← Product Code [DHN](/productcode/DHN) · K022800 # VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM (K022800) _Hyperion, Inc. · DHN · Nov 25, 2002 · Immunology · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K022800 ## Device Facts - **Applicant:** Hyperion, Inc. - **Product Code:** [DHN](/productcode/DHN.md) - **Decision Date:** Nov 25, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 866.5100 - **Device Class:** Class 2 - **Review Panel:** Immunology ## Indications for Use The VisiQuant™ Anti-Nuclear Antibody Test System is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome. ## Device Story VisiQuant™ ANA Test System is an in-vitro diagnostic device for ANA detection in human serum. It consists of the previously cleared VisiQuant™ ANA Test Kit and a VisiQuant™ Microscope. The system uses a CCD camera to capture images of prepared slides. An operator views these images to identify fluorescence patterns and determine positivity. For positive samples, software calculates fluorescence intensity units (FIU) and interpolates ANA titers using a 4-parameter calibration curve generated from calibrators assayed in the same run. The system generates laboratory and calibration reports. It is intended for clinical laboratory use to aid in diagnosing auto-immune and connective tissue diseases. The device benefits patients by providing standardized, semi-quantitative ANA titer results to support clinical decision-making. ## Clinical Evidence Bench testing only. Comparative evaluation of 113 serum samples between the subject system and the predicate device. Qualitative agreement: 95.2% for negative results (40/42) and 100% for positive results (71/71). Pattern agreement for positive samples was 97.2% (69/71). Quantitative correlation of ANA titers (n=71) showed a correlation coefficient of 0.917 with a regression equation of Log VTM = 0.0578 + 0.966 Log VT. ## Technological Characteristics System includes a fluorescent microscope, CCD camera, and software. Sensing principle: immunofluorescence microscopy. Software performs image capture, fluorescence intensity unit (FIU) calculation, and 4-parameter curve interpolation for titer determination. Connectivity: standalone system. Sterilization: not applicable (in-vitro diagnostic). ## 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 - VisiQuant™ ANA Test Kit ([K013213](/device/K013213.md)) ## 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}------------------------------------------------ K022800 # 510(k) Summary of Safety and Effectiveness Information VisiQuant™ Anti-Nuclear Antibody Test System Revised September 20, 2002 NOV 2 5 2002 Hyperion, Inc. 14100 S.W. 136th Street Miami, FL. 33186 Contact Person: Radha Goolabsingh at 305-238-3020 x202 or Victor Rana at 305-238-3020 x208, or by facsimile at 305-232-7375. | Trade or Proprietary Name: | VisiQuant™ Anti-Nuclear Antibody Test System | |----------------------------|------------------------------------------------------------------------------| | Common or Usual Name: | VisiQuant™ ANA Test System | | Classification Name: | Anti nuclear antibody immunological test system | | Registration Number: | Manufacturer | | | Hyperion, Inc.
14100 S.W. 136th Street
Miami, Florida 33186
1028110 | The proposed VisiQuant™ ANA System is substantially equivalent to the VisiQuant™ ANA Test Kit using a specially equipped fluorescent microscope, previously cleared under Document Control No., K013213, on 6/04/2002. The proposed and the predicate device are both in-vitro diagnostic products, intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semi-quantitative measurement of ANA's in human serum sample with a single dilution as an aid in the diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren's Syndrome. There are no changes to the test kit and the VisiQuant Microscope supplied meets the minimum requirements specified for the test kit in K013213. The proposed VisiQuant™ ANA Test System uses the same VisiQuant™ ANA Test Kit as was previously cleared. Hyperion is now proposing to supply the VisiQuant™ Microscope as an additional reader for use with the VisiQuant™ ANA Test Kit. The reading of the samples remains the same except that the software will now generate the calibration curve and interpolate the titer. The prepared slide is placed onto the stage of the microscope. The microscope focuses on the images of each well and the CCD camera collects the images. The software captures and stores the images. The operator views the images to determine if the sample is positive and identifies the pattern. For the samples determined to be positive by the operator, the software calculates a fluorescence intensity unit (FIU) value. The proposed software will now generate a 4-parameter curve using the FIUs and ANA titers of Calibrators assayed in the same run, from which the VisiQuant titer of the test sample is interpolated. The proposed software now has the capability of generating calibration curve reports and laboratory reports. {1}------------------------------------------------ #### Method Comparison: A comparative evaluation of the proposed VisiQuant™ ANA Test System demonstrated substantial equivalence to the VisiQuant™ ANA Test Kit using the specially equipped fluorescent microscope. The results are shown in the following tables and diagrams: | VisiQuant™ ANA Test Kit | No. of samples with VisiQuant™ ANA Test System | | | |-------------------------|------------------------------------------------|----------|-------| | | Negative | Positive | Total | | Negative | 40 | 2 | 42 | | Positive | 0 | 71 | 71 | | Total | 40 | 73 | 113 | Agreement for negative results = 40/42 = 95.2% Agreement for positive results = 71/71 = 100% Table3. Qualitative Results: The following table shows the pattern agreement for the 71 samples found to be positive by both the VisiQuant™ ANA Test Kit and the VisiQuant™ ANA Test System. | VisiQuant™ ANA Test Kit | No. of samples with VisiQuant™ ANA Test System | | | | | | | |-------------------------|------------------------------------------------|----|---|---|-----|-----|-------| | | H | S | N | C | H,S | H,N | Total | | H | 31 | | | | | | 31 | | S | | 19 | | | 1 | | 20 | | N | | | 1 | | | | 1 | | C | | | | 2 | | | 2 | | H,S | 1 | | | | 6 | | 7 | | H,N | | | | | | 10 | 10 | | Total | 32 | 19 | 1 | 2 | 7 | 10 | 71 | Negative (Neg); Homogenous (H); Speckled (S); Nucleolar (N); Centromere (C) Pattern agreement for samples positive by both tests = 69/71 = 97.2 %: Table 4. Discrepant samples: Negative (Neg.), Not applicable (n.a); Speckled (S); Homogenous (H). Slight differences in reading could account for these discrepancies. | Sample ID | VisiQuant™ ANA Test Kit | | VisiQuant™ ANA Test System | | |-----------|-------------------------|---------|----------------------------|---------| | | Titer | Pattern | Titer | Pattern | | Y-SLE17 | 406 | S | 314 | H,S | | X-E4 | 713 | H,S | 526 | H | | Y-SS2 | Neg. | n.a. | 130 | H | | W-14 | Neg. | n.a. | 97 | H,S | {2}------------------------------------------------ Seventy-one (71) serum samples, positive by both the proposed VisiQuant™ ANA Test System and the VisiQuant™ ANA Test Kit using the specially equipped fluorescent microscope were compared for ANA titers. The following figure shows the correlation with all patterns (Homogenous, Speckled, Nucleolar, Centromere and mixed). Image /page/2/Figure/3 description: This image is a scatter plot comparing ANA titers from two different VisiQuant ANA test systems. The x-axis represents the ANA titer of the VisiQuant ANA Test kit (VT), while the y-axis represents the ANA titer of the VisiQuant ANA Test System (VTM). The plot includes data points for various antibody patterns, such as Homogeneous, Speckled, Nucleolar, Centromere, Homog. & speckled, and Homog. & Nucleolar. A regression line and 95% confidence intervals are also displayed on the plot. Fig. 1. Scatter diagram showing correlation in ANA titers for 71 positive results between VisiQuant™ ANA Test System and the VisiQuant™ ANA Test Kit using the specially equipped fluorescent microscope, with a correlation coefficient of 0.917 and a regression equation of Log VTM = 0.0578 + 0.966 Log VT. The Linear Regression and its 95% confidence intervals are also shown. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black. Food and Drug Administrat 2098 Gaither Road Rockville MD 20850 Ms. Radha Goolabsingh Director of Quality Assurance and Regulatory Affairs Hyperion, Inc. 14100 S.W. 136th Street Miami, FL 33186 Re: k022800 Trade/Device Name: VisiQuant™ Anti-Nuclear Antibody Test System Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: Class II Product Code: DHN Dated: October 30, 2002 Received: October 31, 2002 Dear Ms. Goolabsingh: 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. Iisting 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). {4}------------------------------------------------ ### Page 2 This letter 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. Sincerely yours, Steven Putman Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT # 510(K) NUMBER (IF KNOWN): DEVICE NAME: VisiQuant™ Anti-Nuclear Antibody Test System INDICATIONS FOR USE: The VisiQuant™ Anti-Nuclear Antibody Test System is intended for the visual determination of anti-nuclear antibodies (ANA's) immunofluorescence pattern(s) and the semiquantitative measurement of ANA's in human serum with a single dilution as an aid in the in-vitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence Of CDRH, Office Of Device Evaluation (ODE) Prescription Use A (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) J. Reeves for J. Bautista (Division Sign-Off) Division of Clinical Laboratory Devi-510(k) Number . --- **Source:** [https://fda-staging.innolitics.com/device/K022800](https://fda-staging.innolitics.com/device/K022800) **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. If you're preparing [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/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com