(60 days)
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.
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.
Here's a breakdown of the acceptance criteria and study details for the LIAISON® Aldosterone assay, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for the LIAISON® Aldosterone assay. However, it provides performance data that would implicitly be compared against desired clinical or analytical requirements. Below is a table summarizing the reported performance, which serves as evidence of the device meeting its intended analytical characteristics.
| Performance Metric | Reported Device Performance (LIAISON® Aldosterone) | Clinical Context / Implied Acceptance |
|---|---|---|
| Method Comparison (vs. Predicate RIA) | High correlation and agreement with established method | |
| - Serum Samples (n=144) | Slope: 0.98 (95% CI: 0.94 to 1.02) | Slope near 1.0, indicating proportional agreement. |
| Intercept: 1.10 ng/dL (95% CI: 0.43 - 1.49) | Intercept near 0, indicating minimal constant bias. | |
| R: 0.988 | High correlation (close to 1). | |
| - Urine Samples (n=104) | Slope: 0.98 (95% CI: 0.91 to 1.05) | Slope near 1.0, indicating proportional agreement. |
| Intercept: 34 ng/dL (95% CI: 11.43 to 56.7) | Intercept near 0 (though 34 ng/dL for urine is noted). | |
| R: 0.948 | High correlation (close to 1). | |
| Limit of Blank (LoB) | Serum: 0.97 ng/dL | Ability to distinguish analyte absence from presence. |
| Urine: 1.26 ng/dL | ||
| Limit of Detection (LoD) | Serum: 1.45 ng/dL | Lowest concentration detectable with reasonable certainty. |
| Urine: 2.00 ng/dL | ||
| Limit of Quantitation (LoQ) | Serum: 3.0 ng/dL | Lowest concentration quantifiable with acceptable precision and accuracy. |
| Urine: 2.80 ng/dL | ||
| Precision (20-Day Reproducibility) | Consistent and reproducible results across runs, days, sites, and reagent lots. | |
| - Serum (Aldo-S1 to Aldo-S6, n=480 each) | Total %CV: 5.6% - 10.5% | Low Coefficient of Variation (CV) indicating high precision. |
| - Urine (Aldo-U1 to Aldo-U3, n=480 each) | Total %CV: 8.6% - 9.8% | Low Coefficient of Variation (CV) indicating high precision. |
| Dilution Linearity | Serum: Observed = 0.994(Expected) + 0.71, R = 1.000 | Linear response across dilution range. (Slope near 1, intercept near 0, R near 1) |
| EDTA Plasma: Observed = 1.01(Expected) + 1.43, R = 0.998 | ||
| Urine: Observed = 0.996(Expected) + 0.69, R = 0.999 | ||
| Interfering Substances | No interference observed at specified concentrations for various substances. | Robustness against common physiological and therapeutic interferences. |
| Cross-Reactivity | < 0.02% cross-reactivity for all tested substances. | High specificity, minimizing false positives from similar compounds. |
2. Sample Sized Used for the Test Set and the Data Provenance
-
Method Comparison Test Set:
- Serum: 155 samples (144 included in analysis as 11 were below measuring range).
- Urine: 106 samples (104 included in analysis as 2 were above measuring range).
- Data Provenance: Samples were "collected from apparently healthy individuals." A portion (approximately 15%) were spiked with aldosterone to span the measuring range. The study was conducted using the LIAISON® Aldosterone assay and the predicate RIA assay. Although not explicitly stated, the context of a 510(k) submission strongly implies these are likely prospective or retrospective clinical samples (for the healthy individuals) used in a controlled laboratory setting, potentially from the region where DiaSorin Inc. operates (Stillwater, MN, USA), though this is not explicitly stated.
-
LoB/LoD/LoQ Test Set: Not specified, but generally refers to a set of blank and low-concentration samples. The determination was performed according to CLSI EP17-A2.
-
Reference Range/Expected Values Test Set:
- Serum and EDTA Plasma: 126 apparently healthy subjects.
- Urine (24 hour): 91 individuals.
- Data Provenance: Samples collected from apparently healthy subjects aged 21-65 years with normal blood pressure and normal fasting glucose levels. These are prospectively collected clinical samples following specific patient preparation protocols (fasting, upright/supine positions, 24-hour collection). No specific country of origin is mentioned.
-
Reproducibility/Precision Test Set:
- Panel: 6 frozen serum samples and 3 frozen urine samples.
- Controls: 2 levels of controls.
- Data Provenance: A "coded panel" prepared by DiaSorin Inc. Tested at "DiaSorin Inc. and 2 external sites." This indicates laboratory-prepared samples tested in a multi-site, controlled study.
-
Dilution Linearity Test Set: Not specified, but samples of "each sample type" (serum, EDTA plasma, urine) were diluted. This implies laboratory-prepared or clinical samples serially diluted.
-
Interfering Substances & Cross-Reactivity Test Set: Not specified, but involved samples spiked with various substances at defined concentrations. These are laboratory-prepared samples.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This type of immunoassay (measuring a specific analyte concentration) does not typically involve human experts to establish "ground truth" in the same way an imaging or diagnostic AI does. The "ground truth" for this device's performance studies is established by:
- Predicate Device: For method comparison, the Siemens Coat-A-Count® Aldosterone RIA assay (K831178) served as the reference standard. This is a previously cleared and established clinical assay, representing the accepted "truth" for aldosteronemeasurements at the time.
- Known Concentrations: For studies like LoB/LoD/LoQ, Dilution Linearity, Interfering Substances, and Cross-Reactivity, the "ground truth" is based on known, prepared concentrations of the analyte and potential interfering/cross-reacting substances. These are analytically derived standards.
- Statistical Analysis: CLSI guidelines (EP9-A2, EP17-A2, EP6-A) provide the statistical and methodological frameworks for establishing these analytical performance characteristics.
Therefore, no information about human experts (e.g., radiologists) with specific qualifications or experience in establishing ground truth for this analytical device is provided or expected.
4. Adjudication Method for the Test Set
No adjudication method (e.g., 2+1, 3+1) is mentioned or applicable. As a quantitative immunoassay, the output is a numerical concentration. The comparison is between the new device's numerical result and the predicate device's numerical result (or known spike concentrations), not subjective interpretations requiring adjudicated consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was performed or is applicable to this type of in vitro diagnostic device (immunoassay). This device directly measures an analyte concentration, and there is no "human reader" involved in interpreting its output in the context of an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies presented (Method Comparison, LoB/LoD/LoQ, Precision, Dilution Linearity, Interfering Substances, Cross-Reactivity) all represent standalone performance of the LIAISON® Aldosterone assay. The device provides a quantitative measurement directly, without human interpretation for the primary output. Its performance is evaluated purely on its analytical accuracy, precision, and specificity against established methods or known standards.
7. The Type of Ground Truth Used
The ground truth used in these studies consists of:
- Predicate Device Measurements: For method comparison, the results from the Siemens Coat-A-Count® Aldosterone RIA assay served as the comparative ground truth.
- Known/Expected Concentrations: For LoB/LoD/LoQ determinations, dilution linearity, interference, and cross-reactivity studies, the ground truth was based on analytically derived and known concentrations of aldosterone or other substances.
- Biological Referencing: For the reference range studies, the "ground truth" was established by measuring aldosterone levels in clinically defined healthy populations under controlled conditions.
8. The Sample Size for the Training Set
No information about a "training set" is provided. This type of immunoassay (CLIA technology) is a chemical and biological measurement system, not a machine learning or AI algorithm that typically has a distinct training phase requiring a training dataset. The device's operational parameters (e.g., calibration, reagent concentrations, reaction times) are established through analytical development and optimization, rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the context of a machine learning algorithm, this question is not applicable. The device's functionality is based on its underlying chemical and immunoassay principles, which are developed and validated through a series of analytical studies as described in the performance data section, rather than through a machine learning training process.
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APR 0 9 2013
<13032/
5.0 510(k) SUMMARY
SUBMITTED BY:
Carol A. DePouw Regulatory/Clinical Affairs Specialist DiaSorin Inc. 1951 Northwestern Avenue P.O. Box 285 Stillwater. MN 55082-0285 Phone (651) 351-5850 Fax (651) 351-5669 Email: carol.depouw@diasorin.com
NAME OF DEVICE:
Trade Name:
LIAISON® Aldosterone LIAISON® Aldosterone Control Set LIAISON® Aldosterone Calibration Verifiers
Common Names/Descriptions: Aldosterone Assay
Classification:
Aldosterone Test System: Class II 21 CFR 862.1045; Clincal Chemistry (75) Quality Control Material: Class I, reserved 21 CFR 862.1660; Clinical Chemistry (75)
Product Code:
PREDICATE DEVICE:
CJM, JJX
Siemens Coat-A-Count® Aldosterone Reference K831178 LIAISON® 25 OH Vitamin D Control K071480 LIAISON® 25 OH Vitamin D Calibration Verifier K090104
DEVICE DESCRIPTION:
INTENDED 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.
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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.
KIT 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,
| Assay Similarities and Differences | ||
|---|---|---|
| Item | New DeviceLIAISON® Aldosterone (K130321) | Predicate DeviceSiemens Coat-a-countaldosterone (K831178) |
| Intended Use | For the quantitative determination ofAldosterone in human serum andurine. | Same |
| Measuring Range | 3-100 ng/dL | 3-120 ng/dL |
| Test Principle | Chemiluminescent Immunoassay | 125I Radioimmunoassay |
| Sample size | 100 µL | 200 µL |
| Assay time | 40 minutes | >18 hours |
| Sample matrix | Serum, EDTA plasma and 24-hoururine | Serum, 24-hour urine |
| Urine sampleshandling andprocessing time | 1. Acid hydrolysis- 18 hrs.2. Neutralization of urine ~2 minutes | 1. Acid hydrolysis - 24 hrs.2. Ethyl acetate extraction - 1 hr3. Dry down ~ 15 minutes |
| Calibration | Two-point calibration by the user.Stable for 14 days. | 7 calibrators used to generateassay curve in every assay run |
COMPARISON TO PREDICATE DEVICE:
| Control similarity and differences | ||
|---|---|---|
| Item | New DeviceLIAISON® Aldosterone Control(K130321) | Predicate DeviceLIAISON® 25 OH Vitamin DTOTAL Control (K071480) |
| Intended Use | Intended for use as assayed qualitycontrol samples to monitor theaccuracy of assay. | Same |
| Analyte | Aldosterone | 25 OH vitamin D |
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| Matrix | Liquid Human serum basedcontrols provided in vials withphosphate buffer, ProClin® 300and Gentamicin. | Liquid human serum-basedcontrols provided in vials withbuffer salts and sodium azide. |
|---|---|---|
| Levels | Two levels: High and Low | Same |
| Storage conditions | 2-8°C | Same |
| Calibration Verifier similarity and differences | ||
|---|---|---|
| Item | New DeviceLIAISON® Aldosterone CalibrationVerifier (K130321) | Predicate DeviceLIAISON® 25 OH Vitamin DTOTAL Calibration Verifier(K090104) |
| Intended Use | Assayed quality control materialsintended for the quantitativeverification of calibration andreportable range of the assay. | Same |
| Analyte | Aldosterone | 25 OH vitamin D |
| Matrix | Buffered hormone free humanserum based matrix (2 mL/vial)with Proclin® 300 as a preservative | Vitamin D free human serum withbuffer salts and <0.1% sodiumazide |
| Volume | 2 mL | 5 mL |
| Levels | Four levels | Same |
| Storage conditions | 2-8°C | Same |
PERFORMANCE DATA:
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 (<3.0 ng/dL) and therefore, were not included in the analysis. The serum samples ranged from 2.62 ng/dL to 107.6 ng/dL on the RIA predicate assay and 3.02 ng/dL to 97.1 ng/dL on the LIAISON® Aldosterone assay.
One hundred four (104) of the 106 urine samples tested were analyzed. Two samples read above the measuring range of 100 ng/dL (uncorrected). The urine samples ranged from 121.9 ng/dL to 1222.3 ng/dL on the predicate RIA assay and 118.9 ng/dL to 1242 ng/dL on the LIAISON® Aldosterone assay.
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Passing and Bablok regression analyses were performed for all samples across the measuring range of the assays. The results are summarized in the following table and graphs.
| Sample | n | Slope | 95% Confidence Interval | Intercept | 95% Confidence Interval | R |
|---|---|---|---|---|---|---|
| Serum | 144 | 0.98 | 0.94 to 1.02 | 1.10 ng/dL | 0.43 - 1.49 | 0.988 |
| Urine | 104 | 0.98 | 0.91 to 1.05 | 34 ng/dL | 11.43 to 56.7 | 0.948 |
LoB/LoD/LoQ
The Limit of Detection and Limit of Quantitation were determined according to CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline June 2012- Second Edition.
Results:
The limits are reported in the following table:
| Detection Limits | Serum | Urine |
|---|---|---|
| LoB | 0.97 ng/dL | 1.26 ng/dL |
| LoD | 1.45 ng/dL | 2.00 ng/dL |
| LoQ | 3.0 ng/dL | 2.80 ng/dL |
Reference Range/Expected Values:
Serum and EDTA Plasma:
Matched serum and EDTA plasma samples were drawn from 126 apparently healthy subjects aged 21-65 years of age with normal blood pressure and normal fasting glucose levels. Patients were fasting and drawn between 7 and 10 a.m. after being in the upright and supine positions for at least 30 - 60 minutes.
| Population (126) | MedianAldosterone (ng/dL) | Observed Range (ng/dL)2.5th to 97.5th Percentile |
|---|---|---|
| Upright (Serum) | 9.80 | <3.0 - 39.2 |
| Supine (Serum) | 6.76 | <3.0 - 23.2 |
| Upright (EDTA) | 8.91 | <3.0 - 35.3 |
| Supine (EDTA) | 6.42 | <3.0 - 23.6 |
24 hour Urine
To assess the expected reference range, a study was performed with ninety-one (91) 24 hour urine samples. Samples were collected over a 24 hour period from individuals with a normal blood pressure result (diastolic < 85 mmHg) prior to collection. After collection, the pH and total volume of urine for each individual was measured and recorded. Urine patient results were corrected for dilution according to the LIAISON® Aldosterone Instructions for Use.
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| Population (91) | MedianAldosterone (µg/day) | Observed Range (µg/day)2.5th to 97.5th Percentile |
|---|---|---|
| Urine (24 hour) | 5.53 | 1.19 - 28.1 |
Consider these limits as guidelines only. Each laboratory should establish its own reference range
Reproducibility/Precision:
20 Day Study Design
A twenty day reproducibility/precision study was performed at DiaSorin Inc. and 2 external sites. A coded panel comprised of 6 frozen serum samples and 3 frozen urine samples was prepared by DiaSorin Inc. The 9 precision panel samples and 2 levels of controls were tested on the LIAISON® Aldosterone assay on 2 reagent integral lots at each site in two replicates per run, 2 runs per day for 20 operating days.
Results
The mean, standard deviation, and coefficient of variation (%CV) of the results were computed for each of the tested specimens.
| mean conc | Within run | Total across Lotsand across Sites | ||||
|---|---|---|---|---|---|---|
| Sample ID | N | ng/dL | SD | %CV | SD | %CV |
| KC 1 | 480 | 6.8 | 0.24 | 3.5% | 0.65 | 9.5% |
| KC 2 | 480 | 28.8 | 0.53 | 1.8% | 1.61 | 5.6% |
| Aldo - S1 | 480 | 5.9 | 0.25 | 4.2% | 0.62 | 10.5% |
| Aldo - S2 | 480 | 8.8 | 0.27 | 3.1% | 0.79 | 9.0% |
| Aldo - S3 | 480 | 18.5 | 0.42 | 2.3% | 1.27 | 6.9% |
| Aldo - S4 | 480 | 29.8 | 0.78 | 2.6% | 2.05 | 6.9% |
| Aldo - S5 | 480 | 50.4 | 1.16 | 2.3% | 2.92 | 5.8% |
| Aldo - S6 | 480 | 82.6 | 1.76 | 2.1% | 5.21 | 6.3% |
| Aldo - U1 | 480 | 7.4 | 0.26 | 3.6% | 0.72 | 9.8% |
| Aldo - U2 | 480 | 44.1 | 1.24 | 2.8% | 3.87 | 8.8% |
| Aldo - U3 | 480 | 76.3 | 1.91 | 2.5% | 6.58 | 8.6% |
Reproducibility/Precision Results - Combined 3 site
Dilution Linearity:
Study Design
Samples of each sample type, serum, EDTA plasma and urine were diluted and analyzed by the LIAISON® Aldosterone assay following CLSI EP6-A. The results for each sample type were analyzed by a linear regression of Observed Aldosterone Concentration versus Expected Aldosterone Concentration.
Results
The resulting equation for serum sample is: Observed LIAISON® Aldosterone = 0.994(Expected) + 0.71, R = 1.000
The resulting equation for EDTA plasma sample is: Observed LIAISON® Aldosterone = 1.01(Expected) + 1.43, R =0.998
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The resulting equation for urine sample is: Observed LIAISON® Aldosterone = 0.996(Expected) + 0.69, R = 0.999
Interfering Substances
Controlled studies of potentially interfering substances at two Aldosterone levels in serum (15 and 30 ng/dL) and urine (5 and 15 ng/dL) showed no interference in the LIAISON® Aldosterone assay at the highest concentration for each substance listed below The testing was based on CLSI-EP7-A2.
| Substance/Drug | Concentration Tested | Substance/Drug | Concentration Tested | ||
|---|---|---|---|---|---|
| Serum | Urine | Serum | Urine | ||
| Bilirubin (conjugated) | 40 mg/dL | 40 mg/dL | Propranolol | 230 µg/dL | 228 µg/dL |
| Bilirubin (unconj) | 40 mg/dL | N/A | Metoprolol | 1.28 mg/dL | 1.28 mg/dL |
| Hemoglobin | 600 mg/dL | 600 mg/dL | Triamterene | 886 µg/dL | 886 µg/dL |
| Triglycerides | 3000 mg/dL | 3000 mg/dL | Spironolactone | 60 µg/dL | 60 µg/dL |
| Total protein | 12 g/dL | 12 g/dL | Tetracycline | 1.51 mg/dL | 1.51 mg/dL |
| Cholesterol | 500 mg/dL | 500 mg/dL | Amlodipine besylate | 13.9 µg/dL | 13.9 µg/dL |
| Creatinine | 5 mg/dL | 500 mg/dL | Nifedipine | 40 µg/dL | 43.9 mg/dL |
| Glucose | 1 g/dL | 1 g/dL | Verapamil | 216 µg/dL | 237 mg/dL |
| Ascorbic Acid | 6 mg/dL | 200 mg/dL | Furosemide | 5.99 mg/dL | 5.99 mg/dL |
| Urea | N/A | 4 g/dL | Eplerenone | 1.99 mg/dL | 1.99 mg/dL |
| Boric Acid | N/A | 2 g/dL | Enalapril | 42.4 µg/dL | 46.6 mg/dL |
| Acetic Acid | N/A | 2% | Lisinopril | 32.7 µg/dL | 32.7 µg/dL |
| Acetaminophen | 20 mg/dL | 20 mg/dL | Losartan potassium | 225 µg/dL | 249 mg/dL |
| Acetylsalicylic acid | 65.2 mg/dL | 65.2 mg/dL | Valsartan | 1.1 mg/dL | 1.1 mg/dL |
| Salicylic acid | 59.9 mg/dL | 59.9 mg/dL | Hydrochlorothiazide(HCTZ) | 600 µg/dL | 600 µg/dL |
| Valproic Acid | 57.6 mg/dL | 57.6 mg/dL | Uric Acid | N/A | 100 mg/dL |
| Tartaric Acid | N/A | 1g/dL |
Cross-reactivity
Controlled studies of potentially cross reacting substances in serum and urine samples were performed on the LIAISON® Aldosterone assay at the concentrations listed below. All substances showed < 0.02% cross reactivity. The testing was based on CLSI EP7-A2.
The % cross reactivity is calculated as follows:
%Cross-Reactivity = (Mean Corrected Assay Value/ Mean Concentration Spiked)*100.
Where the corrected assay value = Mean Aldosterone conc. of spiked sample - Mean Aldosterone conc. of the original sample (with vehicle).
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DiaSorin LIAISON® Aldosterone Premarket Notification
| Substance | Concentrationng/dL in Serum | Concentrationng/dL in Urine |
|---|---|---|
| Androstendione | 10000 | 100000 |
| Androsterone | 100000 | 1000000 |
| Corticosterone | 100000 | 100000 |
| 18-OH-Corticosterone | 100000 | 100000 |
| Cortisol (Hydrocortisone) | 100000 | 200000 |
| Cortisone | 200000 | 200000 |
| 21-Hydroxyprogesterone | 100000 | 100000 |
| 11-Deoxycortisol | 100000 | 100000 |
| Dexamethasone | 200000 | 200000 |
| DHEA (trans-Dehydroandrosterone) | 100000 | 1000000 |
| Estradiol | 100000 | 100000 |
| Estriol | 10000 | 100000 |
| Estrone | 10000 | 100000 |
| Fludrocortisone | 200000 | 200000 |
| Prazosin HCl | 1200000 | 1200000 |
| Prednisone | 100000 | 100000 |
| Prednisolone | 100000 | 100000 |
| Pregnenolone | 100000 | 100000 |
| Progesterone | 100000 | 100000 |
| 17 alpha Hydroxyprogesterone | 100000 | 100000 |
| Spironolactone | 100000 | 100000 |
| Testosterone | 100000 | 200000 |
CONCLUSION:
The material submitted in this premarket notification is complete and supports the basis for substantial equivalence to the Siemens Coat-A-Count® Aldosterone assay (K831178). The labeling is sufficient and satisfies the requirements of 21 CFR 809.10.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 9, 2013
DiaSorin C/O Carol A. DePouw 1951 Northwestern Ave. P. O. Box 285 STILLWATER MN 55082
Re: K130321
Trade/Device Name: LIAISON® Aldosterone LIAISON® Aldosterone Control Set LIAISON® Aldosterone Calibration Verifiers Regulation Number: 21 CFR 862.1045 Regulation Name: Aldosterone test system Regulatory Class: II Product Code: CJM, JJX Dated: February 07, 2013 Received: February 27, 2013
Dear Ms. DePouw:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{8}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
CarolGBenson -S for
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K130321
- Device Name: LIAISON® Aldosterone LIAISON® Aldosterone Control Set LIAISON® Aldosterone Calibration Verifiers
Indications for 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 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 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
§ 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.