(60 days)
No
The description focuses on standard immunoassay technology and data analysis methods (regression, precision calculations). There is no mention of AI or ML algorithms being used for data processing, interpretation, or decision-making.
No.
This device is an in vitro diagnostic (IVD) assay designed to quantitatively measure Aldosterone levels in human samples for diagnostic purposes, rather than directly treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in the diagnosis and treatment of primary aldosteronism...and other conditions of electrolyte imbalance."
No
The device description clearly states it is a chemiluminescent assay that uses a photomultiplier to measure light signals, 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:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of Aldosterone in human serum. EDTA plasma and treated urine samples." These are human biological samples.
- Purpose: The measurements are intended for use in the "diagnosis and treatment of primary aldosteronism... hypertension... selective hypoaldosteronism, edematous states and other conditions of electrolyte imbalance." This clearly indicates a medical purpose related to diagnosing and managing health conditions.
- Technology: It uses "chemiluminescent immunoassay (CLIA) technology," which is a common method for in vitro diagnostic testing.
- Sample Type: It analyzes "human serum. EDTA plasma and treated urine samples," which are biological specimens taken from the human body.
- Controls and Calibrators: The description includes control and calibration materials specifically for monitoring the accuracy and verifying the calibration of the assay. These are standard components of IVD systems.
- Performance Studies: The document details performance studies like method comparison, LoB/LoD/LoQ, reference range, reproducibility, dilution linearity, interfering substances, and cross-reactivity. These are typical studies required for the validation of IVD devices.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The LIAISON® Aldosterone assay uses chemiluminescent immunoassay (CLIA) technology and is intended for the quantitative determination of Aldosterone in human serum, EDTA plasma and treated urine samples. 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. The test has to be performed on the LIAISON® Analyzer.
The DiaSorin LIAISON® Aldosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy of the DiaSorin LIAISON® Aldosterone assay on the LIAISON® Analyzer.
The DiaSorin LIAISON® Aldosterone Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® Aldosterone assay when performed on the LIAISON® Analyzer.
Product codes
CJM, JJX
Device Description
The LIAISON® Aldosterone assay is a competitive modified 2 step chemiluminescent assay that uses sheep monoclonal antibody for capture of the Aldosterone molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is inversely proportional to the concentration of aldosterone present in the calibrators, controls or samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Method Comparison:
A method comparison study was performed on 155 serum and 106 urine samples following CLSI EP9-A2. In the study samples were tested in singlicate with the LIAISON® Aldosterone assay and in duplicate by the predicate RIA assay. Samples were collected from apparently healthy individuals. In order to cover the assay measuring range approximately 15% of the samples were spiked with enough aldosterone as needed in order to span the measuring range.
One hundred forty-four (144) of the 155 serum samples tested were analyzed. Eleven samples read below the measuring range of the LIAISON® Aldosterone assay (
§ 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.
0
APR 0 9 2013
18 hours |
| Sample matrix | Serum, EDTA plasma and 24-hour
urine | Serum, 24-hour urine |
| Urine samples
handling and
processing time | 1. Acid hydrolysis- 18 hrs.
2. Neutralization of urine ~2 minutes | 1. Acid hydrolysis - 24 hrs.
2. Ethyl acetate extraction - 1 hr
3. Dry down ~ 15 minutes |
| Calibration | Two-point calibration by the user.
Stable for 14 days. | 7 calibrators used to generate
assay curve in every assay run |
COMPARISON TO PREDICATE DEVICE:
| Control similarity and differences | ||
|---|---|---|
| Item | New Device | |
| LIAISON® Aldosterone Control | ||
| (K130321) | Predicate Device | |
| LIAISON® 25 OH Vitamin D | ||
| TOTAL Control (K071480) | ||
| Intended Use | Intended for use as assayed quality | |
| control samples to monitor the | ||
| accuracy of assay. | Same | |
| Analyte | Aldosterone | 25 OH vitamin D |
2
| Matrix | Liquid Human serum based
controls provided in vials with
phosphate buffer, ProClin® 300
and Gentamicin. | Liquid human serum-based
controls provided in vials with
buffer salts and sodium azide. |
|--------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Levels | Two levels: High and Low | Same |
| Storage conditions | 2-8°C | Same |
| Calibration Verifier similarity and differences | ||
|---|---|---|
| Item | New Device | |
| LIAISON® Aldosterone Calibration | ||
| Verifier (K130321) | Predicate Device | |
| LIAISON® 25 OH Vitamin D | ||
| TOTAL Calibration Verifier | ||
| (K090104) | ||
| Intended Use | Assayed quality control materials | |
| intended for the quantitative | ||
| verification of calibration and | ||
| reportable range of the assay. | Same | |
| Analyte | Aldosterone | 25 OH vitamin D |
| Matrix | Buffered hormone free human | |
| serum based matrix (2 mL/vial) | ||
| with Proclin® 300 as a preservative | Vitamin D free human serum with | |
| buffer salts and The LIAISON® Aldosterone Control Set is intended for use as assayed quality control samples to monitor the accuracy of the LIAISON® Aldosterone assay on the LIAISON® Analyzer. ---------- |
The LIAISON® Aldosterone Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® Aldosterone assay when performed on the LIAISON® Analyzer.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use _ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung WDChan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) - . K130321