SERAQUEST ANTI-SSB

K980639 · Quest Intl., Inc. · LLL · Jun 15, 1998 · Immunology

Device Facts

• Record ID: K980639
• Device Name: SERAQUEST ANTI-SSB
• Applicant: Quest Intl., Inc.
• Product Code: LLL · Immunology
• Decision Date: Jun 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5100
• Device Class: Class 2

Intended Use

For the qualitative and semi-quantitative detection of human antibodies to SSB nuclear antigen in uman serum by enzyme immunoassay. For manual use, or for use with the HyPrep System Plus. In Vitro Diagnostic Use Only.

Device Story

SeraQuest Anti-SSB is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against SSB nuclear antigen in human serum. The device uses microwells coated with calf thymus-derived SSB antigen. Patient serum is incubated in the wells; if anti-SSB antibodies are present, they bind to the antigen. After washing, an enzyme-labeled conjugate (goat anti-human IgG with alkaline phosphatase) is added. Following a second incubation and wash, p-Nitrophenyl phosphate substrate is added, converting to a yellow end-product. The reaction is measured photometrically at 405 nm. Results are reported as Index values based on in-house calibrators. The test is performed in a clinical laboratory setting, either manually or using the HyPrep System Plus fluid handler. Healthcare providers use the results as an aid in diagnosing systemic rheumatic diseases, specifically Sjogren's Syndrome.

Clinical Evidence

Clinical study compared SeraQuest Anti-SSB to the Shield Diastat Anti-SSB test using 288 human serum specimens. Results showed 27 positive and 252 negative concordant results. Discrepancies included 7 specimens positive by SeraQuest but negative by Shield, 1 equivocal by SeraQuest/negative by Shield, and 1 negative by SeraQuest/positive by Shield. Relative sensitivity was 96.4% (95% CI: 89.6-100%) and relative specificity was 97.2% (95% CI: 95.3-99.3%). Overall agreement was 99.6%.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) using plastic microwells coated with calf thymus-derived SSB antigen. Employs goat anti-human IgG conjugated with alkaline phosphatase and p-Nitrophenyl phosphate substrate. Readout is spectrophotometric at 405 nm. Manual or semi-automated operation via HyPrep System Plus. Three 30-minute incubation periods at room temperature.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome. For manual use or use with the HyPrep System Plus semi-automated fluid handler. For in vitro diagnostic use only.

Regulatory Classification

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

• Shield Diastat Anti-SSB test

Reference Devices

• Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750, 1986

Submission Summary (Full Text)

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APPENDIX 3 (revised 4/18/98).

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 17, g

JUN 1 5 1998

## 510(k) SUMMARY

K980639

| Applicant: | Quest International, Inc.<br>1938 N.E. 148th Terrace<br>North Miami, FL 33181 |
|------------------------|-------------------------------------------------------------------------------|
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, V.P., Quality Assurance |
| Telephone: | [phone] |
| Telefax: | [phone] |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® Anti-SSB |
| Device Name: | Antinuclear antibody immunological test system (21CFR § 866.5100) |
| Device Classification: | Class II (performance standards) |

# escription:

The SeraQuest Anti-SSB test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thirty minute incubations. It has been developed to detect IgG antibodies which are directed against SSB nuclear antigen (Anti-SSB), in human serum.

The Calibrators in the SeraQuest Anti-SSB test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.

# Principle:

Diluted samples are incubated in wells coated with SSB antigen. Antibodies against SSB (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and coniugate (enzyme-labeled antibodies to human IgG) is added and incubated, If IgG antibodies to SSB are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and draining, and the enzyme substrate is added and incubated. In the presence of the enzyme, the substrate is converted to a vellow end-product which is read photometrically at 405 nm.

#### Intended Use:

For the qualitative and semi-quantitative detection of human antibodies to SSB nuclear antigen in uman serum by enzyme immunoassay. For manual use, or for use with the HyPrep System Plus. ാ In Vitro Diagnostic Use Only.

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### redicate Device:

:

The SeraQuest Anti-SSB test is substantially equivalent in intended use and performance, to the Shield Diastat Anti-SSB test, Shield Diagnostics, Dundee, DD2 1SW.

### Summary of technological characteristics:

| Characteristic | SeraQuest Anti-SSB | Shield Diastat Anti-SSB |
|-------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of<br>antibodies against SSB<br>in human serum. | The detection of<br>antibodies against SSB<br>in human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Source: | Calf Thymus | Calf Thymus |
| Number of Incubation Periods: | Three | Three |
| ample Dilution: | 1:50 | 1:500 |
| Sample Incubation<br>Duration: | 30 minutes | 60 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | | |
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 μl | 100 μl |
| Conjugate Incubation<br>Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl<br>phosphate | phenolthalein<br>monophosphate |
| Subtrate Volume:<br>Substrate Incubation<br>Duration: | 100 μl<br>30 minutes | 100 μl<br>30 minutes |

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| top Reagent: | 0.5 M Trisodium<br>phosphate | Sodium<br>Hydroxide |
|----------------------|------------------------------|----------------------------------|
| Stop Reagent Volume: | 100 μl | 100 μl |
| Readout: | Spectrophotometric<br>405 nm | Spectrophotometric<br>540-565 nm |

Summary of Clinical Testing:

Of the 288 specimens tested, 27 were positive, and 252 were negative in both the SeraQuest and Shield tests (please see Table 1 below). Seven specimens which were negative by the Shield test, were positive in the SeraQuest test. One specimen which was negative in the Shield test, was equivocal in the SeraQuest test. One specimen which was positive in the Shield test, was negative in the SeraQuest test.

#### TABLE 1.

RESULTS OF SeraQuest Anti-SSB ASSAYS AND SHIELD Anti-SSB ASSAYS OF 288 SERUM SPECIMENS.

| SHIELD<br>Anti-SSB<br>ASSAY | SeraQuest Anti-SSB | | | | | |
|-----------------------------|--------------------|-----------|----------|-------------------------------------------|--------------|--------------------------------|
| | Positive | Equivocal | Negative | % | 95 % Cl | |
| Positive | 27 | 0 | 1 | Relative sensitivity 96.4 | 89.6 to100* | |
| Negative | 7 | 1 | 252 | Relative specificity<br>Overall agreement | 97.2<br>99.6 | 95.3 to 99.3*<br>95.3 to 99.1* |

ア Excluding equivocal results.

★ Calculated by the normal method.

> Reference: Gardner, M.J. and Altman, D.G., Confidence Intervals Rather Than Hypothesis Testing. Brit. Med. J., 292: 746-750, 1986.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, representing care and support.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

# JUN 1 5 1998

Mr. Robert A. Cort Vice President, Quality Assurance Ouest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181

Re : K980639/S1 Trade Name: SeraQuest® Anti-SSB Test System Requlatory Class: II Product Code: LLL Dated: April 20, 1998 Received: April 24, 1998

Dear Mr. Cort:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listing 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Butman

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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 173

#### APPENDIX 8 (REVISED 4/17/98)

Page 1

510(k) Number (if known): _K980639

Device Name: SeraQuest Anti-SSB

Indications For Use:

- For in vitro diagnostic use only. 1.
- 2. For the qualitative and semi-quantitative detection of IgG antibodies to SSB antigen in human serum by enzyme immunoassay.
- 3. For use as an aid in the diagnosis of systemic rheumatic disease, particularly Sjogren's Syndrome.
- 4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rita G. Makin

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use - -

(Optional Format 1-2-96)