(273 days)
No
The device description details a standard ELISA assay which relies on chemical reactions and absorbance measurements, not AI/ML algorithms for analysis or interpretation. The summary explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is an in vitro diagnostic (IVD) test used to detect antibodies for determining rubella immunological status or diagnosing a recent rubella infection. It does not provide any therapeutic benefit or treatment.
Yes
The device detects IgG antibodies to rubella, and the instructions state that it can "aid in the diagnosis of current or recent infection with rubella." This direct contribution to diagnosis qualifies it as a diagnostic device.
No
The device description clearly outlines a physical test kit utilizing ELISA technique with reagents, microtiter wells, and measurement of absorbance, indicating it is a hardware-based diagnostic kit, 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 biological sample taken from the human body.
- Technique: The device uses an ELISA (Enzyme-Linked Immunosorbent Assay) technique, which is a common method for performing tests on biological samples in vitro (outside the body).
- Purpose: The test is used to determine rubella immunological status and aid in the diagnosis of current or recent infection. This is a diagnostic purpose.
The definition of an In Vitro Diagnostic (IVD) device is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures. This device clearly fits this definition.
N/A
Intended Use / Indications for Use
The INCSTAR Rubella IgG 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) - all technique. When performed according to instructions, the Rubella IgG 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
Not Found
Device Description
The INCSTAR Rubella IgG 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 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 (nonrubella disease related), newborns, employee/student screenings, and pregnant women.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
In clinical performance studies, 497 serum samples represented by 497 individuals were tested with the INCSTAR Rubella IgG 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 (nonrubella 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 96% 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 assay but negative by the reference ELISA assay, 4 were positive by the Rubazyme assay. Of the 7 samples negative by the INCSTAR Rubella IgG assay but positive by the reference ELISA assay, 4 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 Kit package insert. (See Section VII.A.1. Package Insert)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative sensitivity of 91% to 100% and a relative specificity of 97% to 100%. Overall agreement of 96% 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.
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OCT 2 4 1996
SUMMARY OF SAFETY AND EFFECTIVENESS l.
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SUMMARY OF SAFETY AND EFFECTIVENESS 1.
| DEVICE NAME: | INCSTAR Rubella IgG ELISA Kit |
|---|---|
| CLASSIFICATION: | Rubella virus serological reagents |
| Section 21 CFR 866.3510 | |
| Class III | |
| APPLICANT: | INCSTAR Corporation |
| 1990 Industrial Boulevard |
INTENDED USE:
The INCSTAR Rubella IgG 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) - all technique. When performed according to instructions, the Rubella IgG 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.
Stillwater, Minnesota 55082-0285
DEVICE DESCRIPTION:
The INCSTAR Rubella IgG 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.
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SUMMARY OF SAFETY AND EFFECTIVENESS (continued) ﻨﺴ
SAFETY AND EFFECTIVENESS:
The INCSTAR Rubella IgG 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 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 (nonrubella disease related), newborns, employee/student screenings, and pregnant Upon completion of assay correlation, the results (using 95% women. 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 96% 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 assay but negative by the reference ELISA assay, 4 were positive by the Rubazyme assay. Of the 7 samples negative by the INCSTAR Rubella IgG assay but positive by the reference ELISA assay, 4 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 Kit package insert. (See Section VII.A.1. Package Insert)
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