(261 days)
- For in vitro diagnostic use only.
- For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
- For use as an aid in differentiating active or recent infection, from past infection.
- For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.
The SeraQuest EB VCA IgG 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 Epstein-Barr virus capsid antigen.
The provided text describes the SeraQuest EB VCA IgG test, an Enzyme Immunoassay (EIA) for detecting IgG antibodies to Epstein-Barr virus capsid antigen (VCA) in human serum. The primary study presented aims to demonstrate substantial equivalence to a predicate device, the Gull Laboratories' EBV IgG ELISA test.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for sensitivity, specificity, or overall agreement. Instead, it presents the device's performance in comparison to a predicate device and implicitly uses these results to support substantial equivalence. The predicate device's performance is not exhaustively detailed, but the comparison implies that the SeraQuest EB VCA IgG test should perform comparably.
| Performance Metric | SeraQuest EB VCA IgG Performance (vs. Gull VCA IgG Assay) | Implicit Acceptance Criterion (based on predicate device comparison) |
|---|---|---|
| Relative Sensitivity* | 92.2% (95% CI: 87.8 to 96.6) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
| Relative Specificity* | 90.0% (95% CI: 71.4 to 100) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
| Overall Agreement* | 92.1% (95% CI: 87.7 to 96.4) | To be substantially equivalent to the Gull Laboratories' EBV IgG ELISA test. |
*Excluding equivocal results.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 157 specimens.
- Data Provenance: The study was "performed in-house at Quest International, Inc., Miami, FL." The country of origin of the samples is not specified, but the testing location is in the USA. The design is retrospective, as existing specimens were "tested" with both devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The study uses the Gull Laboratories' EBV IgG ELISA test as the comparator or "reference" for evaluating the SeraQuest device's performance, not an expert panel. Therefore, no information on the number or qualifications of experts used to establish a separate "ground truth" is provided. The Gull test essentially acts as the 'ground truth' in this comparative study for regulatory purposes.
4. Adjudication Method for the Test Set
No explicit adjudication method is described. The comparison is straightforward: results from the SeraQuest test are compared directly against results from the Gull Laboratories' test. Where discrepancies occurred (e.g., equivocal results), they are reported, but no further expert adjudication process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on the performance of an in vitro diagnostic (IVD) device, specifically a serological assay, which typically does not involve human readers interpreting images or data in a way that an MRMC study would assess.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, this was a standalone study. The SeraQuest EB VCA IgG test is an enzyme immunoassay designed for qualitative and semi-quantitative detection of antibodies. The results are generated by the assay process itself, and its performance (sensitivity, specificity, agreement) is reported solely based on its output compared to the predicate device. There is no human interpretation or intervention in the algorithm's performance being assessed.
7. Type of Ground Truth Used
The "ground truth" for this study was established by the predicate device, the Gull Laboratories' EBV IgG ELISA test. The study aims to show substantial equivalence, meaning the SeraQuest device's results align closely with those obtained from the already legally marketed Gull test. There is no mention of pathology, clinical outcomes data, or expert consensus being used as a separate, independent ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set" or "validation set" in the context of machine learning, as this device is a traditional immunoassay. Therefore, this question is not applicable based on the provided text. The numbers given (157 specimens) refer to the clinical evaluation or test set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, the method for establishing its "ground truth" is not applicable based on the provided text.
{0}------------------------------------------------
OCT 2 8 1999
APPENDIX 3.
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. GAL
510(k) SUMMARY
| Applicant: | Quest International, Inc.1938 N.E. 148th TerraceNorth Miami, FL 33181 |
|---|---|
| Registration No. | 1061839 |
| Contact Person: | Robert A. Cort, V.P., Quality Assurance |
| Telephone: | (305) 948-8788 |
| Telefax: | (305) 948-4876 |
| Manufacturing Site: | Same as above |
| Device: | SeraQuest® EB VCA IgG |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |
ascription:
The SeraQuest EB VCA IgG test is a solid-phase enzyme immunoassay (EIA), which is performed in microwells, at room temperature, in three thity minute incubations. It has been developed in
IgG antibodies which are directed against Enotein Romains. It has been develope look to the superialism (in throe thirty minute incubations. It nas been developed to
The Calibrators in the SeraQuest EB VCA IgG 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 Epstein-Barr virus capsid antigen. Antibodies directed against Epstein-Barr virus capsid antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining and online in the well. Hesidual human IgG) is added and including to Epstein-Barr virus capsid antibodies to
human IgG) is added and incubated. If IgG anibodies to Epstein-Barry 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 the substrate is converted to onlymo oubstrate is added and incubation. In the presence of the substrate
Intended Use:
tended Use: The EB VCA IgG test is intended for the qualitive and semi-quantative detection of in of the collection of or rigated in ine qualified and semi-quantative defection of any
{1}------------------------------------------------
munoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past nfection. For manual use, or for use with the HyPrep System Plus. For In Vitro Diagnostic Use Only.
Predicate Device:
The SeraQuest EB VCA IgG test is substantially equivalent in intended use and performance, to the Gull Laboratories' EBV IgG ELISA test, Gull Laboratories, Inc., Salt Lake City, Utah.
Summary of technological characteristics:
| Characteristic | SeraQuest EB VCA IgG | Gull Laboratories ' EBV IgG ELISA |
|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgGantibodies against Epstein-Barr virus capsid antigenin human serum. | The detection of IgGantibodies against Epstein-Barr virus capsid antigenin human serum. |
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| ntigen : | Recombinant p18 | Purified gp 125 |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:21 |
| Sample IncubationDuration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | 37 °C. |
| Ezyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 ul | 100 ul |
| Conjugate IncubationDuration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenylphosphate | p-Nitrophenylphosphate |
{2}------------------------------------------------
| APPENDIX 3. | Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181Page No. 86 | |
|---|---|---|
| ubtrate Volume: | 100 μl | 100 μl |
| Substrate IncubationDuration: | 30 minutes | 30 minutes |
| Stop Reagent: | 0.5 M Trisodiumphosphate | 1.5 N Sodiumhydroxide |
| Stop Reagent Volume: | 100 μl | 100 μl |
| Readout: | Spectrophotometric405 nm | Spectrophotometric405 nm |
Summary of Clinical Testing:
Of the 157 specimens tested, 130 were positive, and 9 were negative in both the SeraQuest and Of the 157 specimens tested, 130 were positive in of remains and the many of in Gull Laboratories tests (please see Table by the SeraQuest test, and 11 specimens which were was negative by the Gull test, was postive by the SeraQuest test. Six specimens gave equivocal results
positive by the Gull test, were negative by the SeraQuest test. Six spe positive by the Gulf test, were nogalive by the been see Table 1 below.
TABLE 1.
.ESULTS OF SeraQuest EB VCA IgG ASSAYS, AND GULL VCA IgG ASSAYS, OF .ESULTS OF Seraudes EB VCA Titles TESTS WERE PERFORMED IN-HOUSE AT QUEST INTERNATIONAL, INC., MIAMI, FL.
| GULLVCAIgG | SeraQuest EB VCA IgG | |||||
|---|---|---|---|---|---|---|
| Positive | Equivocal | Negative | % | 95 % CI | ||
| Positive | 130 | 2 | 11 | Relative sensitivity* | 92.2 | 87.8 to 96.6 |
| Equivocal | 2 | 1 | 0 | Relative specificity* | 90.0 | 71.4 to 100 |
| Negative | 1 | 1 | 9 | Overall agreement* | 92.1 | 87.7 to 96.4 |
- Excluding equivocal results.
V 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.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
OCT 2 8 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, Florida 33181
Re: K990410 Trade Name: SeraQuest EB VCA IgG Regulatory Class: I Product Codc: LSE Dated: August 12, 1999 Received: September 8, 1999
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 datc 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 rcquirements, 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 Eederal 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.
{4}------------------------------------------------
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 (770)488-7655.
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" (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 (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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
Enclosure
{5}------------------------------------------------
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. (UC
APPENDIX 6
Page 1 of 1
510(k) Number (if known): ________
Device Name: SeraQuest EB VCA IgG
Indications For Use:
-
- For in vitro diagnostic use only.
-
- For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr viral capsid antigen (VCA) in human serum by enzyme immunoassay.
-
- For use as an aid in differentiating active or recent infection, from past infection.
-
- 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)
Woody Dubois
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K990410
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).