(892 days)
CME 100
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No
The device description and performance studies detail a standard ELISA assay, which relies on biochemical reactions and optical density measurements, not AI/ML algorithms for interpretation or analysis. There are no mentions of AI, ML, or related concepts.
No
This device is an in vitro diagnostic (IVD) test designed to detect antibodies to CMV, indicating past or current infection. It does not provide any therapy or treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended to "determine an individual's serologic status with respect to IgG antibodies to CMV" and that "a reactive result may indicate current or past infection with CMV," or "detect significant antibody rises associated with seroconversion, reinfection, or reactivation of latent disease." These are all diagnostic purposes, helping to identify or monitor a disease state.
No
The device is an enzyme-linked immunosorbent assay (ELISA), which is a laboratory test that involves physical reagents and a microwell plate, indicating it is a hardware-based device, not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to determine an individual's serologic status with respect to IgG antibodies to CMV." This is a diagnostic purpose, providing information about a person's health status.
- Device Description: The description details an "enzyme-linked immunosorbent assay (ELISA) designed for the qualitative or semi- quantitative detection of circulating InG antibodies to cytomegalovirus in human serum." This describes a test performed in vitro (outside the body) on a biological sample (human serum) to diagnose or provide information about a disease or condition.
- Performance Studies: The document includes performance studies like comparison testing, alternate site evaluations, interfering substances, cross-reactivity, and semi-quantitation evaluations. These are typical studies conducted for IVD devices to demonstrate their analytical and clinical performance.
- Key Metrics: The inclusion of metrics like relative sensitivity and relative specificity are standard performance indicators for diagnostic tests.
The entire description aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This enzyme-linked immunosorbent assay (ELISA) is intended to determine an individual's serologic status with respect to IgG antibodies to CMV. When the assay is used in the qualitative mode, a reactive result may indicate current or past infection with CMV. When used in the semi-quantitative mode, this test can detect significant antibody rises associated with seroconversion. reinfection, or reactivation of latent disease. This product is not FDA-cleared for use in screening blood or plasma donors. The performance of this assay has not been established for neonates and pregnant women. Results from Immunocompromised patients should be interpreted with caution.
Product codes
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Device Description
An enzyme-linked immunosorbent assay (ELISA) designed for the qualitative or semi- quantitative detection of circulating InG antibodies to cytomegalovirus in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified antigens from Övtomegalovirus have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody, which is coniugated to the enzyme horseradish peroxidase, is used to recognize the gamma-chain region of the bound anti-cytomegalovirus antibodies. In the wells where the second antibody remains bound, the enzyme catalyzes a color change in the substrate, tetramethytbenzidine (TMB). After the reaction is stopped, the color is read in an EIA plate reader.
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
- Comparison Testing: The Hemagen kit and the comparative device were used to test serum specimens from normal blood donors. A total of 252 samples were evaluated.
- Alternate Site Evaluations: A panel consisting of nine "blind" serum samples (Four CMV IgG negatives, Five CMV IgG positives) was evaluated by three independent laboratories following a formal protocol. The samples were evaluated in parallel with both the predicate and proposed devices in triplicate on three different days at each laboratory. All 3 sites reported 100% agreement for all 9 of the samples with both the proposed and predicate devices.
- Interfering Substances: Lipemic and hemolytic samples were evaluated with the Hernagen CMV IgG Kit following NCCLS Proposed Guideline, "Interference Testing in Clinical Chemistry" Document EP7-P ISSN 0273-3099. Samples with hemoglobin concentrations of 3.2 are indicative of a significant rise in antibody titer.
Key Metrics
Relative sensitivity: 100% (189/188)
Relative specificity: 98.4% (63/64)
Predicate Device(s)
Gull Laboratories, Inc. CMV IgG ELISA Test Product No. CME 100
Reference Device(s)
Not Found
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
510(k) Summary
1
FEB 20 1997
Submitter's Name/Contact Person
Joseph M. Califano, Regulatory Affairs Manager
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
(617) 890-3766
(617) 890-3748 Phone: Fax: jcalifano@hemagen.com e-mail:
Date Prepared
9 September 1994
Date Amended
13 Feb 1997
Name of Device 2
Anti-cytomegalovirus test kit
Proprietary name:
Hemagen CMV IgG Kit
Comparative Device 3
Gull Laboratories, Inc. CMV IgG ELISA Test Product No. CME 100 (96 determinations)
1
Description of Device ব
An enzyme-linked immunosorbent assay (ELISA) designed for the qualitative or semi- quantitative detection of circulating InG antibodies to cytomegalovirus in human serum.
The ELISA methodology is commonly used for serum antibody evaluations. Purified antigens from Övtomegalovirus have been attached to the inner surfaces of the microwell plate. During the initial incubation step, antibodies in patient serum bind specifically to the immobilized antigen and remain in place after a wash step.
A second antibody, which is coniugated to the enzyme horseradish peroxidase, is used to recognize the gamma-chain region of the bound anti-cytomegalovirus antibodies. In the wells where the second antibody remains bound, the enzyme catalyzes a color change in the substrate, tetramethytbenzidine (TMB). After the reaction is stopped, the color is read in an EIA plate reader.
5 Intended Use of Device
This enzyme-linked immunosorbent assay (ELISA) is intended to determine an individual's serologic status with respect to IgG antibodies to CMV. When the assay is used in the qualitative mode, a reactive result may indicate current or past infection with CMV. When used in the semi-quantitative mode, this test can detect significant antibody rises associated with seroconversion. reinfection, or reactivation of latent disease. This product is not FDA-cleared for use in screening blood or plasma donors. The performance of this assay has not been established for neonates and pregnant women. Results from Immunocompromised patients should be interpreted with caution.
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6.(A) Technological Characteristics
The Hemagen CMV IgG Kit and the Gull Laboratories CMV IgG ELISA Test are both based on similar technologies: they are both enzyme-linked immunosorbent assays. The proposed device and the prodicate device utilize optical density as a measure of antibody presence, with an established cutoff point between a positive and a negative reaction.
The cutoff for the proposed device is based upon the comparative performance with the predicate device. The optimal cutoff value was selected utilizing receiver operating characteristic (ROC) methods. The cutoff is subject to an equivocal zone of +/- 10 %.
The low calibrator supplied with the proposed device is set at the cutoff activity level. The activity of patient specimens is determined by using the standard curve to find the corresponding activity level for the optical density measured.
The proposed device is supplied with three callbrators (low, medium, and high) that have been standardized to a characterized material. A standard curve is generated by plotting the optical densities obtained for each of the calibrators as a function of the calibrator activity level. AU/mL. The activity of patient specimens is determined directly from this standard curve.
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6.(B) Performance Data
1. Comparison Testing
The Hemagen kit and the comparative device were used to test serum specimens from normal blood donors. A total of 252 samples were evaluated. The comparison data for these specimens are summarized in Table 1:
COMPARATIVE DEVICE | |||||
---|---|---|---|---|---|
POS | NEG | IND | TOTAL | ||
PROPOSED | POS | 188 | 1 | 0 | 189 |
NEG | 0 | 63 | 0 | 63 | |
IND | 0 | 0 | 0 | 0 | |
Total | 188 | 64 | 0 | 252 |
The relative sensitivity was found to be 100 % (189/188). ويComidence interval of 98.0 to 100 % The relative specificity was found to be 98.4 % (63/64).
IL Alternate Site Evaluations
A panel consisting of nine "blind" serum samples was evaluated by three independent laboratories following a formal protocol:
- İ. Four CMV IgG negatives
- ii. Five CMV IgG positives
The samples were evaluated in parallel with both the predicate and proposed devices in triplicate on three different days at each laboratory.
Agreement between sites
All 3 sites reported 100 % agreement for all 9 of the samples with both the proposed and predicate devices.
III. Interfering Substances
Lipemic and hemolytic samples were evaluated with the Hernagen CMV IgG Kit following NCCLS Proposed Guideline, "Interference Testing in Clinical Chemistry" Document EP7-P ISSN 0273-3099. Samples with hemoglobin concentrations of ≤ 500 mg/dL and lipid concentrations of ≤ 3,000 mg/dL did not have any significant effect on the assay results.
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IV. Prozone and "Hook Effect"
The Hemagen CMV IgG Kit was used to assay a high titered serum sample to determine if the kit would return unexpectedly low values. The results of this evaluation indicate that the kit gives appropriately high positive results with high titered sera.
V. Cross reactivity
Five samples which were positive for cytomegalovirus antibodies and five samples which were negative for cytomegalovirus antibedies with another commercially available assay were evaluated for the presence of other viral antibodies. IgG antibodies to rubella virus, varicella-zoster virus, and herpes simplex virus did not affect the specificity of the Hemagen CMV IgG Kit.
Evaluation of the CDC CMV/HSV serum panel VI.
The CMV/HSV Evaluation Panel consists of 100 (50 pairs) blind coded serum samples from clinically evaluated patients. All of the 100 samples were evaluated and characterized with the Hemagen CMV IgG Kit in accordance with the draft package insert. The results were submitted to CDC for scoring. The CDC reported that the Hemagen CMV IgG Kit had correctly characterized 66 of 66 samples as "CMV positives," and 34 of 34 samples as negatives.
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Semi-Quantitation Evaluations VII.
Paired sera precision studies A..
Four fold dilutions of CMV reactive serum samples were utilized to evaluate within-run and between-run precision of the Hemagen CMV IgG Kit.
Intra-assay precision
Four positive samples were selected. A 1:4 dilution of each sample was prepared. Each neat and 1:4 Dilution was assayed 10 consecutive times for each of the five samples.
Dilution | Mean AU/ml | Std. Dev | % CV1 | AU Ratio | |
---|---|---|---|---|---|
Sample 1 | Neat | 175 | 12.0 | 6.9 | |
Sample 1 | 1:4 | 45 | 4.6 | 10.4 | 3.90 |
Sample 2 | Neat | 147 | 5.6 | 3.8 | |
Sample 2 | 1:4 | 42 | 1.9 | 4.6 | 3.50 |
Sample 3 | Neat | 129 | 6.8 | 5.3 | |
Sample 3 | 1:4 | 30 | 0.9 | 2.9 | 4.30 |
Sample 4 | Neat | 118 | 5.2 | 4.4 | |
Sample 4 | 1:4 | 30 | 2.1 | 7.0 | 3.93 |
Inter-essay precision
Five positive samples were selected. A 1:4 dilution of each sample was prepared. Each neat and 1:4 dilution was assayed twice a day for 5 different days.
Dilution | Mean AU/mL | Std. Dev | % CV | AU Ratio | |
---|---|---|---|---|---|
Sample 1 | Neat | 156 | 10.8 | 6.9 | |
Sample 1 | 1:4 | 39 | 4.1 | 10.6 | 4.00 |
Sample 2 | Neat | 133 | 15.4 | 11.6 | |
Sample 2 | 1:4 | 37 | 3.9 | 10.5 | 3.59 |
Sample 3 | Neat | 144 | 15.1 | 10.5 | |
Sample 3 | 1:4 | 38 | 5.0 | 13.0 | 3.79 |
Sample 4 | Neat | 122 | 6.7 | 5.5 | |
Sample 4 | 1:4 | 29 | 3.7 | 12.8 | 4.21 |
Sample 5 | Neat | 133 | 13.9 | 10.5 | |
Sample 5 | 1:4 | 33 | 4.3 | 13.1 | 4.03 |
- These values include the well variation interent in the plastic strips, which can range up to 5%, according to the plastic strip supplier.
GIT
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B. AU Ratio Establishment
A total of 43 high titered serum samples were selected. Multiple 2 and 4 fold dilutions were performed. Based on the results, it was determined that AU ratios of > 3.2 are indicative of a significant rise in antibody titer.
7 Conclusions
The results of the comparative studies and the fact that both the Hemagen kit and the predicate kit utilize an enzyme-finked immunosorbent assay method support the claim that the Hemagen kit is a safe and effective in vitro diagnostic test and is substantially equivalent to the comparative device.