(93 days)
The BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is intended for prescription distribution, and is a clinic-use device for collection and transportation of dried capillary blood for in vitro diagnostic quantitative determination of Total Cholesterol, HDL-Cholesterol, Triglycerides and Calculated LDL-Cholesterol in dried blood spots. This kit is not intended for use on neonates. LDL cannot be determined where the triglyceride value is greater than 400 mg/dL.
The device is a kit containing the materials necessary to collect a capillary blood sample onto a filter paper card for transport to a certified clinical laboratory for lipid profile testing. The kit is comprised of a blood collection card packaged in a foil pouch, alcohol prep pad, disposable lancets, gauze pad, bandage strip, collection instructions, return prepaid envelope, and a patient test authorization form.
Here's an analysis of the provided text to extract the acceptance criteria and details about the study proving device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K011970) is a 510(k) summary for a blood collection and transport system, primarily focusing on demonstrating substantial equivalence to predicate devices rather than establishing specific performance acceptance criteria with numerical targets.
The document states: "Results of clinical trials show that professionally collected capillary samples onto the BIOSAFE Blood Collection Card provide results that are substantially equivalent to venous (serum) results for Total Cholesterol, HDL Cholesterol and Triglycerides when analyzed using BIOSAFE Laboratories modified analytical methods."
It further states: "Determination of professionally collected capillary blood Total 7) Performance Studies Cholesterol, HDL Cholesterol and Triglycerides using the BIOSAFE CHOLESTEROL PROFILE Blood Collection and Transport System is substantially equivalent to venous (serum) samples for lipid profile BIOSAFE Laboratories modified analytical methods testing."
Given this, the acceptance criteria are qualitative, centered around robust statistical equivalence to established venous blood testing methods, rather than specific numerical thresholds for accuracy, sensitivity, or specificity. The device performance is reported as meeting this "substantial equivalence."
| Acceptance Criteria (Stated Qualitatively) | Reported Device Performance |
|---|---|
| Substantial equivalence to venous (serum) results for total cholesterol | Provided results substantially equivalent to venous (serum) results for Total Cholesterol |
| Substantial equivalence to venous (serum) results for HDL cholesterol | Provided results substantially equivalent to venous (serum) results for HDL Cholesterol |
| Substantial equivalence to venous (serum) results for triglycerides | Provided results substantially equivalent to venous (serum) results for Triglycerides |
| Capable of determining Calculated LDL-Cholesterol | Yes, when triglyceride values are not greater than 400 mg/dL |
| Stability of samples under abusive storage/transportation conditions | Evaluated; performance characteristics studied included precision, linearity and correlation, and sample stability |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a specific number for the sample size. It mentions "volunteer study subjects" and "professionally collected blood samples from volunteer study subjects at three different geographical sites."
- Data Provenance: The study was conducted using prospective data collection. The subjects were volunteers, and samples were collected specifically for this study. The data was collected from "three different geographical sites." The country of origin is not explicitly stated, but given the FDA 510(k) submission, it's highly likely to be the United States.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of "experts" to establish ground truth in the traditional sense of image or clinical interpretation.
- The ground truth for the study was established by laboratory analysis of venous blood samples using FDA-Cleared laboratory reagent and analysis systems. The "experts" in this context would be the certified clinical laboratory professionals performing the analyses and the established analytical methods themselves. The document states: "A corresponding venous blood sample was collected by the health care professional in order to compare serum lipid results to those obtained from capillary blood samples collected onto the BIOSAFE Blood Collection Card."
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or interpretation where an adjudication method like 2+1 or 3+1 would be relevant. The ground truth was based on laboratory analysis, which inherently includes internal quality controls and standardized procedures.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is focused on the analytical performance of the collection and transport system against standard laboratory methods, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way. The "device" in question is a blood collection and transport system. The performance study evaluates the standalone analytical performance of the collected capillary blood samples (after transport and preparation) when run on standard laboratory analytical systems (Synermed Cholesterol Reagent Kit, Sigma Diagnostics Infinity Triglyceride Reagents, Sigma Diagnostics EZ-HDL Cholesterol Reagents). The "algorithm" here is the combined process of collection, transport, and subsequent laboratory analysis, without direct human intervention in the final analytical measurement itself. The comparison is between the results from the dried capillary blood spots via this process and the results from standard venous serum samples.
7. The Type of Ground Truth Used
The type of ground truth used was laboratory analysis results from venous (serum) blood samples. These are considered the gold standard for lipid profile determination.
8. The Sample Size for the Training Set
Not applicable. This type of device and study does not involve a "training set" in the context of machine learning or AI development. The device's performance is based on its physical/chemical properties and the established analytical methods, not on a learned model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 862.1175 Cholesterol (total) test system.
(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.