(165 days)
The DSL-10-42100 C-Reactive Protein (CRP) Enzyme-Linked Immunosorbent Assay (ELISA) Kit provides materials for the quantitative measurement of CRP in human serum. The measurement of CRP aids in the evaluation of the amount of injury to body tissues.
The DSL C-Reactive Protein (CRP) ELISA kit was developed for the quantitative measurement of CRP in human serum. The ELISA format is a capture assay. Rabbit anti-human polyclonal antibody against CRP is immobilized to the inner surface of the microtiter plate wells. CRP in the standards or serum samples is "sandwiched" between this antibody and the anti-CRP rabbit polyclonal antibody conjugated to horseradish peroxidase enzyme.
The provided text describes a 510(k) submission for the DSL 10-42100 C-Reactive Protein ELISA kit, which aims to demonstrate substantial equivalence to a legally marketed predicate device. While it details the device, its intended use, and a comparative study, it does not explicitly state specific acceptance criteria in terms of numerical thresholds for performance metrics. Instead, the study's aim was to establish "substantial equivalence" based on a correlation coefficient.
Based on the provided information, here's what can be extracted and inferred regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| Correlation Coefficient (r) | Not explicitly stated as a numerical threshold, but implicitly, a strong correlation indicating substantial equivalence. | r = 0.98 |
| Linear Regression Equation | Not explicitly stated as a numerical threshold, but implicitly, a regression equation close to Y=X suggests close agreement. | Y = 0.827x + 349.44 |
Note: The FDA's determination of "substantial equivalence" is the overarching acceptance criterion addressed by the study. The study's results (high correlation coefficient) were deemed sufficient by the FDA for this determination.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
n = 79patient samples. - Data Provenance:
- Country of Origin: Not explicitly stated, but given the submitter's address (Webster, Texas, USA) and the FDA's regulatory context, it's highly probable the samples were collected in the USA.
- Retrospective or Prospective: Not explicitly stated. The phrasing "patient samples (n=79) were collected and assayed simultaneously by both methods" suggests a prospective collection for the purpose of this comparison, but it could also be a mix of newly collected and existing archived samples. Without more detail, it's difficult to definitively categorize. The samples were chosen "from male and female subjects with low, medium and high serum CRP levels," implying a controlled selection rather than purely retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The study compares the new device (DSL CRP ELISA) against a predicate device (Hemagen Diagnostics, Inc. CRP 150 Kit), not against a human expert's interpretation or a "ground truth" established by experts in the typical sense of diagnostic imaging or clinical assessment. The ground truth, in this context, is effectively the measurement obtained by the predicate device.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided in the document. Adjudication methods (like 2+1, 3+1) are usually relevant when multiple human reviewers independently assess data and their discrepancies need to be resolved to establish a consensus ground truth. In this study, measurements are quantitative and compared directly between two devices.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study assesses how human readers' performance changes with and without AI assistance. The described study is a direct comparison of a new laboratory diagnostic device with a predicate laboratory diagnostic device, without human readers in the loop for interpretation in the specified context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was done. The study directly compared the measurements of the new DSL CRP ELISA kit (the "algorithm/device") against the predicate Hemagen Diagnostics CRP 150 Kit, without human interpretation as part of the primary output. The DSL 10-42100 C-Reactive Protein ELISA Kit is the standalone device.
7. The Type of Ground Truth Used
The "ground truth" for this study was effectively the measurements obtained from the legally marketed predicate device, the Hemagen Diagnostics, Inc. CRP 150 Kit. This is a common approach for demonstrating substantial equivalence for in vitro diagnostic devices, where the predicate device's performance is assumed to be acceptable.
8. The Sample Size for the Training Set
This information is not provided in the document. The provided text describes a 510(k) submission, which focuses on validation, not the development or training of the device. ELISA kits are typically based on well-established biochemical principles and do not involve "training sets" in the same way machine learning algorithms do.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As mentioned above, ELISA kits do not typically have a "training set" in the machine learning sense. The assay's design and parameters would have been established through a standard biochemical development process, relying on known chemical reactions and established methodologies for measuring CRP.
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).