(187 days)
K11650, K091849
No
The device description and performance studies focus on standard immunoassay technology and analytical performance metrics, with no mention of AI or ML.
No.
Explanation: The device is an in vitro diagnostic assay used for the quantitative determination of Aldosterone in human EDTA plasma to aid in the diagnosis and treatment of various conditions. It does not exert a therapeutic effect on the patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used in the diagnosis and treatment of primary aldosteronism... hypertension... edematous states and other conditions of electrolyte balance."
No
The device description clearly outlines a chemiluminescence-based assay involving reagents, magnetic particles, and light emission, indicating a hardware-dependent laboratory test, not a software-only device.
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 EDTA plasma" and that these measurements are "used in the diagnosis and treatment of primary aldosteronism... hypertension... selective hyperaldosteronism, edematous states and other conditions of electrolyte balance." This clearly indicates it's used to test samples taken from the human body to provide information for medical diagnosis and treatment.
- Device Description: The description details a laboratory-based assay using chemical reactions (chemiluminescence) to measure a substance (Aldosterone) in a biological sample (plasma). This is characteristic of an in vitro diagnostic test.
- Intended User / Care Setting: The intended user is "clinical laboratories," which are the typical settings where IVD tests are performed.
- Performance Studies: The document describes analytical and comparison studies, which are standard procedures for evaluating the performance of IVD devices.
The information provided for the control set and calibration verifiers also supports the IVD nature of the main assay, as these are components used to ensure the accuracy and reliability of an IVD test.
N/A
Intended Use / Indications for Use
The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used 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 hyperaldosteronism, edematous states and other conditions of electrolyte balance.
The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assayed quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
Product codes (comma separated list FDA assigned to the subject device)
CJM, JJX
Device Description
The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.
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
18-65 years of age
Intended User / Care Setting
clinical laboratories
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)
1. Analytical performance: a. Precision/Reproducibility:
Study type: Precision studies
Sample size: Nine samples were assayed, with three lots of reagents. Samples were assayed in duplicate, twice a day, to provide 80 replicates over 40 runs. Six EDTA plasma samples were used, assayed using three lots of reagents, in duplicate twice per day for 20 days on 2 instruments.
Key results:
Concentration ng/dL (pmol/L) | n | Within-run SD | Within-run CV% | Total SD | Total CV% |
---|---|---|---|---|---|
7.5 (208) | 80 | 0.6 | 8.4 | 1.0 | 12.8 |
21.5 (594) | 80 | 1.0 | 4.8 | 1.5 | 6.9 |
29.3 (812) | 80 | 0.9 | 3.2 | 1.6 | 5.5 |
49.3 (1366) | 80 | 1.6 | 3.3 | 2.6 | 5.2 |
65.7 (1820) | 80 | 1.4 | 2.2 | 4.1 | 6.2 |
98.7 (2734) | 80 | 4.0 | 4.1 | 5.9 | 6.0 |
b. Linearity/Assay Reportable Range:
Study type: Linearity
Sample size: 11 dilution samples run in quadruplicate with one reagent batch.
Key results: The linear regression equation obtained when the observed results were plotted against the expected results was: y = 1.00x - 1.24, R2 = 1.00. The measuring range is from LoQ 3.9 to 120 ng/dL.
c. Traceability, Stability, Expected Values:
Study type: Stability Testing
Key results:
Reagent shelf life | Cartridge | Calibrators | Controls | Calibration Verifiers |
---|---|---|---|---|
Before opening at 2 - 8 °C | Six months | Twelve months | Fifteen months | Not Found |
Cartridge, after opening at 2 - 8 °C | 35 days | NA | NA | NA |
On board the System | 35 days | 4 Hours | 4 Hours | 4 Hours |
Frozen at |
§ 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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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 21, 2015
IMMUNODIAGNOSTIC SYSTEMS LTD. MICK FENTON, REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY, BOLDEN BUSINESS PARK BOLDON, TYNE & WEAR NE35 9PD UNITED KINGDOM
Re: K142994 Trade/Device Name: IDS-iSYS Aldosterone, IDS-iSYS Aldosterone Control Set, IDS-iSYS Aldosterone Calibration Verifiers Regulation Number: 21 CFR 862.1045 Regulation Name: Aldosterone test system Regulatory Class: II Product Code: CJM, JJX Dated: February 6, 2015 Received: February 12, 2015
Dear Mr. Mick Fenton:
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, listing 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 Parts 801 and 809); 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
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,
Katherine Serrano -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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K142994
Device Name
IDS-iSYS Aldosterone IDS-iSYS Aldosterone Control Set IDS-iSYS Aldosterone Calibration Verifiers
Indications for Use (Describe)
The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used 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 hyperaldosteronism, edematous states and other conditions of electrolyte balance.
The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assaved quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) are intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
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510(k) SUMMARY
Introduction | According to the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. | |
---|---|---|
Submitter | Immunodiagnostic Systems Ltd | |
10 Didcot Way | ||
Boldon Business Park | ||
Boldon | ||
Tyne and Wear | ||
NE35 9PD | ||
United Kingdom | ||
Contact Person: Mick Fenton | ||
Phone: +44 191 5190660 | ||
Fax: +44 191 5190760 | ||
Email: michael.fenton@idsplc.com | ||
Secondary Contact: Roma Young | ||
Phone: +44 191 5190660 | ||
Fax: +44 191 5190760 | ||
Email: roma.young@idsplc.com | ||
Date prepared: 04 April 2015 | ||
Device Name | Proprietary names: | IDS-iSYS Aldosterone |
IDS-iSYS Aldosterone Control Set | ||
IDS-iSYS Aldosterone Calibration Verifiers | ||
Common names: | As above | |
Classification: | 21CFR862.1045 (Class II) | |
21CFR862.1660 (Class I, Reserved) | ||
Product Code: | CJM | |
JJX | ||
Predicate Device | The IDS-iSYS Aldosterone assay is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed Siemens Healthcare Diagnostics Ltd. Coat-A-Count® Aldosterone; TKAL 6615154 (K831178). | |
The IDS-iSYS Aldosterone Calibration Verifiers are substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed |
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IDS-iSYS 25-Hydroxy Vitamin DS Calibration Verifiers (K11650). The IDS-iSYS Aldosterone Control Set is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed IDS-iSYS
Device Description The IDS-iSYS Aldosterone assay is based on chemiluminescence technology. A biotinylated monoclonal anti-Aldosterone antibody is incubated with the sample, after an incubation step an Aldosterone acridinium conjugate is added and after a further incubation step streptavidin coated magnetic particles are added. Following a third incubation step the particles are "captured" using a magnet. After a washing step and addition of trigger reagents, the light emitted by the acridinium label is inversely proportional to the concentration of Aldosterone in the original sample.
25-Hydroxy Vitamin DS Control Set (K091849).
- Intended Use The IDS-iSYS Aldosterone assay (IS-3300) is a device intended for use in clinical laboratories for the quantitative determination of Aldosterone in human EDTA plasma on the IDS-iSYS Multi-Discipline Automated System. Aldosterone measurements are used 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 hyperaldosteronism, edematous states and other conditions of electrolyte balance.
The IDS-iSYS Aldosterone Control Set (IS-3330) is intended for use as assayed quality control samples to monitor the accuracy of the IDS-iSYS Aldosterone assay on the IDS-iSYS Multi-Discipline Automated System.
The IDS-iSYS Aldosterone Calibration Verifiers (IS-3335) is a device intended for medical purposes for use in the quantitative verification of calibration of the IDS-iSYS Aldosterone assay when performed on the IDS-iSYS Multi-Discipline Automated System.
Comparison Table Table 1 Similarities and differences
Performance | Predicate | New device | |
---|---|---|---|
Intended Use | IVD; For the quantitative | ||
measurement of aldosterone in | |||
serum (or heparin/EDTA plasma) | IVD; For the quantitative | ||
measurement of aldosterone in | |||
EDTA plasma | |||
Analyte | Aldosterone | same | |
Sample matrix | |||
(primary tube type) | EDTA plasma | same | |
Calibrators -matrix | Lyophilised human serum | same | |
Reagent storage | 2-8°C | same | |
Sample volume | 200μl | same | |
Range of assay | 2.5 to120 ng/dL (reported as 25 – | ||
1200 pg/mL) | 3.9 to 120 ng/dL | ||
Spiking recovery | Average 96.1% [range 86-111% | ||
between 232-847 pg/mL (23.2 - | |||
84.7 ng/dL)] | Average 94.8% [range 77-107.9% | ||
between 27.2-71.3ng/dL] | |||
Analytical specificity | Bilirubin: Presence of bilirubin in | ||
concentrations of up to 200 mg/L | |||
has no effect on results, within the | |||
precision of the assay. | Potentially | ||
Interfering | |||
Agent | Threshold | ||
Concentration | |||
Hemolysis: Presence of packed red | |||
blood cells in concentrations up to | |||
30 µL/mL has no effect on results, | |||
within the precision of the assay. | Triglyceride | 500 mg/dL | |
Lipemia: the 600 pg/mL calibrator | |||
was serially diluted with each of | |||
two lipemic serum pools, results | |||
showed excellent recoveries, even | |||
in presence of severe lipemia. | Haemoglobin | 200 mg/dL | |
Bilirubin | 15 mg/dL | ||
Albumin | 8 g/dL | ||
Red Blood | |||
Cells | 0.2% | ||
Biotin | 22 nM | ||
Rheumatoid | |||
Factor | 1000 IU/mL | ||
Human anti- | |||
mouse | |||
Antibodies | |||
(HAMA) | 30 ng/mL | ||
Antibody | Antiserum against aldosterone | ||
(species origin not stated) | Monoclonal mouse-anti-aldosterone | ||
antibody | |||
Capture | Antibody-coated polypropylene | ||
tubes | Streptavidin covalently coupled to | ||
paramagnetic particles | |||
Method of detection | Radioactivity using 125I-labelled | ||
aldosterone | Chemiluminescence using an | ||
acridinium-ester derivative | |||
Analytical sensitivity | 11 pg/mL (1.1 ng/dL) | 3.2 ng/dL | |
Linearity | The assay has a tendency to over- | ||
recover upon dilution. Patient | |||
samples having values greater than | |||
the highest calibrator (1200pg/mL) | |||
can be reported as greater than | |||
1200 pg/mL or diluted using a | |||
serum pool. Dilution with the zero | |||
calibrator is not recommended. The | |||
uncorrected value observed after | |||
dilution should be greater than 600 | |||
pg/mL. | y=1.00x – 1.24ng/dL; r² = 1.00 | ||
Precision | Intra-assay: 5.4 - 2.3% at 65-813 | ||
pg/mL (6.5 - 81.3 ng/dL) | Within-Run: 8.4-2.2% at 7.5 - 98.7 | ||
ng/dL | |||
Inter-assay: 15.7- 3.8% at 58-548 | |||
pg/mL (5.8 – 54.8 ng/dL) | Total: 12.8-5.2% at 7.5 – 98.7 ng/dL | ||
Reference range | Standing: 4 - 31 ng/dL | Female Supine: 3.9- 33.6 ng/dL | |
Recumbent: 1 – 16 ng/dL | Female Upright:3.9 – 50.1 ng/dL | ||
Male Supine: 3.9 – 19.5 ng/dL | |||
Male Upright: 3.9 - 23.2 ng/dL |
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Cross-reactivity | Analyte | Cross-Reactivity | Analyte | Cross-Reactivity |
---|---|---|---|---|
Aldosterone | 100% | Aldosterone | 100% | |
Androstenedione | Not detectable | Androstenedione | 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. |
Hemolyzed samples should not be used with this assay.
Analyte | Cross-Reactivity |
---|---|
Aldosterone | 100% |
Androstenedione |