(129 days)
No
The description mentions "image processing software" for counting cells, which is a common technique in medical devices and does not inherently imply the use of AI or ML. There is no mention of AI, ML, or related terms like neural networks or deep learning.
No
Explanation: The device is an In Vitro Diagnostic (IVD) tool for quantitative determination of white blood cell count, not a device used for therapy.
Yes
The "Intended Use / Indications for Use" states that "The HemoCue WBC system is for In Vitro Diagnostic use only," which explicitly identifies it as a diagnostic device.
No
The device description explicitly lists hardware components such as a cuvette holder, moving arm, magnifying optic unit, camera, display, and power adapter, in addition to the image processing software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The HemoCue WBC system is for In Vitro Diagnostic use only."
- Nature of the Test: The device performs a quantitative determination of white blood cell count in blood. This is a test performed on a biological sample (blood) outside of the body, which is the definition of an in vitro diagnostic test.
- Device Description: The description details how the device processes a blood sample (lysis, staining, image analysis) to obtain a diagnostic result (WBC count).
- Intended Use Setting: The device is indicated for use in clinical laboratories and point-of-care settings, which are typical environments for IVD testing.
N/A
Intended Use / Indications for Use
The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.
Product codes
GKL
Device Description
The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration.
The HemoCue WBC Analyzer is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter.
The HemoCue WBC Microcuvette is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.
Mentions image processing
Yes
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
clinical laboratories and for point-of-care settings.
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
Studies were conducted in-house, in clinical laboratory settings and point of care settings to demonstrate the performance with intended specifications of the HemoCue WBC system and to validate that the intended user can easily operate the system and obtain results as expected.
Key Metrics
Not Found
Predicate Device(s)
K060656, Manual light microscopic WBC method (class I exempt)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
007 2 5 2007
5.0 510(k) Summary
| Submitter: | HemoCue AB
Box 1204
Ängelholm, Sweden SE-262 23
+46 431 45 82 00 (Telephone)
+46 431 45 82 25 (FAX) |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Allan White (Official Correspondent)
HemoCue, Inc.
40 Empire Drive
Lake Forest, CA 92630-2244
(949) 859-2630 x110 (Telephone)
(949) 598-8630 (FAX)
allan@hemocue.com |
| Date of Preparation: | June 14, 2007 |
| Common name of device: | Semi-Automated Cell Counter |
| Proprietary Name: | HemoCue WBC System |
| Class: | Class II |
| Panel: | Hematology (81) |
| Regulation number: | Automated and Semi-Automated Hematology Devices,
21 CFR § 864.5200 Automated Cell Counter or Semi-
Cell Counter |
| Product Code: | GKL |
| Equivalent to: | HemoCue AB claims substantial equivalence to the current
legally marketed device: Sysmex XS-1000i, Automated
haematology analyzer (K060656) and Manual light
microscopic WBC method (class I exempt) |
5.1 Device Description
The system consists of the HemoCue WBC Analyzer together with specially designed microcuvettes, the HemoCue WBC Microcuvettes. The microcuvette serves both as a sample container and a reaction chamber. A blood sample of approximately 10 uL is drawn into the cavity by capillary action. A hemolysing agent lyses the red cells in the microcuvette and a staining agent colors the white blood cells. An image is taken of the stained white blood cells and the number of cells is counted by image analysis. The result is presented within 3 minutes on the analyzer's display. The system reports results in the measuring range 0.3 - 30.0 x107/L. The system is factory calibrated and needs no further calibration.
1
The test principle consists of three simple steps:
-
- Fill the microcuvette with a drop of blood
-
- Place the microcuvette in the analyzer
-
- Receive a result within 3 minutes.
5.2 Indications for Use
The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.
5.3 Summary of Technological Characteristics The HemoCue WBC Analyzer
The HemoCue WBC Analyzer (figure 1) is a portable device. The main parts are the cuvette holder (in which the microcuvette is placed), the cuvette moving arm (brings the microcuvette into correct measuring position), a magnifying optic unit, a camera, image processing software, a display and a power adapter.
Image /page/1/Picture/9 description: The image shows a black electronic device, possibly a printer or a scanner, from a high-angle perspective. The device has a rectangular shape with a slightly curved front edge. The top surface of the device appears to have some labels or markings, but they are not clearly visible due to the image quality. The device is placed on a white surface, which provides a contrasting background.
Figure 1. The HemoCue WBC Analyzer
The HemoCue WBC Microcuvette
The HemoCue WBC Microcuvette (Figure 2) is made of polystyrene plastic and contains saponin that hemolyzes the red blood cells, methylene blue that stains the white blood cells and nonactive reagents. A blood sample of approximately 10 µL is drawn into the cavity by capillary action. The microcuvette serves as a sample container and a reaction chamber. No dilution of the sample is required.
Image /page/1/Picture/13 description: The image is a black and white photograph. The top portion of the image is lighter in color, and the bottom portion is darker. The image is slightly blurry, and there are some small white spots scattered throughout the image.
Figure 2. The HemoCue WBC Microcuvette
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5.4 Similarities and Differences with Predicate Devices
The HemoCue WBC system is a semi-automated device intended for use for the quantification of White Blood Cells in clinical laboratories and point of care settings.
The Sysmex XS 1000i (predicate device) is an automated hematology analyzer for use in clinical laboratories.
Light microscopes (predicate device) are used as to enumerate leukocytes in a haemocytometer mounted on the stage of the microscope and read manually
Similarities and Differences: All three devices quantify leucocvtes (WBCs), but the Sysmex XS device also quantifies red blood cells, platelets, hemoglobin, hematocrit and provides a differential cell count.
Assessment of Performance 5.5
Studies were conducted in-house, in clinical laboratory settings and point of care settings to demonstrate the performance with intended specifications of the HemoCue WBC system and to validate that the intended user can easily operate the system and obtain results as expected.
5.6 Conclusion
Based on the information and performance data presented in this premarket notification, the HemoCue WBC system meets the manufacturer's intended use specifications and is substantially equivalent to the Sysmex XS-system and the manual light microscopic method of counting WBC.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring a symbol that resembles an abstract eagle or a caduceus, rendered in black.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
OCT 2 5 2007
Hemocue AB Hemocue Inc. c/o Allan White 40 Empire Drive Lake Forest, California 92630
Re: K071652
Trade/Device Name: Hemocue WBC System Regulation Number: 21 CFR 864.5200 Regulation Name: Automated cell counter Regulatory Class: Class II Product Code: GKL Dated: June 14, 2007 Received: June 18, 2007
Dear Mr. White:
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 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). This letter
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Page 2 - Allan White
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 advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
Robert Becker
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K071652
Device Name: HemoCue® WBC system
Indications For Use:
The HemoCue WBC system is indicated for use for quantitative determination of white blood cell (WBC) count in capillary or venous whole blood. The HemoCue WBC system is for In Vitro Diagnostic use only. The HemoCue WBC Analyzer is only to be used with HemoCue WBC Microcuvettes. The HemoCue WBC system is indicated for use in clinical laboratories and for point-of-care settings.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 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)
Division Sign-Off
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071652