(86 days)
K925670/A
K925670/A
No
The summary describes an automated microscopic system that locates, stores, and displays images to aid a technologist. It explicitly states the process is substantially equivalent to the manual microscopic process and focuses on image presentation equivalence, not automated analysis or interpretation using AI/ML. There is no mention of AI, ML, or related terms.
No
The device aids in diagnosis by digitally storing and displaying ANA images for an ANA Screen to detect antinuclear antibody (ANA), which is an aid in the detection of systemic thematic disease. It does not provide any treatment or therapy.
Yes
The device aids in the detection of systemic thematic disease by displaying ANA images to help technologists perform ANA screens for positive or negative results.
No
The device description explicitly states it is an "automated microscopic system" that "locates WBCs, stores digital images of the cells and displays the images". This indicates the device includes hardware components for microscopy, image capture, storage, and display, in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is used to "aid the technologist in performing an ANA Screen for Positive or Negative results." An ANA Screen is a laboratory test performed on a patient serum sample to detect antinuclear antibodies, which is an aid in the detection of systemic thematic disease. This clearly falls under the definition of an in vitro diagnostic test, as it is performed on a sample taken from the human body to provide information about a patient's health.
- Device Description: The device description reinforces this by stating it "locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen." This process is directly related to the analysis of a biological sample (patient serum) for diagnostic purposes.
- Input Imaging Modality: The input is microscopic images of a patient sample, which is typical for many IVD tests.
- Intended User: The intended user is a technologist, who typically performs laboratory diagnostic tests.
While the device itself is an automated microscopic system, its specific application as described in the intended use and device description is for performing an ANA Screen, which is an in vitro diagnostic procedure. The device is a tool used within the IVD workflow.
N/A
Intended Use / Indications for Use
The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results. An ANA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of antinuclear antibody (ANA) which is an aid in the detection of systemic thematic disease. The ANA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® ANA Test System.
Product codes
81JOY
Device Description
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.
The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results. An ANA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of antinuclear antibody (ANA) which is an aid in the detection of systemic thematic disease. The ANA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® ANA Test System. A summary of the MICRO21 with ANA process is as follows:
- Patient serum samples are prepared following the Colorzyme Test Procedure and then placed in designated wells on the ANA slide.
- Each slide has three control wells and nine patient wells.
- Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing.
- The MICRO21 locates the center of each well on the slide and captures four images from each well.
- The ANA images are stored by the instrument and displayed on a color monitor for review by a technologist.
- The technologist reviews the images and confirms that the MICRO21's Positive/Negative determination is correct. If not correct, the technologist changes the determination.
- A report of the ANA screening result for each patient well is printed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Microscopic
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Technologist
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
The Test Method compared 204 patient ANA images from the MICRO21 to the same 204 patient ANA images viewed under a bright light microscope. This was done to confirm that the ANA image presentation on the MICRO21 is equivalent to the ANA image presentation for the manual method under the bright light microscope.
The Test Method consisted of 204 patient ANA images with 112 Positives and 92 Negatives as identified by a technologist at Immuno Concepts® who manually read the 204 ANA patient tests using a bright light microscope. The ANA slides containing the 204 patient ANA tests were then loaded onto the MICRO21 and an image from each sample was captured, stored, and displayed on the review monitor. A technologist reviewed each stored ANA patient image and graded the result as Positive or Negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Method: The Test Method compared 204 patient ANA images from the MICRO21 to the same 204 patient ANA images viewed under a bright light microscope. This was done to confirm that the ANA image presentation on the MICRO21 is equivalent to the ANA image presentation for the manual method under the bright light microscope.
Sample Size: 204 patient ANA images (112 Positives and 92 Negatives).
Key Results: The results which are reported in the Summary of Results confirm that the ANA image presentation on the MICRO21 is equivalent to the manual method. The image comparison performed in the Test Method confirms the safety and effectiveness of the MICRO21 with ANA for the intended use of location, storage and display of ANA images to aid the technologist in performing the ANA Test Screen.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K925670/A
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo features the letters "IMI" in a bold, stylized font. To the left of the letters is a graphic of interconnected dots. The full name of the company is written in a smaller font below the logo.
V 2 2 1996
510(K) SUMMARY
Christine B. Harper, MBA,MT(ASCP) Prepared by: Title Senior Product Development Manager Date: February 7, 1996
Trade Name: Classification Name: Classification Number: Class: Regulation Number:
MICR(21TM with ANA Automated Cell Locating Device 81JOY II 864.5260
The MICRO21™ with WBC Diff (White Blood Cell Differential) Ref. No. K925670/A is an automated microscopic system that locates WBCs, stores digital images of the cells and displays the images in an organized manner to aid technologists in performing the WBC Diff procedure. The MICRO21 process is substantially equivalent to the manual microscopic process.
Description:
The MICRO21 with ANA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays ANA Images to aid the technologist in performing an ANA Screen for Positive or Negative results. An ANA Screen is a microscopic exam of a patient serum sample that has been set-up using an indirect enzyme antibody test for the semi-quantitative detection of antinuclear antibody (ANA) which is an aid in the detection of systemic thematic disease. The ANA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® ANA Test System. A summary of the MICRO21 with ANA process is as follows:
- Patient serum samples are prepared following the Colorzyme Test Procedure and then placed 1. in designated wells on the ANA slide.
- Each slide has three control wells and nine patient wells. 2.
- Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 3. for processing.
- The MICRO21 locates the center of each well on the slide and captures four images from 4. each well.
- న. The ANA images are stored by the instrument and displayed on a color monitor for review by a technologist.
- The technologist reviews the images and confirms that the MICRO21's Positive/Negative 6. determination is correct. If not correct, the technologist changes the determination.
-
- A report of the ANA screening result for each patient well is printed.
1
Image /page/1/Picture/0 description: The image shows the logo for Intelligent Medical Imaging, Inc. The logo features the letters "IMI" in a bold, sans-serif font. To the left of the letters is a graphic of connected dots. The full name of the company is written in a smaller font below the logo.
Test Method:
The Test Method compared 204 patient ANA images from the MICRO21 to the same 204 patient ANA images viewed under a bright light microscope. This was done to confirm that the ANA image presentation on the MICRO21 is equivalent to the ANA image presentation for the manual method under the bright light microscope.
The Test Method consisted of 204 patient ANA images with 1 1 ! ? Positives and 92 Negatives as identified by a technologist at Immuno Concepts® who manually read the 204 ANA patient tests using a bright light microscope. The ANA slides containing the 204 patient ANA tests were then loaded onto the MICRO21 and an image from each sample was captured, stored, and displayed on the review monitor. A technologist reviewed each stored ANA patient image and graded the result as Positive or Negative. The results which are reported in the Summary of Results confirm that the ANA innage presentation on the MICRO21 is equivalent to the manual method.
Conclusion:
The image comparison performed in the Test Method confirms the safety and effectiveness of the MICRO21 with ANA for the intended use of location, storage and display of ANA images to aid the technologist in performing the ANA Test Screen.