Search Results

The DBIL method is an in vitro diagnostic test for the quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of direct bilirubin are used in the diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.

Device Description

Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. The sample is diluted in 0.5M HCl. A blank reading is taken to eliminate interference from nonbilirubin pigments. Upon addition of the diazotized sulfanilic acid, the conjugated bilirubin is converted to diazo-bilirubin, a red chromophore which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique.

AI/ML Overview

The provided text describes the 510(k) summary for the DBIL Flex® reagent cartridge, which is an in vitro diagnostic test for measuring direct (conjugated) bilirubin in human serum and plasma. The study presented is a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense as might be found for a clinical outcome. Instead, it presents performance characteristics of the new device and compares them to a predicate device, aiming to show "substantial equivalence." The "acceptance" can be inferred from the "Conclusion" statement: "The Dimension Vista™ DBIL Flex® reagent cartridge is substantially equivalent in principle and performance to the predicate product."

The key performance characteristics reported are:

Performance Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Dimension Vista™ DBIL Flex®)
Intended Use	Quantitative determination of direct (conjugated) bilirubin in serum and plasma on the Dimension® clinical chemistry system.	Quantitative measurement of direct (conjugated) bilirubin in human serum and plasma on the Dimension Vista™ System. Used in diagnosis and treatment of liver, hemolytic, hematological and metabolic disorders, including hepatitis and gall bladder disease.
Sample Type	Human serum and plasma	Human serum and plasma
Methodology	Photometric (diazo chemistry)	Photometric (diazo chemistry)
Detection	Bichromatic (540, 700 nm)	Bichromatic (540, 700 nm)
Sample Volume	31 uL	5 uL
Hemoglobin Flag	Yes	Yes
Analytical Sensitivity	Not provided	0.05 mg/dL
Repeatability	4.7 %CV at 5 mg/dL	9.1%CV @ 0.4 mg/dL 2.1%CV @ 5.9 mg/dL
Reference Interval	< 0.3 mg/dL	< 0.2 mg/dL
Method Comparison	(Implied to be very close to 1:1 with predicate)	Slope: 0.97 Intercept: 0.01 mg/dL Correlation: 0.999

Note on "Acceptance Criteria": For a 510(k) submission like this, the "acceptance criteria" for substantial equivalence are generally that the new device performs as well as, or better than, the predicate device in relevant analytical performance characteristics, and has the same intended use. The method comparison results (slope, intercept, correlation) are key metrics demonstrating this.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Method comparison results provided a slope of 0.97, intercept of 0.01 mg/dL and correlation of 0.999." However, it does not specify the sample size used for this method comparison study or the data provenance (e.g., country of origin, retrospective or prospective). This information is typically detailed in the full study report, which is not included in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of diagnostic test (quantitative measurement of a biomarker) does not typically involve human experts establishing "ground truth" in the way, for example, an imaging AI system would. The "ground truth" for the method comparison is the measurement obtained from the predicate device on the same samples. Therefore, this section is not applicable (N/A) in the context of this device.

4. Adjudication Method for the Test Set

Since the "ground truth" is derived from the predicate device's measurements, there is no need for an adjudication method involving human readers. This section is not applicable (N/A).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was described. This device is an in vitro diagnostic assay, not an imaging AI or decision support system that would typically employ human readers. This section is not applicable (N/A).

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

The entire evaluation presented is of the device (reagent cartridge on the Dimension Vista™ System), which operates as an automated quantitative measurement system. It does not involve a "human-in-the-loop" once the sample is loaded. Therefore, the reported performance characteristics (analytical sensitivity, repeatability, method comparison) represent its standalone performance.

7. Type of Ground Truth Used

The "ground truth" used for comparison in this study is the measurement obtained from the legally marketed predicate device (Dade Behring DBIL assay, K862359) on the same samples. This is a common approach for establishing substantial equivalence for IVDs.

8. Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic reagent cartridge. This type of device relies on established chemical principles (diazotized sulfanilic acid reaction) and calibration procedures, rather than machine learning algorithms that require "training sets" in the conventional sense. Therefore, this section is not applicable (N/A).

9. How the Ground Truth for the Training Set Was Established

As noted above, this device does not utilize a machine learning "training set." Its analytical performance is validated through traditional analytical chemistry and clinical laboratory methods. This section is not applicable (N/A).

Ask a Question

Ask a specific question about this device

Page 1 of 1