← Product Code [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ) · K022668 # ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD (K022668) _Bayer Diagnostics Corp. · GKZ · Oct 15, 2002 · Hematology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K022668 ## Device Facts - **Applicant:** Bayer Diagnostics Corp. - **Product Code:** [GKZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ.md) - **Decision Date:** Oct 15, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5220 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The ADVIA 120 Hgbcen parameter is intended to provide an in vitro diagnostic. quantitative measurement of hemoglobin concentration in a sample of whole blood. ## Device Story ADVIA 120 Hematology System; utilizes RBC/Plt channel optical light scattering to measure individual RBC volume and hemoglobin concentration; calculates MCV, CHCM, and RBC count; derives cellular hemoglobin concentration via product of RBC count, MCV, and CHCM, scaled by 1/1000; provides quantitative hemoglobin measurement; used in clinical laboratory settings by trained personnel; output assists in hematological assessment and discrimination between cell-associated and cell-free hemoglobin. ## Clinical Evidence Bench testing only. Comparison of accuracy, precision, linearity, and carryover between the cellular Hgb method and the colorimetric predicate method demonstrated substantial equivalence. ## Technological Characteristics Laser optical light scattering; RBC/Plt channel; calculates cellular hemoglobin concentration from RBC count, MCV, and CHCM; no changes to existing system software, reagents, calibrators, or controls. ## Regulatory 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. ## Special Controls *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.” ## Predicate Devices - ADVIA 120 Hgbrotal ([K971998](/device/K971998.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 510(k) Summary of Safety and Effectiveness K022669 # 510(k) Summary of Safety and Effectiveness OCT 1 5 2002 The following information provides data supporting a substantially equivalent determination between the ADVIA 120 cellular Hgb method (Hgbcel) and the ADVIA 120 Hgbrotal predicate method (K971998). ### Intended Use The ADVIA 120 Hgbcen parameter is intended to provide an in vitro diagnostic. quantitative measurement of hemoglobin concentration in a sample of whole blood. ### Device Description Cellular hemoglobin is currently a "laboratory use only" parameter on the ADVIA 120 system. There are no changes to software, reagents, calibrators or controls necessary to derive the cellular hemoglobin parameter. # Principles of Operation The ADVIA 120 cellular hemoglobin method is derived from the RBC/Plt channel of the system. The RBC/Plt channel uses optical light scattering to derive RBC cell volume and cell hemoglobin concentration on a cell-by-by cell basis. The parameters MCV (mean corpuscular volume) and CHCM (corpuscular hemoglobin concentration mean) are then calculated as the mean of the volume and hemoglobin concentration histograms respectively, along with an RBC count. These parameters have previously received 510(k) clearance in K971998. The cellular hemoglobin concentration is then calculated as the product of the RBC count, the MCV, and CHCM, then scaled by a factor of 1/1000 to obtain units of grams per dL of whole blood. ## Similarities and Differences between the ADVIA 120 Cellular Hgb Method and the ADVIA 120 Hgb Predicate Method (K971998) The following table provides similarities and differences between the ADVIA 120 cellular Hgb Method and the ADVIA 120 cyanide containing predicate method. {1}------------------------------------------------ | | | ADVIA 120 | ADVIA 120 | |--------------------------|------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------| | Similarities/Differences | Characteristic | Hgb Method | Cellular Hgb | | Similarities | Intended Use | To provide a quantitative
measurement of
hemoglobin concentration
in whole blood. | Same as predicate
method. | | | Accuracy | As specified in product
labeling. | Equivalent to predicate
method. | | | Precision | As specified in product
labeling. | Equivalent to predicate
method. | | | Linearity | As specified in product
labeling. | Equivalent to predicate
method. | | | Carryover | As specified in product
labeling. | Equivalent to predicate
method. | | Differences | Reagent | ADVIA 120 HGB | ADVIA 120 RBC/PLT | | | Method Principle | Colorimetric method | Laser optical method | | | Sample stability | 72 hours for samples
stored at room
temperature | 24 hours for samples
stored at room
temperature | #### Conclusion The test results included in this submission demonstrate that the ADVIA 120 cellular Hgb Method has equivalent accuracy, precision, linearity, and carryover substantially equivalent to the ADVIA 120 predicate method. Simuets-toke Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097 Date 8/09/02 {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized representation of an abstract design. The design consists of three curved lines that converge at the bottom, resembling a stylized symbol. The text is arranged in a circular pattern around the symbol. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Kenneth T. Edds, Ph.D. Regulatory Affairs Manager Bayer Diagnostics 511 Benedict Avenue Tarrytown, New York 10591-5097 OCT 1 5 2002 Re: k022668 Trade/Device Name: Bayer ADVIA 120 Cellular Hemoglobin Parameter Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 12, 2002 Received: August 12, 2002 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 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2 will allow you to begin marketing your devices as described in your S1000 premarket 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 labeling 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html". Sincerely yours, Steven Toutman 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 {4}------------------------------------------------ 510(k) Number: Device Name: Bayer ADVIA 120 Hematology analyzer Indications for Use: The ADVIA™ 120 Hematology System Complete Blood Count (CBC) method is intended to quantitatively measure the following hematological parameters: White Blood Cell count (WBC) Red Blood Cell count (RBC) Total Hemoglobin concentration (HGBTotal) Cellular Hemoglobin concentration (HGBcell) Hematocrit (HCT) Mean Corpuscular Volume (MCV) Mean Corpuscular Hemoglobin (MCH) Mean Corpuscular Hemoglobin Concentration (MCHC) Corpuscular Hemoglobin Concentration Mean (CHCM) Cellular Hemoglobin Content (CH) Red Cell Volume Distribution Width (RDW) Hemoglobin Concentration Distribution Width (HDW) Platelet Count (PLT) Mean Platelet Volume (MPV) The difference between HGBToul and HGBcen can be used to discriminate between cellassociated hemoglobin and cell-free hemoglobin as found in hemoglobin-based blood substitutes. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Hesheim - Lauter (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number - Prescription Use (Per 21 CFR 801.109) OR Over-The-CounterUse (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K022668](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GKZ/K022668) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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