(209 days)
No
The summary describes a standard in vitro diagnostic assay kit and the automated system it runs on. There is no mention of AI or ML in the device description, intended use, performance studies, or any other section. The performance metrics are standard for a quantitative immunoassay.
No
Explanation: The device is an in vitro diagnostic device used for the quantitative determination of free testosterone to aid in the diagnosis and treatment of disorders, not to treat the disorders itself. It provides information for diagnosis, but does not perform therapy.
Yes.
The "Intended Use / Indications for Use" section explicitly states "The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device".
No
The device is an in vitro diagnostic assay consisting of reagent cartridges, which are physical components, not software. It is used on a separate automated system (IDS-iSYS Multi-Discipline Automated System).
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system." It also details the clinical conditions for which the measurement is used in diagnosis and treatment.
- Device Description: The description outlines the components of the assay (reagents, calibrators) which are used to perform a test on a biological sample (human serum).
- Intended User/Care Setting: It specifies "In vitro diagnostic use. Rx Only." and that it is used on an automated system, indicating it's for use in a clinical laboratory setting.
All 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 IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries and androgenital syndromes.
Product codes
CDZ
Device Description
The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents:
- MP3: Magnetic particles coated with Streptavidin in a phosphate Pluronic buffer with sodium azide (NaN3) as preservative (
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2024
Immunodiagnostic Systems Limited Mick Henderson Regulatory Affairs Manager 10 Didcot Way, Boldon Business Park Boldon Tyne and Wear NE35 9PD United Kingdom
Re: K240865
Trade/Device Name: IDS-iSYS Free Testosterone Regulation Number: 21 CFR 862.1680 Regulation Name: Testosterone Test System Regulatory Class: Class I, reserved Product Code: CDZ Dated: September 20, 2024 Received: September 20, 2024
Dear Mick Henderson:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K240865
Device Name IDS-iSYS Free Testosterone
Indications for Use (Describe)
The IDS-iSYS Free Testosterone assay is an in vitro diagnostic device intended for the quantitative determination of free testosterone in human serum or the IDS system. Measurement of free testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in male and in females; hirsutism (excessive hair) and virilization) due to tumors, polycystic ovaries and androgenital syndromes.
| 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) |
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510(k) SUMMARY
| 510k Number | K240865 |
|---|---|
| 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 Limited |
| 10 Didcot Way | |
| Boldon Business Park | |
| Boldon | |
| Tyne and Wear | |
| NE35 9PD | |
| United Kingdom |
Contact Person: Mick Henderson
Phone: +44 191 5190660
Fax: +44 191 5190760
Email: mick.henderson@idsplc.com
Secondary Contact: Lee Harris
Phone: +44 191 5190660
Fax: +44 191 5190760
Email : lee.harris@idsplc.com |
| | Date prepared: 20th September 2024 |
| Device Name | Proprietary names: IDS-iSYS Free Testosterone |
| | Common names: IDS Free Testosterone |
| | Classification: 21 CFR 862.1680 –Testosterone Test
System
Class 1 reserved |
| | Product Code: CDZ |
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Image /page/5/Picture/1 description: The image shows the logo for Immunodiagnostic Systems (IDS). The logo features the letters "ids" in a stylized, interconnected design, rendered in gray. A red circle is positioned above the "i", serving as a visual accent. Below the gray letters, the words "immunodiagnosticsystems" are written in red, completing the company's name.
| Predicate Device | Free Testosterone AccuBind® ELISA Test System (K181017) | |
|---|---|---|
| Device Description | The IDS-iSYS Free Testosterone assay consists of a reagent cartridge. The reagent cartridge contains multiple reagents: |
- MP3: Magnetic particles coated with Streptavidin in a phosphate Pluronic buffer with sodium azide (NaN3) as preservative (60: 0.5-3.4 | Males 21 - 39: 4.91 - 21.64
Males 40 - 59: 3.73 - 14.96
Males ≥60: 2.25 - 11.37
Females 21 - 39: 0.46 - 2.20
Females 40 - 59: 0.40 - 1.74
Females >60: 0.42-2.20 |
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Image /page/7/Picture/0 description: The image contains a logo for Immunodiagnostic Systems (IDS). The logo features the letters 'ids' in a stylized, interconnected design, with the 'i' having a red circular dot above it. Below the main logo, the words 'immunodiagnosticsystems' are written in a smaller font size, with 'immuno' in red and the rest of the word in gray.
Performance Characteristics
Analytical Limits at Low levels
The limit of blank (LoB), limit of detection (LoD) and limit of quantitation (LoO) were determined with guidance from CLSI EP17-A2, "Protocols for Determination of Limits of Detection and Limits of Quantitation" with three (3) IDS Free testosterone kit lots. I LoB and LoD were determined with 60 replicates of 4 blank samples and 6 low concentration samples per reagent lot. LoQ was determined with 105 replicates of 7 low concentration samples per reagent lot. The LoQ was determined as the lowest concentration with a within-laboratory precision CV