(64 days)
Not Found
No
The document explicitly states "There are no changes to software... necessary to derive the cellular hemoglobin parameter" and "Mentions AI, DNN, or ML: Not Found". The description focuses on standard hematological measurements and comparisons to a predicate device without mentioning any AI/ML components.
No
The device is intended to quantitatively measure hematological parameters for laboratory use, not to treat or diagnose a disease.
Yes
The "Intended Use / Indications for Use" section states that the device is intended to "quantitatively measure ... hematological parameters" and that the difference between HGBTotal and HGBcen "can be used to discriminate between cell-associated hemoglobin and cell-free hemoglobin," both of which are diagnostic measurements.
No
The device description explicitly states it is a "method" on the ADVIA 120 Hematology System, which is a hardware device. While there are no changes to the software for this specific parameter, the device itself is a physical instrument that performs the measurements.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "quantitatively measure" various hematological parameters in "whole blood." This is a classic description of an in vitro diagnostic test, as it analyzes a biological sample outside of the body to provide information about a patient's health.
- Device Description: While it mentions a "laboratory use only" parameter, the overall description points to a system designed for analyzing blood samples.
- Anatomical Site: The anatomical site is "Whole blood," which is a biological specimen analyzed in vitro.
- Intended User / Care Setting: "Laboratory use only" further reinforces that this device is used in a laboratory setting to perform diagnostic tests on patient samples.
The fact that it measures parameters like WBC, RBC, HGB, etc., which are standard components of a Complete Blood Count (CBC), a common diagnostic test, also strongly indicates its IVD nature.
N/A
Intended Use / 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.
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.
Product codes
GKZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
510(k) Summary of Safety and Effectiveness
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.
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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)