(50 days)
The CARESIDE™ Total Bilirubin cartridge is intended for in vitro diagnostic use in conjunction with the CARESIDE™ Analyzer to quantitatively measure the total concentration of bilirubin in anti-coagulated whole blood, plasma or serum. The CARESIDE™ Total Bilirubin test aids in the diagnosis and treatment of patients with liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder blockage.
This product is for in vitro diagnostic use with the CARESIDE™M Analyzer to quantitatively measure total bilirubin concentration in anti-coagulated whole blood, plasma or serum specimens to aid in the diagnosis and treatment of patients with liver, hemolytic, hematological, and metabolic disorders, including hepatitis and gall bladder blockage. It is intended for professional laboratory use: not for point of care use or physician office laboratory use.
CARESIDE™ Total Bilirubin cartridges are used with the CARESIDE™ Analyzer to quantitatively measure the total concentration of bilirubin in anti-coagulated whole blood, plasma or serum specimens. The CARESIDE™ Total Bilirubin cartridge, a single use disposable in vitro diagnostic test cartridge, aids in specimen separation and delivers a measured volume of plasma or serum to a dry film to initiate the measurement of the total concentration of bilirubin. The film cartridge (patent pending) contains all reagents necessary to measure the total concentration of bilirubin.
Each CARESIDE™ Total Bilirubin cartridge consists of a bilirubin-specific multi-layer reagent film mounted in a plastic base with a hinged lid. The user introduces the anticoagulated whole blood, serum, or plasma specimen into the cartridge sample deposition well, closes the lid and inserts the cartridge into the CARESIDE™ Analyzer.
Once loaded, the CARESIDE™ analyzer scans the cartridge barcode, brings the cartridge and the contained specimen to 37℃, and spins the cartridge to move the sample from the sample deposition well into the cartridge channels and chambers. As the cartridge continues to spin, the blood cells are separated from the plasma/serum and the cells accumulate in the separation well. Approximately ten microliters of plasma (or serum, as applicable) remain in the metering passage. Excess sample flows into an overflow well.
The plasma (or serum, as applicable) is automatically dispensed onto the multi-layer reagent film. The spreading and reaction layer distributes the sample evenly on the film and dissociates the unconjugated bilirubin from albumin. Conjugated and unconjugated bilirubin reacts with 2,4-dichlorobenzene diazonium salt to form a red azo dye. The color intensity, as measured by the amount of light reflected at 505 nanometers, directly relates to the total concentration of bilirubin in the specimen.
As the cartridge spins, a photodiodes measures reflectance of light emitted from a wavelength-specific light emitting diode (LED) at a fixed time. The analyzer uses the reflectance measurements and the lot-specific standard curve to calculate the total bilirubin concentration.
The provided document describes the CARESIDE™ Total Bilirubin device and its comparison to a predicate device, the Vitros TBIL DT Slides, for the purpose of seeking 510(k) clearance. The information provided focuses on demonstrating substantial equivalence, rather than a detailed clinical study with predefined acceptance criteria and a comprehensive study report to "prove" the device meets them in a formal sense. However, we can extract the comparative performance characteristics that serve as the basis for the equivalence claim.
Based on the information, the acceptance criteria are implicitly defined by the comparative performance against the predicate device, Vitros TBIL DT Slides. The study conducted is a comparative performance study.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission focusing on substantial equivalence, explicit "acceptance criteria" are not stated in a numerical form that the device must strictly meet. Instead, the performance of the CARESIDE™ Total Bilirubin device is compared directly to the predicate device, the Vitros TBIL DT Slides. The implicit "acceptance" is that the CARESIDE™ device performs as well as or better than the predicate device, as concluded in Section IV.D.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Device) | CARESIDE™ Total Bilirubin Performance |
|---|---|---|
| Detection Limit | Not explicitly provided for predicate | 0.2 mg/dL |
| Reportable Range | 0.1 to 20 mg/dL | 0.2 to 24 mg/dL |
| Accuracy (Mean Recovery) | Not provided for predicate | 96% |
| Precision (Total CV) | 1.2 mg/dL, 6% | 1.1 mg/dL, 12% |
| Method Comparison | r = 0.96 (correlation with another method) | CARESIDE™ = 1.04 (Vitros TBIL DT) + 1.0 mg/dL, r = 0.96 |
| Linearity | Not provided for predicate | Yielded results within acceptable limits |
| Interference | Not provided for predicate | No significant interference observed at tested concentration of interferents: Ascorbic Acid (20 mg/dL), Hemoglobin (100 mg/dL), Protein (9 mg/dL) |
| Specimen Types & Anticoagulants | No clinical difference between serum, heparin plasma, or EDTA plasma. Whole blood unsuitable. | No clinically significant difference between anti-coagulated whole blood, serum, sodium heparin plasma, and EDTA plasma. |
| Expected Values (Reference Range) | 0.1-1.4 mg/dL (male) Central 95% interval | 0.2 to 1.3 mg/dL Central 95% interval |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the studies, nor the data provenance (e.g., country of origin, retrospective/prospective) for each specific performance characteristic study (e.g., accuracy, precision, method comparison, interference). The information provided is a summary of the comparative performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable and not provided in the document. The "ground truth" for a quantitative diagnostic device like a total bilirubin test is typically established through reference methods (e.g., diazotized sulfanilic acid reaction in the presence of caffeine-benzoate-acetate, as mentioned for the CARESIDE™ device as its reference method) or comparison to a cleared predicate device, not by expert consensus or interpretation of images/cases.
4. Adjudication Method for the Test Set
This is not applicable since the device measures a quantitative analyte and doesn't involve subjective interpretation that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance?
This is not applicable. The CARESIDE™ Total Bilirubin device is an in vitro diagnostic (IVD) device for quantitative measurement of a biochemical analyte. It does not involve human readers interpreting cases, nor does it incorporate artificial intelligence for image analysis or diagnostic assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device itself is a standalone analytical system (CARESIDE™ Analyzer with CARESIDE™ Total Bilirubin cartridges) for quantitative measurement. Its performance characteristics listed are inherently "standalone" in the sense of the analytical measurement. There is no "human-in-the-loop" component for the measurement itself, beyond proper specimen collection, loading, and result interpretation by laboratory professionals.
7. The Type of Ground Truth Used
The ground truth for evaluating the CARESIDE™ Total Bilirubin device's performance is established by:
- Comparison to a legally marketed predicate device: Vitros TBIL DT Slides for the Vitros DT 60 II.
- Comparison to a candidate reference method: The document states that the CARESIDE™ device uses "Diazotized sulfanilic acid reaction in the presence of caffeine-benzoate-acetate (candidate ref. method for serum total bilirubin determination)" as its reference method. This is a common and accepted reference method in clinical chemistry for bilirubin measurement.
8. The Sample Size for the Training Set
The document does not provide information on a "training set" or its sample size. For an IVD device like this, the development typically involves analytical validation studies rather than machine learning model training sets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of machine learning, this question is not applicable. The analytical performance of the device is assessed against a predicate device and established reference methods.
§ 862.1110 Bilirubin (total or direct) test system.
(a)
Identification. A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.(b)
Classification. Class II.