(273 days)
No
The device description details a standard ELISA assay based on chemical reactions and optical absorbance measurements. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as an ELISA kit for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum to determine immunological status or aid in the diagnosis of infection. This indicates it is a diagnostic tool, not a therapeutic device designed to treat or prevent disease.
Yes
The device detects IgG antibodies to rubella in human serum to aid in the diagnosis of current or recent infection with rubella, which is a diagnostic purpose.
No
The device description clearly outlines a physical ELISA kit with reagents and a microtiter well, indicating it is a hardware-based diagnostic test, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the detection of IgG antibodies to rubella in human serum. This is a test performed on a sample taken from the human body.
- Method: The device utilizes an ELISA technique, which is a common method for in vitro diagnostic testing.
- Purpose: The test is used to determine rubella immunological status and aid in the diagnosis of current or recent infection. These are diagnostic purposes.
The description clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The INCSTAR Rubella IgG "fast" ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Rubella IgG "fast" ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.
Product codes
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Device Description
The INCSTAR Rubella IgG "fast" ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
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
In clinical performance studies, 497 serum samples represented by 497 individuals were tested with the INCSTAR Rubella IgG "fast" ELISA Kit and results were compared to those results generated from the Rubella IgG Clin-ELISA kit. The samples utilized represent a mixed population of clinical patients (non-rubella disease related), newborns, employee/student screenings and pregnant women.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance studies; 497 serum samples; Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 91% to 100% and a relative specificity of 97% to 100%. In addition, the assay displayed an overall agreement of 97% to 99%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
relative sensitivity of 91% to 100%; relative specificity of 97% to 100%; overall agreement of 97% to 99%.
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.
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.
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 2 4 1996
SUMMARY OF SAFETY AND EFFECTIVENESS -
1
l. SUMMARY OF SAFETY AND EFFECTIVENESS
| DEVICE NAME: | INCSTAR Rubella IgG "fast" ELISA Kit |
|---|---|
| CLASSIFICATION: | Rubella virus serological reagents |
| Section 21 CFR 866.3510 | |
| Class III | |
| APPLICANT: | INCSTAR Corporation |
| 1990 Industrial Boulevard | |
| Stillwater, Minnesota 55082-0285 |
INTENDED USE:
The INCSTAR Rubella IgG "fast" ELISA Kit contains instructions and materials for the qualitative and/or semi-quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Rubella IgG "fast" ELISA test is of value in the determination of rubella immunological status. The evaluation of paired sera, acute and convalescent, by demonstrating seroconversion or a significant rise in antibody can aid in the diagnosis of current or recent infection with rubella.
DEVICE DESCRIPTION:
The INCSTAR Rubella IgG "fast" ELISA test kit utilizes the ELISA technique for the detection of rubella IgG antibodies. Diluted patient serum is incubated with purified rubella antigen bound to the solid surface of a microtiter well. If IgG antibodies to rubella are present in the patient's serum, antigen-antibody complexes are formed. These complexes bind with horseradish peroxidase labeled antihuman IgG which react with the addition of chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm, is directly proportional to the concentration of IgG antibodies to rubella antigen present in the reaction solution.
2
SUMMARY OF SAFETY AND EFFECTIVENESS (continued) l.
SAFETY AND EFFECTIVENESS:
The INCSTAR Rubella IgG "fast" ELISA Kit is substantially equivalent (SE) to the Rubella IgG Clin-ELISA Kit, 510(k) No. K860145, which has been cleared by the FDA and is currently in U.S. commercial distribution.
In clinical performance studies, 497 serum samples represented by 497 individuals were tested with the INCSTAR Rubella IgG "fast" ELISA Kit and results were compared to those results generated from the Rubella IgG Clin-ELISA kit. The samples utilized represent a mixed population of clinical patients (non-rubella disease related), newborns, employee/student screenings and pregnant women. Upon completion of assay correlation, the results (using 95% confidence intervals) demonstrated a relative sensitivity of 91% to 100% and a relative specificity of 97% to 100%. In addition, the assay displayed an overall agreement of 97% to 99%.
Further resolution of discrepant results by a commercial Rubella IgG EIA (Abbott Rubazyme EIA, 510(k) No. K885297) demonstrated that of the 5 samples positive by the INCSTAR Rubella IgG "fast" assay but negative by the reference ELISA assay, 3 were positive by the Rubazyme assay. Of the 3 samples negative by the INCSTAR Rubella IgG "fast" assay but positive by the reference ELISA assay, 2 were negative by the Rubazyme assay.
Prevalency, cross-reactivity, interference, linearity and precision studies have been conducted and are summarized in the INCSTAR Rubella IgG "fast" Kit package insert. (See Section VII.A.1. Package Insert).