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510(k) Data Aggregation
(63 days)
. § 862.1370)
| Submitter's Name and Address: | Cathryn N.
The AquaLite® hGH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® hGH Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human growth hormone in serum. Human Growth Hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland. The AquaLite® Human Growth Hormone Assay is for in vitro diagnostic use.
The AquaLite® hGH Bioluminescent Immunoassay Kit uses a mouse monoclonal anti-hGH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples or appropriate calibrators or controls, are pipetted (150 uL) into the precoated tubes. A sheep anti-hGH antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. hGH in the sample combines with the antibody on the solid phase and conjugate antibody to form an immune complex or "sandwich" bound to the solid phase. Complex formation is complete after a 120-minute incubation period at room temperature on a standard orbital shaker. The tubes are then washed to remove unbound conjugate.
The washed tubes are placed in a luminometer that is capable of reading a triggered, flash-type reaction in 12 x 75 mm tubes. Injection of the calcium trigger buffer causes AquaLite® to oxide its self-contained luciferin molecule, producing a flash of light, which is measured by the luminometer. The intensity of the light emitted from antibody bound to the tubes is directly proportional to the concentration of the hGH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the hGH calibrators is plotted against hGH concentration (in ng per mL) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to hGH concentration in ng/mL.
Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.
Here's an analysis of the provided text regarding the AquaLite® Human Growth Hormone Assay, broken down by your requested categories:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" as a set of pre-defined thresholds. Instead, it presents performance characteristics determined through studies. The implication is that these reported performance characteristics were deemed acceptable by the FDA for substantial equivalence to the predicate device.
| Performance Characteristic | Reported Device Performance (AquaLite® hGH Assay) |
|---|---|
| Sensitivity | 0.005 ng/mL |
| Specificity (Cross-reactivity) | |
| Prolactin | 0.09% (at 500 ng/mL), 0.17% (at 1,000 ng/mL) |
| hPL | < 0.01% (at 10,000 ng/mL), < 0.01% (at 100,000 ng/mL) |
| LH | < 0.01% (at 250 mIU/L), < 0.01% (at 500 mIU/L) |
| TSH | < 0.01% (at 250 µIU/L), < 0.01% (at 500 µIU/L) |
| hCG | < 0.01% (at 10,000 mIU/L), < 0.01% (at 50,000 mIU/L) |
| FSH | < 0.01% (at 250 mIU/L), < 0.01% (at 500 mIU/L) |
| High Dose Hook Effect | No high dose hook effect occurs prior to 500 ng/mL |
| Precision (Intra-assay) | |
| 3.33 ng/mL hGH level | 4.80 % CV |
| 6.20 ng/mL hGH level | 4.97 % CV |
| 12.30 ng/mL hGH level | 6.95 % CV |
| Precision (Inter-assay) | |
| 2.89 ng/mL hGH level | 6.4 % CV |
| 5.19 ng/mL hGH level | 9.8 % CV |
| 9.42 ng/mL hGH level | 11.8 % CV |
| Method Comparison (vs. commercially available chemiluminescence immunoassay) | |
| Slope | 1.2831 |
| Y-intercept | 0.146 |
| Correlation coefficient (R) | 0.9665 |
| Linearity and Non-parallelism (Recovery) | |
| Sample A (dilutions) | 92-101% |
| Sample B (dilutions) | 98-103% |
| Sample C (dilutions) | 100-103% |
| Spike and Recovery | |
| Sample 1 (mixtures) | 92-103% |
| Sample 2 (mixtures) | 99-110% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sensitivity: 20 replicates of the zero-level calibrator.
- Specificity: Aliquots of hormones from the World Health Organization's National Institute for Biological Standards and Control (London, England), diluted in human serum.
- Precision (Intra-assay): Total N = 20 replicates per concentration level (three levels).
- Precision (Inter-assay): Total n = 20 (2 duplicates x 10 assays over 3 weeks).
- Method Comparison: N = 60 patient serum samples.
- Linearity and Nonparallelism: Three human serum samples, each diluted at three levels (1:2, 1:4, 1:8), assayed in duplicate.
- Spike and Recovery: Two hGH serum samples, each mixed in three ratios (2:1, 1:1, 1:2), assayed in duplicate.
The origin of the data is stated as "Studies on the AquaLite® hGH Assay were conducted at SeaLite Sciences." The location of SeaLite Sciences, Inc. is Norcross, GA, USA. The information does not explicitly state if the studies were retrospective or prospective, but the nature of the "Performance Characteristics" section suggests prospective testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is an in vitro diagnostic assay, so the "ground truth" is typically established by reference methods or validated standards rather than expert consensus on images.
- For Specificity, the "ground truth" for the interfering substances was provided by the World Health Organization's National Institute for Biological Standards and Control (London, England) and their specified lot numbers and concentrations.
- For Method Comparison, the "ground truth" for the 60 patient samples was established by a "commercially available chemiluminescence immunoassay" (the predicate device or another validated method).
No "experts" in the sense of human visual assessment for establishing ground truth are mentioned or applicable for this type of device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for subjective interpretations, often in imaging studies. For an in vitro diagnostic assay that produces quantitative results, such adjudication is not applicable. The results are quantitative measurements, and consistency/accuracy is assessed through statistical methods (e.g., %CV for precision, correlation for method comparison, % recovery for linearity/spike and recovery).
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
No such study was conducted or is applicable here. The device is an automated in vitro diagnostic assay, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies presented here are entirely standalone performance evaluations of the AquaLite® hGH Assay as an algorithm/device-only system. It is an automated laboratory test, not designed for human-in-the-loop interaction in the diagnostic process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for various performance characteristics includes:
- Sensitivity: Defined as the concentration associated with the mean + 2 standard deviations of a zero calibrator signal, which is a common practice for analytical sensitivity.
- Specificity (Cross-reactivity): Known concentrations of specific hormones provided by a reputable scientific organization (WHO/NIBSC).
- Precision: Commercial controls with known hGH levels.
- Method Comparison: Results from a "commercially available chemiluminescence immunoassay" on patient samples, serving as a reference.
- Linearity and Nonparallelism: Expected concentrations derived from serial dilutions of human serum samples with endogenous hGH.
- Spike and Recovery: Expected concentrations derived from mixing hGH serum samples in known ratios.
In general, the ground truth relies on established laboratory standards, controls, and comparisons to predicate methods.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning. This is a traditional in vitro diagnostic device, not an AI/ML-based algorithm that requires a separate training set. All data presented are for evaluating the performance of the developed assay.
9. How the ground truth for the training set was established
As there is no "training set" in the AI/ML sense, this question is not applicable. The development of the assay itself would have involved empirical testing and optimization against known standards, but this is a different concept from an AI training set.
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