(251 days)
No
The description mentions image processing and calculation of fluorescence intensity based on pixel brightness, but there is no mention of AI, ML, or related concepts like neural networks, training data, or complex pattern recognition beyond simple intensity measurement.
No
The device is described as an "in vitro diagnostic" device, specifically for the visual determination and semiquantitative measurement of anti-nuclear antibodies (ANA's) to aid in the diagnosis of autoimmune and connective tissue diseases. It is not used for treating or preventing diseases.
Yes
The device 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 as an aid in the in vitro diagnosis of auto-immune and connective tissue diseases. This clearly indicates its role in diagnosis.
No
The device description explicitly mentions a "digital camera through the FAN microscope" and "stained slides," indicating hardware components are integral to the device's function. While software is used for image processing and calculation, it is not a standalone software-only device.
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 device 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... as an aid in the invitro diagnosis of auto-immune and connective tissue diseases". The phrase "in vitro diagnosis" is a key indicator of an IVD.
- Sample Type: The device uses "human serum", which is a biological sample taken from the human body.
- Purpose: The purpose is to detect and measure specific substances (ANA's) in the sample to aid in the diagnosis of diseases. This is the core function of an IVD.
N/A
Intended Use / Indications for Use
The Hyperion VisiQuant™ ANA Test Kit 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 Hyperion VisiQuant™ ANA Test Kit is substantially equivalent to the BION Antinuelear Antibody (ANA) Test Kit/Control manufactured by BION Ent. I.d., previously cleared under Documnti control No., K872845, on 01/17/87. The proposed and the predicate device are in-viro diagnosic products, intended for use to determine the antinuelear antibody in human serum to aid in the diagnosis of certain autoimmune diseases by utilizing the indirect fluorescent antibody technique (FFA),
The proposed Hyperion VisiQuant™ ANA Test Kit differs from the BION Antinuclear Antibody (ANA) Test KirControl in the configuration of the individual components included in their respective kists. They also differ in the way the read. The BION slides are serially diluted and visually read to determine the titer. The VisiQuant™ ANA slides are read off a standard corve to provided and visually titer,
VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camenthrough the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.
The antigen of the ANA substrate is a human cpithelial cell (HEp-2) which are cultured and fixed in wells of a glass slide. Diluted test serum samples are placed in the wells and incubated and incubated. In ANA arc present, they will bind with the antigens expressed by the cells. A fter washing the wells 11 renove unbound antigen, the conjugate (La Jolla Blue labeled goat antibody to human InG) is add and incubated. The conjugate will bind immunologically to the bound ANA on the HEP-2 cell antigens. After another washing of the wells to remove unbound conjugate, the wells are read with a microscope equipped with a digital camera and computer to obtain the immununofluorescence image for the determination of the absence (negative) or presence (positive) of ANA patteres) as in the commonly used qualitative (screen) procedure for ANA IFA.
For the positive sample, a VisiQuant tiler may be obtained by saving the image to a tagged image file format (TTF) file for processing by the VisiQuant software. The sollware calculates a fluorescence intensity unit (FIU) value. The FIU is calculated by measuring the average thrightness of the image from the canera. It then calculates the mean brightness of the picture elements (preditioss on two groups, one and of the love the more below. The difference between the two group mean values is reported as the FIU value. The FIUs and ANA titers of Calibrators assayed in the same run are used to build a standard curve, from which the VisiQuant titer of the test sample is interpolated.
Mentions image processing
For the positive sample, a VisiQuant tiler may be obtained by saving the image to a tagged image file format (TTF) file for processing by the VisiQuant software. The sollware calculates a fluorescence intensity unit (FIU) value. The FIU is calculated by measuring the average thrightness of the image from the canera. It then calculates the mean brightness of the picture elements (preditioss on two groups, one and of the love the more below. The difference between the two group mean values is reported as the FIU value. The FIUs and ANA titers of Calibrators assayed in the same run are used to build a standard curve, from which the VisiQuant titer of the test sample is interpolated.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A comparative evaluation of the proposed Hyperion VisiQuant™ ANA Test Kit demonstrated substantial equivalence to the BION Antinuelear Antibody (ANA) Test KillControl. The results are shown in the following tables and diagrams:
Table 1. Agreement in Test Results
| VisiQuant ANA | Negative | Positive | Total |
|---|---|---|---|
| Negative | 92 | 6 | 98 |
| Positive | 1 | 96 | 97 |
| Total | 93 | 102 | 195 |
Agreement for negative results = 92/93 = 98.92 %
Agreement for positive results = 96/102 = 94.12 %
Table 2. Qualitative Results
| VisiQuant pattern | Neg | H | S | N | C | H,S | H,N | S,N | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neg | 92 | 5 | 1 | 98 | |||||
| H | 1 | 36 | 37 | ||||||
| S | 27 | 27 | |||||||
| N | 4 | 4 | |||||||
| C | 4 | 4 | |||||||
| H,S | 2 | 10 | 12 | ||||||
| H,N | 1 | 9 | 2 | 12 | |||||
| S,N | 1 | 1 | |||||||
| Total | 93 | 36 | 34 | 5 | 4 | 11 | 2 | 3 | 195 |
Pattern agreement for samples positive by both tests = 91/96 = 94.79 %; for Bion positive samples = 91/102= 89.21 %
Table 3. Discrepant samples (Negative, --; positive, titer with pattern; Speckled (S); Homogenous (H) and Nucleolar (N); positive but not titrated, n.a.). Borderline reactivity accounts for 7 discrepancies as detailed below. Six (6) showed titers of 40 by the Bion ANA but negative by VisiQuant ANA test; one (1) was negative by the Bion ANA but positive low titer of 175 by the VisiQuant ANA test. Slight differences in assay detection and in reading could account for these discrepancies. Some normal subjects may demonstally tow level ANA's which are clinically insignificant,
| Item no. | Sample ID | Bion test Titer | Bion test Pattern | VisiQuant ANA Titer | VisiQuant ANA Pattern |
|---|---|---|---|---|---|
| 1 | W-27 | -- | 175 | H | |
| 2 | Y-N17 | 40 | S | -- | -- |
| 3 | Y-N25 | 40 | S | -- | -- |
| 4 | W-21 | 40 | S | -- | -- |
| 5 | W-2 | 40 | S | -- | -- |
| 6 | W-14 | 40 | H,S | -- | -- |
| 7 | Y-SS2 | n.a. | S | -- | -- |
| 8 | X-B15 | n.a. | S | 128 | H,S |
| 9 | X-B8 | 160 | N | 196 | H,N |
| 10 | W-24 | 40 | S,N | 254 | H,N |
| 11 | W-5 | 1280N; 160S | 227 | H,N | |
| 12 | W-41 | 640 | S | 189 | H,S |
Table 4. Titration of 11 serum samples with VisiQuant ANA. Because VisiQuant titer values could be underestimated for some test samples with contromere, nucledian or some speckled patterns, nine (9) such samples were titrated by the traditions, 2-fold serial dilution and assayed with the VisiQuant ANA. The results as summarized below revealed the equivalence of VisiQuant ANA titers from titration with Bion's IFA ANA titers. Two high positive controls (items 10 and 11) were included in the experiment.
| Item no. | Sample ID | VisiQuant ANA Assay at 1/40 Pattern | VisiQuant ANA Titer | Bion IFA ANA Titration Titer* | Bion IFA ANA Titer & Pattern |
|---|---|---|---|---|---|
| 1 | W-5 | H, N | 227 | 160II,N | 1280N; 160S |
| 2 | X-C2 | C | 215 | 1280 | 2560C |
| 3 | X-C4 | C | 135 | 1280 | 2560C |
| 4 | Z8 | C | 60 | 640 | 640C |
| 5 | Z6 | N | 95 | 240 | 640N |
| 6 | Z11 | N | 72 | 960 | 640N |
| 7 | X-B12 | S | 104 | 960 | 1280S |
| 8 | W-42 | S | 172 | 960 | 1280S |
| 9 | X-E1 | N,S | 474 | 1280N,# | 2560N; 320S |
| 10 | 13-3-1 | H | 5540 | 3840 | 5120H |
| 11 | 13-3-11 | S | 2913 | 2560 | 5120S |
*Average of separate readings by two persons.
#This sample showed a speckled pattern at the initial dilution of 1:40. It was not tested at 1:80, however it was tested at 1:160 and did not show a speckled pattern.
Ninety-six (96) serum samples, positive by both the VisiQuant ANA and the Bion ANA, were compared for ANA titers. Figure 2 shows the correlation with all patterns (Homogenous, Speckled, Nucleolar, Centromere and mixed) and Figure 3 shows the correlation with the Homogenous pattern only.
Figure 2. Scatter diagram showing correlation between VisiQuant titer (VT) and Bion II A titer (BT) for 96 samples positive by both test. R=0.731, N=96, p
§ 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
6-4-02
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string is "KO13213". The characters are written in a simple, slightly messy style, with varying stroke thicknesses. The image is in black and white.
510(k) Summary of Safety and Effectiveness Information Hyperion VisiQuant™ ANA Test Kit September 25, 2001 Revised: May 31, 2002
Hyperion, Inc. 14100 S.W. 136th Street Miami, FL. 33186 Contact Person: Radba 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: Hyperion VisiQuant™ ANA Test Kit
| Common or Usual Name: | ANA IFA Kit |
|---|---|
| Classification Name: | Anti nuclear Antibody immunological test system |
| Registration Number: | Manufacturer |
| Hyperion, Inc. | |
| 14100 S.W. 136th Street | |
| 1028110 |
Miami, Florida 33186
The proposed Hyperion VisiQuant™ ANA Test Kit is substantially equivalent to the BION Antinuelear Antibody (ANA) Test Kit/Control manufactured by BION Ent. I.d., previously cleared under Documnti control No., K872845, on 01/17/87. The proposed and the predicate device are in-viro diagnosic products, intended for use to determine the antinuelear antibody in human serum to aid in the diagnosis of certain autoimmune diseases by utilizing the indirect fluorescent antibody technique (FFA),
The proposed Hyperion VisiQuant™ ANA Test Kit differs from the BION Antinuclear Antibody (ANA) Test KirControl in the configuration of the individual components included in their respective kists. They also differ in the way the read. The BION slides are serially diluted and visually read to determine the titer. The VisiQuant™ ANA slides are read off a standard corve to provided and visually titer,
VisiQuant™ ANA is a unique ANA IFA. The test samples are assayed with a single dilution as in the traditional qualitative procedure to determine positive and pattern while obtaining a VisiQuant titer from the same image. The stained slides are read objectively with a digital camenthrough the FAN microscope to measure the fluorescence intensity of reacted substrate (Hip-2 calls). The Visiguant tive of the test sample is interpolated from a standard curve. VisiQuant ANA uses a unique fluorophore, La Jolla Blue (LJB), which has a longer fluorescence life (photostability) than fluorescent. LJJP has nearinfrared peak excitation and emission wavelengths to minimize autofluoresconce commonly present in biological substances.
1
510(k) Summary of Safety and Effectiveness Information Hyperion VisiQuant™ ANA Test Kit Atlachment D, Page 2
Header Revised on 7/24/02
The antigen of the ANA substrate is a human cpithelial cell (HEp-2) which are cultured and fixed in wells of a glass slide. Diluted test serum samples are placed in the wells and incubated and incubated. In ANA arc present, they will bind with the antigens expressed by the cells. A fter washing the wells 11 renove unbound antigen, the conjugate (La Jolla Blue labeled goat antibody to human InG) is add and incubated. The conjugate will bind immunologically to the bound ANA on the HEP-2 cell antigens. After another washing of the wells to remove unbound conjugate, the wells are read with a microscope equipped with a digital camera and computer to obtain the immununofluorescence image for the determination of the absence (negative) or presence (positive) of ANA patteres) as in the commonly used qualitative (screen) procedure for ANA IFA.
For the positive sample, a VisiQuant tiler may be obtained by saving the image to a tagged image file format (TTF) file for processing by the VisiQuant software. The sollware calculates a fluorescence intensity unit (FIU) value. The FIU is calculated by measuring the average thrightness of the image from the canera. It then calculates the mean brightness of the picture elements (preditioss on two groups, one and of the love the more below. The difference between the two group mean values is reported as the FIU value. The FIUs and ANA titers of Calibrators assayed in the same run are used to build a standard curve, from which the VisiQuant titer of the test sample is interpolated.
A counparative evalualion of the proposed Hyperion VisiQuant™ ANA Test Kit demonstrated substantial cquivalence to the BION Antinuelear Antibody (ANA) Test KillControl. The results are shown in the following tables and diagrams:
Table 1. Agreement in Test Results
| VisiQuant
| ANA | No. samples with Bion Test results | ||
|---|---|---|---|
| Negative | Positive | Total | |
| Negative | 92 | 6 | 98 |
| Positive | 1 | 96 | 97 |
| Total | 93 | 102 | 195 |
Agreement for negative results = 92/93 = 98.92 % Agreement for positive results = 96/102 = 94.12 %
Table2. Qualitative Results
| Negative (Neg); Homogenous (H); Speckled (S); Nucleolar (N); Centromere (C) | ||||
|---|---|---|---|---|
| ----------------------------------------------------------------------------- | -- | -- | -- | -- |
| VisiQuant
| pattern | Neg | II | S | N | C | H,S | H,N | S,N | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neg | 92 | 5 | 1 | 98 | |||||
| H | 1 | 36 | 37 | ||||||
| S | 27 | 27 | |||||||
| N | 4 | 4 | |||||||
| C | 4 | 4 | |||||||
| H,S | 2 | 10 | 12 | ||||||
| H,N | 1 | 9 | 2 | 12 | |||||
| S,N | 1 | 1 | |||||||
| Total | 93 | 36 | 34 | 5 | 4 | 11 | 2 | 3 | 195 |
Pattern agreement for samples positive by both tests = 91/96 = 94.79 %; for Bion positive samples = 91/102= 89.21 %
2
510(k) Summary of Safety and Effectiveness Information Hyperion VisiQuant™ ANA Test Kit Attachment D, Page 3
Header Revised on 7/24/02
Table 3. Discrepant samples (Negative, --; positive, titer with pattern; Speckled (S); Homogenous (H) and Nucleolar (N); positive but not titrated, n.a.). Borderline reactivity accounts for 7 discrepancies as detailed below. Six (6) showed titers of 40 by the Bion ANA but negative by VisiQuant ANA test; one (1) was negative by the Bion ANA but positive low titer of 175 by the VisiQuant ANA test. Slight differences in assay detection and in reading could account for these discrepancies. Some normal subjects may demonstally tow level ANA's which are clinically insignificant,
| Item no. | Sample ID | Bion test | VisiQuant ANA | ||
|---|---|---|---|---|---|
| Titer | Pattern | Titer | Pattern | ||
| 1 | W-27 | -- | 175 | H | |
| 2 | Y-N17 | 40 | S | -- | -- |
| 3 | Y-N25 | 40 | S | -- | -- |
| 4 | W-21 | 40 | S | -- | -- |
| 5 | W-2 | 40 | S | -- | -- |
| 6 | W-14 | 40 | H,S | -- | -- |
| 7 | Y-SS2 | n.a. | S | -- | -- |
| 8 | X-B15 | n.a. | S | 128 | H,S |
| 9 | X-B8 | 160 | N | 196 | H,N |
| 10 | W-24 | 40 | S,N | 254 | H,N |
| 11 | W-5 | 1280N; 160S | 227 | H,N | |
| 12 | W-41 | 640 | S | 189 | H,S |
Table 4. Titration of 11 serum samples with VisiQuant ANA. Because VisiQuant titer values could be underestimated for some test samples with contromere, nucledian or some speckled patterns, nine (9) such samples were titrated by the traditions, 2-fold serial dilution and assayed with the VisiQuant ANA. The results as summarized below revealed the equivalence of VisiQuant ANA titers from titration with Bion's IFA ANA titers. Two high positive controls (items 10 and 11) were included in the experiment.
| Item
no. | Sample
ID | VisiQuant ANA | | Bion IFA ANA
Titer & Pattern | |
|-------------|--------------|--------------------------|-------|---------------------------------|-------------|
| | | Assay at 1/40
Pattern | Titer | Titration
Titer* | |
| 1 | W-5 | H, N | 227 | 160II,N | 1280N; 160S |
| 2 | X-C2 | C | 215 | 1280 | 2560C |
| 3 | X-C4 | C | 135 | 1280 | 2560C |
| 4 | Z8 | C | 60 | 640 | 640C |
| 5 | Z6 | N | 95 | 240 | 640N |
| 6 | Z11 | N | 72 | 960 | 640N |
| 7 | X-B12 | S | 104 | 960 | 1280S |
| 8 | W-42 | S | 172 | 960 | 1280S |
| 9 | X-E1 | N,S | 474 | 1280N,# | 2560N; 320S |
| 10 | 13-3-1 | H | 5540 | 3840 | 5120H |
| 11 | 13-3-11 | S | 2913 | 2560 | 5120S |
- Average of separate readings by two persons.
#This sample showed a speckled pattern at the initial dilution of 1:40. It was not tested at 1:80, however it was tested at 1:160 and did not show a speckled pattern.
3
510(k) Summary of Sufety and Effectiveness Information Hyperion VisiQuant™ ANA Test Kit Attachment D, Page 4
Header Revised on 7/24/02
Un25
Nincty-six (96) serum samples, positive by both the VisiQuant ANA and the Bion ANA, were compared for ANA titers. Figure 2 shows the correlation with all patterns (Homogenous, Speckled, Nucleolar, Centromere and mixed) and Figure 3 shows the correlation with the Homogenous pattern only.
Image /page/3/Figure/4 description: This image is a scatter plot comparing VisiQuant ANA titer and IIF ANA titer. The x-axis represents the IIF ANA titer, ranging from 10 to 10000, while the y-axis represents the VisiQuant ANA titer, also ranging from 10 to 10000. The plot includes a regression line with dotted lines indicating confidence intervals, and data points are categorized by VisiQuant ANA pattern, including Homogeneous, Speckled, Nucleolar, Centromere, Homogeneous & speckled, Homogeneous & nucleolar, and Speckled & nucleolar.
Figure 2. Scatter diagram showing correlation between VisiQuant titer (VT) and Bion II A titer (BT) for 96 samples positive by both test. R=0.731, N=96, p