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510(k) Data Aggregation
(161 days)
The BioCheck CRP Rapid Test is intended for the qualitative detection of C-reactive protein (CRP) in human serum. Measurements of CRP can be useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
The BioCheck CRP Rapid Test is a colloidal gold/antibody conjugate-based immunoassay designed for the detection of CRP in human serum samples. To perform the serum CRP test, serum is added to the Sample Well. CRP in the specimen is bound by a gold-antibody conjugate forming a gold-antigen complex. This complex migrates across the membrane by capillary action and reacts with a goat anti-human CRP polyclonal antibody immobilized in the test region to produce a pink color band when the CRP concentration is equal to or greater than 4.0 mg/L. If the CRP concentration is less than 4.0 mg/L, there is no line in the test line area. The gold-conjugate continues to migrate to the control line area and produce a pink color band, indicating a valid test.
BioCheck CRP Rapid Test Study Analysis
Here's a breakdown of the acceptance criteria and the study proving the BioCheck CRP Rapid Test meets them, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Precision | 100% agreement between multiple testing sites for various CRP concentrations. | Four laboratories tested blinded serum samples spiked with purified CRP at 5 concentrations (1.0, 2.0, 5.0, 4.0 mg/L - note: the document lists 4.0 thrice and 1.0 five times, which seems like a typo, assuming 5 distinct concentrations were intended for the 5-sample set). Five replicates of each sample were tested. The results demonstrated 100% agreement between sites. |
| Interference | No interference from specified endogenous substances and common-used drugs at predefined levels. | The following potentially interfering substances showed no interference: Biotin (200 ng/mL), Bilirubin (10 mg/dL), Hemoglobin (200 mg/dL), Cholesterol (800 mg/dL), Triglyceride (1250 mg/dL). In addition, no interference was observed from a long list of common-used drugs (~10 µg/ml final concentration) within their normal therapeutic ranges. |
| Hook Effect | No hook effect up to a specified high CRP concentration. | When a CRP standard of 200 mg/L was used, the test line appeared within 5 minutes, indicating no hook effect if the CRP concentration in the patient serum sample is equal to or below 200 mg/L. |
| Recovery | 100% agreement between expected and observed results for fortified samples at various CRP concentrations. | Normal human serum was supplemented with purified human CRP at 5 concentrations (numbers not specified, but implied to be distinct from the precision study). These samples were tested in six replicates. The data showed 100% agreement between the expected and the observed results at each CRP concentration. |
| Clinical Comparison | High positive, negative, and overall agreement with a commercially available quantitative predicate assay (BioCheck hsCRP ELISA) at a 4.0 mg/L cutoff. | The BioCheck CRP Rapid Test was compared to the BioCheck hsCRP ELISA. Overall Positive Agreement (>= 4 mg/L) = 98.2% Overall Negative Agreement (< 4 mg/L) = 96.3% Individual group results: - Group #1: Positive Agreement = 97.2%, Negative Agreement = 97.1%, Overall Accuracy = 97.1%. - Group #2: Positive Agreement = 98.6%, Negative Agreement = 94.7%, Overall Accuracy = 96.6%. - Group #3: Positive Agreement = 100%, Negative Agreement = 100%, Overall Accuracy = 100%. |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Clinical Comparison (Test Set): A total of 384 patient serum samples were used.
- Data Provenance: The document does not explicitly state the country of origin. It indicates retrospective testing of patient serum samples, as they were "patient serum samples from three separate testing groups." The study was conducted by BioCheck, Inc. in Foster City, CA, suggesting the data is likely from the USA, but it's not explicitly stated for the patient samples themselves.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the use of "experts" to establish ground truth for the test set. The ground truth for the clinical comparison was established by a predicate device: a commercially available quantitative assay for CRP (BioCheck hsCRP ELISA). Therefore, no information on the number or qualifications of human experts is provided for this study.
4. Adjudication Method for the Test Set
Since the ground truth was established by a quantitative laboratory assay (BioCheck hsCRP ELISA) rather than human interpretation, there was no adjudication method described or necessary in the traditional sense (e.g., 2+1, 3+1). The results of the rapid test were directly compared to the numerical results of the predicate ELISA assay against a defined clinical cutoff.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study evaluates a rapid diagnostic test (BioCheck CRP Rapid Test) against a laboratory-based quantitative assay, not human readers with or without AI assistance. The BioCheck CRP Rapid Test is a qualitative, immunoassay-based device that gives a visual result (pink color band), not an AI-driven imaging interpretation system.
6. Standalone (Algorithm Only) Performance
This question is not entirely applicable in the context of this device. The BioCheck CRP Rapid Test is a standalone diagnostic device in the sense that its performance, as described in the "Clinical Comparison" section, is the performance of the device itself (the qualitative rapid test) without a human-in-the-loop for interpretation beyond simply observing the presence or absence of a line. There is no "algorithm only" component separate from the physical test strip and its chemical reactions. The performance metrics presented (positive and negative agreement) are those of the device in its intended use.
7. Type of Ground Truth Used (Clinical Comparison)
The ground truth used for the clinical comparison was the results from a commercially available quantitative predicate assay for CRP (BioCheck hsCRP ELISA). This is a laboratory-based assay providing a numerical CRP concentration, which was then compared to the qualitative result of the rapid test based on a clinical cutoff of 4.0 mg/L.
8. Sample Size for the Training Set
The document does not provide information on a specific "training set" for an algorithm. This type of rapid test is based on immunoassay principles, not machine learning algorithms that typically require training data. The development and validation likely involved internal development studies (e.g., optimizing antibody concentrations, membrane properties) rather than algorithmic training on a labeled dataset. The studies described (precision, interference, hook effect, recovery) are more akin to verification and validation tests for a chemical-based assay.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" or an algorithm that requires training, this information is not applicable and is not provided in the document. The device's mechanism is based on antigen-antibody reactions, not a trained algorithm.
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