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The AquaLite® Free T Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Free T . Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human free T4 in serum.
The AquaLite® FT4 Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® F14 Assay) is an in vitro diagnostic product intended for use in the quantitative measurement of FT4 in human serum in clinical laboratories. Free thyroxine measurements are used to diagnosis and treat diseases of the thyroid.

The AquaLite® Free T. Assay is a single-site, competitive inhibition bioluminescent immunoassay kit. A T carrier complex is immobilized on polystyrene tubes (solid phase). Serum samples, appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. A mouse monoclonal anti-T antibody covalently linked to AquaLite® (100 uL) is then added to the tubes. Free T. in the sample competes with immobilized T for the available T binding sites of the anti-T antibody conjugate. Complex formation is complete after a 90-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 presence of Ta in the sample or calibrator reduces the binding of the conjugate to the immobilized T . pre-coated on the tubes. The amount of signal inhibition is indirectly proportional to the Free T concentration. To calculate results, the luminometer uses a cubic spline curve fit applied to a log-log transformation of the light intensity (in relative light units, RLU) of the Free T calibrators versus Free T, concentration (in ng/dL).

The document describes a 510(k) submission for the SeaLite Sciences, Inc. AquaLite® Free T Assay, a bioluminescent immunoassay kit for the quantitative determination of human free T4 in serum. The submission aims to demonstrate substantial equivalence to the Nichols Institute Free T4 Assay.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as pass/fail thresholds in the provided document for all tests, but rather implied by the reported performance and comparison to a legally marketed predicate device. The performance characteristics were generally deemed acceptable by the FDA through the 510(k) clearance process.

• 0.75 ng/dL: 10.1% CV
• 2.6 ng/dL: 4.1% CV
• 4.4 ng/dL: 2.9% CV
  Inter-Assay Precision (n=2x20=40 over 2 weeks):
• 0.6 ng/dL: 13.0% CV
• 2.6 ng/dL: 5.0% CV
• 4.2 ng/dL: 3.4% CV |
  | 5. Method Comparison (good correlation with predicate) | Linear regression analysis with a commercially available chemiluminescence immunometric assay for Free T4 yielded:
• Slope: 1.1
• y-intercept: -0.2
• Correlation coefficient (r): 0.92
  (for Free T4 ranging from 0.27 to 3.67 ng/dL in n=127 serum samples). |
  | 6. Kinetics (optimal incubation time) | 90-minute incubation shown to be optimal based on parallel assays of three human serum samples at 60, 90, and 120 minutes. |
  | 7. Recovery in Serum and Plasma (no significant differences) | No significant differences found for Free T4 recovery between standard serum, SST tubes, heparin plasma, and EDTA plasma in blood samples from 7 normal subjects. |
  | 8. Effect of Hemolysis (not significantly affected) | Not significantly affected by mild, moderate, or severe hemolysis (tested with three patient samples spiked with hemoglobin preparations). |
  | 9. Effect of TBG (no interference at normal levels) | No interference at normal TBG levels (15-34 mg/L). Slight inhibition of %B/Bo observed at 200 and 300 mg/L TBG (5.9 and 8.8 times normal physiologic level), potentially leading to an apparent increase in Free T concentration at very high supra-physiological levels. |
  | 10. Effect of Albumin (not significantly affected) | Not significantly affected by albumin at concentrations of 15, 25, and 75 mg/mL (tested with three patient samples). |
  | 11. Effect of Nonesterified Fatty Acids (not significantly affected) | Not significantly affected by oleic acid at 2.5, 5, and 10 mmol/L (tested with three patient samples). |
  | 12. Effect of Bilirubin (not significantly affected) | Not significantly affected by bilirubin at 10 and 20 mg/dL (tested with three patient samples). |
  | 13. Effect of Salicylate (not significantly affected) | Not significantly affected by salicylate at 1, 5, 10, and 25 mg/dL (tested with three patient samples). |
  | 14. Effect of Phenytoin (potential effect at high levels) | "Not significantly affected by phenytoin at the levels tested" is stated, but the data shows increasing Free T4 values with increasing phenytoin concentrations, particularly at 10 µg/mL and 25 µg/mL (e.g., Sample 1: 1.1 (Neat) to 2.22 (25µg/mL); Sample 2: 1.5 (Neat) to 2.2 ng/mL (25µg/mL)). The accompanying text "Assay is needing to patients falling Should be interpreted with courtion" (sic: caution) suggests a recognition of potential interference at higher levels. This implies that while low levels might not significantly affect, higher levels might, requiring clinical judgment. |
  | 15. Effect of Phenylbutazone (not significantly affected) | Not significantly affected by phenylbutazone at 1, 5, and 10 µg/mL (tested with three patient samples). |

2. Sample Sizes Used for the Test Set and Data Provenance

The document doesn't explicitly refer to "test sets" in the modern AI/machine learning sense, but rather "studies" for performance characterization.

• Sensitivity: 20 replicates of a 0 ng/dL calibrator.
• Drift: Two patient samples, each run in 5 duplicates, across 100 tubes (implied data from 10 groups of 10 tubes).
• Intra-assay precision: 20 replicates per concentration level for three serum controls (total 60 measurements).
• Inter-assay precision: Duplicates in 20 assays for three serum controls (total 40 measurements * 3 levels = 120 control measurements, plus each assay included a standard curve).
• Method Comparison: 127 serum samples.
• Kinetics: Three human serum samples.
• Recovery in Serum and Plasma: Blood samples from 7 normal subjects.
• Effect of Hemolysis: Three patient samples.
• Effect of TBG: TBG added to calibrator A (0 ng/dL Free T4) at various concentrations.
• Effect of Albumin: Three patient samples.
• Effect of Nonesterified Fatty Acids: Three patient samples.
• Effect of Bilirubin: Three patient samples.
• Effect of Salicylate: Three patient samples.
• Effect of Phenytoin: Two patient samples.
• Effect of Phenylbutazone: Three patient samples.

Data Provenance: The studies were conducted at SeaLite Sciences, Inc. The samples used (serum controls, patient samples, normal subjects' blood) are implied to be retrospective clinical samples or laboratory-prepared samples. The country of origin is not explicitly stated, but since SeaLite Sciences, Inc. is based in Norcross, GA, and the submission is to the US FDA, it is highly likely the data originated from the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For an in vitro diagnostic immunoassay, "ground truth" often refers to reference methods, certified standards, or clinical diagnoses. The document compares the device's performance to established analytical methods and other commercially available assays, implying that these existing methods or values serve as the reference. There's no mention of expert consensus for establishing ground truth for the performance studies themselves, as is common for subjective image interpretation.

4. Adjudication Method for the Test Set

This is not applicable and therefore not described. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., by radiologists) where discrepancies need to be resolved. For an objective quantitative immunoassay, the result is a numerical value, and "adjudication" in this sense is not performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. Such studies are relevant for devices where human interpretation is involved and improved by AI assistance (e.g., AI for radiology). This device is an in-vitro diagnostic immunoassay kit, where the result is quantitative and read by a luminometer, not interpreted by a human reader in the same way.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this entire submission describes the standalone performance of the AquaLite® Free T Assay. As an in-vitro diagnostic assay, it is inherently a "standalone" device providing a quantitative measurement. Human involvement is in sample preparation, running the assay, and interpreting the numerical result in a clinical context, but the assay's performance characteristics (sensitivity, precision, accuracy, etc.) are evaluated intrinsically.

7. The Type of Ground Truth Used

The ground truth or reference used for assessing performance varied by study:

• Sensitivity: Defined using replicates of a 0 ng/dL calibrator.
• Specificity/Cross-reactivity: Measured against known concentrations of potentially interfering compounds.
• Drift, Precision, Kinetics, Interference Studies: Measured against the device's own internal calibration/control system, with consistency and expected behavior serving as the "ground truth."
• Method Comparison: A commercially available chemiluminescence immunometric assay kit for Free T4 was used as the comparator, which serves as a widely accepted reference method in the field for demonstrating substantial equivalence.
• Recovery in Serum and Plasma: Compared to standard serum samples.

Essentially, the ground truth relies on established laboratory practices, verified calibrators, and comparison to a legally marketed predicate device (the Nichols Institute Free T4 Assay) which itself would have been validated against accepted reference methods.

8. The Sample Size for the Training Set

This information is not provided and is not typically described in a 510(k) submission for an immunoassay. Immunoassay development relies on chemical and biological optimization, rather than a "training set" in the machine learning sense. The "standard curve" generated for each assay run is analogous to a form of internal calibration or "on-the-fly training," but this differs from a large, predefined training dataset for an algorithm.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" in the machine learning context for this device, this question is not applicable. The underlying principles of the immunoassay (antibody-antigen binding, bioluminescence) are based on established scientific knowledge. The "ground truth" for the calibrators used in each assay's standard curve would have been established through a robust process of analytical validation, likely involving established reference materials and methods, but the details are not in this document.

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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.

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The AquaLite® Ferritin Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® Ferritin Assay) is an in vitro diagnostic product intended for use in clinical laboratories for the quantitative determination of human ferritin in serum and plasma. Ferritin measurements are used in the diagnosis of diseases affecting iron metabolism.

The AquaLite® Ferritin Bioluminescent Immunoassay Kit uses a mouse monoclonal antiferritin antibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma), or appropriate calibrators or controls, are pipetted (25 uL) into the precoated tubes. A mouse monoclonal anti-ferritin antibody covalently linked to AquaLite® (150 uL) is then added to the tubes. Ferritin in the sample simultaneously 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 60-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 ferritin in the sample. To calculate results, the light intensity (in relative light units, RLU) of the ferritin calibrators is plotted against ferritin 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 ferritin 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.

The provided document describes the SeaLite Sciences, Inc. AquaLite® Ferritin Assay, a bioluminescent immunoassay for the quantitative determination of human ferritin in serum and plasma.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Sensitivity: 20 replicates of a zero-level calibrator.
  • Specificity: 2 human serum samples (spiked).
  • Precision (Intra-assay): N = 20 per concentration level for commercial controls.
  • Precision (Inter-assay): N = 20 (2 replicates x 10 assays) for commercial controls.
  • Method Comparison: N = 99 patient samples.
  • Linearity: 3 human serum samples, each diluted.
  • Spike and Recovery: 3 normal human serum samples.
  • Recovery in Serum and Plasma: 6 normal subjects.
  • Effect of Common Interferents: Pooled normal human serum (spiked).
• Data Provenance: The studies were conducted at SeaLite Sciences. All samples appear to be human (serum, plasma, human spleen ferritin for spiking). The document does not specify the country of origin for the human samples. The studies are by nature prospective for the device's validation, as they were specifically designed and executed to evaluate the AquaLite® Ferritin Assay.

3. Number of Experts and Qualifications for Ground Truth

This device is an in vitro diagnostic (IVD) assay for quantitative measurement. The "ground truth" is typically established instrumentally or by reference methods/materials rather than expert consensus on images or clinical assessments.

• No "experts" in the sense of clinical reviewers (e.g., radiologists) were used to establish ground truth.
• The "ground truth" for quantitative assays like this relies on:
  • Reference materials: Commercial controls with known ferritin concentrations, calibrators traceable to international standards (e.g., WHO 2nd IS 80/578 for spike and recovery).
  • Predicate device: The Chiron Diagnostics ACS:180 Ferritin Assay served as a reference for method comparison.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative IVD assay, adjudication by multiple human readers (as in image-based diagnostic aids) is not relevant. The results are numerical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. Such studies are typically performed for diagnostic imaging devices or AI-powered clinical decision support tools where human interpretation plays a significant role. This document describes an automated laboratory assay.

6. Standalone Performance

Yes, the studies listed (Sensitivity, Specificity, Precision, High Dose Hook Effect, Linearity, Spike and Recovery, Recovery in Serum and Plasma, Effect of Common Interferents) describe the standalone performance of the AquaLite® Ferritin Assay. These evaluations assess the algorithm (the assay's chemical/biological reaction and measurement system) without human interpretation in the results generation process itself. The "Method Comparison" also shows the standalone performance relative to an existing predicate device.

7. Type of Ground Truth Used

The ground truth used is primarily based on:

• Known concentrations: From commercial controls, calibrators, and spiked samples.
• Reference methods/materials: Comparison against a legally marketed predicate device (Chiron Diagnostics ACS:180 Ferritin Assay) and internationally recognized standards (WHO 2nd IS 80/578 for spleen ferritin).

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For an immunoassay like this, the "training" typically refers to the development and optimization of the assay's reagents and parameters, which is an iterative process often involving experimental work rather than a distinct, labeled "training set" of patient data as seen in machine learning contexts. The calibrators and controls used would be part of the ongoing validation and quality control, but not a separate "training set" for an algorithm in the modern sense.

9. How the Ground Truth for the Training Set Was Established

Not explicitly stated in terms of a formal "training set ground truth." However, the equivalent process for an immunoassay involves:

• Development and Optimization: During the development phase, reagents, incubation times, concentrations, and detection methods are optimized using known ferritin concentrations (potentially from purified ferritin, spiked samples, or commercial controls) to achieve desired performance characteristics.
• Calibrators: The assay uses calibrators with established ferritin concentrations to generate its standard curve. These calibrators are usually traceable to primary reference materials.
• Quality Control (QC) Materials: Commercial QC materials with defined ferritin values are used to monitor assay performance over time.

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The AquaLite® Intact PTH Bioluminescent Immunoassay (BLA) Kit (or the AquaLite® Intact PTH assay) is intended to be used in clinical laboratories for the quantitative determination of human intact parathyroid hormone in serum mongunested, Intact PTH measurements are used in the diagnosis of disorders of calcium metabolism and the parathyroid gland. The AquaLite® Intact PTH assay is for in vitro diagnostic use.

The AquaLite® Intact PTH Bioluminescent Immunoassay Kit uses a goat polyclonal anti-PTH antibody that is pre-coated onto polystyrene tubes (solid phase). Serum samples, appropriate calibrators, and controls, are pipetted (100uL) into the pre-coated tubes. A second goat polyclonal anti-PTH antibody covalently linked to AquaLite® (150µL) is then added to the tubes. Intact PTH in the sample simultaneously combines with anti-PTH 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 (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. 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 intact PTH 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 intact PTH calibrators versus intact PTH concentration (in pg/mL).

Here's a breakdown of the acceptance criteria and study information for the SeaLite Sciences, Inc. AquaLite® Intact PTH device, based on the provided text:

Acceptance Criteria and Reported Device Performance

• 1-34 fragment (400 pg/mL): 50% inhibition
• 39-84 fragment (100,000 pg/mL): 0% inhibition
• 53-84 fragment (100,000 pg/mL): 0% inhibition
• 39-68 fragment (100,000 pg/mL): 0% inhibition
• 44-68 fragment (100,000 pg/mL): 0% inhibition |
  | High Dose Hook Effect | No hook effect at high concentrations of intact PTH | No high dose hook effect prior to 100,000 pg/mL |
  | Precision | Intra-assay: Low coefficient of variation (CV) within a single assay |
• PTH Level 26.10 pg/mL: 6.95% CV
• PTH Level 173.71 pg/mL: 5.45% CV |
  | | Inter-assay: Low coefficient of variation (CV) across multiple assays |
• PTH Level 51.7 pg/mL: 8.9% CV
• PTH Level 332.3 pg/mL: 8.3% CV |
  | Method Comparison | Good correlation with a commercially available chemiluminometric kit for PTH |
• Slope: 0.964
• Y-intercept: 10.017
• Correlation coefficient: 0.95 |
  | Linearity and Nonparallelism | Consistent recovery across dilutions of human serum samples |
• Sample A: Recovery 103-106%
• Sample B: Recovery 99-108%
• Sample C: Recovery 100-105% |
  | Recovery | Consistent recovery when mixing PTH serum samples in various ratios |
• Sample A (2A:1B, 1A:1B, 1A:2B): Recovery 89-93%
• Sample C (2C:1D, 1C:1D, 1C:2D): Recovery 90-92% |
  | Overall Performance | Similar and substantially equivalent to other commercially available assays for intact PTH | Data demonstrate similarity and substantial equivalence |

Study Details

1. Sample Size used for the test set and the data provenance:

   • Specificity: Not explicitly stated, but involves spiking a sample (17 pg/mL) with PTH fragments.
   • Precision:
     • Intra-assay: 20 replicates for each of two commercial control concentrations.
     • Inter-assay: 20 assays (each with duplicate measurements, so a total of 40 measurements) for each of two commercial control concentrations.
   • Method Comparison: 57 patient samples.
   • Linearity and Nonparallelism: 3 human serum samples, each diluted and assayed in duplicate.
   • Recovery: Not explicitly stated, but involved mixing multiple PTH serum samples in various ratios and assaying in duplicate.
   • Data Provenance: Studies were conducted at SeaLite Sciences, Inc. The samples for Method Comparison are referred to as "patient samples," but no specific country of origin or whether they were retrospective or prospective is mentioned. Commercial controls and human serum samples were also used.

2. 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):

   • Not applicable. This device is an in vitro diagnostic (IVD) assay that measures a biomarker (Intact PTH). The "ground truth" for method comparison is another commercially available chemiluminometric kit, not expert interpretation. For other performance characteristics, the "ground truth" is based on expected values for controls, dilutions, or spiked samples.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. This is an IVD assay, not a device that relies on human interpretation requiring adjudication.

4. 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 assay, not an AI-assisted diagnostic tool that involves human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the entire study focuses on the standalone performance of the AquaLite® Intact PTH assay (algorithm/device only). The method comparison is against another standalone commercial assay.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" varies depending on the specific performance characteristic:
     • Sensitivity: Defined by statistical calculation from the zero calibrator.
     • Specificity: Based on expected behavior with known PTH fragments.
     • Precision: Based on repeated measurements of known control samples.
     • Method Comparison: Comparison against a "commercially available chemiluminometric kit for PTH." This kit serves as the reference standard.
     • Linearity and Recovery: Based on calculated expected values after dilution or mixing of samples.

7. The sample size for the training set:

   • Not applicable. This document describes the performance characteristics and validation of a laboratory assay, not a machine learning model that requires a "training set" in the typical sense. The assay is based on chemical reactions and luminosity measurements, not an algorithm that learns from data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of IVD device.

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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

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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

*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.

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The AquaLite® LH Bioluminescent Immunoassay (BIA) Kit (or the AquaLite® LH assay) is intended to be used for the quantitative determination of human LH in sera and plasma. The AquaLite® LH assay is for in vitro diagnostic use.

The AquaLite® LH Bioluminescent Immunoassay Kit uses a polyclonal anti-LH aitibody that is pre-coated onto polystyrene tubes (solid phase). Samples (serum or plasma and appropriate calibrators or controls, are pipetted (50 uL) into the pre-coated tubes. Anti-LH Conjugate (150uL) 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-LH monoclonal antibody. LH 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 LH in the sample. To calculate results, the light intensity (in relative light units. RLU) of the LH calibrators is plotted against LH concentration (in International Units per liter, IU/L) to yield a calibration curve. This curve is used to relate the light intensity generated from the samples and controls to LH concentration in IU/L. Note that the numerical value for LH in mIU/mL is the same as for IU/L (International System). For example, 15.6 mIU/mL equals 15.6 IU/L.

Note: Samples that generate signals greater than the signal from the highest calibrator are off-scale. These samples must be diluted with Calibrator A and re-assayed. Remember to multiply the results from diluted samples by the dilution factor used.

Here's an analysis of the acceptance criteria and study detailed in the provided text for the SeaLite Sciences, Inc. AquaLite® LH immunoassay, structured as requested:

Acceptance Criteria and Device Performance (AquaLite® LH)

Note: This document does not explicitly state pre-defined "acceptance criteria" but rather reports the performance characteristics observed during testing. The reported performance is the criteria met for demonstrating safety and effectiveness compared to other commercially available assays for LH.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• Sensitivity: 20 replicates of the zero-level calibrator.
• Specificity (Cross-reactivity): Aliquots of WHO/NIBSC preparations (specific quantities not detailed beyond "diluted to the following levels").
• Intra-assay precision: N = 20 per solution (three different concentrations).
• Inter-assay precision: N = 20 (10 assays, duplicate measurements per assay) per solution (three different concentrations).
• Method Comparison: N = 62 patient samples.
• Linearity and Nonparallelism: Three human serum samples (SLS#4, SLS#18, SLS#26) subjected to serial dilutions.
• Spike and Recovery: Eight normal male human serum samples.
• Recovery in Serum and Plasma: Blood samples from 2 normal subjects, processed into various types of serum and plasma.
• Effect of Common Interferents: Pooled normal male human serum.

Data Provenance:

• Country of Origin: Not explicitly stated for all samples. However, human sialoglycoprotein hormones for specificity were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England).
• Retrospective or Prospective: Unclear for patient samples. The study involved controlled laboratory experiments using commercial controls, patient samples, and spiked samples.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts: Not applicable. The ground truth for this in vitro diagnostic (IVD) device is typically established by:
  • Calibrators: Precisely defined concentrations of the analyte.
  • Reference Methods: Established methods (e.g., the "commercially available kit" for method comparison) that are accepted as accurate.
  • Known Spiked Concentrations: Artificially created samples with a defined amount of analyte.
• Qualifications of Experts: Not applicable in the context of establishing ground truth for an IVD test.

4. Adjudication Method (Test Set)

• Not applicable for an in vitro diagnostic (IVD) device where ground truth is based on quantitative measurements against known standards or established reference methods, not expert interpretation of images or clinical data requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not done. This is an in vitro diagnostic (IVD) device for quantitative measurement of an analyte. MRMC studies are typically for imaging devices or devices requiring human interpretation.

6. Standalone Performance (Algorithm Only)

• Yes, implied. The entire study describes the performance of the AquaLite® LH assay itself, which is a standalone in vitro test kit. There is no human-in-the-loop performance component beyond operating the luminometer and interpreting the calibration curve.

7. Type of Ground Truth Used

• Reference/Assigned Values:
  • Calibrators: For sensitivity, intra-assay, and inter-assay precision.
  • World Health Organization's National Institute for Biological Standards and Control (WHO/NIBSC) preparations: For specificity/cross-reactivity.
  • Commercial Reference Kit: For method comparison (the "commercially available kit").
  • Known Spiked Concentrations: For linearity and spike & recovery.
  • Expected values based on dilution: For linearity.

8. Sample Size for the Training Set

• The document describes performance studies for a finished in vitro diagnostic kit. It does not mention a "training set" in the typical machine learning sense. The device is a chemical immunoassay, not an AI/ML algorithm that requires training on a dataset in that manner. Any "training" would refer to the internal development and optimization of the assay by SeaLite Sciences, Inc., the details of which are not provided here.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As stated above, this is not an AI/ML device with a "training set" in the conventional sense. The development of the assay would have involved various optimization steps using known concentrations of LH and other related substances, but these would fall under assay development rather than "training set ground truth establishment."

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