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510(k) Data Aggregation
(77 days)
VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are intended for use as a system for the quantitative determination of triglycerides in serum and plasma. Triglycerides results may be used for the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver diseases involving lipid metabolism, various endocrine disorders, or for assessing of the risk of developing cardiovascular diseases.
The Vitalab Triglycerides Reagent, the Vitalab Calibrator and the Vitalab Selectra Analyzer are used as a system for the quantitative analysis of triglycerides in serum and plasma. The Vitalab Triglycerides Reagent determines triglycerides using the lipase/GPO enzymatic assay procedure coupled to a Trinder indicator reaction. The resulting increase in absorbance at 505 nm is proportional to the triglycerides concentration of the sample.
This response is based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Linearity/Recovery | Linear from 5 to at least 900 mg/dL | Linear from 5 to at least 900 mg/dL, with a span from 0 mg/dL to 930 mg/dL. Regression statistics forced through the origin: sy.x = 3.7 mg/dL, (Vitalab Recoveries) = 1.164 x (Dilution Factor), n = 44. |
| Precision (Within Run) | Implicitly comparable to predicate or acceptable for intended use | Serum 1 (mean 69 mg/dL): 1SD = 0.6, %CV = 0.9% |
| Serum 2 (mean 291 mg/dL): 1SD = 1.6, %CV = 0.6% | ||
| Serum 3 (mean 624 mg/dL): 1SD = 3.5, %CV = 0.6% | ||
| Precision (Total) | Implicitly comparable to predicate or acceptable for intended use | Serum 1 (mean 69 mg/dL): 1SD = 1.1, %CV = 1.6% |
| Serum 2 (mean 291 mg/dL): 1SD = 4.4, %CV = 1.5% | ||
| Serum 3 (mean 624 mg/dL): 1SD = 11.3, %CV = 1.8% | ||
| Method Comparison (Serum) | Low intercept, slope near 1, low sy.x (comparable to predicate) | Intercept: -4.0 mg/dL (-6.9 to 1.16 mg/dL 95% CI) |
| Slope: 1.071 (1.059 to 1.083 95% CI) | ||
| sy.x: 3.6 mg/dL | ||
| Method Comparison (Plasma) | Low intercept, slope near 1, low sy.x (comparable to predicate) | Intercept: -0.2 mg/dL (-2.4 to 2.1 mg/dL 95% CI) |
| Slope: 1.068 (1.057 to 1.079 95% CI) | ||
| sy.x: 3.6 mg/dL | ||
| Minimum Detection Limit | Clearly defined and adequately low for clinical use | 1 mg/dL (calculated as mean + 2 standard deviations of 30 replicate measurements of normal saline, where both mean and SD were 0 mg/dL. Rounded up due to assay's round-off error). |
| Onboard Reagent Stability | Total imprecision of triglycerides recoveries less than 2 mg/dL over 14 days | Documented by assay of serum controls over 14 days. Total imprecision of triglycerides recoveries was less than 2 mg/dL. |
| Calibration Stability | Total imprecision of triglycerides recoveries less than 2 mg/dL over 7 days | Documented by assay of serum controls over 7 days. Total imprecision of triglycerides recoveries was less than 2 mg/dL. |
| Reconstituted Calibrator Stability | Observed change in triglycerides concentration less than 5% and statistically insignificant over 3 days | Documented by assaying calibrators of increasing ages. The observed change in triglycerides concentration over three days was less than 5% and statistically insignificant. |
(Note: The "Acceptance Criteria (Implied)" column contains interpretations of what would generally be considered acceptable performance for such a device in comparison to a predicate, as explicit criteria are not always stated but inferred from the study design and conclusion of substantial equivalence.)
2. Sample Size Used for the Test Set and Data Provenance:
- Linearity/Recovery: n = 44 (This sample size likely refers to dilution factors or individual measurements across the range). Provenance: Not explicitly stated, but likely laboratory-prepared standards or spiked samples.
- Precision:
- Serum 1: 60 replicates
- Serum 2: 60 replicates
- Serum 3: 60 replicates
Provenance: Commercially available control serum.
- Method Comparison:
- Serum samples: 59 specimens
- Heparinized plasma samples: 60 specimens
Provenance: Collected from adult patients. Country of origin not specified, but the submission is to the FDA, implying studies likely conducted in the US or internationally to US standards. Retrospective or prospective design is not explicitly stated, but the description "were collected from adult patients and were assayed for triglycerides" often implies a prospective or at least recently collected set of samples for the purpose of the study.
- Minimum Detection Limit: 30 replicate measurements of normal saline. Provenance: Laboratory materials.
- Onboard Reagent Stability & Calibration Stability: Not explicitly stated beyond "serum controls."
- Reconstituted Calibrator Stability: Not explicitly stated beyond "calibrators of increasing ages."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This device is a quantitative clinical chemistry assay. The "ground truth" for such assays is typically established by reference methods or comparison to a legally marketed predicate device, rather than expert consensus on individual cases.
- In this case, the "ground truth" for the method comparison study was the results from "another commercially available method," which served as the reference standard for comparison. The predicate device, the Beckman Trighycerides Reagent Kit and Synchron Multi-Calibrator, also serves as a benchmark for substantial equivalence.
- Therefore, traditional "experts" like radiologists establishing ground truth for images are not applicable here. The "expertise" lies in the validated performance of the reference method and the established accuracy of commercially available control sera.
4. Adjudication Method for the Test Set:
- Not applicable. This is a quantitative chemical assay, not a subjective interpretation task that would typically involve adjudication by multiple experts. The comparison is statistical (Deming regression) between the new device and a reference 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:
- Not applicable. This is a standalone in-vitro diagnostic (IVD) device for quantitative measurement of triglycerides, not an AI-assisted diagnostic tool that involves human readers interpreting results. Therefore, no MRMC study with human readers was conducted, and the concept of "improvement with AI vs without AI" does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Yes, this entire submission describes standalone performance studies for the Vitalab Triglycerides Reagent and Calibrator on the Vitalab Selectra Analyzer. The performance metrics (linearity, precision, method comparison, detection limit, stability) are all intrinsic to the device system itself, operating without direct human interpretive input influencing the quantitative result. The device outputs a numerical value for triglyceride concentration.
7. The Type of Ground Truth Used:
- Reference Method Comparison: For the method comparison studies, the "ground truth" was established by analyzing patient samples with "another commercially available method" (presumably a validated and accepted diagnostic method for triglycerides).
- Known Concentrations/Standards: For linearity and detection limit, the ground truth was based on known concentrations of standards or normal saline (effectively 0 mg/dL).
- Certified Control Sera: For precision and stability studies, commercially available control serum with established target values was used.
8. The Sample Size for the Training Set:
- This submission describes performance validation studies for an IVD reagent and calibrator. It does not mention any "training set" in the context of machine learning or AI algorithms. The assay procedure is based on a well-established lipase/GPO enzymatic reaction coupled to a Trinder indicator, not a statistical model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no mention of a training set for an AI/machine learning algorithm.
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