Search Results
Found 1 results
510(k) Data Aggregation
(84 days)
The Access sTfR assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of soluble transferrin receptor (sTR) levels in human serum and plasma (heparin) using the Access Immunoassay Systems. This assay is intended as an aid in the diagnosis of Iron Deficiency Anemia (IDA), and for the differential diagnosis of IDA and Anemia of Chronic Disease (ACD).
This assay may also be used in conunction with an Access Ferritin measurement to provide a calculated sTR log ferritin index. This index is intended as an aid in the diagnosis of IDA, and for the differential diagnosis of IDA and ACD.
Access sTfR: The sTfR assay reagent pack consists of two specific reagents: (R1a) paramagnetic particles coated with streptavidin:biotinylated soluble transferrin receptor monoclonal antibody, proteins (mouse, goat, bovine), bovine serum albumin (BSA), 0.1% sodium azide, and 0.17% ProClin 300; and (R1b) Monoclonal mouse anti-human soluble transferrin receptor alkaline phosphatase (bovine) conjugate, BSA, 0.1% sodium azide and 0.17% ProClin 300. Two assay packs containing 50 tests per pack are provided for a total of 100 assay determinations.
The Access sTfR assay is a sequential two-step immunoenzymatic ("sandwich") assay. A sample is added to a reaction vessel along with paramagnetic particles coated with anti-sTfR antibody. During incubation, the sTfR antigen in the sample binds to the immobilized anti-sTfR antibody on the solid phase. Alkaline phosphatase conjugated anti-sTfR antibody is then added and reacts with a different antigenic site on the sTfR molecule.
After incubation, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then, the chemiluminescent substrate is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of analyte in the sample. Analyte concentration is automatically determined from a stored calibration.
Here's a breakdown of the acceptance criteria and study information for the Access sTfR device, based on the provided FDA 510(k) summary:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Method Comparison | Slope: 0.99 – 1.01 (95% CI) | Slope: 1.00 (95% CI: 0.99 – 1.01) | Yes |
| Intercept: -0.14 - 0.15 (95% CI) | Intercept: -0.016 (95% CI: -0.14 - 0.15) | Yes | |
| Correlation Coefficient (R): Not explicitly stated as acceptance, but comparison shows R = 1.00 | Correlation Coefficient (R): 1.00 | Yes (Excellent) | |
| Imprecision | ≤ 0.72 nmol/L SD at concentrations ≤ 9 nmol/L | Sample 1 (9.1 nmol/L): 0.24 nmol/L SD | Yes |
| ≤ 8.0% CV at concentrations > 9 nmol/L | Sample 2 (17 nmol/L): 2.6% CV < 8% | Yes | |
| Sample 3 (20 nmol/L): 2.4% CV < 8% | Yes | ||
| Sample 4 (33 nmol/L): 1.8% CV < 8% | Yes | ||
| Sample 5 (67 nmol/L): 2.0% CV < 8% | Yes | ||
| Sample 6 (118 nmol/L): 2.2% CV < 8% | Yes | ||
| Linearity | "The assay demonstrated linearity across the measuring interval." | "The assay demonstrated linearity across the measuring interval." | Yes (Direct statement) |
| Detection Capability | Not explicitly stated as acceptance criteria, but listed as targets to be determined. | LoB: 0.04 nmol/L | Achieved targets |
| LoD: 0.05 nmol/L | Achieved targets | ||
| LoQ: 0.05 nmol/L (≤ 20% within-lab CV) | Achieved targets |
Study Details
-
Sample size used for the test set and the data provenance:
- Method Comparison: N = 200 patient samples.
- Imprecision: N = 6 samples (Sample 1-6) tested in duplicate, in 2 runs/day for a minimum of 20 days (total N for each sample is 80 measurements).
- Linearity & Detection Capability: Sample sizes for these specific studies are not explicitly stated, but the studies were performed on the Dxl 9000 Access Immunoassay Analyzer.
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective or prospective).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is an in vitro diagnostic (IVD) immunoassay for the quantitative determination of soluble transferrin receptor (sTfR) levels. The performance studies (method comparison, imprecision, linearity, detection capability) do not involve human experts establishing a "ground truth" in the way an imaging AI might. Instead, the "ground truth" (or reference standard) for method comparison is the measurement from the predicate device (Access sTfR Assay on Access 2 Immunoassay System). For imprecision, linearity, and detection capability, the ground truth is established by the analytical measurement procedures themselves against defined statistical targets.
-
Adjudication method for the test set:
- Not applicable. As noted above, this is an IVD immunoassay, not a system requiring human adjudication of results in the traditional sense. The reference method (predicate device) serves as the comparator for the method comparison study.
-
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 an IVD immunoassay, not an imaging AI or a device that assists human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the performance studies (method comparison, imprecision, linearity, detection capability) represent the standalone performance of the Access sTfR assay on the Dxl 9000 Access Immunoassay Analyzer. Its output is a quantitative sTfR value.
-
The type of ground truth used:
- Method Comparison: Measurements from the predicate device (Access sTfR Assay on Access 2 Immunoassay System). This serves as the reference for comparison against the new device.
- Imprecision, Linearity, Detection Capability: Analytical measurements are compared against pre-defined statistical performance targets (e.g., SD, CV, LoB, LoD, LoQ) established according to CLSI guidelines.
-
The sample size for the training set:
- Not applicable. This is a conventional immunoassay, not a machine learning/AI device requiring a separate "training set" in that context. The device uses established biochemical reactions and a stored calibration curve.
-
How the ground truth for the training set was established:
- Not applicable (see above). The device establishes its "calibration" using internal calibrators and controls to create a stored calibration curve, as is typical for immunoassays. This is distinct from machine learning model training with labeled ground truth data.
Ask a specific question about this device
Page 1 of 1