(62 days)
Abbott CMV Total AB EIA
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No
The summary describes a standard ELISA assay and does not mention any AI or ML components.
No
The device is described as an in vitro diagnostic (IVD) assay for detecting CMV antibodies to determine evidence of previous CMV infection, used for screening blood and plasma donors. It does not treat or alleviate a disease, but rather provides diagnostic information.
Yes
The device is an in vitro diagnostic (IVD) test that detects total antibody to cytomegalovirus (CMV) in human serum or plasma to determine serological evidence of previous CMV infection, functioning as a diagnostic tool.
No
The device description clearly outlines a physical ELISA kit with reagents and a test module, indicating it is a hardware-based diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used for the "detection of total antibody to cytomegalovirus in human serum or heparin plasma". This involves testing a sample taken from the human body in vitro (outside the body).
- Device Description: The description details a "qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA)" which is a common laboratory technique used for in vitro diagnostic testing. It also mentions the components of the test module, which are used to perform the assay on the sample.
- Sample Type: The assay uses "human serum or heparin plasma," which are biological samples taken from a patient.
- Purpose: The purpose is to "determine serological evidence of previous CMV infection" and "screen blood and/plasma donors," which are diagnostic and screening purposes.
All of these characteristics align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.
Product codes
866-3175
Device Description
OPUS Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA), based on liquid phase binding of CMV antibodies to enzyme labeled recombinant CMV antigen. Each test module contains a solid phase recombinant protein A/G immobilized onto glass fiber. A recombinant CMV antigentalkaline phosphatase conjugate solution and a wash/substrate solution (4-methylumbellifery) phosphate) are sealed in separate well within the test module.
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
Precision: Precision of the OPUS Anti-CMV test system was evaluated on the OPUS Immunoassay System. Intra-assay precision %CV's ranged from 5.8-20%. Inter-assay precision %/CV's ranged from 8.9-21.4%.
Interfering Substances: Levels of total protein, triglycerides, cholesterol, hemoglobin, immunoglobulins, bilirubin, Rheumatoid factor, ANA, Epstein-Barr, herpes simplex I/II, Herpes-Zoster, HBsAg, Elevated IgM, Anti-HIV Positive, Anti-HCV postive, Anti-HAV positive do not appear to interfere with the OPUS Anti CMV assay.
Accuracy by Correlation: Results of comparative studies using the OPUS Anti CMV assay and the Abbott CMV test in both preselected and blood donor populations ranged from a relative sensitivity of 96.6-97.7% and a relative specificity of 100% respectively.
Expected Values: Based on the studies performed in blood and plasma donor centers using the OPUS Anti CMV assay, the expected CMV antibody positive frequency for the population tested is 27.4% in Massachusetts, 14.4% in Florida and 30.6% in Illinois.
Key Metrics
Sensitivity: 96.6-97.7%, Specificity: 100%
Predicate Device(s)
Abbott CMV Total AB EIA
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.3175 Cytomegalovirus serological reagents.
(a)
Identification. Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.(b)
Classification. Class II (performance standards).
0
OCT - 9 1996
510(k) Summary for OPUS Anti CMV Expanded Intended Use
Manufacturer Name, Address, phone number, contact name and date of 1. preparation:
Manufacturer
Behring Diagnostics Inc., 151 University Avenue Westwood, MA 02090 617-320-3153 Contact name: Kathleen Dray-Lyons
date of preparation: October 2, 1996
Device Name/Classification: 2.
Cytomegalovirus serological reagents OPUS Anti-CMV
Class II (866-3175) Classification number:
Identification of the legally marketed device to which the submitter claims 3. equivalence.
Abbott CMV Total AB EIA
Proposed Device Description: বঁ
OPUS Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA), based on liquid phase binding of CMV antibodies to enzyme labeled recombinant CMV antigen. Each test module contains a solid phase recombinant protein A/G immobilized onto glass fiber. A recombinant CMV antigentalkaline phosphatase conjugate solution and a wash/substrate solution (4-methylumbellifery) phosphate) are sealed in separate well within the test module.
5. Proposed Device Intended Use:
OPUS® Anti CMV is a qualitative fluorogenic enzyme-linked immunosorbent assay (ELISA) used in the detection of total antibody to cytomegalovirus in human serum or heparin plasma to determine serological evidence of previous CMV infection. The OPUS Anti CMV assay is also intended for use to screen blood and/plasma donors to determine serological evidence of previous CMV infection. OPUS Anti CMV is intended for use with the OPUS analyzers.
6. Medical device to which equivalence is claimed and comparison information:
The OPUS Anti CMV assay is substantially equivalent in intended use to the Abbott CMV Total AB ElA test system. Both products are in vitro diagnostic test systems intended for use as a qualitative measurement of Cytomegalovirus (CMV) in the blood/plasma donor population. The Abhott CMV Total AB EIA, like the proposed product, employs an enzyme-labeled conjugate for the qualitative detection of total antibody to CMV in human serum. Both are bused on a two level calibrator system.
The OPUS Anti-CMV differs from the Abbott CMV Total AB EIA in that the OPUS CMV contains Omnibind™ A/G to bind human immunoglobulins whereas the Abbott CMV contains anti-human immunoglobulins. Additionally, the OPUS CMV uses a recombinant CMV antigen in its conjugate preparation whereas Abbott uses native CMV coated onto a bead.
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7. Proposed Device Performance characteristics:
Precision:
Precision of the OPUS Anti-CMV test system was evaluated on the OPUS Immunoassay System. Assay precision was determined by the evaluation of reactive and nonreactive calibrator signals (assay value/cutoff) and individual clinical specimen signals.
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Intra-assay precision %CV's ranged from 5.8-20%.
Inter-assay precision %/CV's ranged from 8.9-21.4%.
Interfering Substances:
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Levels of the following do not appear to interfere with the OPUS Anti CMV assay:
| Up to: | |
|---|---|
| total protein | 11.5 g/dL |
| triglycerides | 780 mg/dL |
| cholesterol | 450 mg/dL |
| hemoglobin | 1000 mg/dL |
| immunoglobulins | 16000 mg/dL |
| bilirubin | 25.4 mg/dL |
| Rheumatoid factor | 567 IU/mL |
| ANA | 1:640 |
| Epstein-Barr | 3.33 (signal/cutoff) |
| herpes simplex I/II | I=3.64/II=2.17 (signal/cutoff) |
| Herpes-Zoster | 2.31(signal/cutoff) |
| HBsAg | 118 (signal/cutoff) |
| Elevated IgM | 1550 (signal/cutoff) |
| Anti-HIV Positive | (western blot confirmed) |
| Anti-HCV postive | >4.505 signal over range |
| Anti-HAV positive | 26.000 (signal/cutoff) |
Accuracy by Correlation:
Results of comparative studies using the OPUS Anti CMV assay and the Abbott CMV test in both preselected and blood donor populations ranged from a relative sensitivity of 96.6-97.7% and a relative specificity of 100% respectively.
Expected Values:
Based on the studies performed in blood and plasma donor centers using the OPUS Anti CMV assay, the expected CMV antibody positive frequency for the population tested is 27.4% in Massachusetts, 14.4% in Florida and 30.6% in Illinois.