(44 days)
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No
The device description details a standard bioluminescent immunoassay process involving chemical reactions, light measurement, and calculation based on a calibration curve. There is no mention of AI or ML algorithms being used for data analysis, interpretation, or any other function. The performance studies also focus on traditional assay metrics.
No.
The device is an in vitro diagnostic (IVD) intended for quantitative determination of human LH in samples, not for direct treatment or diagnosis.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The AquaLite® LH assay is for in vitro diagnostic use."
No
The device description clearly outlines a physical kit containing antibodies, tubes, and reagents used in a laboratory setting with a luminometer, indicating it is a hardware-based in vitro diagnostic device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The AquaLite® LH assay is for in vitro diagnostic use."
- Method of Analysis: The device analyzes human LH in sera and plasma, which are biological samples taken in vitro (outside the body).
- Purpose: The purpose is the "quantitative determination of human LH," which is a diagnostic measurement used to assess a patient's physiological state.
- Device Description: The description details a laboratory-based assay using reagents, tubes, and a luminometer to perform the analysis on the collected samples.
All these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
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
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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)
Studies on SeaLite Sciences, Inc. AquaLite® LH were conducted at SeaLite Sciences. The results are summarized below:
Performance Characteristics:
-
Sensitivity: The sensitivity or detection limit of the AquaLite® LH assay is 0.01 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 LH concentration (IU/L) corresponding to this calculated signal is defined as the analytical sensitivity of the assay.
-
Specificity: The AquaLite® LH assay measures intact LH. Human sialoglycoprotein hormones (TSH, FSH, hCG) were tested for cross-reactivity.
- TSH: 4.9% cross-reactivity at 1,000 IU/L
- FSH: 0.68% cross-reactivity at 1,000 IU/L
- hCG: 1.2% cross-reactivity at 2,500 IU/L
- High Dose Hook Effect: No high dose hook effect occurs prior to 5,000 IU/L LH.
-
Precision:
- Intra-assay precision: Tri-level commercial controls (Total N = 20 per solution) were assayed.
- Mean LH Level (IU/L): 1.069, SD: 0.0807, % CV (calibration values): 7.55%
- Mean LH Level (IU/L): 9.821, SD: 0.578, % CV (calibration values): 5.9%
- Mean LH Level (IU/L): 40.129, SD: 2.728, % CV (calibration values): 6.8%
- Inter-assay precision: Tri-level commercial controls were assayed in duplicate repetitively (Ten assays, Total N = 2 x 10 = 20).
- Mean LH Level (IU/L): 1.585, SD: 0.131, % CV: 8.2%
- Mean LH Level (IU/L): 11.303, SD: 0.924, % CV: 8.17%
- Mean LH Level (IU/L): 40.09, SD: 3.60, % CV: 8.9%
- Intra-assay precision: Tri-level commercial controls (Total N = 20 per solution) were assayed.
-
Method Comparison: The AquaLite® LH assay was used to test patient samples (N=62) that were previously assayed by a commercially available kit. Samples ranged from 0.5 to 62.0 IU/L. A slope of 0.89 with a y-intercept of 1.53 was obtained. The correlation coefficient was 0.938.
-
Linearity and Nonparallelism: Three human serum samples were diluted in parallel using Calibrator A with 0.9% sodium chloride added. Results showed varying percentages of expected values upon dilution.
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Spike and Recovery: Normal male human serum samples were spiked with LH and assayed. Percent recovered ranged from 91.6% to 109.3%.
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Recovery in Serum and Plasma: Blood Samples from 2 normal subjects prepared as sera and various plasma types (heparin, EDTA, oxalate, citrate) were quantified for LH. No significant differences were found among serum and SST serum, nor among serum and heparin, EDTA, and citrate plasmas. Oxalate plasma is not recommended.
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Effect of Common Interferents: Pooled normal male human serum was spiked with hemoglobin (at 500 mg/dL), bilirubin (at 20 mg/dL), human serum albumin (at 12 mg/dL), and triglycerides (at 3000 mg/dL). The data demonstrate that the AquaLite® LH assay is not significantly affected by these interferents at the levels tested.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.01 IU/L
Specificity: Cross-reactivity results provided in performance summary.
Precision: Intra-assay %CV (7.55%, 5.9%, 6.8%), Inter-assay %CV (8.2%, 8.17%, 8.9%).
Correlation coefficient: 0.938 (method comparison).
Percent recovered: (range 91.6% to 109.3%).
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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§ 862.1485 Luteinizing hormone test system.
(a)
Identification. A luteinizing hormone test system is a device intended to measure luteinizing hormone in serum and urine. Luteinizing hormone measurements are used in the diagnosis and treatment of gonadal dysfunction.(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.
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K9604925
ﻤ
JAN 2 2 1997
EXHIBIT D
SUMMARY OF SAFETY AND EFFECTIVENESS
1
GENERAL INFORMATION I.
Trade or proprietary name - SeaLite Sciences, Inc. AquaLite® LH
Common or usual name - Bioluminescent immunoassay (BIA)
Classification name - FDA has classified LH test systems intended for the measurement of LH in the diagnosis of gonadal dysfunction.
INDICATIONS FOR USE II.
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.
III. DEVICE DESCRIPTION
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.
2
ALTERNATIVE PRACTICES AND PROCEDURES IV.
There are several assay technologies commonly employed to measure the presence of human LH in serum or plasma. They include: radioimmunoassay (RIA) and enzymelinked immunosorbent immunoassay (ELISA).
MARKETING HISTORY V.
The modified SeaLite Sciences, Inc. AquaLite® LH that is the subject of this submission is not currently marketed.
POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH VI.
Use Universal Precautions. No known test method can offer complete Caution: 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 from explosive metal azides. Flush with large volumes of water when disposing of materials containing sodium azide.
As an in virro 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. SUMMARY OF STUDIES
Studies on SeaLite Sciences, Inc. AquaLite® LH were conducted at SeaLite Sciences. The results are summarized below:
Performance Characteristics
1. Sensitivity
The sensitivity or detection limit of the AquaLite® LH assay is 0.01 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 LH concentration (IU/L) corresponding to this calculated signal is defined as the analytical sensitivity of the assay.
3
2. Specificity
The AquaLite® LH assay measures intact LH. The following human sialoglycoprotein hormones were supplied by the World Health Organization's National Institute for Biological Standards and Control (London, England). Aliquots of these preparations were diluted to the following levels in zero calibrator and assayed. Percent crossreactivity (%) is reported below:
| Substance | WHO/NIBSC
Lot Number | Tested at (IU/L) | % Cross-reactivity |
|-----------|-------------------------|------------------|--------------------|
| TSH | 2nd IRP 80-558 | 1,000 | 4.9 |
| FSH | I.S. 83-575 | 1,000 | 0.68 |
| hCG | IRP 75-551 | 2,500 | 1.2 |
- High Dose Hook Effect No high dose hook effect occurs prior to 5,000 IU/L LH. 3.
-
- Precision
- Intra-assay precision. Tri-level commercial controls containing LH at the following (a) concentrations were assayed to determine intra-assay precision. (Total N = 20 per solution.)
| Mean LH Level (IU/L) | SD | % CV (calibration values) |
|---|---|---|
| 1.069 | 0.0807 | 7.55% |
| 9.821 | 0.578 | 5.9% |
| 40.129 | 2.728 | 6.8% |
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- Inter-assay precision. Tri-level commercial controls containing LH at the following (b) concentrations were assayed in duplicate repetitively. Ten assays were performed using ten sets of calibration values. Inter-assay precision observed for the solutions (Total N = 2 x 10 = 20) is shown below.
| Mean LH Level (IU/L) | SD | % CV |
|---|---|---|
| 1.585 | 0.131 | 8.2% |
| 11.303 | 0.924 | 8.17% |
| 40.09 | 3.60 | 8.9% |
ડ. Method Comparison
)
The AquaLite® LH assay was used to test patient samples (N=62) that were previously assayed by a commercially available kit. The samples ranged from 0.5 to 62.0 IU/L. A slope of 0.89 with a y-intercept of 1.53 was obtained. The correlation coefficient was 0.938.
6. Linearity and Nonparallelism
Three human serum samples containing the levels of endogenous LH shown below were diluted in parallel using Calibrator A with 0.9% sodium chloride added.
| Sample
ID | Dilution
Factor | Found
(IU/L) | Expected
(IU/L) | Percent
(%) |
|--------------|--------------------|-----------------|--------------------|----------------|
| SLS#4 | Undiluted | 80.83 | -- | -- |
| | 1:2 | 39.55 | 40.42 | 97.9 |
| | 1:4 | 19.575 | 20.21 | 96.9 |
| | 1:8 | 13.4 | 10.1 | 130 |
| SLS#18 | Undiluted | 63.82 | -- | -- |
| | 1:2 | 30.436 | 31.91 | 95.4 |
| | 1:4 | 15.84 | 15.95 | 99.4 |
| | 1:8 | 9.09 | 8.0 | 113 |
| SLS#26 | Undiluted | 75.46 | -- | -- |
| | 1:2 | 44.4 | 37.73 | 115 |
| | 1:4 | 19.65 | 18.86 | 104 |
| | 1:8 | 10.4 | 9.43 | 111 |
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7. Spike and Recovery
Normal male human serum samples were spiked with LH in the amounts noted below. The spiked samples were assayed using the AquaLite® LH assay. All values are in IU/L.
| Endogenous
LH | Added
LH | Measured
LH | Expected
LH | Percent
Recovered |
|------------------|-------------|----------------|----------------|----------------------|
| 6.83 | 50 | 60.35 | 56.83 | 106.1 |
| 11.82 | 50 | 56.59 | 61.82 | 91.6 |
| 3.14 | 50 | 57.69 | 53.14 | 108.6 |
| 0.922 | 50 | 48.88 | 51.0 | 96 |
| 2.17 | 50 | 53.29 | 52.17 | 101.5 |
| 0.16 | 50 | 52.7 | 50.2 | 104.6 |
| 2.06 | 50 | 56.89 | 52.06 | 109.3 |
| 2.53 | 50 | 56.02 | 52.53 | 106.6 |
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. LH was quantified using the AquaLite® LH assay. Recovered LH was compared with LH 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, and citrate plasmas when using the AquaLite® LH assay. Oxalate plasmas is not recommended.
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 LH were spiked into normal male serum as well as the normal male serum aliquots containing potential interferents. LH was quantified using the AquaLite® LH assay. Recovered LH was compared with the LH recovered in normal male serum. The data (in IU/L) demonstrate that the AquaLite® LH assay is not
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significantly affected by hemoglobin, bilirubin, human serum albumin or triglycerides at the levels tested.
| LH | Neat | 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 | 4.8 | - | - | - | - | - | - | - | - |
| 65 | 70.0 | 68.7 | 98.2 | 72.4 | 103 | 71.0 | 101 | 69.1 | 98.7 |
VIII. CONCLUSIONS DRAWN FROM STUDIES
The data from the studies conducted demonstrated that the performance of SeaLite Sciences, Inc. AquaLite® LH is similar and substantially equivalent to that of other commercially available assays for LH.