← Product Code [JOY](/productcode/JOY) · K960774 # MICRO21 WITH ANA (K960774) _Triangle Biomedical Sciences, Inc. · JOY · May 22, 1996 · Hematology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K960774 ## Device Facts - **Applicant:** Triangle Biomedical Sciences, Inc. - **Product Code:** [JOY](/productcode/JOY.md) - **Decision Date:** May 22, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 864.5260 - **Device Class:** Class 2 - **Review Panel:** Hematology ## Indications for Use The MICRO21™ with ANA is an automated microscopic system that 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 rheumatic disease. ## Device Story The MICRO21 with ANA is an automated microscopic system used in clinical laboratories. It processes patient serum samples prepared via the Immuno Concepts Colorzyme ANA Test System. The device locates the center of wells on prepared slides, captures four digital images per well, and stores them. These images are displayed on a color monitor for review by a technologist. The technologist reviews the images, confirms or corrects the device's positive/negative determination, and generates a printed report. The system automates the location and display of images, replacing manual microscopic examination to aid in the detection of systemic rheumatic disease. ## Clinical Evidence Bench testing compared 204 patient ANA images (112 positive, 92 negative) captured by the MICRO21 against manual readings of the same samples under a bright light microscope. The study confirmed that the ANA image presentation on the MICRO21 is equivalent to the manual method, supporting the device's safety and effectiveness for its intended use. ## Technological Characteristics Automated microscopic system; utilizes digital image capture, storage, and display technology. Operates with Immuno Concepts Colorzyme ANA Test System. System includes slide frame holder, barcode reader, and color monitor for technologist review. No specific materials or software architecture details provided. ## Regulatory 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.) ## Predicate Devices - MICRO21 with WBC Diff ([K925670](/device/K925670.md)/A) ## Reference Devices - Immuno Concepts® Colorzyme® ANA Test System ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} IMI Intelligent Medical Imaging, Inc. K960774 MAY 22 1996 # 510(K) SUMMARY Prepared by: Christine B. Harper, MBA,MT(ASCP) Title: Senior Product Development Manager Date: February 7, 1996 Trade Name: MICRO21™ with ANA Classification Name: Automated Cell Locating Device Classification Number: 81JOY Class: II Regulation Number: 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 rheumatic 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: 1. Patient serum samples are prepared following the Colorzyme Test Procedure and then placed in designated wells on the ANA slide. 2. Each slide has three control wells and nine patient wells. 3. Barcode the slides, place the slides into a frame holder, and insert the slides on the MICRO21 for processing. 4. The MICRO21 locates the center of each well on the slide and captures four images from each well. 5. The ANA images are stored by the instrument and displayed on a color monitor for review by a technologist. 6. The technologist reviews the images and confirms that the MICRO21’s Positive/Negative determination is correct. If not correct, the technologist changes the determination. 7. A report of the ANA screening result for each patient well is printed. Page 3 of 20 Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410 Phone (407) 627-0344 • FAX (407) 627-0409 {1} iMi Intelligent Medical Imaging, Inc. ## 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 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. 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. ## 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. Page 4 of 20 Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410 Phone (407) 627-0344 • FAX (407) 627-0409 --- **Source:** [https://fda-staging.innolitics.com/device/K960774](https://fda-staging.innolitics.com/device/K960774) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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