(144 days)
For in vitro diagnostic use only.
For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-Barr virus nuclear antigen in human serum by enzyme immunoassay.
May be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis.
The SeraQuest EB NA 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 nuclear antigen, in human serum.
The Calibrators in the SeraQuest EB NA IgG test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Here's an analysis of the provided text regarding the SeraQuest® EB NA IgG device, focusing on acceptance criteria, study details, and ground truth establishment:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SeraQuest EB NA IgG test were established relative to the predicate device, Gull Laboratories' EBNA IgG ELISA test. The performance metrics are reported as relative sensitivity, relative specificity, and overall agreement.
| Metric | Acceptance Criteria (Implied / Comparator Performance) | Reported Device Performance (SeraQuest EB NA IgG) |
|---|---|---|
| Relative Sensitivity | Performance comparable to predicate device | 99.0 % (95% C.I.: 97.2 % to 100 %) |
| Relative Specificity | Performance comparable to predicate device | 95.6 % (95% C.I.: 89.8 % to 100 %) |
| Overall Agreement | Performance comparable to predicate device | 98.0 % (95% C.I.: 95.8 % to 100 %) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 157 archival serum specimens.
- Data Provenance: The specimens included:
- 80 from patients whose sera were submitted to a clinical laboratory for EBV serological testing.
- 11 from donors reported to be positive for EBV antibodies, obtained through serum brokers.
- 66 from normal serum donors.
- The term "archival serum specimens" suggests a retrospective nature for the study. The country of origin is not explicitly stated, but the applicant (Quest International, Inc.) is based in North Miami, FL, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth for the test set was established by the predicate device, the Gull Laboratories' EBNA IgG test. Therefore, no human experts were explicitly used to establish ground truth in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. The study compared the new device (SeraQuest EB NA IgG) directly against a predicate device (Gull Laboratories' EBNA IgG test). There was no adjudication process involving multiple human readers to resolve discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This study compares a new in-vitro diagnostic device to a predicate in-vitro diagnostic device, not human readers with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance study was done. The SeraQuest EB NA IgG test is an in-vitro diagnostic kit and its performance was evaluated directly without human interpretation as part of the primary outcome measure, other than following manufacturers' instructions.
7. The Type of Ground Truth Used
The ground truth for this comparison study was established by the performance of the predicate device, the Gull Laboratories' EBNA IgG ELISA test.
8. The Sample Size for the Training Set
No training set is mentioned or applicable in the context of this submission. The SeraQuest EB NA IgG test is a laboratory kit, not an AI/machine learning algorithm requiring a training dataset. The submission focuses on the analytical and clinical performance of the manufactured kit.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
{0}------------------------------------------------
NOV - 2 1999
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 NA IgG |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) |
| Device Classification: | Class I (general controls) |
Description:
The SeraQuest EB NA 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 nuclear antigen, in human serum.
The Calibrators in the SeraQuest EB NA 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 nuclear antibodies directed against Epstein-Barr nuclear antigen (if present) are immobilized in the wells. Residual sample is eliminated by washing and draining, and conjugate (enzyme-labeled antibodies to human IQG) is added and incubated. If IoG antibodies to Epstein-Barr nuclear antigen 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:
Intended Use: The SeraQuest EB NA IgG test is intended for the qualitive and semi-quantative detection of human IgG antibodies to Epstein-Barr nuclear antigen, in human serum by enzyme
{1}------------------------------------------------
immunoassay. The test may be used in conjunction with other EBV serologicals as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.
Predicate Device:
The SeraQuest EB NA IgG test is substantially equivalent in intended use and performance, to the Gull Laboratories' EBNA 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 |
| Antigen : | RecombinantEBNA-1 | RecombinantEBNA-1 |
| 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 μl | 100 μl |
| Conjugate IncubationDuration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenylphosphate | p-Nitrophenylphosphate |
| APPENDIX 3. | Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181Page No. 12 | |
| Subtrate 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 |
{2}------------------------------------------------
Summary of Clinical Testing:
Experimental Procedure
To challenge the cutoff values, 157 archival serum specimens were tested at Quest International, Inc., concurrently by the SeraQuest EB NA IgG test and Gull Laboratories' EBNA IgG test. The test specimens included: 80 from patients whose sera were submitted to a clinical laboratory for EBV serological testing, 11 from donors reported to be positive for EBV antibodies, which were obtained through serum brokers, and 66 from normal serum donors. The assays were performed and interpreted according to the manufacturers package inserts.
Results and Conclusion
Of the 157 specimens tested, 105 were positive, and 44 were negative in both the SeraQuest and Gull Laboratories' tests (please see Table 1). Of the 8 remaining specimens which were negative by the Gull test, were positive by the SeraQuest test, and 1 specimen which was positive by the Gull test, was negative by the SeraQuest test. Five specimens which gave equivocal results in the SeraQuest test were negative in the Gull test. The Gull test has no equivocal interpretation.
Excluding the equivocal results, the sensitivity of the SeraQuest EB NA IgG test relative to Gull Laboratories NA IgG test was 99.0 %, or 97.2 % to 100 % (95% C.I.); the specificity was 95.6 %, or 89.48% to 100 % (95% C.I.); respectively. The overall agreement was 98.0%, or 95.8 to 100% (95% C.I.) (please see Table C-3).
{3}------------------------------------------------
APPENDIX 3. Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. رج
TABLE 1.
RESULTS OF SeraQuest EBNA IgG ASSAYS, AND GULL EBNA IgG ELISA TESTS OF 157 SERUM SPECIMENS.
SeraQuest EBNA IgG
| GULLEBNA IgG | Positive | Negative | Equivocal | % | 95% CI√ | |
|---|---|---|---|---|---|---|
| Positive | 105 | 1 | 0 | Relative Sensitivity | 99.0 | 97.2 to 100 |
| Negative | 2 | 44 | 5 | Relative specificity*Overall agreement* | 95.698.0 | 89.8 to 10095.8 to 100 |
- Excluding equivocals.
V Calculated by the normal method.
{4}------------------------------------------------
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines that suggest the wings and body of the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV - 2 1999
Mr. Robert A. Cort Vice President, Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami. Florida 33181
Re: K991975 Trade Name: SeraQuest EB NA IgG Regulatory Class: I Product Code: LSE Dated: September 10, 1999 Received: September 13, 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 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.
{5}------------------------------------------------
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
{6}------------------------------------------------
Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181 Page No. 14
APPENDIX 5 (REVISED)
Page . 1 _ of _ 1 _ 1 .
510(k) Number (if known): _K991975
Device Name: __SeraQuest EB_NA IgG
Indications For Use:
- For in vitro diagnostic use only. 1.
- For the qualitative and semi-quantitative detection of IgG antibodies to Epstein-2. Barr virus nuclear antigen in human serum by enzyme immunoassay.
- May be used in conjunction with other EBV serologicals as an aid in the diagno-3. sis of infectious mononucleosis.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
§ 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).