consistent with NCCLS H-20A.
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4. Device Information
Proprietary Name: Bayer ADVIA 2120 Hematology Analyzer with Autoslide System Common name: Automated Hematology Analyzer and Automated Slide Maker and Stainer Classification 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
The only change between the predicate device and the new device is the introduction of a new method for nucleated red blood cell analysis.
5. Device Description
The technological and methodological principles of the ADVIA 2120 with Autoslide used for the quantitative measurement of blood cells in whole blood specimens will be used without change except for the addition of a new methodology to quantitate nucleated red blood cells and correct for white blood cells in peripheral whole blood.
The ADVIA 2120 Nucleated Red Blood Cell (nRBC) method is described below:
- a) The ADVIA 2120 nRBC Analysis method uses histogram analysis routines to analyze the unstained region of the Peroxidase channel as well as an arithmetic algorithm that combines counts from the Peroxidase and Basophil/Lobularity channels to enumerate nRBCs.
- b) The analysis corrects the White Blood Cell Count for the presence of nRBCs, as well as the WBC Differential. It reports the corrected WBC count and the corrected differential.
The new nRBC method will report the following Red Blood Cell Parameters-
-
- % nucleated Red Blood Cells (% nRBC)
-
- absolute nRBC (# of nRBC per microliter)
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6. Summary of Technological Characteristics
Nucleated red blood cells (nRBCs, erythroblasts, normoblasts, or normocytes) are immature red blood cells that are normally found only in the bone marrow of healthy adults. Cells of this stage are usually observed in the peripheral blood of newborn infants or in patients with responses to hemolytic crisis.
The presence of nRBCs in peripheral blood can falsely elevate the WBC count in automated hematology analyzers and interfere with the accuracy of the automated WBC differential.
The ADVIA 2120 nRBC method reports nRBC counts for whole blood samples with either 200 or more nRBC/uL, or with at least 2% nRBCs with a WBC count of at least 3,000/ uL.
The method reports both an absolute nRBC count (10°/L) and a percentage count (#NRBC/100 WBC). The software also corrects the WBC count for nRBC, recalculates the WBC differential, and recalculates %MN and %PMN.
The method identifies nRBCs by nuclear size in the peroxidase negative area of the Peroxidase channel, and by nuclear density and volume in the Basophil/Lobularity channel.
In the unstained region of the Peroxidase channel cytogram, nRBC nuclei are located between the noise and lymphocytes. They often form distinct populations that are analyzed to produce counts.
In the Basophil/Lobularity channel cytogram, nRBC nuclei are located in the polymorphonuclear region, rather than the mononuclear region, because they are denser than lymphocyte or monocyte nuclei. Since they are not the nuclei of polymorphonuclear cells, the difference between the number of nuclei in this region and the sum of neutrophils and eosinophils in the Peroxidase channel may equal the nRBC count.
7. Conclusion
The information and performance data provided as part of this submission demonstrate that the nRBC method on the ADVIA 2120 with Autoslide is substantially equivalent to products already in commercial distribution
Paul de
Andres Holle Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
6/21/2005
Date
Date
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" encircles the eagle. The text is arranged in a circular fashion around the eagle, with "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the left side and "USA" on the right.
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
2005 DEC 7
Re: K051693
Trade/Device Name: ADVIA® 2120 with nRBC Method Regulation Number: 21 CFR § 864.5200 Regulation Name: Automated cell counter Regulatory Class: II Product Code: GKL, GKZ, KPA Dated: October 26, 2005 Received: October 27, 2005
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 10 rate exaction 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 or any I 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.
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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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
lobatz Beckerh
Robert L. Becker, Jr., MD, P Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 4051693
Device Name: ADVIA® 2120 with nRBC Method
Indications For Use:
The ADVIA® 2120 Nucleated Red Blood Cell (nRBC) method is intended to provide an in vitro diagnostic, quantitative determination of nucleated red blood cells in peripheral whole blood.
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)
Josephine Bautista
Division Sign-Off
Page 1 of 1
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K051693
§ 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).