(63 days)
Nichols Institute Intact PTH assay
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No
The device description details a standard immunoassay with a luminometer reading and a cubic spline curve fit for calculation, which are not AI/ML technologies. There are no mentions of AI, DNN, or ML in the provided text.
No.
The document states that the device is an "in vitro diagnostic use" kit for the quantitative determination of human intact parathyroid hormone, indicating its use in diagnosis rather than treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Intact PTH measurements are used in the diagnosis of disorders of calcium metabolism and the parathyroid gland."
No
The device description clearly outlines a hardware-based immunoassay kit involving physical components like pre-coated tubes, reagents, and a luminometer for measurement. While software is used for calculation, the core device is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The AquaLite® Intact PTH assay is for in vitro diagnostic use." This is the primary indicator that the device is an IVD.
Furthermore, the description details a test performed on human serum samples in a clinical laboratory setting to diagnose disorders of calcium metabolism and the parathyroid gland, which aligns with the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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).
Mentions image processing
Not Found
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)
Studies on SeaLite Sciences, Inc. AquaLite® Intact PTH were conducted at SeaLite Sciences.
- Sensitivity: The sensitivity or detection limit of the AquaLite® Intact PTH is 0.7 pg/mL. 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 PTH concentration (pg/mL) associated with this calculated signal is defined as the sensitivity of the assay.
- Specificity: The AquaLite® Intact PTH captures antibody coated onto the solid phase, and the conjugate antibody recognizes distinct segments of intact (1-84) PTH. A complex bound to the solid phase is formed only with the intact PTH molecule. Cross reactivity of the Aqualite® Intact PTH assay with PTH fragments was determined by spiking a sample containing intact PTH (17 pg/mL) with PTH fragments.
- 1-34 PTH Fragment (400 pg/mL): 50% Inhibition
- 39-84 PTH Fragment (100,000 pg/mL): 0% Inhibition
- 53-84 PTH Fragment (100,000 pg/mL): 0% Inhibition
- 39-68 PTH Fragment (100,000 pg/mL): 0% Inhibition
- 44-68 PTH Fragment (100,000 pg/mL): 0% Inhibition
- High Dose Hook Effect: No high dose hook effect occurs prior to 100,000 pg/mL intact PTH.
- Precision:
- Intra-assay precision. Two serum commercial controls containing PTH were assayed. (Total N = 20 per concentration level.)
- PTH Level 26.10 pg/ml: 6.95% CV
- PTH Level 173.71 pg/ml: 5.45% CV
- Inter-assay precision. Two serum controls containing prolactin were assayed in 20 assays. (n=2x20=40).
- PTH Level 51.7 pg/ml: 8.9% CV
- PTH Level 332.3 pg/ml: 8.3% CV
- Intra-assay precision. Two serum commercial controls containing PTH were assayed. (Total N = 20 per concentration level.)
- Method Comparison: The AquaLite® Intact PTH was used to assay PTH in patient samples (N=57) previously assayed by a commercially available chemiluminometric kit for PTH. Correlation by linear regression analysis gave a slope of 0.964 with a y-intercept of 10.017. The correlation coefficient was 0.95.
- Linearity and Nonparallelism: Three human serum samples with endogenous PTH were diluted using Calibrator A (0 pg/mL) and assayed in duplicate. Recovery percentages for various dilutions ranged from 99% to 108%.
- Recovery: PTH serum samples were mixed in 2:1, 1:1 and 1:2 ratios and assayed in duplicate. Recovered percentages ranged from 89% to 93%.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 0.7 pg/mL
Specificity: Demonstrated by cross-reactivity study (see Summary of Performance Studies).
Precision:
Intra-assay CV: 6.95% and 5.45%
Inter-assay CV: 8.9% and 8.3%
Correlation coefficient (r) with predicate device: 0.95
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.
Nichols Institute Intact PTH assay
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.
Not Found
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).
Not Found
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.
0
APR
1 4
1997
510(k) SUMMARY
As described in 21 C.F.R. § 807.92, the following is a summary of the safety and effectiveness of the SeaLite Sciences, Inc. AquaLite® Intact PTH.
GENERAL INFORMATION I.
Trade or proprietary name - SeaLite Sciences, Inc. AquaLite® Intact PTH
Common or usual name - Bioluminescent immunoassay (BLA)
Classification name - PDA has classified parathyroid hormone test systems intended for the measurement of PTH in the diagnosis of disorders of calcium metabolism as Class II devices. 21 C.F.R. §862.1545.
| Submitter's Name and Address: | Cathryn N. Cambria
Director, Regulatory Affairs
and Quality Assurance
SeaLite Sciences, Inc.
3000 Northwoods Parkway
Suite 200
Norcross, GA 30071
(800) 874-4471, x227 |
|------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission Date: | February 7, 1997 |
| Legally Market Device to Which
Claim Substantial Equivalence: | Nichols Institute |
Nichols Institute Intact PTH assay
INDICATIONS FOR USE D.
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
1
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.
DEVICE DESCRIPTION III.
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).
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.
399309.1
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SUMMARY OF STUDIES AND TECHNOLOGICAL CHARACTERISTICS IV.
Studies on SeaLite Sciences, Inc. AquaLite® Intact PTH were conducted at SeaLite Sciences. The results are summarized below:
Performance Characteristics
1. Sensitivity
The sensitivity or detection limit of the AquaLite® Intact PTH is 0.7 pg/mL. 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 PTH concentration (pg/mL) associated with this calculated signal is defined as the sensitivity of the assay.
2. Specificity
The AquaLite® Intact PTH captures antibody coated onto the solid phase, and the conjugate antibody recognizes distinct segments of intact (1-84) PTH. A complex bound to the solid phase is formed only with the intact PTH molecule. Cross reactivity of the Aqualite® Intact PTH assay with PTH fragments was determined by spiking a sample containing intact PTH (17 pg/mL) with PTH fragments.
| PTH Fragment | Concentration
(pg/mL) | % Inhibition |
|--------------|--------------------------|--------------|
| 1-34 | 400 | 50 |
| 39-84 | 100,000 | 0 |
| 53-84 | 100,000 | 0 |
| 39-68 | 100,000 | 0 |
| 44-68 | 100,000 | 0 |
3. High Dose Hook Effect
No high dose hook effect occurs prior to 100,000 pg/mL intact PTH.
3
4. Precision
- Intra-assay precision. Two serum commercial controls containing PTH (a) at the following concentrations were assayed to determine intra-assay precision. (Total N = 20 per concentration level.)
لاعب العامل المقاربة المقارمة المستوى المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب المنتخب
| PTH Level (pg/ml) | % CV |
|---|---|
| 26.10 | 6.95% |
| 173.71 | 5.45% |
- (b) Inter-assay precision. Two serum controls containing prolactin at the following concentrations were assayed in 20 assays. A new standard curve was generated for each assay (n=2x20=40).
| PTH Level (pg/ml) | % CV |
|---|---|
| 51.7 | 8.9% |
| 332.3 | 8.3% |
ડ. Method Comparison
The AquaLite® Intact PTH was used to assay PTH in patient samples (N=57) that were previously assayed by a commercially available chemiluminometric kit for PTH. Correlation by linear regression analysis gave a slope of 0.964 with a y- intercept of 10.017. The correlation coefficient was 0.95.
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6. Linearity and Nonparallelism
Three human serum samples containing the levels of endogenous PTH shown below were diluted as indicated using Calibrator A (0 pg/mL) and assayed in duplicate using AquaLite® Intact PTH. All concentrations are in pg/mL.
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প্রকল্প
মাধ্যমান
| Sample
ID | Dilution
Factor | PTH Found
(pg/mL) | PTH
Expected
(pg/mL) | Recovery
(%) |
|--------------|--------------------------------|---------------------------------|-------------------------------|--------------------------|
| A | Undiluted
1:2
1:4
1:8 | 37.4
19.9
9.7
5.0 | ---
18.7
9.4
4.7 | ---
106
103
106 |
| B | Undiluted
1:2
1:4
1:8 | 85.7
46.4
22.9
10.6 | ---
42.9
21.4
10.7 | ---
108
107
99 |
| C | Undiluted
1:2
1:4
1:8 | 709.0
354.0
182.0
92.6 | ---
354.0
177.0
88.6 | ---
100
103
105 |
5
7. Recovery
PTH serum samples were mixed in 2:1, 1:1 and 1:2 ratios and assayed in duplicate. All values are in pg/mL. ·
| Sample | Dilution | PTH Observed | PTH Expected | % Recovered |
|---|---|---|---|---|
| A | UndilutedA | 4.0 | --- | --- |
| A | 2A:1B | 24.9 | 28.0 | 89 |
| A | 1A:1B | 37.5 | 40.2 | 93 |
| A | 1A:2B | 48.2 | 52.0 | 93 |
| B | Undiluted B | 76.4 | --- | --- |
| C | Undiluted C | 15.0 | --- | --- |
| C | 2C:1D | 52.0 | 58.0 | 90 |
| C | 1C:1D | 71.0 | 79.0 | 90 |
| C | 1C:2D | 92.0 | 100 | 92 |
| D | Undiluted D | 143.0 | --- | --- |
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V. POTENTIAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH
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 from explosive metal azides. Flush with large volumes of water when disposing of materials containing sodium azide.
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.
VI. CONCLUSIONS DRAWN FROM STUDIES
The data from the studies conducted demonstrated that the performance of SeaLite Sciences, Inc. AquaLite® Intact PTH is similar and substantially equivalent to that of other commercially available assays for intact PTH.