(61 days)
Sickle-Chex Solubility Kit is a qualitative solubility test kit for tasting the presence of sickling hemoglobins in human blood or sickle cell control materlal.
Sickle-Chex Solubility Kit consists of:
- Sickle-Chex Solubility Buffer; two LDPE bottles, each illied ville 100mL of a A. 2.3M potassium phosphate buffer solution containing Saponin.
- Sickle-Chex Reagent Powder; two glass vials, each filled with 4 grams of B. Sodium Hydrosulfite.
The testing principles of the kit is based on NCCLS, H10-F.
Here's an analysis of the provided text regarding the Sickle-Chex Solubility Kit, with an emphasis on the acceptance criteria and supporting study details.
Important Note: The provided document is a 510(k) summary, which is a regulatory document filed to demonstrate substantial equivalence to a predicate device. It typically summarizes studies and conclusions without going into granular detail on study designs, statistical methodologies, or all acceptance criteria. Therefore, some specific details requested (like exact sample sizes for test/training sets, blinding protocols, or multi-reader studies) are not explicitly stated in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Sickle-Chex Solubility Kit primarily focuses on demonstrating equivalence to a predicate device (Dade® Sickle-Sol™ Test) and confirming the product's stability and reliability. The acceptance criteria, while not explicitly listed as quantitative metrics in a table, can be inferred from the "Conclusions Drawn from the Tests."
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Functional Equivalence: Device performs satisfactorily as a qualitative solubility test for sickling hemoglobins. | "Sickle-Chex Solubility Kit will perform satisfactorily as a qualitative solubility test kit for testing for the presence of sickling hemoglobins in numan blood or sickle cell control material." |
| This performance was verified through "Off-site studies... to verify the performance ofck's Sickle-Chex Solubility Kit verses competitor(s) solubility kits." This implies the performance was comparable to or met expectations relative to predicate/competitor devices. | |
| Stability - Closed Vial: Long-term stability of Solubility Buffer and Reagent Powder. | "Closed Vial Long Term studies on the Solubility Buffer and Reagent Powder" were performed. The conclusion states: "Laboratories can be assured of correct results over the shelf life of the product." This indicates the closed-vial components maintain their integrity and performance. |
| Stability - Open Vial: Stability of the working solubility buffer once opened. | "Open Vial Studies on the working solution" were conducted. The device has a "45 day open vial dating for the working solubility buffer," which is an improvement over the predicate device (30 days). The overall conclusion regarding assured correct results over shelf life also applies to this aspect. |
| Qualitative Output: Ability to correctly identify positive/negative for sickling hemoglobins. | The device is designed as a "qualitative solubility test kit." The successful performance verification implies it correctly provides qualitative results. Specific sensitivity/specificity metrics were not provided in this summary. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the 510(k) summary. The document mentions "Off-site studies" and "in house studies," but does not provide the number of samples or cases used in these evaluations.
- Data Provenance:
- Country of Origin: Not explicitly stated. Given that Streck Laboratories is located in La Vista, NE (USA) and the regulatory body is the FDA (USA), it is highly probable the data was collected within the USA.
- Retrospective or Prospective: Not explicitly stated. "Off-site studies" could be either, but often includes prospective testing in a laboratory setting. "In house studies" would also typically be prospective testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not mentioned. This type of qualitative solubility test typically relies on direct chemical reaction observation, and the "ground truth" for evaluating the kit's performance would likely be established by comparing its qualitative results against established laboratory methods or reference materials.
- Qualifications of Experts: Not mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not mentioned. For a chemical solubility test, the "adjudication method" involving human experts reading results is usually not relevant in the same way it would be for image-based diagnostics. The ground truth for such a test is typically based on the chemical principle itself, or comparison to established reference methods/materials.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not performed. This type of study is primarily relevant for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. This device is a qualitative chemical test kit.
- Effect Size of AI Improvement: Not applicable, as no MRMC study was conducted and this is not an AI-assisted device.
6. Standalone Performance Study
- Standalone Performance Study: Yes, a standalone performance evaluation was implicitly done. The "Off-site studies" that verified the performance against competitor kits, and the "in house" stability studies, represent the device's performance characteristics independent of human interpretation beyond recording the qualitative reaction. The device itself is the "algorithm" in this context, producing a qualitative result.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this type of device would typically be:
- Reference Method Comparison: Comparing the results of the Sickle-Chex kit to a gold-standard or well-established method for detecting sickling hemoglobins (e.g., electrophoresis, or another validated solubility test).
- Known Samples: Testing with control materials or patient samples with known sickle cell status (e.g., confirmed by genetic testing or other definitive methods).
- Clinical Outcomes Data: Unlikely to be the primary ground truth for a qualitative screening test.
- Expert Consensus: Unlikely to be the primary ground truth for a chemical reaction test.
The summary mentions "sickle cell control material" and "human blood," suggesting a combination of known samples and potentially clinical samples verified by other means.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / not mentioned. This device is a chemical reagent kit, not an AI/ML algorithm that requires a distinct "training set" in the computational sense. Its performance is based on its chemical formulation and reaction properties.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable. As this is not an AI/ML device, there is no "training set" or establishment of ground truth for such a set in the context of machine learning. The chemical properties and formulation are developed and refined through R&D and quality control, not via a machine learning training process.
§ 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).