(261 days)
The SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System is intended for over-the-counter distribution, for the self-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 self-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.
The provided text describes a 510(k) premarket notification for the "SAFE AT HOME CHOLESTEROL PROFILE Blood Collection and Transport System." While it mentions performance studies and substantial equivalence, it does not explicitly state specific acceptance criteria or provide a detailed table comparing acceptance criteria with reported device performance.
However, I can infer some general performance aspects and describe the associated study based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As specific numerical acceptance criteria are not provided, this table will reflect the general performance claims and the comparison method.
| Performance Metric | Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance (Summary) |
|---|---|---|
| Total Cholesterol | Results substantially equivalent to venous (serum) results | Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods. |
| HDL-Cholesterol | Results substantially equivalent to venous (serum) results | Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods. |
| Triglycerides | Results substantially equivalent to venous (serum) results | Self-collected capillary samples provide results substantially equivalent to venous (serum) results when analyzed using BIOSAFE Laboratories modified analytical methods. |
| LDL-Cholesterol (Calculated) | Results substantially equivalent to venous (serum) results (where triglycerides 400 mg/dL. | |
| Precision | Not explicitly stated, but implied to be acceptable for clinical use. | Performance characteristics studied included precision. |
| Total Error | Not explicitly stated, but implied to be acceptable for clinical use. | Performance characteristics studied included total error. |
| Correlation | Not explicitly stated, but implied to be strong with venous samples. | Performance characteristics studied included correlation. |
| Sample Stability | Acceptable stability when exposed to abusive storage and transportation conditions. | Evaluated for sample stability when exposed to abusive storage and transportation conditions. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "clinical trials" and "volunteer study subjects," but does not provide the number of subjects or samples.
- Data Provenance:
- Country of Origin: Not explicitly stated, but likely the United States given the FDA submission and the company's address.
- Retrospective or Prospective: The study involved "volunteer study subjects" and the collection of "corresponding venous blood sample and a professionally collected capillary blood sample" alongside the self-collected samples, indicating a prospective study design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This device is for in vitro diagnostic determination of lipid profiles, not interpretation by human experts. The ground truth would be established by laboratory analysis using predicate devices and validated methods, not expert consensus. Therefore, this section is not applicable in the traditional sense of human expert review.
4. Adjudication Method for the Test Set
Not applicable. The "ground truth" for lipid levels is determined by established laboratory analytical methods, not by adjudication among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic devices where human interpretation plays a significant role. For this in vitro diagnostic device, the comparison is between blood collection methods (self-collected capillary vs. venous/professionally collected capillary) and their analytical results.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not directly applicable in the context of this device. The "device" is a blood collection and transport system. The analysis of the blood samples is performed by standard laboratory instruments and reagents (Synermed Cholesterol Reagent Kit, Sigma Diagnostics Infinity Triglyceride Reagents, Sigma Diagnostics EZ-HDL Cholesterol Reagents), which can be considered "standalone" in their analytical capacity once the sample is prepared. The study evaluates the sample quality and the method modifications used by BIOSAFE Laboratories to analyze these specific dried capillary blood spots.
7. The Type of Ground Truth Used
The ground truth used was comparative laboratory results from venous (serum) blood samples and professionally collected capillary blood samples, analyzed using predicate or established laboratory methods. This acts as the "gold standard" against which the self-collected capillary samples were compared.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the device itself. The primary study described is a performance study comparing different sample types. If there was an internal development or optimization phase for their "modified analytical methods," the sample size used for that is not specified.
9. How the Ground Truth for the Training Set Was Established
As no explicit training set for the device is mentioned, this is not applicable. The "ground truth" for the overall validation was established by standard laboratory analysis of venous and professionally collected capillary blood, as described in point 7.
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.