(35 days)
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No
The device description details a standard bioluminescent immunoassay process involving chemical reactions, light measurement, and a calibration curve for result calculation. There is no mention of AI or ML in the description, performance studies, or key metrics.
No.
Explanation: The device is an in vitro diagnostic immunoassay intended for the quantitative determination of human FSH in sera and plasma, used in clinical laboratories. It does not provide any therapy or treatment.
Yes
The text explicitly states in the "Intended Use / Indications for Use" section that the device is "for in vitro diagnostic use."
No
The device description clearly outlines a physical kit containing reagents, tubes, and requiring a luminometer for measurement. It is an in vitro diagnostic assay kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The AquaLite® FSH assay is for in vitro diagnostic use." This is the primary indicator that the device is intended for use in diagnosing conditions outside of the living body, using samples such as serum and plasma.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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. Note that the numerical value for FSH in mIU/mL is the same as for IU/L (International System). For example, 15.6 mIU/mL equals 15.6 IU/L.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
clinical laboratories
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics
- Sensitivity: The sensitivity or detection limit of the AquaLite® FSH assay is 0.03 IU/L. Sensitivity is determined by adding the mean signal of twenty (20) replicates of the zero level calibrator plus two (2) standard deviations above this mean.
- Specificity: The AquaLite® FSH assay measures intact FSH. Cross-reactivity results: hCG 0.02%, LH 0.10%, TSH 1.90%. No high dose hook effect occurs prior to 4,000 IU/L FSH.
- Precision:
- Intra-assay precision (N = 10 per solution):
- Mean FSH Level (IU/L) 6.69, SD 0.36, % CV 5.4
- Mean FSH Level (IU/L) 26.89, SD 1.80, % CV 6.65
- Mean FSH Level (IU/L) 45.28, SD 3.23, % CV 7.15
- Inter-assay precision (N = 20, 10 assays):
- SD 0.485, % CV 7.52
- SD 1.679, % CV 6.39
- Intra-assay precision (N = 10 per solution):
- Method Comparison: The AquaLite® FSH assay was used to test patient samples (N=92) that were previously assayed by a commercially available kit. The samples ranged from 1.4 to 230 IU/L. A slope of 0.66 with a y-intercept of 0.78 was obtained. The correlation coefficient was 0.90.
- Linearity and Nonparallelism: Five human serum samples were diluted in parallel. Recovery rates ranged from 90.7% to 118%.
- Spike and Recovery: Eight normal human serum samples were spiked with 25 IU/L FSH. Recovery rates ranged from 100% to 128%.
- Recovery in Serum and Plasma: Blood Samples from 2 normal subjects were prepared as sera and various plasma types. Data demonstrate no significant differences among serum and SST serum nor among serum and heparin, EDTA, oxalate and citrate plasmas.
- Effect of Common Interferents: Pooled normal male human serum was spiked with hemoglobin, bilirubin, human serum albumin and triglycerides. The data demonstrate that the AquaLite® FSH assay is not significantly affected by these interferents at the levels tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.03 IU/L
Cross-reactivity: hCG 0.02%, LH 0.10%, TSH 1.90%
Intra-assay %CV: 5.4 to 7.15
Inter-assay %CV: 6.39 to 7.52
Correlation coefficient (Method Comparison): 0.90
Recovery (%): 90.7 to 128
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
SeaLite Sciences. Inc.
510(K) SUMMARY
FEB 1 4 1997
GENERAL INFORMATION I.
Trade or proprietary name - SeaLite Sciences, Inc. AquaLite® FSH
Common or usual name - Bioluminescent immunoassay (BIA)
Classification name - FDA has classified FSH test systems intended for the measurement of FSH in the diagnosis of pituitary gland and gonadal function.
Submitter's Name and Address: Cathryn N. Cambria Director Regulatory Affairs and Quality Assurance, SeaLite Sciences, Inc. 3000 Northwoods Parkway, Suite 200 Norcross. Georgia 30071 (800) 874-4471, extension 227 Submission Date: January 9, 1997
Legally Marketed Device to which Claim Substantial Equivalence: SeaLite Sciences, Inc. AquaLite® FSH Assay
DEVICE DESCRIPTION II.
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.
386422.1
1
SeaLite Sciences. Inc.
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. Note that the numerical value for FSH 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 These samples must be diluted with Calibrator A and re-assayed. are off-scale. Remember to multiply the results from diluted samples by the dilution factor used.
III. SUMMARY OF STUDIES AND TECHNOLOGICAL CHARACTERISTICS
Studies on SeaLite Sciences, Inc. AquaLite® FSH were conducted at SeaLite Sciences. The results are summarized below:
Performance Characteristics
1. Sensitivity
The sensitivity or detection limit of the AquaLite® FSH assay is 0.03 IU/L. Sensitivity is determined by adding the mean signal of twenty (20) replicates of the zero level calibrator plus two (2) standard deviations above this mean. The FSH concentration (IU/L) corresponding to this calculated signal is defined as the analytical sensitivity of the assay.
2. Specificity
The AquaLite® FSH assay measures intact FSH. The following human sialoglycoprotein hormones were supplied by the World Health Organization's National Institute for Biological Standards and Controls (London, England). Aliquots of these preparations were diluted to the following levels in zero calibrator and assayed. Percent cross-reactivity (%) is reported below:
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SeaLite Sciences, Inc.
| Substance | WHO/NIBSC
Lot Number | Tested at | % Cross-reactivity |
|-----------|-------------------------|-------------|--------------------|
| hCG | 3rd IS 75/537 | 2,500 IU/L | 0.02 |
| LH | 2nd IS 80/552 | 1,000 IU/L | 0.10 |
| TSH | 2nd IRP 80/558 | 1,000 mIU/L | 1.90 |
- High Dose Hook Effect No high dose hook effect occurs prior to 4,000 3. IU/L FSH.
Precision 4.
- Intra-assay precision. Tri-level commercial controls containing FSH at (a) the following concentrations were assayed to determine intra-assay precision. (Total N = 10 per solution.)
| Mean FSH Level
(IU/L) | SD | % CV
(calibration values) |
|--------------------------|------|------------------------------|
| 6.69 | 0.36 | 5.4 |
| 26.89 | 1.80 | 6.65 |
| 45.28 | 3.23 | 7.15 |
- Inter-assay precision. Tri-level commercial controls containing FSH at (b) the following concentrations were assayed in duplicate repetitively. Ten assays were performed using ten sets of calibration values. Interassay precision observed for the solutions (Total N = 2 x 10 = 20) is shown below.
| SD | % CV |
|---|---|
| 0.485 | 7.52 |
| 1.679 | 6.39 |
| 4.049 | તે જેવી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં પ્રાથમિક શાળા, પંચાયતઘર, આંગણવાડી તેમ |
3
Method Comparison 5.
The AquaLite® FSH assay was used to test patient samples (N=92) that were previously assayed by a commercially available kit. The samples ranged from 1.4 to 230 IU/L. A slope of 0.66 with a y-intercept of 0.78 was obtained. The correlation coefficient was 0.90.
Linearity and Nonparallelism 6.
Five human serum samples containing the levels of endogenous FSH shown below were diluted in parallel using Calibrator A.
| Sample
ID | Dilution
Factor | Found
(IU/L) | Expected
(IU/L) | Recovery
(%) |
|--------------|--------------------------------|-------------------------------|-----------------------------|--------------------------|
| 2 | Undiluted
1:2
1:4
1:8 | 179.6
92.1
42.1
24.2 | --
89.9
44.9
22.45 | --
102
94
108 |
| 3 | Undiluted
1:2
1:4
1:8 | 104.8
48.8
29.4
12.7 | --
52.4
26.2
13.1 | --
93
109
97.6 |
| 6 | Undiluted
1:2
1:4
1:8 | 54.1
24.5
14.9
8.1 | --
27
13.5
6.8 | --
90.7
110
115 |
| 30 | Undiluted
1:2
1:4
1:8 | 134.6
75.1
36.1
19.7 | --
67.3
33.6
16.8 | --
111
106
113 |
| 42 | Undiluted
1:2
1:4
1:8 | 163.5
84.3
41.4
26.1 | --
81.75
41
20.5 | --
102
101
118 |
4
7. Spike and Recovery
Eight normal human serum samples were spiked with 25 IU/L FSH using WHO FSH (2nd IRP 78/549). The spiked samples were assayed using the AquaLite® FSH assay. All values are in IU/L.
| Sample ID | Unspiked | FSH
Measured | FSH
Expected | %
Recovery |
|-----------|----------|-----------------|-----------------|---------------|
| 1 | 4.2 | 29.2 | 29.2 | 100 |
| 12 | 4.4 | 34.3 | 29.4 | 115 |
| 14 | 7.3 | 37.4 | 32.3 | 115 |
| 17 | 4.9 | 32.6 | 29.9 | 109 |
| 20 | 7.1 | 35.5 | 32.1 | 110 |
| 54 | 7.9 | 42.4 | 32.9 | 128 |
| 57 | 7.4 | 35.1 | 32.4 | 108 |
| 81 | 7.3 | 37.2 | 32.3 | 115 |
8. Recovery in Serum and Plasma
Blood Samples from 2 normal subjects were prepared as sera (standard technique and SST tubes) as well as heparin, EDTA, oxalate, and citrate plasmas. FSH was quantified using the AquaLite® FSH assay. Recovered FSH was compared with FSH recovered in serum (standard technique). The data demonstrate that there are no significant differences among serum and SST serum nor among serum and heparin, EDTA, oxalate and citrate plasmas when using the AquaLite® FSH assay. All values are in IU/L.
| Sample | P1 | % | P2 | % |
|---|---|---|---|---|
| Serum | 9.35 | 100 | 9.59 | 100 |
| SST | 9.54 | 102 | 10.5 | 109 |
| EDTA | 9.07 | 97 | 8.62 | 90 |
| Heparin | 9.89 | 106 | 10.4 | 109 |
| Oxalate | 8.50 | 91 | 8.8 | 92 |
| Citrate | 7.75 | 83 | 9.1 | 95 |
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SeaLite Sciences, Inc.
9. Effect of Common Interferents
Pooled normal male human serum was spiked with preparations of hemoglobin, bilirubin, human serum albumin and triglycerides to the levels shown below. Equal amounts of FSH were spiked into normal male serum as well as the normal male serum aliquots containing potential interferents. FSH was quantified using the AquaLite® FSH assay. Recovered FSH was compared with the FSH recovered in normal male serum. The data (in IU/L) demonstrate that the AquaLite® FSH assay is not significantly affected by hemoglobin, bilirubin, human serum albumin or triglycerides at the levels tested.
| FSH | | Hemoglobin
(at 500 mg/dL) | | Bilirubin
(at 20 mg/dL) | | Albumin
(at 12 mg/dL) | | Triglycerides
(at 3000 mg/dL) | |
|-------|-------|------------------------------|-----|----------------------------|----|--------------------------|-----|----------------------------------|-----|
| Spike | Serum | IU/L | % | IU/L | % | IU/L | % | IU/L | % |
| 0 | 9.77 | 9.83 | 100 | 9.13 | 93 | 10.2 | 105 | 8.56 | 88 |
| 25.7 | 35.5 | 36.3 | 102 | 35.6 | 94 | 37.0 | 104 | 36.6 | 103 |
CONCLUSIONS DRAWN FROM STUDIES IV.
The data from the studies conducted demonstrated that the performance of SeaLite Sciences, Inc. AquaLite® FSH is similar and substantially equivalent to that of other commercially available assays for FSH.
V. ALTERNATIVE PRACTICES AND PROCEDURES
There are several assay technologies commonly employed to measure the presence of human FSH in serum or plasma. They include: radioimmunoassay (RIA) and enzyme-linked immunosorbent immunoassay (ELISA).
POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH VI.
Use Universal Precautions. No known test method can offer complete assurance that products derived from human serum are pathogen-free; therefore, handle all materials of human origin as though they were potentially infectious.
Sodium azide is used as a preservative. This preservative may react with metallic plumbing to form explosive metal azides. Flush with large volumes of water when disposing of materials containing sodium azide.
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As an in vitro diagnostic test, there are not direct adverse effects on the health of a patient from the use of this product. However, failure of the device to perform as indicated, the contamination of reagents, the use of reagents past the labeled expiration dates, the use of improper specimens, or human error during the performance of the test may lead to erroneous results and possible improper patient management.
VII. INDICATIONS FOR USE
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.