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510(k) Data Aggregation
(248 days)
ST AIA-PACK SHBG is designed for In Vitro Diagnostic Use Only for the quantitative measurement of sex hormone binding globulin (SHBG) in human serum or Na heparinized plasma on Tosoh AIA System Analyzers. The ST AIA-PACK SHBG assay is intended for use as an aid in the diagnosis of androgen disorders.
The ST AIA-PACK SHBG Calibrator Set is intended for In Vitro Diagnostic Use Only for the calibration of the ST AIA-PACK SHBG assay.
The ST AIA-PACK SHBG is a two-site immunoenzymometric assay which is performed entirely in the ST AIA-PACK SHBG test cups. SHBG present in the test sample is bound with monoclonal antibody immobilized on a magnetic solid phase and enzyme-labeled monoclonal antibody in the test cups. The magnetic beads are washed to remove unbound enzyme-labeled antibody and are then incubated with a fluorogenic substrate, 4-methylumbelliferyl phosphate (4MUP). The amount of enzyme-labeled monoclonal antibody that binds to the beads is directly proportional to the SHBG concentration in the test sample. A standard curve is constructed, and unknown sample concentrations are calculated using this curve.
The provided text describes the performance characteristics of the ST AIA-PACK SHBG device, which is an in vitro diagnostic assay for measuring Sex Hormone Binding Globulin (SHBG). The studies conducted for this device do not involve AI or human readers for image interpretation, but rather focus on analytical performance criteria typical for a laboratory diagnostic assay. Therefore, questions related to AI assistance, human reader improvement, and adjudication methods are not applicable.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For analytical devices like the ST AIA-PACK SHBG, acceptance criteria are typically specified in terms of performance metrics like precision (CV%), linearity (measuring range), limit of detection (LoD), and correlation with a predicate device. The document generally presents the performance metrics achieved by the device without explicitly stating pre-defined "acceptance criteria" numerical targets. However, comparisons to the predicate device and CLSI guidelines serve as implicit benchmarks for acceptability.
| Performance Characteristic | Implicit Acceptance Criteria (based on CLSI guidelines/predicate comparison/industry standards) | Reported Device Performance (ST AIA-PACK SHBG) |
|---|---|---|
| Precision (Total Precision CV%) | Typically <10% for immunoassay (Often below 5-10% for various levels) | Serum: 2.8% to 3.7% (for individual lots/levels), Combined Summary Table: 4.6% to 5.8% (for serum), Plasma: 3.5% to 3.7% (for individual lots/levels), Combined Summary Table: 5.3% to 6.8% (for plasma). All reported values are within the typical acceptance range for immunoassays. |
| Linearity (Measuring Range) | Should cover a clinically relevant range. Predicate range: 0.1 to 250 nmol/L. | Demonstrated linearity from 0.2 to 250 nmol/L. This range is comparable to the predicate and clinically relevant. |
| Limit of Detection (LoD) | Low enough for clinical utility. Predicate LoD: 0.02 nmol/L. | 0.063 nmol/L. The predicate specified a LoD of 0.02 nmol/L, meaning the subject device's LoD is slightly higher, but still low. |
| Limit of Quantitation (LoQ) | Low enough for accurate quantitation. | 0.2 nmol/L (based on 12% total error). |
| Method Comparison (Correlation with Predicate) | High correlation (e.g., Correlation Coefficient (R) > 0.95, slope near 1, intercept near 0). | Deming Slope: 0.949 (0.926 to 0.972), Intercept: -0.64 (-2.61 to 1.34), Corr Coef (R): 0.991. These values demonstrate excellent correlation with the predicate. |
| Matrix Comparison (Serum vs. Plasma) | High correlation between different sample matrices. | Deming Slope: 0.977 (0.964 to 0.991), Intercept: 0.269 (-0.629 to 1.168), Corr Coef (R): 0.997. These values demonstrate excellent correlation between serum and Na heparinized plasma. |
| Interference | No significant interference from common interfering substances (e.g., hemoglobin, bilirubin, lipids, HAMA). Recovery typically within +/-10%. | No interference observed from: Hemoglobin (up to 446 mg/dL), free and conjugated bilirubin (up to 17.6 mg/dL and 18.5 mg/dL respectively), lipemia (triglycerides up to 1,667 mg/dL), ascorbic acid (up to 20 mg/dL), protein (albumin up to 5.00 g/dL), Na Heparin (up to 100.0 U/mL), Rheumatoid factor (up to 550 IU/mL), HAMA (up to 24,269 ng/mL). This meets the non-interference expectation. |
| Cross-Reactivity | Minimal to no cross-reactivity with related or common substances. | Generally N.D. (not detectable) or very low percentage (e.g., 0.003% for Cortisol, 0.019% for Testosterone). Thyroglobulin had a 2.544% cross-reactivity, which may be noted but specific acceptance for such levels is not provided. |
| Calibrator Stability (Real Time) | Recovery within 100 +/- 10%; Reproducibility (CV%) <= 10%. | Supports 12-month shelf life at refrigerated temperatures. |
| Calibrator Stability (Open Vial) | Recovery within 100 +/- 10%; Reproducibility (CV%) <= 10%. | Supports 1-day in-use claim when refrigerated. |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study:
- Three levels of serum and heparinized plasma specimens were assayed.
- Measurements were taken in 2 replicates in a single run, 2 times a day for 20 non-consecutive days.
- This implies a total of 3 (levels) * 2 (matrices) * 2 (reps/run) * 2 (runs/day) * 20 (days) = 480 measurements per reagent lot, but the actual number of distinct biological samples is not directly specified beyond "three levels of serum and heparinized plasma specimens".
- Linearity Study: Sample size not explicitly stated for this particular study, but it was performed with guidance from CLSI Protocol EP6-A.
- Method Comparison: 126 serum specimens.
- Matrix Comparison: 116 patient specimens (diluted to obtain the low end of the measuring range).
- Reference Ranges Study: 488 apparently healthy American and European individuals (244 male and 244 female).
- Interference Study: Not specified, but involved adding various interfering substances to "human specimens".
- Limit of Detection (LoD) and Limit of Quantitation (LoQ):
- LoD: 60 measurements of 4 different blank specimens; 12 measurements of 10 low-level samples.
- LoQ: 12 measurements of 5 samples.
Data Provenance:
- Reference Ranges: "488 apparently healthy American and European individuals." This indicates a prospective collection from multiple geographical locations.
- For other studies (Precision, Method Comparison, Matrix Comparison, Interference, LoD/LoQ), the provenance (country of origin, retrospective/prospective) is not explicitly stated, but the use of "human serum or Na heparinized plasma," "patient specimens," and "human specimens" suggests clinical samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device is an in vitro diagnostic assay that generates quantitative measurements of a biochemical marker (SHBG). The "ground truth" for such devices is established through analytical validation against reference methods or accepted standards, not through expert consensus on qualitative assessments like image interpretation. There are no "experts" in the traditional sense mentioned, but rather scientific and clinical validation methodologies.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as in point 3. Adjudication is typically relevant for studies where subjective interpretation (e.g., by radiologists) is part of establishing ground truth or evaluating performance, which is not the case for this quantitative assay.
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
This information is not applicable. This device is a standalone laboratory assay and does not involve AI assistance or human readers for diagnostic interpretation in the manner described for MRMC studies (e.g., in radiology).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies performed (e.g., precision, linearity, LoD, method comparison) represent the standalone performance of the analytical instrument and assay kit. These tests evaluate the accuracy and reliability of the device's measurements directly, without human interpretation in the diagnostic pathway, other than performing the test and reviewing the quantitative results.
7. The Type of Ground Truth Used
The ground truth used for this device's validation is primarily reference methods and established analytical standards:
- Predicate Device Comparison: The ST AIA-PACK SHBG assay's performance was compared against the Abbott Architect SHBG Immunoassay (K060818), which serves as a legally marketed predicate and a standard for comparison.
- International Standards: The calibrators are traceable to the 2nd International Standard for SHBG from the National Institute for Biological Standards and Control (NIBSC) code 08/266. This is a critical aspect of establishing the "ground truth" for the quantitative values.
- CLSI Protocols: The studies were conducted with reference to widely accepted Clinical and Laboratory Standards Institute (CLSI) protocols (e.g., EP5-A2 for precision, EP6-A for linearity, EP9-A2 for method comparison), which define rigorous scientific methods for demonstrating analytical performance.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI, as this is an analytical diagnostic assay. The term "training set" would not typically apply here. Instead, numerous samples are used during the development and validation phases to establish the assay's performance characteristics. For example, during the creation of calibrators or development of the assay, various characterized samples would have been used.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of AI/machine learning for this device, this question is not applicable. The ground truth for the assay's performance validation is established through comparison to predicate devices, traceability to international standards, and adherence to CLSI guidelines, as described in point 7.
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