(242 days)
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Abbott Rubazyme M EIA, BioWhittaker RUBASTAT M
No
The description details a standard immunoassay technology and automated analyzer, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an in vitro diagnostic (IVD) assay designed to detect IgM antibodies to rubella virus to aid in diagnosis, not to treat or prevent a disease.
Yes
The "Intended Use / Indications for Use" section states: "...to aid in the diagnosis of primary or acute infection." This clearly indicates its purpose is diagnostic.
No
The device description clearly states it is an "automated microparticle enzyme immunoassay performed with the AxSYM, a random and continuously accessed automated immunoassay analyzer." This indicates a physical instrument and reagents are involved, not just software.
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 assay is for the "qualitative measurement of IgM antibodies to rubella virus in human serum and plasma... to aid in the diagnosis of primary or acute infection." This clearly indicates that the device is intended to be used in vitro (outside the body) to analyze a biological sample (serum and plasma) for diagnostic purposes.
- Device Description: The "Device Description" further reinforces this by describing it as an "in vitro immunologic test method intended for use in the detection of IgM antibody to rubella virus in human serum or plasma."
- Sample Type: The device analyzes human serum and plasma, which are biological samples.
- Diagnostic Purpose: The stated purpose is to "aid in the diagnosis of primary or acute infection," which is a diagnostic application.
Therefore, based on the provided information, the AxSYM Rubella IgM Antibody assay fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AxSYM Rubella IgM Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to rubella virus in human serum and plasma (EDTA, heparin or sodium citrate) to aid in the diagnosis of primary or acute infection. The AxSYM Rubella IgM assay is not for use with cord blood or neonatal specimens.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The AxSYM Rubella IgM Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to rubella virus in human serum and plasma (EDTA, heparin or sodium citrate). It is performed on the AxSYM, a random and continuously accessed automated immunoassay analyzer. The assay pretreats all samples with an RF neutralization buffer.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The AxSYM Rubella IgM Antibody assay was compared to the Abbott IMx Rubella IgM Antibody assay in three clinical sites using 1300 samples from pregnant women, non-pregnant individuals and individuals positive for IgM antibodies to rubella. The AxSYM Rubella IgM Antibody assay showed a relative sensitivity of 95.7%, relative specificity of 99.4% and a relative agreement of 99.1%. Percent CV's on positive panel members and positive controls was 6.9% to 12.6%. Further evaluation of 11 discordant specimens was performed using two additional legally marketed assays (Abbott Rubazyme M EIA and BioWhittaker RUBASTAT M).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative Sensitivity: 95.7%
Relative Specificity: 99.4%
Relative Agreement: 99.1%
Percent CV's on positive panel members and positive controls: 6.9% to 12.6%
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.
Abbott's legally marketed IMx Rubella IgM Antibody assay
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.
Abbott Rubazyme M EIA, BioWhittaker RUBASTAT M
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).
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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.
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ATTACHMENT A
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination and Certification of Search for Adverse Safety and Effectiveness
MAY 1 4 1996
1
Abbott Laboratories AxSYM Rubella IgM Antibody Assay [ 510(k)] Submission
[510(k)] Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination
The following information presented in the [510(k)] Submission for the AxSYM Rubella IgM Antibody assay constitutes data supporting a substantially equivalent determination:
[510(k) ]Summary of Device Performance
The AxSYM Rubella IgM Antibody assay is a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to rubella virus in human serum and plasma (EDTA, heparin or sodium citrate) to aid in the diagnosis of primary or acute infection. The AxSYM Rubella IgM assay is not for use with cord blood or neonatal specimens.
The predicate device for determination of substantial equivalence is Abbott's legally marketed IMx Rubella IgM Antibody assay, a Microparticle Enzyme Immunoassay (MEIA) for the qualitative measurement of IgM antibodies to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate) to aid in the diagnosis of primary infection. The IMx Rubella IgM assay is not for use with cord blood or neonate specimens.
In three clinical sites, the AxSYM Rubella IgM Antibody assay was compared to the Abbott IMx Rubella IgM Antibody assay using 1300 samples from pregnant women, non-pregnant individuals and individuals positive for IgM antibodies to rubella. The AxSYM Rubella IgM Antibody assay was shown to have a relative sensitivity of 95.7%, relative specificity of 99.4% and a relative agreement of 99.1%. Percent CV's on positive panel members and positive controls was 6.9% to 12.6%.
Further evaluation of 11 discordant specimens was performed using two additional legally marketed assays (Abbott Rubazyme M EIA and BioWhittaker RUBASTAT M). Of the seven specimens positive by AxSYM and negative by EIA, two were found to be positive, four were found to be negative and one was found to be equivocal for IgM antibody. Of the four specimens negative by AxSYM and positive by EIA, one was found to be negative and three were found to be equivocal for IgM antibody. Specimens giving equivocal results using AxSYM and/or ElA were not included in the calculation of relative agreement, relative sensitivity and relative specific ty.
In conclusion, the AxSYM Rubella IgM Antibody assay is substantially equivalent to the Abbott IMx Rubella IgM Antibody assay for the detection of IgM antibodies to rubella virus in humarı serum and plasma (EDTA, heparin or sodium citrate) specimens to aid in the diagnosis of primary or acute infection.
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[510/k)] Summary Of Technological Comparison
The AxSYM Rubella IgM Antibody Assay and the IMx Rubella IgM Antibody assay are Substantially Equivalent in that:
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- Both are in vitro immunologic test methods.
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- Both are intended for use in the detection of IgM antibody to rubella virus in human serum or plasma (EDTA, heparin or sodium citrate).
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- Both are based on the formation of immune complexes between rubella virus antigens and antibody.
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- Both use a polystyrene microparticle solid phase.
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- Both are qualitative assays.
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- Both use a solid phase coated with antigen from rubella virus strain HPV-77.
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- Both use antigen produced in Vero cell culture.
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- Both use goat anti-human IgM antibody conjugated to alkaline phosphatase.
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- Both use MUP as the enzyme substrate.
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- Both use an automated instrument.
The AxSYM Rubella IgM Antibody Assay and the IMx Rubella IgM Antibody assay Differ in that:
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- The AxSYM Rubella IgM Antibody assay is an automated microparticle enzyme immunoassay performed with the AxSYM, a random and continuously accessed automated immunoassay analyzer. The IMx Rubella IgM Antibody assay is an automated microparticle enzyme immunoassay performed with the IMx automated immunoassay analyzer.
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- The IMx Rubella IgM Antibody assay requires that all positive samples be treated (RF neutralized) with human IgG microparticles and retested due to the potential for RF interference. The AxSYM Rubella IgM Antibody assay pretreats all samples with an RF neutralization buffer and does not require additional treatment and testing of positive samples.
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| Assay Characteristics | AxSYM Rubella IgM | IMx Rubella IgM |
|---|---|---|
| Assay Type | Qualitative | Qualitative |
| Antibody Measured | Specific IgM | Specific IgM |
| Assay Principle | MEIA | MEIA |
| Solid Phase | Polystyrene | |
| microparticles | Polystyrene | |
| microparticles | ||
| Solid Phase Coating | Rubella virus antigen | |
| strain HPV-77 | ||
| grown in Vero cells | Rubella virus antigen | |
| strain HPV-77 | ||
| grown in Vero cells | ||
| Conjugate | Goat anti-human IgM | |
| conjugated to alkaline | ||
| phosphatase | Goat anti-human IgM | |
| conjugated to alkaline | ||
| phosphatase | ||
| Specimen | Human serum and | |
| plasma (EDTA, heparin | ||
| or sodium citrate) | Human serum and | |
| plasma (EDTA, heparin | ||
| or sodium citrate) | ||
| Automation | Performed on automated | |
| instrument | Performed on automated | |
| instrument | ||
| Relative Sensitivity | 95.7% | 95.4% |
| Relative Specificity | 99.4% | 99.4% |
Comparison of Methods
ﺮﻧﺎ ﻓﻲ ﺍﻟﻤﺮﻛﺰ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ
一
4
Certification of search for adverse safety and effectiveness
The undersigned certifies to the best of his knowledge and belief that reasonable search of all information known or otherwise presently available to Abbott Laboratories has been conducted. The scope of the search was as follows:
Accuracy/Clinical Utility/Reproducibility/Safety of Rubella Immunoassays Biohazard of Rubella Antigen Adverse Effects and Safety of Sodium Az de
The searches were performed by Abbott Laboratories Information Services Department for the undersigned individual on March 2, 1995.
Dialog® Information Service was used for database searches. A list of databases is included on the following page in this section.
Conclusion: No adverse safety and effectiveness data was found in the search provided the product is used as intended for in vitro diagnostic use.
Richard M. Fleming
Richard M. Fleming Associate Scientist CRG Business Unit Abbott Laboratories One Abbott Park Road Abbott Park, IL 60064
Databases Searched:
Database File Name
5: BIOSIS PREVIEWS® 1969-1995/Feb W2 72: EMBASE 1985-1995/ISS 06 73: EMBASE 1974-1995/ISS 05 144: PASCAL 1973-1994/Aug 154: MEDLINE (R) 1985-1995/Apr W2 155: MEDLINE® 1966-1995/Apr W2 156: TOXLINE(R) 1965-1995/Jan 336: REG TOX EFF CHEM SUB 1994/Oct 434: SCISEARCH(R) 1974-1995/Jan W5