(33 days)
Sickle-Chex is intended to be used as a sickle cell control in testing for the presence of hemoglobin S in solubility tests and hemoglobin electrophoresis.
Sickle-Chex consists of Control materials for verifying performance of sickle cell hemoglobin testing systems. The controls contain human red blood cells and preservative suspension media packaged in a polyethylene dropper bottle with dispensing tip. Product fill is 2.5 ml per vial.
Here's an analysis of the provided text regarding the Sickle-Chex 510(k) notification, focusing on the acceptance criteria and the study that proves the device meets them:
Disclaimer: This device is a quality control material, not a diagnostic device for direct patient use. Therefore, the "acceptance criteria" and "study" described are about the performance of the control material itself in verifying diagnostic tests, rather than its diagnostic accuracy on patient samples. Many of the questions provided in the prompt are more applicable to diagnostic devices, and the information in the 510(k) for a control material will naturally be different.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Positive Control Performance | "Will produce a positive test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents." | The submission implies that the Positive Control meets this by its intended use description. No specific numerical data on its "positivity rate" or "consistency" across multiple tests/labs is directly provided in the accessible text. It functions as a known positive. |
| Negative Control Performance | "Will produce a negative test for sickling hemoglobin using standard sickle cell hemoglobin solubility test reagents." | The submission implies that the Negative Control meets this by its intended use description. No specific numerical data on its "negativity rate" or "consistency" is directly provided in the accessible text. It functions as a known negative. |
| Hemoglobin Electrophoresis Use | "May also be used as a control in hemoglobin electrophoresis methods." | The submission states this as an intended use. No specific performance data for this application is provided in the accessible text, but its utility as a control assumes it exhibits predictable electrophoretic properties for hemoglobin S (in the positive control) and normal hemoglobin (in the negative control). |
| Stability (Implied) | Maintain performance over its stated shelf life. | Not explicitly stated in the provided text, but essential for any control material. The fact it's "Assayed Sickle Cell Control" suggests its characteristics are measured and stable. |
| Matrix Compatibility (Implied) | Compatible with standard sickle cell hemoglobin solubility test reagents and electrophoresis methods. | Implied by the intended use. |
Study Proving Acceptance Criteria:
The provided text does not contain a detailed study section with explicit methodology, results, or statistical analysis to "prove" the device meets acceptance criteria in the way a diagnostic device would.
Instead, for a quality control material like Sickle-Chex, the "proof" primarily relies on:
- Manufacturing and Characterization: The control material is manufactured to contain human red blood cells with specific hemoglobin characteristics (presence of Hb S in the positive control, absence in the negative control).
- Intended Use Statements: The submission defines the intended use, which inherently outlines the expected performance: "The Positive Control will produce a positive test..." and "The Negative Control contains normal human red blood cells that will produce a negative test...". This is a statement of what the product is designed to do and what has been verified during its development.
- Substantial Equivalence: The FDA's 510(k) clearance is based on a determination of substantial equivalence to a predicate device. This means that the FDA found the Sickle-Chex to be as safe and effective as a legally marketed predicate device, likely by demonstrating similar performance characteristics through internal testing and possibly comparison to the predicate. The document refers to "Predicate product package insert and assay sheet," suggesting that the performance of Sickle-Chex was benchmarked against an existing similar product.
Without access to the full 510(k) submission, specific details of laboratory characterization and comparison to the predicate device are not available in the provided text.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided text. For a control material, the "test set" would likely refer to a series of internal characterization tests and comparisons to a predicate device.
- Data Provenance: Not specified. It can be inferred that any testing would have been conducted by Streck Laboratories, Inc. (USA) as part of their manufacturing and regulatory submission process.
- Retrospective or Prospective: Not specified.
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)
This concept of "experts establishing ground truth" is generally not applicable to the characterization of a quality control material. The "ground truth" for Sickle-Chex is inherent in its design and manufacturing:
- The Positive Control is designed to contain sickling hemoglobin (Hb S).
- The Negative Control is designed to contain normal hemoglobin.
The presence or absence of Hb S would be determined through standard laboratory methods (e.g., electrophoresis, high-performance liquid chromatography, or other definitive assays) during the manufacturing and quality control process, not by expert consensus in the same way a diagnostic image might be interpreted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not specified. Adjudication methods are typically used for interpreting subjective data (like imaging) from multiple human readers. For the characterization of a chemical/biological control, objective laboratory measurements are used, not human reader adjudication.
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. Sickle-Chex is a quality control material, not an AI diagnostic device. An MRMC study would not be performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. Sickle-Chex is a physical control material, not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the Sickle-Chex controls is their inherent biochemical composition.
- The Positive Control contains human red blood cells with hemoglobin S. This is confirmed through definitive laboratory assays during its production.
- The Negative Control contains human red blood cells with normal hemoglobin. This is also confirmed through definitive laboratory assays.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this is not an AI/machine learning device.
§ 864.7825 Sickle cell test.
(a)
Identification. A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.(b)
Classification. Class II (performance standards).