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510(k) Data Aggregation
(67 days)
TBIL Flex® reagent cartridge: The TBIL method is an in vitro diagnostic test for the quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Measurements of total bilirubin are used in the diagnosis and treatment of liver, hemolytic hematological and metabolic disorders, including hepatitis and gall bladder disease.
TDBIL Calibrator: The TDBIL CAL is an in vitro diagnostic product for calibration of the Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System.
TBIL Flex® reagent cartridge: Diazotized sulfanilic acid is formed by combining sodium nitrite and sulfanilic acid at low pH. Bilirubin (unconjugated) in the sample is solubilized by dilution in a mixture of caffeine/benzoate/acetate/EDTA. Upon addition of the diazotized sulfanilic acid, the solubilized bilirubin including conjugated bilirubins (mono and diglucoronides) and the delta form (biliprotein-bilirubin covalently bound to albumin) is converted to diazo-bilirubin, a red chromophore representing the total bilirubin which absorbs at 540 nm and is measured using a bichromatic (540, 700 nm) endpoint technique. A sample blank correction is used.
Total bilirubin and Direct bilirubin calibrator: The TDBIL calibrator is a two level calibrator. Level 1, purified water, is provided through the on-board Dimension Vista™ system. Level 2 is a lyophilized human serum based material spiked with ditaurobilirubin and traceable to NIST Standard Reference Material 916a.
Here's a breakdown of the acceptance criteria and the study information for the Dade Behring Dimension Vista™ TBIL Flex® reagent cartridge and TDBIL Calibrator, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Dimension Vista™ TBIL Assay) |
|---|---|---|
| TBIL Flex® reagent cartridge | ||
| Intended Use | Quantitative determination of total bilirubin in serum and plasma. | Quantitative measurement of total bilirubin in human serum and plasma on the Dimension Vista™ System. Used in diagnosis and treatment of liver, hemolytic hematological and metabolic disorders (hepatitis, 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 | 28 uL | 5 uL |
| Hemoglobin Correction | Up to 500 mg/dL Hemoglobin | Up to 1000 mg/dL Hemoglobin |
| Analytical Sensitivity | Not provided | 0.1 mg/dL |
| Within Lab Precision | 2.4%CV at 0.9 mg/dL; 9.6%CV @ 18.9 mg/dL | 5%CV @ 0.9 mg/dL; 2.9%CV @ 19.3 mg/dL |
| Reference Interval | < 1 mg/dL | <1 mg/dL |
| TDBIL Calibrator | ||
| Intended Use | Calibration of DBIL and TBIL methods on Dimension® clinical chemistry system. | Calibration of Direct Bilirubin (DBIL) and Total Bilirubin (TBIL) methods on the Dimension Vista™ System. |
| Analyte | Ditaurobilirubin | Ditaurobilirubin |
| Matrix | Human serum | Human serum |
| Levels | Three (L1 (0.8), L2 (9.4), L3 (21) for TBIL; L1 (0.6), L2 (6.9), L3 (14.5) for DBIL) | One (Level 2 (27.5) for TBIL; Level 2 (19.25) for DBIL). On-board purified system water is used for level 1. |
| Form | Lyophilized | Lyophilized |
| Volume | 6 vials, 2 vials each level, 1 mL each vial (hydrated volume) | 3 vials, 1mL each vial (hydrated volume). |
| Overall Comparison | Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999 when compared to the predicate device. The conclusion states "substantially equivalent in principle and performance." This implies acceptance relative to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Method comparison results provided a slope of 0.94, intercept of 0.4 mg/dL and correlation of 0.999." However, the sample size (N) for this method comparison or the provenance of the data (e.g., country of origin, retrospective or prospective) for the test set is not explicitly mentioned in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The device is an in vitro diagnostic test for quantitative measurement, which typically relies on analytical methods rather than expert interpretation for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/not provided for this type of analytical device. Adjudication methods are typically used when subjective interpretations (e.g., image readings) are involved in establishing ground truth.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
This information is not provided in the document. An MRMC study is relevant for devices that assist human readers (e.g., imaging devices), which is not the case for this in vitro diagnostic assay.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
The performance data presented (Analytical Sensitivity, Within Lab Precision, Method Comparison) are inherently standalone performance of the device, as it is an automated in vitro diagnostic assay. It operates without human interpretation in the loop for the actual measurement.
7. The Type of Ground Truth Used
The ground truth for the comparison was established by the predicate device's measurements, along with traceability of the TDBIL calibrator to NIST Standard Reference Material 916a. This indicates a reliance on established analytical standards and a legally marketed predicate device as the reference for equivalence.
8. The Sample Size for the Training Set
The document pertains to a 510(k) submission for an in vitro diagnostic device, not a machine learning algorithm. Therefore, the concept of a "training set" in the context of AI/ML does not apply here. The device's performance is based on its chemical methodology and analytical validation, not on being "trained" with data.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a training set is not applicable to this device.
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