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510(k) Data Aggregation
(8 days)
The Vitalab Direct Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of conjugated (direct) bilirubin in serum and plasma. Direct bilirubin results may be used for the diagnosis and treatment of liver, hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Total Bilirubin Reagent is intended for use with the Vitalab Selectra Analyzer for the quantitative determination of total bilirubin in serum and plasma. Total bilirubin results may be used for the diagnosis and treatment af liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.
The Vitalab Bilirubin Calibrator is intended to calibrate the Vitalab Selectra Analyzer for the quantitative determination of total and direct bilirubin in serum and plasma.
The Vitalab Direct Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines conjugated bilirubin through a reaction with diazotized 2,4-dichloroanaline to produce a colored chromogen in acidic solution.
The Vitalab Total Bilirubin Reagent is a two-part reagent for use with the Vitalab Selectra Analyzer. This reagent determines total bilirubin through a reaction with diazotized 2,4-dichloroanaline in the presence of detergents to produce a colored chromogen in acidic solution.
The Vitalab Bilirubin Calibrator is a liquid stable bilirubin calibrator prepared from purified components in a human serum albumin matrix. Bilirubin set points are traceable to NIST reference materials.
Below is a summary of the acceptance criteria and performance study details for the Vitalab Direct Bilirubin Reagent, Vitalab Total Bilirubin Reagent, and Vitalab Bilirubin Calibrator, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Vitalab Direct Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Direct Bilirubin Reagent Reported Performance | Vitalab Total Bilirubin Reagent Acceptance Criteria / Predicate Performance (Implicit) | Vitalab Total Bilirubin Reagent Reported Performance |
|---|---|---|---|---|
| Linearity/Usable Range | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 10.0 mg/dL. | Sufficiently linear to meet clinical needs (implicit, typically based on predicate). | Linear to at least 25.0 mg/dL. |
| Detection Limit | Low enough for clinical utility (implicit). | 0.0 mg/dL. | Low enough for clinical utility (implicit). | 0.0 mg/dL. |
| Precision | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.3 mg/dL): Within Run 1SD = 0.03, %CV = 11.3%; Total 1SD = 0.03, %CV = 11.4%.Serum 2 (1.7 mg/dL): Within Run 1SD = 0.02, %CV = 1.3%; Total 1SD = 0.05, %CV = 2.8%.Serum 3 (4.0 mg/dL): Within Run 1SD = 0.02, %CV = 0.5%; Total 1SD = 0.10, %CV = 2.6%. | Acceptable within-run and total precision for clinical use (implicit, often referenced to NCCLS guidelines). | Serum 1 (0.4 mg/dL): Within Run 1SD = 0.02, %CV = 5.8%; Total 1SD = 0.03, %CV = 6.7%.Serum 2 (1.4 mg/dL): Within Run 1SD = 0.04, %CV = 3.1%; Total 1SD = 0.07, %CV = 4.8%.Serum 3 (5.8 mg/dL): Within Run 1SD = 0.07, %CV = 1.1%; Total 1SD = 0.15, %CV = 2.5%. |
| Correlation/Method Comparison | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent (r=0.9995, syx = 0.12 mg/dL if we assume the r and syx from linearity applies to correlation, which is probably incorrect, but no other value given for correlation specific r, syx). Range = 0.1 - 11.6 mg/dL. syx = 0.14 mg/dL (from calibration section, which seems to refer back to this data). | Substantially equivalent to predicate device (implicit standard for 510(k)). | Selectra = -0.4 mg/dL + 1.037 x Competitive Reagent. Range = 0.1 - 25.9 mg/dL. syx = 0.20 mg/dL. |
| Stability (Onboard Reagent & Calibration) | Meet claimed stability (implicit). | 14 day onboard reagent stability and 7 day calibration stability met (total imprecision < 0.2 mg/dL). | Meet claimed stability (implicit). | 7 day onboard reagent stability and 7 day calibration stability met (total imprecision < 0.2 mg/dL). |
| Calibrator Accuracy | Assigned set points documented through method comparison (implicit, comparable to predicate). | Direct Bilirubin: Selectra = 0.05 mg/dL + 0.832 x Competitive Reagent, syx = 0.14 mg/dL, n = 90, range= 0.1-11.6 mg/dL. Total Bilirubin: Selectra = - 0.4 mg/dL + 1.037 x Competitive Reagent, syx = 0.20 mg/dL, n = 103, range = 0.1 - 25.9 mg/dL. | N/A | N/A |
| Calibrator Open Stability | Meet claimed open stability (implicit). | Open stability confirmed for 3 days at 2℃ to 8℃ (changes < 0.03 mg/dL). | N/A | N/A |
Note on Acceptance Criteria: The document primarily describes the study results ("reported device performance") rather than explicitly stating pre-defined "acceptance criteria" with numerical thresholds for each metric. The implicit acceptance criterion for a 510(k) submission is that the device is "substantially equivalent" to a legally marketed predicate device, meaning its performance must be comparable and demonstrate safety and effectiveness for its intended use. Therefore, the reported performance is compared against what would be considered acceptable for such a device in the market.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Vitalab Direct Bilirubin Reagent (Correlation):
- Sample Size: 49 serum and 41 plasma specimens (total n = 90).
- Data Provenance: Adult patients, specific country of origin not stated, but generally assumed to be within North America or where Clinical Data, Inc. operates. The data is retrospective, as specimens are “assayed,” implying they were collected prior to the study.
- Vitalab Total Bilirubin Reagent (Correlation):
- Sample Size: 59 serum and 44 heparinized plasma specimens (total n = 103).
- Data Provenance: Adult patients, specific country of origin not stated. The data is retrospective.
- Vitalab Bilirubin Calibrator (Accuracy):
- Sample Size: At least 40 serum and plasma specimens (for both total and direct bilirubin).
- Data Provenance: Adult patient specimens. The data is retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. This device is an in vitro diagnostic (IVD) reagent for quantitative biochemical analysis, not an imaging or AI diagnostic device requiring expert interpretation for ground truth. The "ground truth" for method comparison studies is established by the results from a legally marketed, predicate/competitive reagent method.
4. Adjudication Method for the Test Set:
Not applicable. Ground truth for these types of studies is not established by expert consensus or adjudication but by comparison to an established, legally marketed method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No. These are IVD reagents; MRMC studies are typically for imaging/AI-assisted diagnostic devices involving human reader interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done:
Yes, the studies described are standalone performance evaluations of the reagents on the Vitalab Selectra Analyzer. There is no human-in-the-loop component for the interpretation of results beyond standard laboratory technician handling and quality control.
7. The Type of Ground Truth Used:
The ground truth was established by comparison to results obtained using commercially available (predicate or competitive) methods for direct and total bilirubin. This is the standard for demonstrating substantial equivalence for IVD reagents. For the calibrator, the bilirubin set points are traceable to NIST reference materials.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a "training set." The performance evaluation focuses on the analytical performance of the chemical reagents.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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