(65 days)
DSL-8600 ACTIVE® Aldosterone Coated-Tube 3. Radioimmunoassay Kit.
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No
The summary describes a standard immunoassay kit and system for measuring aldosterone levels. There is no mention of AI, ML, or any computational methods beyond standard statistical analysis of performance data.
No
The device is described as an "in vitro diagnostic laboratory immunoassay (IVD device)" intended for "quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine." It measures a substance in the body for diagnostic purposes, rather than treating a condition.
Yes
The device is described as an "in vitro diagnostic laboratory immunoassay (IVD device)" intended "for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine." It is also stated that "Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism... hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance." These statements clearly indicate its use for diagnostic purposes.
No
The device is an in vitro diagnostic immunoassay kit, which is a physical reagent-based system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is "intended for in vitro diagnostic laboratory use".
- Device Description: The "Device Description" section also clearly labels it as an "in vitro diagnostic laboratory immunoassay (IVD device)".
- Purpose: The assay is designed to measure a substance (aldosterone) in human biological samples (serum, plasma, urine) to aid in the diagnosis and treatment of various medical conditions. This is the core function of an IVD.
N/A
Intended Use / Indications for Use
The Nichols Advantage Aldosterone Assay is intended for in vitro diagnostic laboratory use with the Nichols Advantage® Specialty System for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
Product codes
CJM
Device Description
The Nichols Advantage® Aldosterone Assay is a competitive immunochemiluminometric in vitro diagnostic laboratory immunoassay (IVD device) that utilizes a biotinylated mouse monoclonal anti-aldosterone antibody as the capture reagent and an acridinium ester labeled aldosterone as a tracer reagent. This Aldosterone IVD device immunoassay is intended for use for the measurement of aldosterone in human serum, EDTA plasma, and extracted urine, as an extended diagnostic method utilized within the Nichols Advantage® Specialty System.
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
in vitro diagnostic laboratory use
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)
Method Comparison (for urine samples):
- Study Type: Comparison to a commercially available Aldosterone radioimmunoassay (X) using NCCLS EP9-A procedures for method comparison and bias analysis.
- Sample Size: n=118 urine samples.
- Key Results:
- Range of values observed with the commercially available kit: 0.8 to 80.2 µg/24 Hr.
- Range of values with Nichols Advantage Aldosterone: 0.4 to 66.7µg/24 Hr.
- Passing Bablok regression analysis: Y = 1.23X - 1.19 (95% confidence intervals of the slope and intercept were 1.2 to 1.28, and -1.43 to -0.81 respectively).
- Pearson's correlation coefficient (r): 0.96 (95% confidence interval was 0.94 to 0.97).
Reproducibility (for urine):
- Study Type: Estimated within-run and total imprecision using NCCLS EP5-A method (Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline)18.
- Sample Size: 4 urine samples, assayed in duplicate, one run per day over 20 days.
- Key Results:
| Urine Sample | Mean (ng/dL) | Within-Run SD | Within-Run %CV | Total Imprecision SD | Total Imprecision %CV |
|---|---|---|---|---|---|
| Sample A | 8.6 | 0.53 | 6.1 | 1.32 | 15.3 |
| Sample B | 17.6 | 0.4 | 2.3 | 1.95 | 11.1 |
| Sample C | 37.4 | 0.61 | 1.6 | 3.84 | 10.3 |
| Sample D | 61.2 | 1.32 | 2.2 | 6.21 | 10.2 |
Parallelism (for urine):
- Study Type: Serial dilution of extracted urine samples.
- Key Results: Percentage recovery ranging from 85% to 116%.
Recovery (for urine):
- Study Type: Mixing of high and low urine samples in different ratios.
- Key Results: Percentage recovery ranging from 93% to 110%.
Specificity (for urine):
- Study Type: Cross-reactivity testing with various compounds.
- Key Results: Most cross-reactants showed undetectable apparent amounts detected, with Aldosterone showing 98-102% crossreactivity and Estradiol showing 0.85% for one concentration.
Urine Extraction Efficiency:
- Study Type: Spiking known quantities of Aldosterone into urine and measuring recovery.
- Key Results: Percentage recovery ranging from 98% to 103% for spiked samples.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 1.2 ng aldosterone/dL
Within-run (%CV): 1.6 to 6.1%
Total Precision (%CV): 10.2 to 15.3%
Recovery: 93% to 110%
Linearity: 85% to 116%
Pearson's correlation coefficient (r) from method comparison: 0.96 (95% confidence interval was 0.94 to 0.97).
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.
DSL-8600 ACTIVE® Aldosterone Coated-Tube 3. Radioimmunoassay Kit.
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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§ 862.1045 Aldosterone test system.
(a)
Identification. An aldosterone test system is a device intended to measure the hormone aldosterone in serum and urine. Aldosterone measurements are used in the diagnosis and treatment of primary aldosteronism (a disorder caused by the excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.(b)
Classification. Class II.
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12.0 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
510(k) Number: K050784
1. Name of Submitter, Contact Person and Date Summary Prepared:
Nichols Institute Diagnostics 1311 Calle Batido San Clemente, CA 92673 Phone: 949-940-7358 Fax: 949-940-7313
Contact Person: Xie Qiyi, MD., MPH, Director of Clinical and Regulatory Affairs Date Prepared: 5/13/2005
2. Device Name and Classification
| Trade/Proprietary Name: | Nichols Advantage® Aldosterone Assay |
|---|---|
| Common/Usual Name: | Aldosterone Immunoassay |
| Classification Name: | Radioimmunoassay System, Test, Aldosterone |
| Classification: | Class II |
| Regulation Number: 862.1054 | |
| Product code: CJM, Clinical Chemistry |
- DSL-8600 ACTIVE® Aldosterone Coated-Tube 3. Predicate Device: Radioimmunoassay Kit.
4. Device Description:
The Nichols Advantage® Aldosterone Assay is a competitive immunochemiluminometric in vitro diagnostic laboratory immunoassay (IVD device) that utilizes a biotinylated mouse monoclonal anti-aldosterone antibody as the capture reagent and an acridinium ester labeled aldosterone as a tracer reagent. This Aldosterone IVD device immunoassay is intended for use for the measurement of aldosterone in human serum, EDTA plasma, and extracted urine, as an extended diagnostic method utilized within the Nichols Advantage® Specialty System.
5. Intended Use
The Nichols Advantage Aldosterone Assay is intended for in vitro diagnostic Inhoratory use with the Nichols Advantage® Specialty System for quantitative measurement of aldosterone in human serum, EDTA plasma, and extracted urine. Aldosterone measurements are intended for use in the diagnosis and treatment of primary aldosteronism (a disorder caused by excessive secretion of aldosterone by the adrenal gland), hypertension caused by primary aldosteronism, selective hypoaldosteronism, edematous states, and other conditions of electrolyte imbalance.
1
6. Comparison to predicate device :
The Nichols Advantage Aldosterone(Y) was compared to a commercially The Nionolo Aldosterone radioimmunoassay (X) previously cleared by the FDA using the NCCLS EP9-A procedures for method comparison and bias analysis. (n=118) urine samples were assayed by both methods following each manufacturers' directions and without modifications. The range of values observed with the commercially available kit was 0.8 to 80.2 µg/24 Hr; with the Nichols Advantage Aldosterone the range was 0.4 to 66.7µg/24 Hr . Computing the Passing Bablok regression analysis of these data yielded an equation of Y = 1.23X - 1.19 (95% confidence intervals of the slope and intercept were 1.2 to 1.28, and -1.43 to -0.81 respectively). Pearson's correlation coefficient (r) of the paired data was 0.96 (95% confidence interval was 0.94 to 0.97). User laboratories should perform their own method comparison following their inhouse procedures.
7. Similarities:
- Both assays use same specimen type [i.e., 24 hour human urine sampling] �
- Both assays use human-derived aldosterone standards and controls. .
- Both assays use a specific antibody to aldosterone, use competitive direct . immunoassay methods to measure the hormone in urine.
- The sensitivity of both assays is sufficient to measure aldostrerone levels . found in urine in the range of normal and abnormal values.
- Both assays are IVD laboratory-based medical device products. .
Differences: 8.
| | DSL-8600 ACTIVE®
Aldosterone Coated-
Tube
Radioimmunoassay Kit | Nichols Advantage®
Aldosterone Assay |
|-------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------|
| Feature
Sample Volume | 100 microliters | 250 microliters |
| Sample preparation | Extracted Urine samples | Hydrolyzed Urine Samples |
| Analytical
sensitivity | 0.7 ng aldosterone/dL | 1.2 ng aldosterone/dL |
| Analytical prinicpal | Radioimmunassay or RIA | limmunochemiluminometri
c Assay or ICL Assay |
| Incubation steps
and temperature | Several steps, 18 hours
at room temperature
[~25°C] | 3 steps, 10 minutes each
at 37C |
REPORTING RESULTS 9.
The recommended reportable range is 3 to 120 ng/dL. Values below 3 ng/dL should be reported as "less than 3 ng/dL" ( OND Concurrence of CDRH, Office of Device Evaluation (OBE)
Alberto Serta
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) L050784