← Product Code [DHN](/productcode/DHN) · K013213

# HYPERION VISIQUANT ANA TEST KIT (K013213)

_Hyperion, Inc. · DHN · Jun 4, 2002 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K013213

## Device Facts

- **Applicant:** Hyperion, Inc.
- **Product Code:** [DHN](/productcode/DHN.md)
- **Decision Date:** Jun 4, 2002
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5100
- **Device Class:** Class 2
- **Review Panel:** Immunology

## 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 invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

## Device Story

In-vitro diagnostic test kit for ANA detection in human serum; utilizes HEp-2 cell substrate on glass slides. Process: serum incubation; washing; addition of La Jolla Blue (LJB) labeled goat anti-human IgG conjugate; secondary washing. Imaging: microscope with digital camera captures fluorescence. Software: calculates fluorescence intensity unit (FIU) by measuring average image brightness; interpolates titer from standard curve. Used in clinical laboratory settings by trained personnel. Output: visual pattern determination and semiquantitative titer. Benefits: objective measurement of fluorescence intensity; photostable fluorophore (LJB) minimizes autofluorescence; single-dilution assay simplifies workflow compared to traditional serial dilution methods.

## Clinical Evidence

Bench testing comparing VisiQuant ANA to BION IFA ANA using 195 human serum samples. Primary endpoints: qualitative pattern agreement and titer correlation. Results: 98.92% agreement for negative results, 94.12% for positive results. Pattern agreement for positive samples was 94.79%. Correlation (R) between VisiQuant and BION titers was 0.731 (p<0.0001) for all patterns and 0.909 (p<0.0001) for homogeneous patterns. Discrepancies attributed to borderline reactivity and differences in assay detection limits.

## Technological Characteristics

Substrate: HEp-2 human epithelial cells. Fluorophore: La Jolla Blue (LJB) labeled goat anti-human IgG. Imaging: Microscope with digital camera. Software: Image processing for fluorescence intensity unit (FIU) calculation and standard curve interpolation. Connectivity: Standalone workstation. Sterilization: Not specified.

## 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

- BION Antinuclear Antibody (ANA) Test Kit/Control ([K872845](/device/K872845.md))

## Submission Summary (Full Text)

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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.<br>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.

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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<br>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<br>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 %

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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<br>no. | Sample<br>ID | VisiQuant ANA            |       | Bion IFA ANA<br>Titer & Pattern |             |
|-------------|--------------|--------------------------|-------|---------------------------------|-------------|
|             |              | Assay at 1/40<br>Pattern | Titer | Titration<br>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.

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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<0.0001, Log VT= 0.964+0.654 x Log BT. The Linear Regression (solid line) and its 95% confidence intervals (dotted lines) are also shown.

Image /page/3/Figure/6 description: This image is a scatter plot comparing "VisiQuant ANA Titer" on the y-axis and "Dion IFA ANA titer" on the x-axis. Both axes are on a logarithmic scale, ranging from 10 to 10000. The plot shows a positive correlation between the two measures, with data points clustered around a regression line and a legend indicating that the data points represent "Homogeneous" ANA patterns.

Figure 3. A scatter diagram showing correlation between VisiQuant titer (VT) and Bion IFA titer (BT) for 36 samples with homogenous ANA pattern. R=0.909, N=36, p<0.0001, Log VT-0.631+0.806 x I.og BT. The Linear Regression (solid line) and its 95% confidence intervals (dottod lines) are also shown.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird with three heads, each head facing to the right.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 0 4 2002

Ms. Radha Goolabsingh Director of Quality Assurance and Regulatory Affairs Hyperion, Inc. 14100 S.W. 136th Street Miami. Florida 33186

Re: k013213

Trade/Device Name: Hyperion VisiQuant™ ANA Test Kit Regulation Number: 21 CFR & 866.5100 Regulation Name: Antinuclear Antibody Immunological Test System Regulatory Class: II Product Code: DHN Dated: May 24, 2002 Received: May 28, 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. Ilsting 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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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### Page 2

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE STATEMENT

### 510(K) NUMBER (IF KNOWN): K013213

# DEVICE NAME: Hyperion VisiQuant™ ANA Test Kit

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 invitro diagnosis of auto-immune and connective tissue diseases such as systemic lupus erythematosus (SLE) and Sjogren Syndrome.

Sousnn S. Alta.e

(Division Sign-Off) Division of Clinical Laboratory Devices

619(k) Number K013213

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence Of CDRH, Office Of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) \$\checkmark\$

OR

Over-The-Counter-Use .

(Optional Format 1-2-96)

---

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