(108 days)
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Diamedix Rubella IgM Microassay
No
The device description and performance studies focus on a standard enzyme immunoassay (EIA) and a semi-automated fluid handler. There is no mention of AI, ML, or related concepts.
No
The device is an in vitro diagnostic (IVD) test used to detect Rubella virus antibodies, aiding in diagnosis, not for treating or preventing disease.
Yes
This device is intended to aid in the diagnosis of Rubella infection by detecting human IgM antibodies to Rubella virus. This function aligns directly with the definition of a diagnostic device.
No
The device is an in vitro diagnostic (IVD) kit that performs a solid-phase enzyme immunoassay (EIA) using physical components (microwells, reagents) and can be used manually or with a semi-automated fluid handler (HyPrep System Plus). It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For In Vitro Diagnostic Use Only." It also describes the device's purpose as the "qualitative detection of human IgM antibodies to Rubella virus in human serum by enzyme immunoassay, to aid in the diagnosis of Rubella infection." This clearly indicates the device is intended for use on biological samples (serum) outside of the body to provide information for diagnostic purposes.
- Device Description: The description details a "solid-phase enzyme immunoassay (EIA)" performed in microwells, which is a common format for in vitro diagnostic tests.
- Intended User/Care Setting: While not explicitly stating a clinical lab, the mention of "For In Vitro Diagnostic Use Only" and the use of a semi-automated fluid handler (HyPrep System Plus) strongly suggest a professional laboratory setting.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
LFX
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Agreement excluding equivocal results, 97.7 %
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.3510 Rubella virus serological reagents.
(a)
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).(b)
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.
0
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
- (305) 948-8788 Telephone:
- Telefax: (305) 948-4876
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.
1
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 | ||
| antibodies against Rubella | |||
| virus in human serum. | The detection of IgM | ||
| antibodies against Rubella | |||
| virus in human serum. | |||
| Antigen Strain | HPV-77 | Not stated in | |
| 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 | |||
| Duration: | None | None | |
| Sample Incubation | |||
| 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 | |||
| Duration: | |||
| Substrate: | 30 minutes | 30 minutes | |
| p-Nitrophenyl | |||
| phosphate | p-Nitrophenyl | ||
| phosphate | |||
| Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL | |||
| 33181 | |||
| Page No. | |||
| APPENDIX 5, revised. | |||
| Subtrate Volume: | 100 µl | 100 µl | |
| Substrate Incubation | |||
| Duration: | 30 minutes | 30 minutes | |
| Stop Reagent: | 0.5 M Trisodium | ||
| phosphate | 0.5 M Trisodium | ||
| phosphate | |||
| Stop Reagent Volume: | 100 µl | 100 µl | |
| Readout: | Spectrophotometric | ||
| 405 nm | Spectrophotometric | ||
| 405 nm |
2
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.
3
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
Rubella
| IgM | SeraQuest Rubella IgM | ||
|---|---|---|---|
| Positive | Equivocal | Negative | |
| Positive | 46 | 0 | 0 |
| Negative | 2 | 3 | 40 |
Agreement excluding equivocal results, 97.7 %
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 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.
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 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
6
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
(Division Sign-Off)
Division of Clinical Laboratory Devices |
|---------------|--------------------------------------------------------------------------------|
| 510(k) Number | K98 2281 |
| Prescription Use | X | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
(Optional Format 1-2-96)