(243 days)
MA reagent, when used in conjunction with SYNCHRON CX® System(s) and SYNCHRON CX® MA Calibrator, is intended for the quantitative determination of albumin (MA) concentration in human urine. Measurement of albumin in urine aids in the diagnosis of kidney dysfunction.
Synchron Systems Microalbumin (MA) reagent is intended for the quantitative determination of albumin in urine. MA reagent is used to measure the albumin concentration by a turbidimetric method. In the reaction, albumin combines with specific antibody to form insoluble antigen-antibody complexes. The Synchron System(s) automatically proportions the appropriate sample and reagent volumes into the cuvette. The ratio used is one part sample to 24 parts reagent. The system monitors the change in absorbance at 380 nanometers. This change in absorbance is proportional to the concentration of albumin in the sample and is used by the system to calculate and express albumin concentration based upon a non-linear calibration curve.
Here's a breakdown of the acceptance criteria and study information for the SYNCHRON® Systems Microalbumin (MA) Reagent, based on the provided text:
Acceptance Criteria and Device Performance
The provided document describes performance characteristics rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer the desired performance from the reported results and the comparison to the predicate device. The study aims to demonstrate substantial equivalence to the predicate.
| Performance Metric | Acceptance Criteria (Inferred) | Reported Device Performance (SYNCHRON® Systems MA Reagent) |
|---|---|---|
| Method Comparison (Correlation with Predicate) | High correlation (R close to 1), slope close to 1, intercept close to 0 with the predicate. | Slope: 0.990 |
| Intercept: -0.11 | ||
| R: 0.987 | ||
| Within-Run Precision (CV) | Low coefficient of variation (CV) at different concentration levels. | Level 1 (0.8 mg/dL): 9.7% |
| Level 2 (3.0 mg/dL): 4.5% | ||
| Level 3 (40.1 mg/dL): 1.0% | ||
| Total Precision (CV) | Low coefficient of variation (CV) across multiple runs and days. | Level 1 (0.8 mg/dL): 16.3% |
| Level 2 (3.0 mg/dL): 7.5% | ||
| Level 3 (40.1 mg/dL): 1.5% | ||
| Measuring Range (Initial) | Wider or comparable to predicate. | 0.2 - 30 mg/dL (Predicate: 0.2 - 4.0 mg/dL) |
| Measuring Range (Extended) | Wider or comparable to predicate, with effective extension methods. | 24 - 97 mg/dL (achieved via smaller sample size) (Predicate: 4.0 - 864.0 mg/dL via on-line dilutions) |
Study Information
2. Sample Size Used for the Test Set and Data Provenance:
- Method Comparison (N): 111 (samples)
- Precision Studies (N): 80 (measurements per level for both within-run and total imprecision)
- Data Provenance: Not explicitly stated (e.g., country of origin). The document implies these are laboratory-generated data for performance validation. It is retrospective in the sense that the data used to prove substantial equivalence was collected prior to the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device is a quantitative diagnostic test for a chemical analyte (albumin). The "ground truth" for the test set is established by the reference method (predicate device measurements) and the intrinsic chemical properties/concentrations of the samples used in the precision studies, not by expert interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3.
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 reagent for an automated laboratory instrument, not an AI-assisted diagnostic tool that involves human readers/interpreters in the diagnostic process.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone performance study was done. The entire performance evaluation (method comparison, precision data) for the SYNCHRON® Systems Microalbumin (MA) Reagent is a standalone evaluation of the device's analytical performance on the SYNCHRON CX® System, without human interpretation as part of the primary measurement.
7. The Type of Ground Truth Used:
- Reference Method/Quantitative Measurement: For the method comparison, the "ground truth" is the quantitative measurement provided by the legally marketed predicate device (IMMAGE Microalbumin (MA) Reagent). For precision, the "ground truth" for each sample level is its mean concentration as determined by repeated measurements.
8. The Sample Size for the Training Set:
- Not explicitly stated in terms of a separate "training set" for an algorithm. For this type of device (chemical reagent for an automated system), "training" generally refers to the development and optimization of the reagent formulation and the instrument's calibration curve. The document mentions a "6 level non-linear calibration curve" for the Synchron CX systems, which suggests calibration data were used to establish the assay's operational parameters, but the specific sample size for this is not provided.
9. How the Ground Truth for the Training Set was Established:
- Not explicitly detailed as a distinct "ground truth" for a training set. The calibration curve construction (mentioned as "6 level non-linear calibration curve") would involve using calibrator materials with known, accurately determined concentrations of albumin. These concentrations would be established through a traceable reference method or gravimetric preparation.
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.