(204 days)
Not Found
No
The device description details a standard chemiluminescent enzyme immunoassay process, and there is no mention of AI or ML in the device description, performance studies, or key metrics.
No
The device is an in vitro diagnostic device intended for the qualitative detection of antibodies to aid in determining immune status to rubella. It does not treat or cure any disease.
Yes
The "Intended Use / Indications for Use" states that the device is "intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella." Diagnostic devices are used to identify or determine a disease or condition. This device aids in determining immune status, which is a diagnostic purpose.
No
The device description clearly outlines a solid-phase, two-step, chemiluminescent enzyme immunoassay involving physical components like a polystyrene bead, a Test Unit, and the use of a luminometer to measure photon output. This indicates a hardware-based in vitro diagnostic device, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the device is "intended strictly for in vitro diagnostic use".
- Sample Type: The device is designed to detect antibodies in "human serum", which is a biological sample taken from the body.
- Purpose: The purpose is to aid in the "determination of immune status to rubella", which is a diagnostic assessment.
- Method: The "Device Description" details a laboratory-based assay (chemiluminescent enzyme immunoassay) performed on the sample outside of the body.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
IMMULITE Rubella IgG is designed for the qualitative detection of IgG antibodies to Rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella. This assay is particularly useful as an indicator of immune status for women of childbearing age.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
IMMULITE Rubella IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer.
IMMULITE® Rubella IgG is a solid-phasc, two-step, chemiluminescent enzyme immunoassay The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with partially purified rubella antigen.
Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, rubella IgG in the sample binds to the rubella antigen-coated bead. Unbound serum is then removed by a centrifugal wash.
An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for an additional 10 minutes.
The chemiluminescent substrate, a phosphate cster of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus the photon output, as measured by the luminometer - is directly related to the presence of rubella IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The clinical performance of the IMMULITE Rubella IgG assay was studied at Diagnostic Products Corporation (DPC) using a Rubella proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC).
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Rubella IgG assay, and sending the results to the CDC for unmasking. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 82% positive and 18% negative samples.
Studies on the clinical performance of the IMMULITE Rubella IgG assay were also conducted at a university medical center located in the northwestern United States. A total of 300 serum specimens (previously collected and frozen by the investigators) were tested. Of the 300 specimens used in the prospective clinical study, 31 were from healthy, asymptomatic individuals undergoing a pre-employment screening, 256 were from pregnant women undergoing rubella screening and the remainder were obtained from female patients with miscellaneous diseases and conditions (AIDS. heart disease, unmunocompromised, kidney transplant/dialysis). There were 9 male and 291 female subjects, with ages ranging from 11 to 57 vears.
All 300 specimens were evaluated with the IMMULITE Rubella IgG assay and the IMx Rubella IgG, an enzyme-linked fluorescent immunoassay (ELFA) which is commercially available on the IMx automated system.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The in-house (DPC) retrospective study with the CDC serum panel demonstrated 98% total agreement with the CDC results. Of the results obtained by DPC, there was 98% agreement with the positive specimens and 100% agreement with the negative specimens.
Clinical performance study at a university medical center (n=300):
98.6% Agreement
95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 97.4% - 99.9% and 72.0% - 98.9%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 99.3%
Relative Specificity: 91.3%
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.
IMx® Rubella IgG K885297
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.
Not Found
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).
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
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, CA 90045-5597 Tel: (213) 776-0180 Fax: (213) 776-0204
APR - 2 1997
Image /page/0/Picture/3 description: The image shows the logo for DPC. The letters are in a bold, sans-serif font and are arranged horizontally. The letters are all capitalized and are black. There is a registered trademark symbol to the right of the letter C.
510 (k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.
Name: Address:
Telephone Number: Facsimile Number:
Contact Person:
Date of Preparation:
Device Name: Trade: Catalog Number: Common:
Classification:
Manufacturer:
Establishment Registration #: Substantially Equivalent Predicate Device:
Description of Device:
Intended Use of the Device:
Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045
(213) 776-0180 (213) 776-0204
Edward M. Levine, Ph.D. Director of Clinical Affairs Januarv 20, 1997
IMMULITE® Rubella IgG LKRBZ (50 tests); LKRB2 (200 tests) Reagent system for the determination of rubella IgG antibodies in human serum.
Class III device (866.3510)
Diagnostic Products Corporation (DPC) 5700 West 96th Street Los Angeles, California 90045
#2017183
Abbott Laboratories' IMx® Rubella IgG K885297
IMMULITE Rubella IgG is a clinical device for use with the IMMULITE Automated Immunoassay Analyzer
IMMULITE Rubella IgG is designed for the qualitative detection of IgG antibodies to Rubella virus in human serum. It is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella. This assay is particularly useful as an indicator of immune status for women of childbearing age.
Image /page/0/Picture/26 description: The image shows a logo with the text "EXCELLENCE in DIAGNOSTICS" arranged in a circular fashion around a globe. The globe is stylized with visible continents and grid lines. To the left of the globe, the number "25" is prominently displayed, with the word "YEARS" underneath it. The logo appears to be for a company or organization celebrating 25 years of excellence in diagnostics.
1
Diagnostic Products Corporation 700 West 96th Street geles CA 90045 (213) 776-0180 (213) 776-0204
Summary and Explanation of the Device:
IMMULITE® Rubella IgG is a solid-phasc, two-step, chemiluminescent enzyme immunoassay The solid phase, a polystyrene bead enclosed within an IMMULITE® Test Unit, is coated with partially purified rubella antigen.
Prediluted patient sample (1-in-21 dilution) and a protein-based buffer are simultaneously introduced into the Test Unit, and incubated for approximately 30 minutes at 37°C with intermittent agitation. During this time, rubella IgG in the sample binds to the rubella antigen-coated bead. Unbound serum is then removed by a centrifugal wash
An alkaline phosphatase-labeled anti-human IgG antibody is introduced, and the Test Unit is incubated for another 30-minute cycle. The unbound enzyme conjugate is removed by a centrifugal wash. Substrate is then added, and the Test Unit is incubated for an additional 10 minutes.
The chemiluminescent substrate, a phosphate cster of adamantyl dioxetane, undergoes hydrolysis in the presence of alkaline phosphatase to vield an unstable intermediate. The continuous production of this intermediate results in the sustained emission of light, thus improving precision by providing a window for multiple readings. The bound complex - and thus the photon output, as measured by the luminometer - is directly related to the presence of rubella IgG in the sample. A qualitative result is then obtained by comparing the patient result to an established Cutoff.
Performance Equivalence - Technology Comparison:
Diagnostic Products Corporation (DPC) asserts that IMMULITE® Rubella IgG is substantially equivalent to the IMx® Rubella IgG kit marketed by Abbott Laboratories (Abbott Park, IL).
Each product is designed for the detection of igG antibodics to rubella virus in human serum. Each product is intended strictly for in vitro diagnostic use as an aid in the determination of immune status to rubella
IMMULITE® Rubella IgG is a chemiluminescent enzyme immunoassay, and IMx Rubella IgG is a microparticle enzyme immunoassay (MEIA) The technology in DPC's IMMULITE Rubella IgG is identical to technology used in previously cleared and commercially marketed IMMULITE® products.
In the IMx Rubella IgG assay, the patient sample and diluent buffer are added to predilution well of a reaction cell Rubella virus coated microparticles and the diluted sample are added to an incubation well. The Rubella antibody binds to the Rubella virus coated microparticles, forming an antigen-antibody complex. Diluent buffer is added to the reaction mixture and an aliquot of the antigen-antibody complex is transferred to the glass fiber matrix. The microparticles bind irreversibly to the glass fiber matrix. The matrix is washed to remove unbound materials. The anti-human IgG/alkaline phosphatase conjugate is dispensed onto the matrix and binds to the antigen-antibody complex. Finally, the matrix is washed to remove unbound materials, the substrate, 4-Methylumbellifery1 Phosphat: is added to the matrix, and the fluorescent product is measured by the optical assembly.
2
Diagnostic Products Corporation 5700 West 96th Street s Angeles, CA 90045 (213) 776-0180 Fax: (213) 776-0204
Performance Equivalence - Clinical Performance:
The clinical performance of the IMMULITE Rubella IgG assay was studied at Diagnostic Products Corporation (DPC) using a Rubella proficiency panel obtained from the United States Centers for Disease Control and Prevention (CDC)
The in-house (DPC) retrospective study was conducted by assaying the CDC serum panel with the IMMULITE Rubella IgG assay, and sending the results to the CDC for unmasking. The results are presented as a means to convey further information on the performance of this assay with a masked, characterized serum panel. This does not imply an endorsement of the assay by the CDC.
The panel consisted of 82% positive and 18% negative samples. The IMMULITE Rubella IgG assay demonstrated 98% total agreement with the CDC results. Of the results obtained by DPC, there was 98% agreement with the positive specimens and 100% agreement with the negative specimens
Studies on the clinical performance of the IMMULITE Rubella IgG assay were also conducted at a university medical center located in the northwestern United States. A total of 300 serum specimens (previously collected and frozen by the investigators) were tested. Of the 300 specimens used in the prospective clinical study, 31 were from healthy, asymptomatic individuals undergoing a pre-employment screening, 256 were from pregnant women undergoing rubella screening and the remainder were obtained from female patients with miscellaneous diseases and conditions (AIDS. heart disease, unmunocompromised, kidney transplant/dialysis). There were 9 male and 291 female subjects, with ages ranging from 11 to 57 vears
All 300 specimens were evaluated with the IMMULITE Rubella IgG assay and the IMx Rubella IgG, an enzyme-linked fluorescent immunoassay (ELFA) which is commercially available on the IMx automated system
IMMULITE Rubella IgG
| IMx | Positive | Indeterminate | Negative | Relative
Sensitivity | Relative
Specificity |
|---------------|----------|---------------|----------|-------------------------|-------------------------|
| Positive | 271 | 1 | 2 | 99.3% | 91.3% |
| Indeterminate | 0 | 0 | 0 | | |
| Negative | 2 | 3 | 21 | | |
98.6% Agreement: 95% Confidence Limits for Relative Sensitivity and Specificity, respectively: 97.4% - 99.9% and 72.0% - 98.9%
Conclusion:
The conclusions drawn from the clinical and nonclinical studies demonstrate that the device is safe, effective, and performs as well as, or better, than the current legally marketed devices.
Edward R. Lewis
Edward M. Levine., Ph.I). Director of Clinical Affairs
1/23/97
Date
DPC®