(579 days)
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No
The device description and performance studies focus on a standard enzyme immunoassay (EIA) read by a spectrophotometer, which provides an objective absorbance value. There is no mention of AI, ML, or any complex algorithmic processing beyond a simple threshold interpretation of the absorbance value.
No.
The device is an in vitro diagnostic immunoassay used for the detection of antibodies, not for treatment.
Yes
Explanation: The device is explicitly named "Abbott CMV Total AB Diagnostic EIA" in the "Device Description" section, and its "Intended Use" is for the "detection of antibody to CMV," which directly supports a diagnostic purpose.
No
The device description clearly states it is an enzyme immunoassay (EIA) and is designed to be used with a spectrophotometer, indicating it is a hardware-based in vitro diagnostic device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states the device is "intended for use in the detection of antibody to CMV." Detecting antibodies in a biological sample (like serum, as indicated in the performance studies) is a classic example of an in vitro diagnostic test.
- Device Description: The description further clarifies that both the Abbott CMV Total AB Diagnostic EIA and the predicate device are "in vitro immunological test systems" and are used to "determine serologic status on a single specimen." This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies involve testing "specimens from random healthy adults" and "serum specimens from CMV infected pediatric patients." The analysis of these specimens in a laboratory setting is characteristic of IVD testing.
N/A
Intended Use / Indications for Use
Both are intended for use in the detection of antibody to CMV .
Product codes
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Device Description
The Abbott CMV Total AB Diagnostic EIA enzyme immunoassay is substantially equivalent to the CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA) which is based on the IHA of Yeager. and originally used for CMV antibody detection by Bernstein and Stewart prior to May 28, 1976. The Abbott CMV Total AB Diagnostic EIA and the CETUS CMV IHA are substantially equivalent in that:
- a. Both are intended for use in the detection of antibody to CMV .
- b. Both are in vitro immunological test systems.
- c. Both are used to determine serologic status on a single specimen.
- d. Both are based on the formation of complexes between CMV antigens and CMV antibody.
The assays differ in that:
The Abbott CMV Total AB Diagnostic EIA is designed to be used with a spectrophotometer to give an absorbance value which is interpreted objectively. The IHA result, on the other hand, is determined by a subjective interpretation of the erythrocyte settling pattern.
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
random healthy adults, pediatric patients
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
Five facilities evaluated a total of 2312 specimens from random healthy adults by CMV Total AB Diagnostic EIA and IHA. Twenty-three specimens were uninterpretable with IHA. Of the remaining 2289 specimens, 51.07% (1169/2289) were positive for antibody to CMV as determined with the CMV Total AB Diagnostic EIA and 49.37% (1130/2289) were positive for antibody to CMV as determined by IHA. The overall agreement between CMV Total AB Diagnostic EIA and IHA was 95.50% (2186/2289). Relative specificity was calculated to be 93.87% [(1159-71)/1159] with a 95% confidence interval of 92.34 to 95.18%. Relative sensitivity was calculated to be 97.17% [(1130-32)/1130] with a 95% confidence interval of 96.03 to 98.06%.
In addition, a total of 11 serum specimens from CMV infected pediatric patients was tested and all specimens were positive for anti-CMV with the Abbott CMV Total AB Diagnostic EIA.
Summary of Performance Studies
STUDY TYPE: Equivalence Study
SAMPLE SIZE: 2312 specimens from random healthy adults; 11 serum specimens from CMV infected pediatric patients
RESULTS:
Overall agreement between CMV Total AB Diagnostic EIA and IHA was 95.50% (2186/2289).
Key Metrics
Relative specificity: 93.87% [(1159-71)/1159] with a 95% confidence interval of 92.34 to 95.18%.
Relative sensitivity: 97.17% [(1130-32)/1130] with a 95% confidence interval of 96.03 to 98.06%.
Predicate Device(s)
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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).
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MAR 24 1997
제품 피부
510(K) SUMMARY Abbott CMV Total AB Diagnostic EIA
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING A I . SUBSTANTIALLY EQUIVALENT DETERMINATION
The Abbott CMV Total AB Diagnostic EIA enzyme immunoassay is substantially equivalent to the CETUS Cytomegalovirus Indirect Hemagglutination Assay (IHA) which is based on the IHA of Yeager. and originally used for CMV antibody detection by Bernstein and Stewart prior to May 28, 1976. The Abbott CMV Total AB Diagnostic EIA and the CETUS CMV IHA are substantially equivalent in that:
- a. Both are intended for use in the detection of antibody to CMV .
- b. Both are in vitro immunological test systems.
- c. Both are used to determine serologic status on a single specimen.
- d. Both are based on the formation of complexes between CMV antigens and CMV antibody.
The assays differ in that:
The Abbott CMV Total AB Diagnostic EIA is designed to be used with a spectrophotometer to give an absorbance value which is interpreted objectively. The IHA result, on the other hand, is determined by a subjective interpretation of the erythrocyte settling pattern.
Five facilities evaluated a total of 2312 specimens from random healthy adults by CMV Total AB Diagnostic EIA and IHA. Twenty-three specimens were uninterpretable with IHA. Of the remaining 2289 specimens, 51.07% (1169/2289) were positive for antibody to CMV as determined with the CMV Total AB Diagnostic EIA and 49.37% (1130/2289) were positive for antibody to CMV as determined by IHA. The overall agreement between CMV Total AB Diagnostic EIA and IHA was 95.50% (2186/2289). Relative specificity was calculated to be 93.87% [(1159-71)/1159] with a
1
95% confidence interval of 92.34 to 95.18%. Relative sensitivity was calculated to be 97.17% [(1130-32)/1130] with a 95% confidence interval of 96.03 to 98.06%.
In addition, a total of 11 serum specimens from CMV infected pediatric patients was tested and all specimens were positive for anti-CMV with the Abbott CMV Total AB Diagnostic EIA.
In conclusion, these data demonstrate that Abbott CMV Total AB Diagnostic EIA is as safe and effective and is substantially equivalent to CETUS CMV IHA.
Prepared and submitted (December 22, 1995) by: Mary Spiewak 708/937-5376 Abbott Laboratories 200 Abbott Park Road Abbott Park, IL 60064-3537