K Number
K142994
Device Name
IDS-iSYS Aldosterone,IDS iSYS Aldosterone Control Set, and IDS iSYS Aldosterone Calibration Verifiers
Date Cleared
2015-04-21

(187 days)

Product Code
Regulation Number
862.1045
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 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.
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.
More Information

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)nWithin-run SDWithin-run CV%Total SDTotal CV%
7.5 (208)800.68.41.012.8
21.5 (594)801.04.81.56.9
29.3 (812)800.93.21.65.5
49.3 (1366)801.63.32.65.2
65.7 (1820)801.42.24.16.2
98.7 (2734)804.04.15.96.0

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 lifeCartridgeCalibratorsControlsCalibration Verifiers
Before opening at 2 - 8 °CSix monthsTwelve monthsFifteen monthsNot Found
Cartridge, after opening at 2 - 8 °C35 daysNANANA
On board the System35 days4 Hours4 Hours4 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.

0

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

1

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

2

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

3

K142994

510(k) SUMMARY

IntroductionAccording to the requirements of 21CFR807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
SubmitterImmunodiagnostic 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 NameProprietary 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 DeviceThe 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

4

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

PerformancePredicateNew device
Intended UseIVD; For the quantitative
measurement of aldosterone in
serum (or heparin/EDTA plasma)IVD; For the quantitative
measurement of aldosterone in
EDTA plasma
AnalyteAldosteronesame
Sample matrix
(primary tube type)EDTA plasmasame
Calibrators -matrixLyophilised human serumsame
Reagent storage2-8°Csame
Sample volume200μlsame
Range of assay2.5 to120 ng/dL (reported as 25 –
1200 pg/mL)3.9 to 120 ng/dL
Spiking recoveryAverage 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 specificityBilirubin: Presence of bilirubin in
concentrations of up to 200 mg/L
has no effect on results, within the
precision of the assay.Potentially
Interfering
AgentThreshold
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.Triglyceride500 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.Haemoglobin200 mg/dL
Bilirubin15 mg/dL
Albumin8 g/dL
Red Blood
Cells0.2%
Biotin22 nM
Rheumatoid
Factor1000 IU/mL
Human anti-
mouse
Antibodies
(HAMA)30 ng/mL
AntibodyAntiserum against aldosterone
(species origin not stated)Monoclonal mouse-anti-aldosterone
antibody
CaptureAntibody-coated polypropylene
tubesStreptavidin covalently coupled to
paramagnetic particles
Method of detectionRadioactivity using 125I-labelled
aldosteroneChemiluminescence using an
acridinium-ester derivative
Analytical sensitivity11 pg/mL (1.1 ng/dL)3.2 ng/dL
LinearityThe 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
PrecisionIntra-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 rangeStanding: 4 - 31 ng/dLFemale Supine: 3.9- 33.6 ng/dL
Recumbent: 1 – 16 ng/dLFemale Upright:3.9 – 50.1 ng/dL
Male Supine: 3.9 – 19.5 ng/dL
Male Upright: 3.9 - 23.2 ng/dL

5

6

Cross-reactivityAnalyteCross-ReactivityAnalyteCross-Reactivity
Aldosterone100%Aldosterone100%
AndrostenedioneNot detectableAndrostenedione5 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.

AnalyteCross-Reactivity
Aldosterone100%
Androstenedione