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510(k) Data Aggregation
(34 days)
The AquaLite® Prolactin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Prolactin assay) is intended to be used in clinical laboratories for the quantitative determination of human prolactin levels in sera and plasma. The AquaLite® Prolactin assay is for in vitro diagnostic use.
The AquaLite® Prolactin Bioluminescent Immunoassay Kit uses a mixture of mouse monoclonal and rabbit polyclonal with anti-prolactin activity that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the pre-coated tubes. Anti-prolactin conjugate consisting of mouse monoclonal antibody covalently linked to AquaLite® (150µL) is then added to the tubes. The conjugate uses the photoprotein, AquaLite® (recombinant aequorin: U.S. Patent Nos. 5,422,266 and 5,486,455) which is covalently linked to an anti-prolactin polyclonal antibody. Prolactin in the sample simultaneously combines with polyclonal 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 60-minute incubation period at room temperature (18° to 25°C) 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. An injected calcium trigger solution causes AquaLite® to oxide its self-contained luciferin molecule. This reaction produces a twosecond flash of light at 469 nm, which is measured by the luminometer. The intensity of the light is directly proportional to the concentration of the prolactin in the sample. To calculate results, the luminometer uses a cubic spline curve fit applied to a logit-log transformation of the light intensity (in relative light units, RLU) of the prolactin calibrators versus prolactin 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 a breakdown of the acceptance criteria and study details for the SeaLite Sciences, Inc. AquaLite® Prolactin Bioluminescent Immunoassay (BIA) Kit:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Metric (Unit) | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Sensitivity | Detection Limit (ng/mL) | Not explicitly stated (implied to be low) | 0.01 ng/mL |
| Specificity | Cross-reactivity (%) | Not explicitly stated (implied to be low for non-prolactin hormones) | rh: <0.007 FSH: Not detectable TSH: <0.001 hCG: Not detectable hPL: 0.38% hGH: 0.52% |
| High Dose Hook Effect | Prolactin Level (ng/mL) | No hook effect below the highest calibrator level (implied) | No high dose hook effect occurs prior to 1,000 ng/mL prolactin. |
| Precision (Intra-assay) | % CV | Not explicitly stated (implied to be acceptably low) | 13.6 ng/mL: 7.3% 29.1 ng/mL: 7.2% 68.7 ng/mL: 8.9% |
| Precision (Inter-assay) | % CV | Not explicitly stated (implied to be acceptably low) | 12.8 ng/mL: 8.17% 28.1 ng/mL: 8.96% 67.8 ng/mL: 9.76% |
| Method Comparison | Correlation CoefficientSlopeY-intercept | Not explicitly stated (implied to be strong correlation with existing assay) | 0.9669 0.8665 -1.9869 |
| Linearity & Nonparallelism | Recovery (%) | Not explicitly stated (implied to be within an acceptable range for diluted samples) | Sample #22: 100%-124% Sample #51: 99%-111% Sample #96: 84%-109% |
| Spike and Recovery | Percent Recovered (%) | Not explicitly stated (implied to be within an acceptable range) | Sample 1: 94% Sample 2: 104% Sample 3: 91.5% Sample 4: 94.5% Sample 5: 92.5% |
| Recovery in Serum and Plasma | Relative Recovery (%) | No significant differences among serum and SST serum nor serum and heparin, EDTA, and citrate plasmas. Oxalate plasma is not recommended. | Ranges from 82% to 116% observed across different matrix types, with specific recommendation against oxalate plasma. |
2. Sample Size Used for the Test Set and Data Provenance
- Sensitivity: 20 replicates of the zero-level calibrator. Data provenance is internal to SeaLite Sciences, Inc.
- Specificity: Not explicitly stated how many aliquots or how many times each substance was tested, but they were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England).
- Precision (Intra-assay): N = 20 per concentration level for tri-level commercial controls. Data provenance is internal to SeaLite Sciences, Inc.
- Precision (Inter-assay): N = 2 x 10 = 20 (duplicate assays across 10 sets of calibration values) for tri-level commercial controls. Data provenance is internal to SeaLite Sciences, Inc.
- Method Comparison: N = 100 patient samples. Data provenance is internal to SeaLite Sciences, Inc., as these were patient samples previously assayed by another method. This would be considered retrospective in the context of the AquaLite Prolactin study.
- Linearity and Nonparallelism: Three human serum samples, each diluted at 4 levels, assayed in duplicate. Data provenance is internal to SeaLite Sciences, Inc.
- Spike and Recovery: Five normal male human serum samples. Data provenance is internal to SeaLite Sciences, Inc.
- Recovery in Serum and Plasma: Blood samples from 4 normal subjects, prepared into various matrices. Data provenance is internal to SeaLite Sciences, Inc.
3. 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) assay for measuring prolactin levels. The "ground truth" for such assays is typically established by:
- Reference materials: For specificity, WHO/NIBSC standards were used.
- Known concentrations: For sensitivity, linearity, spike and recovery, and precision, predefined calibrators, controls, or spiked samples with known prolactin concentrations were used.
- Comparison to a legally marketed predicate device: For method comparison, the results were compared to a "commercially available automated chemiluminescent immunoassay."
Therefore, the concept of "experts establishing ground truth for a test set" as one might find in image analysis (e.g., radiologists reviewing images) does not directly apply here. Instead, it relies on the chemical and biological properties of the assay and comparison to established and validated reference methods/materials.
4. Adjudication Method for the Test Set
Not applicable. As this is an IVD assay measuring an analyte, there isn't a subjective "adjudication" process in the way there would be for image interpretation by multiple human readers. The results are quantitative measurements.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not an AI-assisted diagnostic device or an imaging study that involves human readers interpreting cases. It is a standalone in vitro diagnostic assay.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies presented are all standalone performance evaluations of the AquaLite® Prolactin assay itself. The device is designed to quantitatively determine prolactin levels without direct human interpretation of the results beyond reading the numerical output.
7. The Type of Ground Truth Used
- Known concentrations: For sensitivity, linearity, spike and recovery, and precision, the ground truth was based on samples with experimentally determined or certified prolactin concentrations (e.g., calibrators, commercial controls, spiked samples).
- Reference materials: For specificity, internationally recognized reference preparations from the World Health Organization's National Institute for Biological Standards and Control (WHO/NIBSC) were used.
- Predicate device comparison: For method comparison, a "commercially available automated chemiluminescent immunoassay" was used as a reference for patient sample measurements.
8. The Sample Size for the Training Set
Not applicable. This is a traditional immunoassay, not a machine learning or AI-based device that requires a "training set" in the computational sense. The "training" of the assay refers to its chemical and biological formulation and optimization during development, before the performance studies presented here.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See point 8.
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