(75 days)
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods. For in vitro diagnostic use. The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Each Hemoglobin Capillary Collection System (HCCS) contains a combination of the following components (quantity is dependent upon kit size): 1. Sample Preparation Vials: clear microvials with blue pierceable caps, each contains 1.5 mL of the HCCS reagent. 2. Capillaries: plastic capillaries (5 uL) in a dispenser. 3. Capillary Holder: holder for manipulating the capillaries. 4. Labels: to label prepared samples. The HCCS provides the necessary materials for a professional user to collect and prepare whole blood samples (capillary or venous blood) for analysis with the VARIANT™ II Hemoglobin A1c Program run on the VARIANT™ II Hemoglobin Testing System or the D-10™ Hemoglobin A1c Program run on the D-10™ Hemoglobin Testing System.
Acceptance Criteria and Study Summary for Hemoglobin Capillary Collection System (HCCS)
This document summarizes the acceptance criteria and the study that demonstrates the Bio-Rad Laboratories, Inc. Hemoglobin Capillary Collection System (HCCS) meets these criteria, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes a method comparison study to establish substantial equivalence rather than explicit quantitative acceptance criteria with predefined thresholds. The acceptance criterion implicitly sought was no significant difference between HCCS capillary samples and traditional venous EDTA samples when analyzed by the predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance (from Method Comparison Studies) |
|---|---|
| No significant difference in hemoglobin A1c values between capillary samples collected with HCCS and venous whole blood samples. | HCCS Comparison Study on the VARIANT™ II Hemoglobin A1c Program: |
- Sample Value Range: 4.2% HbAlc to 12.6% HbAlc
- The specific performance metrics (e.g., correlation coefficient, bias) are not fully legible in the provided table but the conclusion states "no significant difference". |
| HCCS Comparison Study on the D-10™ Hemoglobin A1c Program: - Sample Value Range: 4.2% HbAlc to 14.3% HbAlc
- The specific performance metrics (e.g., correlation coefficient, bias) are not fully legible in the provided table but the conclusion states "no significant difference". |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The exact number of patients included in each method comparison study (VARIANT™ II and D-10™) is not explicitly stated. The text only mentions that "One HCCS capillary sample and one venous EDTA primary tube sample were collected from each patient."
- Data Provenance: The study was conducted at an external site, implying data was collected from a clinical setting. The country of origin is not specified but given the submitter's location (Hercules, California, USA) and the FDA submission, it is likely the US. The study appears to be prospective, as it involved collecting samples specifically for the comparison.
3. Number of Experts and Qualifications for Establishing Ground Truth (Test Set)
This study does not involve expert readers or a ground truth established by experts in the traditional sense of image interpretation or diagnostic decision-making. The ground truth for hemoglobin A1c values is established by the predicate HPLC methods (VARIANT™ II and D-10™ Hemoglobin A1c Programs) using venous blood samples, which are the established and legally marketed methods for this measurement.
4. Adjudication Method (Test Set)
Not applicable. This was a method comparison study for quantitative measurement, not a study requiring adjudication of expert interpretations. The "ground truth" was derived from the reference methods (predicate HPLC systems).
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not performed. This study evaluates a sample collection system for a quantitative analyte (HbA1c), not an imaging or diagnostic interpretation device requiring human reader assessment or AI assistance.
6. Standalone Performance
Yes, a standalone performance was done in the sense that the HCCS was evaluated with the predicate devices. The "performance evaluation studies" mentioned in the conclusion, along with the method comparison, assess the HCCS's ability to provide samples that yield comparable HbA1c results to the established venous collection methods when processed by the predicate instruments. The HCCS itself is a collection system, and its standalone performance is intrinsically tied to the accuracy of the HbA1c measurement obtained from samples collected with it.
7. Type of Ground Truth Used
The ground truth used was comparative analytical results from legally marketed and established predicate devices (VARIANT™ II Hemoglobin A1c Program and D-10™ Hemoglobin A1c Program) performing HbA1c measurements on venous whole blood samples. This serves as the reference standard against which the HCCS collected capillary samples are compared.
8. Sample Size for the Training Set
The document does not mention a training set as this device is not an AI/ML algorithm that requires training. It is a medical device for sample collection.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.