(314 days)
The Mono G Test is a qualitative enzyme immunoassay (EIA) that detects IgG antibodies to Epstein-Barr virus capsid antigen (EBV-VCA), Epstein-Barr early nuclear antigen (EBV-EBNA), cytomegalovirus (CMV), and toxoplasma (toxo). When used in conjunction with Mono-M Test it is an aid in the serodiagnosis of infectious (EBV) mononucleosis and presumptive serodiagnosis of CMV or toxoplasma mononucleosis-like syndrome.
This assay has not been FDA cleared or approved for the screening of blood or plasma donors. Performance with this device has not been established for either prenatal screening or newborn testing. Performance for this assay has not been established in a non-clinical laboratory environment (e.g., point of care testing).
The product is an ELISA test method detecting viral capsid antigen Epstein-Barr nuclear antigen, cytomegalovirus and toxoplasma IgG antibodies.
Here's an analysis of the provided 510(k) summary, extracting the requested information about acceptance criteria and the supporting study:
The provided document describes the ImmunoDOT Mono G Test, an ELISA method for detecting IgG antibodies related to mononucleosis. The "acceptance criteria" in this context refer to the performance characteristics, specifically sensitivity and specificity, deemed acceptable for the device to be marketed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as target values, but rather implied by the reported performance characteristics that establish substantial equivalence.
| Performance Metric | Acceptance Criteria (Implied by Predicate & Regulatory Approval) | Reported Device Performance (ImmunoDOT Mono G Test) |
|---|---|---|
| EBV Infectious Mononucleosis | ||
| Sensitivity | Comparable to predicate device's established performance | 98.8% (238/241) [Range: 96-99.7%] |
| Specificity | Comparable to predicate device's established performance | 93% (42/45) [Range: 93-99%] |
| Mononucleosis Syndrome (Overall) | ||
| Sensitivity | Comparable to predicate device's established performance | 98.7% (236/239) [Range: 96-99.7%] |
| Specificity | Comparable to predicate device's established performance | 89% (42/47) [Range: 77-96%] |
Note: The document implies that these performance characteristics were found to be substantially equivalent to a legally marketed predicate device, thus meeting the "acceptance criteria" for regulatory clearance.
2. Sample Size Used for the Test Set and Data Provenance
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Sample Size for Test Set:
- EBV Performance Summary (Table 3):
- Negative: 47 (42 negative, 3 current, 2 indeterminate)
- Current: 40 (33 current, 1 past/recent, 6 indeterminate)
- Past/Recent: 215 (1 past/recent, 204 past/recent, 8 indeterminate)
- Total (including Indeterminate): 302 specimens
- Overall Performance Summary (Table 4):
- Negative: 49 (42 negative, 5 current, 2 indeterminate)
- Current: 43 (36 current, 1 past/recent, 6 indeterminate)
- Past/Recent: 210 (2 past/recent, 199 past/recent, 8 indeterminate)
- Total (including Indeterminate): 302 specimens
- Performance Characteristics (Table 5) (Excluding Indeterminates):
- EBV Infectious Mononucleosis: 241 Current/Past/Recent + 45 Negative = 286 specimens
- Mononucleosis Syndrome: 239 Current/Past/Recent + 47 Negative = 286 specimens
- EBV Performance Summary (Table 3):
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Data Provenance: The study was a "prospective study" conducted at "Site A" and "Site B." The country of origin is not explicitly stated, but the sponsor's address is San Diego, CA, USA, implying the study was likely conducted in the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document refers to "Reference Results" for establishing ground truth, but does not specify the number of experts or their qualifications. It only states that these reference results were used to classify samples as Negative, Current, or Past/Recent mononucleosis.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set. It mentions "Reference Results" as the ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not performed. This device is an in-vitro diagnostic (ELISA test) that yields an objective result, not an imaging device requiring human reader interpretation in the same way an MRMC study would apply. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable and not reported.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The reported sensitivity and specificity values are for the ImmunoDOT Mono G Test device itself (algorithm only, if one considers the assay as a deterministic algorithm). There is no human-in-the-loop described for the interpretation of the primary quantitative results. The device provides a qualitative output (Negative, Current, Past/Recent, Indeterminate) based on the test's reaction, which is then objectively read.
7. The Type of Ground Truth Used
The ground truth used was based on "Reference Results" which classified samples into "Negative," "Current," and "Past/Recent" categories for mononucleosis. The specific methods or assays used for these reference results are not detailed, but it is implied to be a standard clinical diagnostic method for mononucleosis serodiagnosis. For the CMV and Toxoplasma IM cases, "reference results" were also used to confirm the presumptive diagnoses.
8. The Sample Size for the Training Set
The document does not explicitly mention a training set or its sample size. The performance data presented is from a "prospective study" used to assess assay performance, which would typically be analogous to a test or validation set in the context of device approval. For an ELISA assay, the "training" aspect is more related to assay development and optimization rather than a distinct dataset for machine learning.
9. How the Ground Truth for the Training Set Was Established
Since a distinct training set for this type of device (ELISA test) is not described, the method for establishing its ground truth is not applicable and not provided.
§ 866.3235 Epstein-Barr virus serological reagents.
(a)
Identification. Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).(b)
Classification. Class I (general controls).