(78 days)
Not Found
K925670/A
No
The device description and performance studies indicate that the device captures and displays images for a technologist to review and make a determination. There is no mention of the device itself performing any automated analysis or interpretation of the images using AI/ML. The technologist is the one making the positive or negative determination.
No.
This device is for aiding in the detection/diagnosis of systemic rheumatic disease by performing a nDNA screen. It does not provide therapy or treatment for the disease.
Yes
The device aids in the semi-quantitative detection of nDNA from patient serum samples, which is used as an aid in detecting systemic rheumatic disease. This falls under the definition of a diagnostic device as it provides information for the diagnosis of a disease.
No
The device description explicitly states that the MICRO21 is an "instrument" that "locates the central area of each well on the slide and captures four images from each well." This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended to aid in the detection of systemic rheumatic disease by performing a nDNA screen on patient serum samples. This involves analyzing biological specimens (serum) to provide information about a patient's health status.
- Device Description: The device processes patient serum samples that have been prepared using an indirect enzyme antibody test. It then captures, stores, and displays images from these samples for review by a technologist to determine a positive or negative result. This entire process is focused on analyzing a biological sample outside of the body to aid in diagnosis.
- Sample Type: The device uses patient serum samples, which are biological specimens.
- Test Performed: The device performs a "nDNA Screen," which is a microscopic exam of a patient serum sample set up using an indirect enzyme antibody test for the semi-quantitative detection of nDNA. This is a laboratory test performed on a biological sample.
- Aid in Detection: The results of the nDNA screen are used to "aid in the detection of systemic rheumatic disease." This indicates the device provides diagnostic information.
The definition of an In Vitro Diagnostic (IVD) device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. This device clearly fits within this definition by analyzing a biological sample (serum) to aid in the detection of a disease (systemic rheumatic disease).
N/A
Intended Use / Indications for Use
The MICRO21™ with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA 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 nDNA which is an aid in the detection of systemic rheumatic disease.
Product codes
JOY
Device Description
The MICRO21™ with nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA 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 nDNA which is an aid in the detection of systemic rheumatic disease. The nDNA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® nDNA Test System. A summary of the MICRO21 with nDNA process is as follow:
- Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA 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 central area of each well on the slide and captures four images from each well.
- The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
- The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
- A report of the nDNA screening result for each patient well is printed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Microscopic imaging
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 205 patient nDNA images viewed under a bright light microscope to the same 205 patient nDNA images viewed on the MICRO21. This was done to confirm that the nDNA image presentation on the MICRO21 is equivalent to the nDNA image presentation for the manual method under the bright light microscope.
The Test Method consisted of 205 patient nDNA images with 91 Positives and 114 Negatives as identified by a technologist at Immuno Concepts who manually read the 205 nDNA patient tests using a bright light microscope. The nDNA slides containing the 205 patient nDNA 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 nDNA patient image and graded the result as Positive or Negative.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Test Method compared 205 patient nDNA images viewed under a bright light microscope to the same 205 patient nDNA images viewed on the MICRO21. The results reported in the Summary of Results confirm that the nDNA image presentation on the MICRO21 is equivalent to the manual method.
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.
Not Found
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.
K925670/A
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(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 consists of the letters "IMI" in a bold, stylized font, with a series of interconnected dots and lines above the letters. Below the letters, the full name of the company, "Intelligent Medical Imaging, Inc.", is written in a smaller, simpler font.
K964165
JAN. 3, 1997
510(K) SUMMARY
Prepared by: Title Date:
Christine B. Harper, MBA,MT(ASCP) Senior Product Development Manager September 18, 1996
Trade Name: Classification Name: Classification Number: Class: Regulation Number:
MICRO21™ with nDNA Automated Cell Locating Device 81JOY I 864 - 260
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 nDNA is a new MICRO21 intended use that follows the same process as the MICRO21 with WBC Diff, but instead locates, digitally stores and displays nDNA Images to aid the technologist in performing a nDNA Screen for Positive or Negative results. A nDNA 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 nDNA which is an aid in the detection of systemic rheumatic disease. The nDNA Test System used on the MICRO21 is Immuno Concepts® Colorzyme® nDNA Test System. A summary of the MICRO21 with nDNA process is as follow:
-
- Patient serum samples are prepared following the Color zyme Test Procedure and then placed in designated wells on the nDNA 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 for processing.
-
- The MICRO21 locates the central area of each well on the slide and captures four images from each well.
- પં The nDNA images are stored by the instrument and displayed on a color monitor for review by a technologist.
-
- The technologist reviews the images and confirms a positive determination by selecting the appropriate result.
-
- A report of the nDNA screening result for each patient well is printed.
28
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 stylized font, with a network of lines and dots above the letters. The full name of the company, "Intelligent Medical Imaging, Inc.," is printed in a smaller font below the logo.
Test Method:
The Test Method compared 205 pa Summer MICRO21 to the same 205 patient nDNA images viewed under a bright light m s done to confirm that the nDNA image presentation on the MICRO21 is equivalent to the nDNA umage presentation for the manual method under the bright light microscope.
The Test Method consisted of 205 patient nDNA images with 91 Positives and 114 Negatives as identified by a technologist at Immuno Concepts who manually read the 205 nDNA patient tests using a bright light microscope. The nDNA slides containing the 205 patient nDNA 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 nDNA patient image and graded the result as Positive or Negative. The results which are reported in the Summary of Results confirm that the nDNA image 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 nDNA for the intended use of location, storage and display of nDNA images to aid the technologist in performing the nDNA Test Screen.