(23 days)
Not Found
No
The description focuses on reagent formulation, hardware modifications, and standard algorithms for calculating hemoglobin concentration. There is no mention of AI, ML, or related concepts.
No.
The device is intended to measure hemoglobin concentration, which is a diagnostic function, not a therapeutic one. It analyzes a sample of whole blood to determine a quantitative value rather than treating a condition or restoring health.
Yes
Explanation: The device measures the hemoglobin concentration in a blood sample, which is a quantitative measurement used in the diagnosis and monitoring of various medical conditions, such as anemia. A device that provides quantitative measurements of physiological parameters for diagnosis or monitoring is considered a diagnostic device.
No
The device description explicitly lists hardware components (reformulated reagent, special cap and straw, modified colorimeter) in addition to modified software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "quantitatively measure hemoglobin concentration in a sample of whole blood." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (whole blood) outside of the body to provide information about a patient's health status (hemoglobin concentration).
- Device Description: The device description details a method and components used to perform this measurement on a blood sample.
- Performance Studies: The performance studies evaluate the accuracy, precision, linearity, and carryover of the method, which are standard metrics for evaluating the performance of IVD devices.
- Predicate Device: The predicate device is another method for measuring hemoglobin, further indicating that this device falls within the realm of IVD testing.
The core function of analyzing a biological sample in vitro (outside the body) to provide diagnostic information is the defining characteristic of an IVD.
N/A
Intended Use / Indications for Use
The ADVIA 120 Cn-free Hgb Method is intended to provide an in vitro diagnostic, quantitative measurement of hemoglobin concentration in a sample of whole blood.
The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.
Product codes
GKZ
Device Description
The ADVIA 120 Cn-free Hgb Method consists of the following optional changes to the ADVIA 120 Hematology System:
-
- A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
-
- A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
-
- A modified colorimeter that measures the hemoglobin reaction at 565 nm.
-
- Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.
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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method.
Key Metrics
Accuracy, Precision, Linearity, Carryover
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
SEP 2 1 2001 510(k) Summary of Safety and Effectiveness
The following information provides data supporting a substantially equivalent determination between the ADVIA 120 Cn-free Hqb Method and the ADVIA 120 cyanide containing Hgb predicate method (K971998).
Intended Use
The ADVIA 120 Cn-free Hgb Method is intended to provide an in vitro diagnostic, quantitative measurement of hemoglobin concentration in a sample of whole blood.
Device Description
The ADVIA 120 Cn-free Hgb Method consists of the following optional changes to the ADVIA 120 Hematology System:
-
- A reformulated reagent used to measure hemoglobin without the use of potassium cyanide.
-
- A special cap and straw for the reagent bottle that restricts air exchange with the reagent.
-
- A modified colorimeter that measures the hemoglobin reaction at 565 nm.
-
- Modified software to implement the algorithms necessary to calculate hemoglobin concentration when using the optional reagent and hardware for the method.
Principles of Operation
When using the ADVIA 120 Cn-free Hgb Method, the blood sample is diluted 1:250 with diluent. The dilyent contains an ionic surfactant which is dissolved in NaOH. The surfactant causes hemolysis of red cells, plus emulsification of cellular debris and plasma lipids. Following the release of hemoglobin by hemolysis, the combined action of alkaline pH and surfactant results in rapid denaturation of the protein with release of the hemes. The hemes then undergo air oxidation of heme iron to the iron III state and coordinate one hydroxide ion and one water molecule as axial ligands to form monoaquomonohydroxyiron III-porphyrin. The diaxial-coordinated hemes are then incorporated into surfactant micelles to yield the reaction product. Absorbance is measured at approximately 565 nm in a colorimeter flow cuvette, with an 8-mm light path.
Similarities and Differences between the ADVIA 120 Cn-free Hgb Method and the ADVIA 120 Cyanide Containing Hgb Predicate Method (K971998)
The following table provides similarities and differences between the ADVIA 120 Cnfree Hgb Method and the ADVIA 120 cyanide containing predicate method.
1
| ADVIA 120 Cyanide | ADVIA 120 | ||
|---|---|---|---|
| Similarities/Differences | Characteristic | Containing Method | Cn-free Method |
| Similarities | Intended Use | To provide a quantitative | |
| measurement of | |||
| hemoglobin concentration | |||
| in whole blood. | Same as predicate | ||
| method. | |||
| Calibrator Material | ADVIA SETpoint | ||
| Calibrator | Same as predicate | ||
| method. | |||
| Quality Control Materials | ADVIA TESTpoint | ||
| Hematology Controls | 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 and System | ||
| Effluent | Hgb reagent and system | ||
| effluent contain cyanide. | Hgb and system | ||
| effluent do not contain | |||
| cyanide. | |||
| Absorbance | |||
| Measurement | Measured at 546 nm. | Measured at 565 nm. | |
| Air Exchange with | |||
| Reagent | No precaution taken. | Restricted air | |
| exchange using | |||
| specially designed cap | |||
| and straw for reagent | |||
| bottle. |
Conclusion
The test results included in this submission demonstrate that the ADVIA 120 Cn-free Hgb Method has equivalent accuracy, precision, linearity, and carryover similar to the ADVIA 120 predicate method.
Leweet. Joda
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
Date 8/25/01
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines that resemble a bird's wing or a ribbon.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 1 2001
Kenneth T. Edds, Ph.D. Manager, Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
K012904 Re:
Trade/Device Name: Cyanide-Free Hemoglobin Determination Option for the Advia 120 Hematology Analyzer
Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: August 29, 2001 Received: August 29, 2001
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 (QS) 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
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/cdrlvdsma/dsmamain.html".
Sincerely yours.
Steven Autman
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
K012904 510(k) Number:
Device Name: Cyanide-free Hemoglobin Determination Option for the Advia 120 Hematology Analyzer
Indications for Use: The Advia 120 Cn-free Hgb method is intended to quantitatively measure hemoglobin concentration in a sample of whole blood.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Josephine Bautista
Division of Clinical Laboratory Devices
510(k) Number K012904
Prescription Use ﻟﻤﺴﺎ (Per 21 CFR 801.109)
Ov
Over-The-CounterUse
(Optional Format 1-2-96)