SERAQUEST ANTI-SM/RNP

K980811 · Quest Intl., Inc. · LKP · May 12, 1998 · Immunology

Device Facts

• Record ID: K980811
• Device Name: SERAQUEST ANTI-SM/RNP
• Applicant: Quest Intl., Inc.
• Product Code: LKP · Immunology
• Decision Date: May 12, 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 Sm/RNP nuclear antigen human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic disease, particularly mixed connective tissue disease. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest Anti-Sm/RNP is a solid-phase enzyme immunoassay (EIA) for detecting IgG antibodies against Sm/RNP nuclear antigen in human serum. Input: human serum samples. Principle: samples incubated in microwells coated with Sm/RNP antigen; immobilized antibodies detected via enzyme-labeled goat anti-human IgG conjugate; substrate added to produce yellow end-product. Output: photometric reading at 405 nm converted to Index values. Used in clinical laboratories; manual operation or semi-automated via HyPrep System Plus. Healthcare providers use results as an aid in diagnosing systemic rheumatic disease, specifically mixed connective tissue disease. Benefits: provides standardized immunological testing for specific autoantibodies.

Clinical Evidence

Clinical study compared SeraQuest Anti-Sm/RNP against the Shield Diastat Anti-Sm/RNP predicate using 252 serum specimens. Results showed 100% relative sensitivity (95% CI: 99.9-100%) and 90.4% relative specificity (95% CI: 86.4-94.4%), with an overall agreement of 95.4% (95% CI: 88.6-95.3%).

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) using plastic microwells coated with calf thymus-derived Sm/RNP antigen. Employs goat anti-human IgG conjugated with alkaline phosphatase. Detection via p-Nitrophenyl phosphate substrate and photometric readout at 405 nm. Manual or semi-automated operation via HyPrep System Plus.

Indications for Use

Indicated for the qualitative and semi-quantitative detection of IgG antibodies to Sm/RNP in human serum as an aid in the diagnosis of systemic rheumatic disease, particularly mixed connective tissue disease (MCTD). For in vitro diagnostic use.

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-Sm/RNP test (Shield Diagnostics)

Submission Summary (Full Text)

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K980811

APPENDIX 3 (revised 4/24/98)

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 124

MAY 1 2 1998

510(k) SUMMARY

| 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-Sm/RNP |
| Device Name: | Antinuclear antibody immunological test system (21CFR § 866.5100)<br>Device Classification: Class II (performance standards) |

#### >scription:

The SeraQuest Anti-Sm/RNP 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 Sm/RNP nuclear antigen (Anti-Sm/RNP), in human serum.

The Calibrators in the SeraQuest Anti-Sm/RNP 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 Sm/RNP antigen. Antibodies against Sm/RNP (if present) are immobilized in the wells. Residual sample is eliminated by washing and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to Sm/RNP 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 yellow end-product which is read photometrically at 405 nm.

### Intended Use:

For the qualitative and semi-quantitative detection of human antibodies to Sm/RNP nuclear antigen human serum by enzyme immunoassay. For use as an aid in the diagnosis of systemic rheumatic

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APPENDIX 3 (revised 4/24/98)

sease, particularly mixed connective tissue disease. For manual use, or for use with the HyPrep رو. ystem Plus. For In Vitro Diagnostic Use Only.

## Predicate Device:

----

The SeraQuest Anti-Sm/RNP test is substantially equivalent in intended use and performance, to the Shield Diastat Anti-Sm/RNP test, Shield Diagnostics, Dundee, U.K.

#### Summary of technological characteristics:

| Characteristic | SeraQuest Anti-Sm/RNP | Shield Diastat Anti-Sm/RNP |
|-----------------------------------|------------------------------------------------------------------|------------------------------------------------------------------|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of<br>antibodies against Sm/RNP<br>in human serum. | The detection of<br>antibodies against Sm/RNP<br>in human serum. |
| Antigen Source: | Calf Thymus | Calf Thymus |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:500 |
| Sample Incubation<br>Duration: | 30 minutes | 60 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Enzyme-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 |
| Substrate Volume: | 100 μl | 100 μl |
| ubstrate Incubation | 30 minutes | 30 minutes |
| Stop 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 |

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APPENDIX 3 (revised 4/24/98)

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 126

Summary of Clinical Testing:

Of the 252 specimens tested, 40 were positive, and 189 were negative in both the SeraQuest and Shield tests (please see Table C-3). Of the remaining specimens, 23 specimens which were negative by the Shield test, 20 were positive and 3 equivocal by the SeraQuest test. Please see Table 1 below.

#### TABLE 1.

Sm/Anti-RNP SHIELD ASSAYS AND RESULTS OF SeraQuest Anti-Sm/RNP ASSAYS OF 252 SERUM SPECIMENS.

| SeraQuest Anti-Sm/RNP | | | | | |
|-----------------------|----------|-----------|----------|-------------------------------------------------------------|------------------------------|
| Shield<br>Anti-Sm/RNP | Positive | Equivocal | Negative | % | 95 % CIv |
| Positive | 4 0 | 0 | 0 | Relative sensitivity<br>100 | 99.9 to 100 |
| Negative | 2 0 | 3 | 189 | Relative specificity*<br>Overall agreement*<br>90.4<br>95.4 | 86.4 to 94.4<br>88.6 to 95.3 |

· 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three heads facing to the right. The eagle is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAY | 2 1998

Robert A. Cort Vice President, Ouality Assurance QUEST INTERNATIONAL, INC. 1938 N.E. 148th Terrace North Miami, FL 33181

Re: K980811 Trade Name: SeraQuest® Anti-Sm/RNP Regulatory Class: II Product Code: LKP Dated: April 28, 1998 Received: April 28, 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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation 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 -

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 [phone],or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Autman

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

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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 154

APPENDIX 8

Page _ 1 of _ し

510(k) Number (if known): K 980 & //

Device Name: SeraQuest Anti-Sm/RNP

Indications For Use:

- 1 . For in vitro diagnostic use only.
- 2. For the qualitative and semi-quantitative detection of IgG antibodies to Sm/RNP in human serum by enzyme immunoassay.
- For use as an aid in the diagnosis of systemic rheumatic disease, particularly 3. mixed connective tissue disease (MCTD).
- For manual use, or for use with the HyPrep System Plus semi-automated fluid 4. handler.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | L990811 |

| Prescription Use | <div style="text-align:center;">✓</div> |
|----------------------|-----------------------------------------|
| (Per 21 CFR 801.109) | |

OR
Over-The-Counter Use
(Optional Format 1-2-96)