(44 days)
The Synermed® Direct Billirubin reagent is intended for use in the quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
Direct Bilirubin Reagent Kit
This document is a 510(k) clearance letter for the Synermed® IR750 Direct Bilirubin Reagent. It is not a study report or a detailed description of the device's performance characteristics. Therefore, much of the requested information regarding acceptance criteria and a study proving those criteria are met is not present in the provided text.
Based on the provided text, I can extract the following limited information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain a table of acceptance criteria or reported device performance for the Synermed® IR750 Direct Bilirubin Reagent. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices, which implies that its performance is expected to be comparable, but no specific performance metrics or acceptance criteria are detailed here.
Regarding the other points, the document provides insufficient information to answer most of them:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available. The document gives no details about any specific test set used, its size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/Not available. This is a reagent for quantitative determination, not an imaging device requiring expert interpretation for ground truth. No information on experts establishing ground truth is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not available. This is a reagent for quantitative determination. Adjudication methods are typically relevant for interpretive tasks (e.g., radiology reads), not for the performance validation of a chemical reagent.
5. 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:
- Not applicable. This document describes a chemical reagent, not an AI-assisted diagnostic tool or an imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a chemical reagent. Its performance would be evaluated as a standalone assay, not an algorithm. The document doesn't provide details of such an evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available. Given this is a quantitative determination of a biomarker, "ground truth" would typically refer to a reference method or a highly accurate "gold standard" measurement of direct bilirubin. However, the document does not specify the method used to establish this.
8. The sample size for the training set:
- Not applicable/Not available. This is a chemical reagent. Training sets are typically associated with machine learning algorithms. While method development involves optimization, it's not referred to as a "training set" in this context.
9. How the ground truth for the training set was established:
- Not applicable/Not available. (See point 8).
Summary of available information from the document:
- Device Name: Synermed® IR750 Direct Bilirubin Reagent
- Intended Use: Quantitative determination of conjugated (direct reacting) bilirubin in serum or plasma.
- Regulatory Status: Cleared under 510(k) as substantially equivalent to legally marketed predicate devices.
- Regulatory Class: II
- Product Code: CIG
To obtain the detailed information requested, one would need to review the actual 510(k) submission document (if publicly available) or the internal validation studies performed by Synermed Inc. This FDA clearance letter primarily confirms the substantial equivalence determination.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.