(94 days)
No
The description focuses on image capture, storage, and basic software functions like calibration curve generation and interpolation based on operator input. There is no mention of automated image analysis, pattern recognition, or learning algorithms that would indicate AI/ML. The operator is explicitly stated as determining positivity and identifying the pattern.
No.
This device is an in-vitro diagnostic tool used to detect and measure anti-nuclear antibodies for diagnosis, not to treat or cure a disease.
Yes
The device is intended for the visual determination and semiquantitative measurement of ANAs as an aid in the in-vitro diagnosis of autoimmune and connective tissue diseases. This explicit statement of diagnostic purpose aligns with the definition of a diagnostic device.
No
The device description explicitly mentions hardware components like a microscope and a CCD camera, which are integral to the system's function. While software is used for image processing and data analysis, the device is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the system is intended for the "in-vitro diagnosis of auto-immune and connective tissue diseases". This is a key characteristic of an IVD.
- Sample Type: The device uses "human serum", which is a biological sample taken from the body and analyzed outside of the body. This is consistent with the definition of an in vitro diagnostic.
- Measurement: The system performs "visual determination" and "semiquantitative measurement" of anti-nuclear antibodies, which are analytes measured in a biological sample to aid in diagnosis.
- Device Description: The description details a system that processes a biological sample (prepared slide from serum) and provides results (immunofluorescence pattern and titer) to aid in diagnosis.
The device fits the definition of an In Vitro Diagnostic device as it is intended for use in the examination of specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / 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.
Product codes
DHN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescent microscope
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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.
Sample Size: 113 samples. 71 serum samples positive by both systems were compared for ANA titers.
Correlation Coefficient: 0.917 for ANA titers in 71 positive results.
Key Metrics
Agreement for negative results = 40/42 = 95.2%
Agreement for positive results = 71/71 = 100%
Pattern agreement for samples positive by both tests = 69/71 = 97.2 %:
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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 |
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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.
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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).
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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
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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 .