(42 days)
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No
The device description and performance studies describe a standard enzyme immunoassay (EIA) for detecting antibodies, which does not involve AI/ML. There are no mentions of AI, ML, or related concepts in the provided text.
No
The device is an in vitro diagnostic (IVD) test for detecting antibodies, which aids in diagnosis rather than providing treatment or therapy.
Yes
The intended use explicitly states "For in vitro diagnostic use only" and "as an aid in differentiating active or recent Epstein-Barr virus infection from past infection," which are characteristics of a diagnostic device.
No
The device description clearly states it is a solid-phase enzyme immunoassay (EIA) performed in microwells, indicating a physical laboratory test kit with reagents and hardware components, not software alone.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use only."
- Device Description: The description details a test performed "in microwells" using "human serum," which are characteristic of in vitro diagnostic procedures.
- Purpose: The purpose is to detect antibodies in a biological sample (serum) to aid in diagnosing an infection, which is a core function of an IVD.
N/A
Intended Use / Indications for Use
For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.
- For In Vitro Diagnostic Use
- For the qualitative detection of human IgM antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay, as viral oupold antigoritiating active or recent Epstein-Barr virus infection from past infection.
A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.
Product codes (comma separated list FDA assigned to the subject device)
LJN
Device Description
The SeraQuest VCA 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 Epstein-Barr virus capsid antigen, in human serum.
The Calibrators in the SeraQuest VCA IgM test set have been assigned Index values based on an in-house standard. Test results are reported as Index values.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
113 specimens tested, 18 of which were positive and 91 were negative in both the SeraQuest and Zeus' VCA IgM tests. The specimens were archival patient specimens tested at SeraQuest, Miami, FL.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: Of the 113 specimens tested, 18 were positive, and 91 were negative in both the SeraQuest and Zeus' VCA IgM tests. Of the 4 remaining specimens, 2 specimens which were positive by the Zeus' test, one was negative and the other equivocal by the SeraQuest test. One specimen which was equivocal by the Zeus' test, was negative by the SeraQuest test. One specimen which was negative by the Zeus' test, was equivocal by the SeraQuest test.
Overall agreement [ (TP + TN) / (TP + TN + FP + FN ) ] = 99.0 % * 95 % CI = 97.3 to 100 % **
- Excluding equivocal results
** Calculated by the normal method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall agreement = 99.0 %
95 % CI = 97.3 to 100 %
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The SeraQuest VCA IgM test is substantially equivalent in intended use and performance, to the Zeus' EBV IgM ELISA test, Zeus Scientific, Inc., Raritan, New Jersey. 08869.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
| JAN 1 5 2004 | 510(k) SUMMARY | K033780 |
|---|---|---|
| Applicant: | Quest International, Inc. | |
| 1938 N.E. 148th Terrace | ||
| North 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® VCA IgM | |
| Device Name: | Epstein-Barr virus serological reagents (21CFR § 866.3235) | |
| Device Classification: | Class I (general controls) |
Description:
The SeraQuest VCA 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 Epstein-Barr virus capsid antigen, in human serum.
The Calibrators in the SeraQuest VCA 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 Epstein-Barr virus capsid antigen. Absorbents have been included in the Diluent to neutralize the affects of rheumatoid factor and IgG antibody. Antibodies directed against Epstein-Barr virus capsid antigen (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 Epstein-Barr virus capsid antigen are present, the coniugate 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.
1
Intended Use:
For the qualitative detection of IgM antibodies to Epstein-Barr (EB), viral capsid antigen (VCA) in human serum by enzyme immunoassay, as an aid in differentiating active or recent Epstein-Barr virus infection from past infection. For in vitro diagnostic use only.
Predicate Device:
The SeraQuest VCA IgM test is substantially equivalent in intended use and performance, to the Zeus' EBV IgM ELISA test, Zeus Scientific, Inc., Raritan, New Jersey. 08869.
Summary of technological characteristics:
| Characteristic | SeraQuest VCA IgM | Zeus' EBV-VCA IgM ELISA | |
|---|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay | |
| Intended Use: | The detection of IaM | ||
| antibodies against Epstein- | |||
| Barr virus capsid antigen | |||
| in human serum. | The detection of IgM | ||
| antibodies against Epstein- | |||
| Barr virus capsid antigen | |||
| in human serum. | |||
| Solid Phase: | Plastic Microwell | Plastic Microwell | |
| Antigen : | Purified gp125 | Purified gp 125 | |
| Number of Incubation Periods: | Three | Three | |
| Sample Dilution: | 1:51 | 1:21 | |
| Sample Incubation | |||
| Duration: | 30 minutes | 25 minutes | |
| Incubation Temperature: | |||
| Ezyme-labeled Conjugate: | Room temperature | Room temperature | |
| Antibodv | Goat anti-human IgM | Goat anti-human IgM | |
| Label | Alkaline phosphatase | Horseradish Peroxidase | |
| Conjugate Volume: | 100 µl | 100 ul | |
| Conjugate Incubation | |||
| Duration: | 30 minutes | 25 minutes |
2
| Quest International, Inc. 1938 N.E. 148th Terrace, N. Miami, Fl. 33181
| ATTACHMENT 5 | Page No. 18 | |
|---|---|---|
| Substrate: | p-Nitrophenyl | |
| phosphate | TMB | |
| Subtrate Volume: | 100 μl | 100 μl |
| Substrate Incubation | ||
| Duration: | 30 minutes | 10 minutes |
| Stop Reagent: | 0.5 M Trisodium | |
| phosphate | 1M H2SO4,0.7M HCL | |
| Stop Reagent Volume: | 100 μl | 50 μl |
| Readout: | Spectrophotometric | |
| 405 nm | Spectrophotometric | |
| 450 nm |
Summary of Clinical Testing:
Of the 113 specimens tested, 18 were positive, and 91 were negative in both the SeraQuest and Zeus' VCA IgM tests (please see Table 1). Of the 4 remaining specimens, 2 specimens which were positive by the Zeus' test, one was negative and the other equivocal by the SeraQuest test. One specimen which was equivocal by the Zeus' test, was negative by the SeraQuest test. One specimen which was negative by the Zeus' test, was equivocal by the SeraQuest test.
Table 1.
Results of Tests of 113 Archival Patient Specimens Tested at SeraQuest, Miami, FL, Using the SeraQuest EB VCA IgM Test and the Zeus EBV VCA IgM EIA Test.
| SeraQuest VCA IgM | ||||
|---|---|---|---|---|
| Zeus | ||||
| EBV-VCA IgM | Positive | Negative | Equivocal | Total |
| Positive | 18 | 1 | 1 | 20 |
| Negative | 0 | 91 | 1 | 92 |
| Equivocal | - | 1 | - | 1 |
| Total | 18 | 93 | 2 | 113 |
Overall agreement [ (TP + TN) / (TP + TN + FP + FN ) ] = 99.0 % * 95 % CI = 97.3 to 100 % **
- 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, 198
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features an abstract eagle design with three stylized wing segments. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administratio 2098 Gaither Road Rockville MD 20850
JAN 1 5 2004
Mr. Robert A. Cort V. P., Quality Assurance Quest International, Inc. 1938 N.E. 148th Terrace North Miami, FL 33181
Re: K033780
Trade/Device Name: SeraQuest® VCA IgM Regulation Number: 21 CFR 866.3235 Regulation Name: Epstein-Barr virus serological reagents Regulatory Class: Class I Product Code: LJN Dated: November 26, 2003 Received: December 16, 2003
Dear Mr. Cort:
We have reviewed your Section 510(k) premarket notification of intent to market the device w f nave a showe and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may) aters, and second in 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that 119 Federal statutes and regulations administered by other Federal agencies. You must or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter with and The FDA finding of substantial equivalence of your device to a legally premaince revilledied. to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or guestions on the promotion and advertising of your device, please contact the Office of of questions on the provice Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Saqartys
Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number ________________________________________________________________________________________________________________________________________________________________
Device Name __ SeraQuest EB VCA IgM
Indications for Use:
-
- For In Vitro Diagnostic Use
-
- For the qualitative detection of human IgM antibodies to Epstein-Barr (EB) viral capsid antigen (VCA) in human serum by enzyme immunoassay, as viral oupold antigoritiating active or recent Epstein-Barr virus infection from past infection.
- A positive result is presumptive for the detection of anti-Epstein-Barr virus IgM antibodies and presumptive for the diagnosis of acute or recent Epstein-Barr virus infection.
| Prescription Use |
|---|
| (Part 21 CFR Subpart D) |
OR
Over-The-Counter-Use (21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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KO33780 -510(k)________________________________________________________________________________________________________________________________________________________________________