(448 days)
The A/C Enzymatic Vitamin B6 Assay is intended for the quantitative in vitro diagnostic determination of pyridoxal 5'-phosphate (PLP, vitamin Bo) in EDTAhuman plasma. The device will be used to monitor PLP concentrations in plasma for aid in diagnosis of vitamin B6 deficiency. The A/C Enzymatic Vitamin B6 Assay is for IN VITRO DIAGNOSTIC USE ONLY.
The A/C Enzymatic Vitamin B6 Assay is calibrated with external standardization and matrix-matched calibration solutions. Two sources of quality control material (A low and high level of PLP) are assaved in each run together with A/C Calibrators and samples for the verification of the accuracy and precision of the A/C Enzymatic Vitamin B6 Assay.
The A/C Enzymatic Vitamin B6 Assay uses the apo form of recombinant PLPdependent enzyme, homocysteine-a.y-lyase (rHCYase). The restoration of enzymatic activity by reconstitution of the holo-enzyme is linearly dependent on the amount of PLP bound to apo-enzyme. Nanomolar concentrations of PLP can then be measured by the conversion of millimolar concentrations of homocysteine to hydrogen sulfide, which is determined using DBPDA, the combination of which forms a chromophore, the absorbance is read with 96-well plate absorbance reader.
The A/C Enzymatic Vitamin B6 Assay is a three-step reaction with four reagents. which runs at 37°C or room temperature. The total assay takes 90 minutes. The assay can be performance on 96-well absorbance reader with 660-690m filter.
Here's a breakdown of the acceptance criteria and the study details for the A/C Enzymatic Vitamin B6 Assay, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the comparison to the predicate device. The study aims to demonstrate substantial equivalence, meaning the new device performs similarly to the already legally marketed predicate (ALPCO Vitamin B6 REA method). The performance is assessed through correlation and regression analysis, and bias.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Strong linear correlation (r) to predicate device | r = 0.909 |
| Regression equation close to ideal y = x | y = 0.969x + 7.6 |
| Low bias/average difference compared to predicate device | 2.42 nmol/L (average difference between A/C and ALPCO assays) |
| Measurement range comparable to predicate device | A/C: 16.3 - 189.3 nmol/L; ALPCO: 15.8 - 185.8 nmol/L |
| Ability to quantify PLP in EDTA-human plasma | Quantitative determination of pyridoxal 5'-phosphate (PLP) in EDTA-human plasma. |
| Aid in diagnosis of vitamin B6 deficiency | Intended to monitor PLP concentrations for aid in diagnosis. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Fifty-four (54) EDTA-plasma samples.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be retrospective, using existing EDTA-plasma samples. No information suggests prospective data collection.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided in the summary. For this type of in vitro diagnostic device (IVD) assay, the "ground truth" for the test set is established by the results obtained from the predicate device itself, as the goal is to demonstrate equivalence, not diagnostic accuracy against a clinical gold standard (like pathology).
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication involved in comparing the results between the new device and the predicate device. The comparison was a direct statistical analysis of the numerical results generated by both assays.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or other assessments where human interpretation is a key component, comparing human performance with and without AI assistance. This 510(k) pertains to a laboratory assay (an IVD) where the device provides a direct quantitative result, not an interpretation requiring human readers.
6. Standalone (Algorithm-Only) Performance Study
Yes, implicit in the study. The comparison of the A/C Enzymatic Vitamin B6 Assay to the ALPCO Vitamin B6 REA assay is inherently a standalone performance study. The algorithm (assay) generates a quantitative value, which is then directly compared to the values generated by the predicate assay. There is no "human-in-the-loop" component for the measurement itself.
7. Type of Ground Truth Used
The "ground truth" for this comparative study was the results obtained from the predicate device (ALPCO Vitamin B6 REA assay). The new device's performance was evaluated by its agreement with these predicate device results. This is a common approach for IVD devices demonstrating substantial equivalence.
8. Sample Size for the Training Set
The 510(k) summary does not explicitly mention a "training set" in the context of machine learning, as this is a biochemical assay, not an AI/ML algorithm that requires training data in the typical sense. The assay is developed based on biochemical principles and optimized through research and development, but there's no data provided about a distinct "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for establishing "ground truth" is not directly applicable in the summary provided for this type of enzymatic assay. The assay's analytical characteristics and performance are based on its underlying biochemical mechanism and empirical validation, rather than learning from a labeled training dataset.
§ 862.1810 Vitamin B
12 test system.(a)
Identification. A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.(b)
Classification. Class II.