← Product Code [DHN](/productcode/DHN) · K964165

# MICRO21 WITH NDNA (K964165)

_Triangle Biomedical Sciences, Inc. · DHN · Jan 3, 1997 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K964165

## Device Facts

- **Applicant:** Triangle Biomedical Sciences, Inc.
- **Product Code:** [DHN](/productcode/DHN.md)
- **Decision Date:** Jan 3, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5100
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

The MICRO21™ with nDNA is an automated microscopic system that 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.

## Device Story

System automates microscopic examination of nDNA slides; inputs are patient serum samples prepared via indirect enzyme antibody test (Immuno Concepts Colorzyme nDNA Test System). Device locates central area of slide wells; captures, stores, and displays digital images on color monitor. Operated by technologists in clinical settings. Technologist reviews displayed images to confirm positive or negative results; system prints final screening report. Device replaces manual microscopic viewing; aids clinical decision-making by organizing and presenting images for review.

## Clinical Evidence

Bench testing only. Comparison of 205 patient nDNA images between MICRO21 and manual bright light microscopy. Study included 91 positive and 114 negative samples. Results confirmed equivalence of image presentation between automated and manual methods.

## Technological Characteristics

Automated microscopic system; captures and stores digital images of nDNA slides. Uses Immuno Concepts Colorzyme nDNA Test System. Includes slide frame holder, barcode reader, and color monitor for image display. System is an automated cell locating device.

## Regulatory 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).

## Predicate Devices

- MICRO21 with WBC Diff ([K925670](/device/K925670.md)/A)

## Submission Summary (Full Text)

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{0}

IMI
Intelligent Medical Imaging, Inc.
K964165
Jan. 3, 1997

# 510(K) SUMMARY

Prepared by: Christine B. Harper, MBA,MT(ASCP)
Title: Senior Product Development Manager
Date: September 18, 1996

Trade Name: MICRO21™ with nDNA
Classification Name: Automated Cell Locating Device
Classification Number: 81JOY
Class: I
Regulation Number: 8645260

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 follows:

1. Patient serum samples are prepared following the Colorzyme Test Procedure and then placed in designated wells on the nDNA 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 central area of each well on the slide and captures four images from each well.
5. The nDNA 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 a positive or negative determination by selecting the appropriate result.
7. A report of the nDNA screening result for each patient well is printed.

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Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410
Phone (561) 627-0344 • FAX (561) 627-0409

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IMI
Intelligent Medical Imaging, Inc.

## Test Method:

The Test Method compared 205 patient nDNA images from the *MICRO21* to the same 205 patient nDNA images viewed under a bright light microscope. 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. 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.

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Corporate: 4360 Northlake Blvd., Suite 214 • Palm Beach Gardens, FL 33410
Phone (561) 627-0344 • FAX (561) 627-0409
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