(35 days)
The AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® FSH assay) is intended to be used in clinical laboratories for the quantitative determination of human FSH in sera and plasma. The AquaLite® FSH assay is for in vitro diagnostic use.
The AquaLite® FSH Bioluminescent Immunoassay Kit uses a polyclonal anti-FSH antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma) and appropriate calibrators or controls, are pipetted (25 µL) into the pre-coated tubes. Anti-FSH Conjugate (150 uL) is then added to the tubes. The conjugate uses the photoprotein. AquaLite® (recombinant aequorin; Patent Nos. 5, 422, 266 and 5, 486, 455) which is covalently linked to an anti-FSH monoclonal antibody. FSH 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°C 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 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 FSH in the sample. To calculate results, the light intensity (in relative light units, RLU) of the FSH calibrators is plotted against FSH concentration (in International Units per liter. IU/L) to vield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to FSH concentration in IU/L.
The information provided is for an in vitro diagnostic test (AquaLite® FSH Bioluminescent Immunoassay (BIA) Kit), not a medical device in the typical sense of AI-powered systems analyzed for clinical improvement. Therefore, many of the requested fields, particularly those related to AI, multi-reader multi-case studies, and ground truth established by expert consensus or pathology, are not applicable.
However, I can extract and present the acceptance criteria and the study results for the performance characteristics of this immunoassay as an analogy to the requested format.
Here’s an interpretation of the provided 510(k) summary into the requested structure:
Acceptance Criteria and Device Performance for SeaLite Sciences, Inc. AquaLite® FSH
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sensitivity | Low detection limit for FSH | 0.03 IU/L |
| Specificity | Low cross-reactivity with related hormones (hCG, LH, TSH) | hCG: 0.02%, LH: 0.10%, TSH: 1.90% |
| High Dose Hook Effect | No hook effect at clinically relevant high concentrations | No high dose hook effect occurs prior to 4,000 IU/L FSH. |
| Precision (Intra-assay) | Low % CV across a range of FSH concentrations (e.g., 0.9) | Correlation coefficient: 0.90 (Slope: 0.66, y-intercept: 0.78) |
| Linearity and Nonparallelism | Consistent recovery across dilutions (e.g., 90-110%) | Recovery range: 93% to 118% |
| Spike and Recovery | Recovery within an acceptable range (e.g., 90-110%) | Recovery range: 100% to 128% (Most within 100-115%) |
| Recovery in Serum and Plasma | No significant differences across different sample types | No significant differences among serum and SST serum, or heparin, EDTA, oxalate, and citrate plasmas. Recoveries mostly 90-109% compared to standard serum. |
| Effect of Common Interferents | No significant effect on FSH quantification by common interferents | No significant effect by hemoglobin, bilirubin, human serum albumin, or triglycerides at tested levels. Recoveries: 88-105% (for 0 spike), 94-104% (for 25.7 spike). |
*Note on Inter-assay precision: The table formatting for inter-assay precision is corrupted in the input document, but the provided %CV values indicate similar low variability to intra-assay (7.52%, 6.39%, and 4.049%).
2. Sample size used for the test set and the data provenance
- Sensitivity: 20 replicates of a zero-level calibrator.
- Specificity: Not explicitly stated as a "test set" in terms of patient samples. Tested using aliquots of WHO/NIBSC preparations of purified hormones.
- Precision (Intra-assay): N = 10 per solution for each of three FSH levels (total 30 samples).
- Precision (Inter-assay): N = 20 per solution (2 replicates x 10 assays) for three FSH levels (total 60 samples).
- Method Comparison: N = 92 patient samples.
- Linearity and Nonparallelism: 5 human serum samples.
- Spike and Recovery: 8 normal human serum samples.
- Recovery in Serum and Plasma: Blood samples from 2 normal subjects, processed into 6 different sample types each.
- Effect of Common Interferents: Pooled normal male human serum.
Data Provenance: The studies were conducted at SeaLite Sciences, Inc. The samples appear to be clinical samples (patient samples, human serum), but the specific country of origin is not explicitly stated, although WHO/NIBSC (London, England) reference materials were used for specificity. The data is retrospective in the sense that the experiments were conducted and then analyzed, but not in the context of analyzing pre-existing patient data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is an immunoassay, and the "ground truth" for the test set (e.g., FSH concentration, absence of interferents, hormone specificity) is established by the known characteristics of the samples or the reference measurements, not by expert interpretation.
4. Adjudication method for the test set
Not applicable. As an immunoassay, the results are quantitative measurements, not subjective evaluations requiring adjudication.
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 an immunoassay, not an AI-powered diagnostic system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in so far as an immunoassay can be considered "standalone." The device (AquaLite® FSH assay) provides quantitative results directly from the sample without human interpretation of complex images or signals requiring an 'algorithm' in the AI sense. Its performance characteristics (sensitivity, specificity, precision, etc.) are measured as direct outputs of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this immunoassay is primarily based on:
- Known concentrations/compositions of reference materials: For sensitivity (zero calibrator), specificity (purified hormones), linearity (dilution of samples with known FSH), spike-and-recovery (known amount of spiked FSH).
- Reference standard methods/devices: For method comparison (comparison to a "commercially available kit").
- Biological realism: For assessing recovery in different matrices (serum/plasma) and the effect of interferents.
8. The sample size for the training set
Not applicable. This is a biochemical assay, not an machine learning algorithm that requires a discrete training set. The assay's parameters (e.g., antibody concentrations, incubation times) are developed through R&D, but not in the same way an AI model is "trained."
9. How the ground truth for the training set was established
Not applicable (see point 8). The assay's performance is optimized through traditional experimental design and chemical/biological principles during its development phase.
§ 862.1300 Follicle-stimulating hormone test system.
(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.