(170 days)
Rubella IgG Clin-ELISA™ kit
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No
The summary describes a standard enzyme immunoassay (EIA) for detecting antibodies, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is an in-vitro diagnostic test used to detect Rubella IgG antibodies, aiding in the diagnosis of infection or assessment of immune response, rather than treating a disease.
Yes
The device is described as aiding "in the determination of infection with rubella virus" and in the "assessment of the patient's immunological response to rubella," which are diagnostic purposes. It also performs qualitative and quantitative detection of human IgG antibodies to Rubella, which is a diagnostic function.
No
The device description clearly states it is a "solid-phase enzyme immunoassay (EIA), which is performed in microwells," indicating a physical kit with reagents and components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus." This describes a test performed on a sample taken from the human body (serum) to provide information about a medical condition (rubella infection).
- Device Description: The description details a "solid-phase enzyme immunoassay (EIA), which is performed in microwells... to detect IgG antibodies which are directed against rubella virus, in human serum." This further confirms it's a laboratory test performed on a biological sample.
- Performance Studies: The performance studies describe testing human serum samples and comparing the results to another similar test. This is typical for validating an IVD.
The core function of the device is to analyze a biological sample (human serum) in vitro (outside the body) to provide diagnostic information about a disease. This aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus. When used as a qualitative test, SeraQuest Rubella IgG aids in the assessment of the patient's immunological response to rubella. For manual use, or for use with the HyPrep System Plus.
Product codes
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Device Description
The SeraQuest™ Rubella 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 rubella virus, in human serum.
The Calibrators in the SeraQuest Rubella IgG test set have been assigned Index values based on an in-house standard, and International Unit values (IU / ml) which are traceable to the WHO International Reference Preparation of Anti-rubella Serum. Test results may be reported as Index values, or as IU / ml.
Mentions image processing
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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
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Summary of Performance Studies
Two hundred and sixty sera from normal blood donors were assayed for the presence of Rubella IgG antibodies, using the SeraQuest™ Rubella IgG test and the INCSTAR Rubella IgG Clin-'SA™ test. Two hundred and four specimens were positive and forty-one specimens were yative in both tests. Seven specimens were negative in the SeraQuest Rubella IgG test, which were weakly positive in the INCSTAR Rubella IgG Clin-ELISA™ test; and 8 specimens gave equivocal results in the SeraQuest test, which were also weakly positive in the INCSTAR test. The latter test does not have an equivocal interpretation. Excluding the equivocal results, the overall agreement between the two tests was 97.2 % (95% Confidence Interval = 95.2 to 99.3).
Key Metrics
Relative sensitivity: 94.3 to 99.1
Relative specificity: 95.4 to 100
Overall agreement: 95.2 to 99.3
Predicate Device(s)
Rubella IgG Clin-ELISA™ kit
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
510(k) SUMMARY
| Applicant: | Quest International, Inc.
1938 N.E. 148th Terrace
North Miami, FL 33181 | SEP - 4 1996 |
|------------------------|-------------------------------------------------------------------------------|--------------|
| Registration No. | FDA form 2891 was submitted on April 1, 1995. | |
| Contact Person: | Robert A. Cort, President | |
| Telephone: | (305) 948-8788 | |
| Telefax: | (305) 948-4876 | |
| Manufacturing Site: | Same as above | |
| Device: | SeraQuest™ Rubella IgG | |
| Device Name: | Rubella serological reagents (21CFR § 866.3510) | |
| Device Classification: | Class III (premarket approval) | |
scription:
The SeraQuest™ Rubella 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 rubella virus, in human serum.
The Calibrators in the SeraQuest Rubella IgG test set have been assigned Index values based on an in-house standard, and International Unit values (IU / ml) which are traceable to the WHO International Reference Preparation of Anti-rubella Serum. Test results may be reported as Index values, or as IU / ml.
Principle:
Diluted samples are incubated in rubella antigen-coated wells. Rubella antibodies (if present) are immobilized in the wells. Residual sample is eliminated by washing, and conjugate (enzyme-labeled antibodies to human IgG) is added and incubated. If IgG antibodies to rubella 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 yellow end-product which is read photometrically.
1
anded Use:
For the qualitative and quantitative detection of human IgG antibodies to Rubella in human serum by enzyme immunoassay, to aid in the determination of infection with rubella virus. When used as a qualitative test, SeraQuest Rubella IgG aids in the assessment of the patient's immunological response to rubella. For manual use, or for use with the HyPrep System Plus.
Predicate device:
The SeraQuest™ Rubella IgG test is substantially equivalent in intended use and performance, to the Rubella IgG Clin-ELISA™ kit, INCSTAR Corporation, Stillwater Minnesota.
Summary of technological characteristics:
| Characteristic | SeraQuest™ Rubella IgG | INCSTAR Rubella IgG Clin-ELISA™ |
|---|---|---|
| Description: | Enzyme Immunoassay | Enzyme Immunoassay |
| Intended Use: | The detection of IgG | |
| antibodies against Rubella | ||
| in human serum. | The detection of IgG | |
| antibodies against Rubella | ||
| in human serum. | ||
| Solid Phase: | Plastic Microwell | Plastic Microwell |
| Antigen Strain: | HPV 77 | Not Stated in Package Insert |
| Number of Incubation Periods: | Three | Three |
| Sample Dilution: | 1:50 | 1:50 |
| Sample Incubation | ||
| Duration: | 30 minutes | 30 minutes |
| Incubation Temperature: | Room temperature | Room temperature |
| Ezyme-labeled Conjugate: | ||
| Antibody | Goat anti-human IgG | Goat or Sheep anti-human IgG |
| Enzyme | Alkaline phosphatase | Alkaline phosphatase |
| Conjugate Volume: | 100 µl | 200 µl |
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| APPENDIX 8. | Quest International, Inc., 1938 N.E. 148th Terrace, N. Miami, FL 33181
Page No. | |
|--------------------------------|------------------------------------------------------------------------------------|---------------------------|
| njugate Incubation Duration: | 30 minutes | 30 minutes |
| Substrate: | p-Nitrophenyl phosphate | p-Nitrophenyl phosphate |
| Subtrate Volume: | 100 μl | 200 μl |
| Substrate Incubation Duration: | 30 minutes | 45 minutes |
| Stop Reagent: | 0.5 M Trisodium phosphate | 3 N Sodium Hydroxide |
| Stop Reagent Volume: | 100 μl | 50 μl |
| Readout: | Spectrophotometric 405 nm | Spectrophotometric 405 nm |
Summary of Clinical Testing:
Two hundred and sixty sera from normal blood donors were assayed for the presence of Rubella IgG antibodies, using the SeraQuest™ Rubella IgG test and the INCSTAR Rubella IgG Clin-'SA™ test. Two hundred and four specimens were positive and forty-one specimens were yative in both tests. Seven specimens were negative in the SeraQuest Rubella IgG test, which were weakly positive in the INCSTAR Rubella IgG Clin-ELISA™ test; and 8 specimens gave equivocal results in the SeraQuest test, which were also weakly positive in the INCSTAR test. The latter test does not have an equivocal interpretation. Excluding the equivocal results, the overall agreement between the two tests was 97.2 % (95% Confidence Interval = 95.2 to 99.3). These results are shown below in Table 1.
TABLE 1.
RESULTS OF SeraQuest™ RUBELLA IgG ASSAYS, AND INCSTAR RUBELLA IgG Clin-ELISA ASSAYS, OF 260 SERUM SPECIMENS.
| INCSTAR
| RUBELLA IgG | SeraQuest RUBELLA IgG | 95 % CI* | |||
|---|---|---|---|---|---|
| Positive | Equivocal | Negative | |||
| Positive | 204 | 8 | 7 | Relative sensitivity | 94.3 to 99.1 |
| Negative | 0 | 0 | 41 | Relative specificity | |
| Overall agreement | 95.4 to 100 | ||||
| 95.2 to 99.3 |
ixcluding equivocal results.
Calculated by the normal method .