SERAQUEST RUBELLA IGM

K982281 · Quest Intl., Inc. · LFX · Oct 16, 1998 · Microbiology

Device Facts

• Record ID: K982281
• Device Name: SERAQUEST RUBELLA IGM
• Applicant: Quest Intl., Inc.
• Product Code: LFX · Microbiology
• Decision Date: Oct 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3510
• Device Class: Class 2

Intended Use

For the qualitative detection of human IgM antibodies to Rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection. A positive result is presumptive for the detection of rubella antibodies and presumptive for the diagnosis of active or recent rubella infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

Device Story

SeraQuest Rubella IgM is a solid-phase enzyme immunoassay (EIA) for detecting IgM antibodies against Rubella virus in human serum. Input: human serum samples. Process: samples incubated in microwells coated with Rubella virus; immobilized antibodies detected via enzyme-labeled goat anti-human IgM conjugate; substrate added to produce yellow end-product; photometric reading at 405 nm. Output: Index values based on in-house standard. Used in clinical laboratories; manual operation or with HyPrep System Plus semi-automated fluid handler. Healthcare providers use results to aid in diagnosis of active or recent Rubella infection, particularly in women of childbearing age.

Clinical Evidence

Clinical study compared SeraQuest Rubella IgM to Diamedix Rubella IgM using 91 archival serum specimens (49 symptomatic, 42 known positive). Results showed 46 positive/40 negative concordant results. Excluding equivocal results, overall agreement was 97.7%.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA) using plastic microwells. Antigen strain: HPV-77. Conjugate: Goat anti-human IgM labeled with alkaline phosphatase. Substrate: p-Nitrophenyl phosphate. Stop reagent: 0.5 M Trisodium phosphate. Readout: Photometric at 405 nm. Manual or semi-automated (HyPrep System Plus) operation.

Indications for Use

Indicated for qualitative detection of IgM antibodies to Rubella in human serum to aid in diagnosis of Rubella infection. Indicated for use in women of childbearing age. Presumptive for detection of anti-rubella antibodies and diagnosis of acute or recent rubella infection.

Regulatory Classification

Identification

Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

Special Controls

*Classification.* Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards': (i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,” (ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,” (iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,” (iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and (v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,” (2) Centers for Disease Control's: (i) Low Titer Rubella Standard, (ii) Reference Panel of Well Characterized Rubella Sera, and (3) World Health Organization's International Rubella Standard.

Predicate Devices

• Diamedix Rubella IgM kit (Diamedix Corporation)

Submission Summary (Full Text)

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OCT 16 1998

Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181

## APPENDIX 5, revised.

## 510(k) SUMMARY

- Quest International, Inc. Applicant: 1938 N.E. 148th Terrace North Miami, FL 33181
- May 15, 1998 Date prepared:
- Contact person: Robert A. Cort. President
- [phone] Telephone:
- Telefax: [phone]

SeraQuest Rubella IgM Device:

Device Classification: Class III (premarket approval)

- Rubella serological reagents (21CFR § 866.3510) Device Name:
## Description:

The SeraQuest Rubella IgM 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 IgM antibodies which are directed against Rubella virus, in human serum.

The Calibrators in the SeraQuest Rubella IgM 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 Rubella virus antibodies directed against rubella (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IgM) is added and incubated. If IgM antibodies to Rubella are present, the conjugate will be immobilized in the wells. Residual conjugate is eliminated by washing and training, 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 detection of human IgM antibodies to Rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection. A positive result is presumptive for the detection of rubella antibodies and presumptive for the diagnosis of active or recent rubella infection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.

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## APPENDIX 5, revised.

## Predicate device:

The SeraQuest Rubella IgM test has been shown to be substantially equivalent to the Diamedix Rubella IgM kit, Diamedix Corporation, Miami, FL.

# Summary of technological characteristics:

| Characteristic | SeraQuest Rubella IgM | Diamedix Rubella IgM Microassay | |
|-------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay | |
| Intended Use: | The detection of IgM<br>antibodies against Rubella<br>virus in human serum. | The detection of IgM<br>antibodies against Rubella<br>virus in human serum. | |
| Antigen Strain | HPV-77 | Not stated in<br>package insert | |
| Solid Phase: | Plastic Microwell | Plastic Microwell | |
| Number of Incubation Periods: | Three | Three | |
| Sample Dilution: | 1:26 | 1:41 | |
| Sample Volume: | 100 µl | 100 ul | |
| Sample Pretreatment<br>Duration: | None | None | |
| Sample Incubation<br>Duration: | 30 minutes | 30 minutes | |
| Incubation Temperature: | Room temperature | Room temperature | |
| Ezyme-labeled Conjugate: | | | |
| Antibody | Goat anti-human IgM | Goat anti-human IgM | |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase | |
| Conjugate Volume: | 100 ul | 100 µl | |
| Conjugate Incubation<br>Duration:<br>Substrate: | 30 minutes | 30 minutes | |
| | p-Nitrophenyl<br>phosphate | p-Nitrophenyl<br>phosphate | |
| | Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL<br>33181<br>Page No. | | |
| APPENDIX 5, revised. | | | |
| Subtrate Volume: | 100 µl | 100 µl | |
| Substrate Incubation<br>Duration: | 30 minutes | 30 minutes | |
| Stop Reagent: | 0.5 M Trisodium<br>phosphate | 0.5 M Trisodium<br>phosphate | |
| Stop Reagent Volume: | 100 µl | 100 µl | |
| Readout: | Spectrophotometric<br>405 nm | Spectrophotometric<br>405 nm | |

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Summary of Clinical Testing:

### Experimental Procedure

Ninty-one archival serum specimens including: 49 specimens from patient presenting with symptoms consistent with rubella infection and 42 specimens reported to be positive for IgM antibodies to rubella which were obtained from serum brokers, were tested at Quest International. Inc., concurrently by the SeraQuest Rubella IgM test and the Diamedix Rubella IgM Microassay. The assays were performed and interpreted according to the manufacturers package inserts. Specimens giving discordant results were tested with a second legally marketed device, along with a representative number of positive and negative samples which gave concordant results by both test methods.

### Results and Conclusion

Of the 91 specimens tested, 46 were positive, and 40 were negative in both the SeraQuest and Diamedix tests (please see Table 1). Of the 5 remaining specimens which were negative by the Diamedix test were positive by the SeraQuest test, and 3 specimens which were positive by the Diamedix test were negative in the SeraQuest test.

Excluding the equivocal results, the overall agreement between the SeraQuest Rubella IgM test, and the Diamedix Rubella IgM Microassay, was 97.7 percent.

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#### APPENDIX 5, revised.

TABLE 1.

RESULTS OF SeraQuest RUBELLA IgM ASSAYS, AND DIAMEDIX RUBELLA IgM MICROASSAYS, OF 91 SERUM SPECIMENS. THE SPECIMENS INCLUDED: 49 SPECIMENS FROM PATIENTS PRESENTING WITH SYMPTOMS CONSISTENT WITH RUBELLA INFECTION, AND 42 SPECIMENS REPORTED TO BE POSITIVE FOR IgM ANTIBODIES TO RUBELLA, WHICH WERE OBTAINED FROM SERUM BROKERS. THESE TESTS WERE PERFORMED IN-HOUSE AT QUEST INTERNATIONAL, INC., MIAMI, FL.

| Diamedix<br>Rubella<br>IgM | SeraQuest Rubella IgM | | |
|----------------------------|-----------------------|-----------|----------|
| | Positive | Equivocal | Negative |
| Positive | 46 | 0 | 0 |
| Negative | 2 | 3 | 40 |

Agreement excluding equivocal results, 97.7 %

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Image /page/4/Picture/1 description: The image shows the 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" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 16 1998

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

Re: K982281 Trade Name: SeraQuest Rubella IgM Regulatory Class: III Product Code: LFX Dated: August 24, 1998 Received: August 31, 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 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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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 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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Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No.

> Page 1 of of 1

510(k) Number (if known):

Device Name: SeraQuest Rubella IgM

Indications For Use:

(Per 21 CFR 801.109)

APPENDIX 10

- For the qualitative detection of IgM antibodies to Rubella in human serum by 1. enzyme immunoassay, to aid in the diagnosis of Rubella infection.
- A positive result is presumptive for the detection of anti-rubella antibodies and 2. presumptive for the diagnosis of acute or recent rubella infection.
- Useful for the above indications, with specimens obtained from women of 3. childbearing age.
- 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)

| | Woody Dubois<br>(Division Sign-Off)<br>Division of Clinical Laboratory Devices |
|---------------|--------------------------------------------------------------------------------|
| 510(k) Number | K98 2281 |

| Prescription Use | X | OR | Over-The-Counter Use |
|------------------|---|----|----------------------|
|------------------|---|----|----------------------|

(Optional Format 1-2-96)