(65 days)
The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "RUBELLACOL™ Test". It does not contain the information requested regarding acceptance criteria or a study proving device performance on several specific points.
Here's a breakdown of why the requested information cannot be extracted from this document:
- This is a regulatory clearance letter, not a scientific study report. It confirms that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance studies conducted for this equivalence determination.
- The letter refers to a "510(k) premarket notification" which would contain the study details, but that notification document itself is not provided.
Therefore, I cannot provide the requested table or answer most of the specific questions.
However, based on the context of what a 510(k) submission typically entails, I can infer some general information about the type of study that would have been done for a device like this, but this is inferential and not directly stated in the provided text.
Inference about a typical study for a device like this:
For an in vitro diagnostic device like the RUBELLACOL™ Test (a serological reagent for rubella virus antibodies), the acceptance criteria would typically revolve around its agreement with a reference standard, often another legally marketed and validated rubella antibody test. The study would generally assess sensitivity and specificity.
- Test Set Data & Ground Truth: The test set would consist of patient samples (serum) with known rubella antibody status. The ground truth would likely be established using a highly sensitive and specific reference method (e.g., another FDA-cleared rubella ELISA, or potentially a hemagglutination inhibition assay (HAI) if it was the established gold standard at the time).
- Sample Size: The sample size would be chosen to demonstrate statistically significant agreement with the reference method across relevant populations (e.g., pregnant women, those at risk of infection). While not specified, it's typically in the hundreds to low thousands for such assays.
- Adjudication: For serological tests, "adjudication" in the sense of multiple human readers for a single case is usually not applicable. The result is typically an objective measurement (e.g., optical density value) interpreted against a cutoff. Any discrepancies with the reference method would be investigated, perhaps by re-testing.
- No AI Involvement: This device, cleared in 2003, is a laboratory diagnostic kit, not an AI-powered diagnostic. Therefore, there would be no discussion of AI assistance, MRMC studies, or standalone algorithm performance.
- Training Set: While the term "training set" is more common with machine learning, for a traditional IVD, the development and optimization of the assay (e.g., antibody concentrations, incubation times, cutoff values) would be based on internal studies using well-characterized samples. The ground truth for this internal development would be established similarly to the test set, using reference methods.
Specific answers based only on the provided text:
- A table of acceptance criteria and the reported device performance: Not provided. The document is a clearance letter, not a performance study report.
- Sample size used for the test set and the data provenance: Not provided. This information would be in the 510(k) submission itself.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. For a serological test, ground truth is typically established by laboratory methods, not by expert consensus on primary data like images.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. This method is typically used for subjective interpretations (e.g., pathology slide reading, radiology image interpretation), not for objective laboratory assays.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No. This device is an in vitro diagnostic test, not an AI-powered image analysis or decision support system.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a manual or semi-automated laboratory assay, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided. However, for a serological test for antibodies, the ground truth would typically be established by a reference serological method (e.g., another validated rubella antibody test) or sometimes confirmation by culture/PCR in acute cases, though for antibody detection, the reference assay is most common.
- The sample size for the training set: Not provided.
- How the ground truth for the training set was established: Not provided. (See inference above for a typical approach).
§ 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.