(133 days)
No
The summary describes a standard immunoassay kit and automated system for measuring vitamin D levels. There is no mention of AI, ML, or any computational analysis beyond basic quantitative determination and statistical analysis of performance data.
No.
Explanation: The device is intended for the quantitative determination of 25-hydroxyvitamin D to assist in the assessment of vitamin D sufficiency, which is a diagnostic purpose, not a therapeutic one. It does not treat or prevent disease.
Yes
The device is described as assisting "the clinician in the assessment of vitamin D sufficiency in an adult population" by quantitatively determining total 25-hydroxyvitamin D (25(OH)D) in human serum or plasma. This measurement provides information used to diagnose or assess a health condition related to vitamin D levels.
No
The device description clearly outlines physical components such as reagent kits, cartridges, vials, and a mini-CD, indicating it is a hardware-based system with associated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The description details reagents and components used to perform a test on a biological sample (serum or plasma).
- Performance Studies: The performance studies describe analytical and comparison studies conducted on biological samples (serum and plasma).
- Predicate Device: The predicate device listed (K140554; IDS-iSYS 25-Hydroxy Vitamin DS) is also an IVD, indicating the regulatory pathway for this type of device.
All these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
N/A
Intended Use / Indications for Use
The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.
The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD assay on the IDS-iSYS Multi-Discipline Automated System.
For in vitro diagnostic use only. Conditions for use: Rx Only
Product codes
MRG, JJX
Device Description
The IDS-iSYS 25 VitDS reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.
IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:
- Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
- . Sodium hydroxide solution.
- . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
- . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
- . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.
The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (
§ 862.1825 Vitamin D test system.
(a)
Identification. A vitamin D test system is a device intended for use in clinical laboratories for the quantitative determination of 25-hydroxyvitamin D (25-OH-D) and other hydroxylated metabolites of vitamin D in serum or plasma to be used in the assessment of vitamin D sufficiency.(b)
Classification. Class II (special controls). Vitamin D test systems must comply with the following special controls:(1) Labeling in conformance with 21 CFR 809.10 and
(2) Compliance with existing standards of the National Committee on Clinical Laboratory Standards.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2016
IMMUNODIAGNOSTIC SYSTEMS LTD MICK HENDERSON REGULATORY AFFAIRS OFFICER 10 DIDCOT WAY, BOLDON BUSINESS PARK BOLDON NE35 9PD GREAT BRITAIN
Re: K161831
Trade/Device Name: IDS-iSYS 25VitD8, IDS-iSYS 25VitD8 Control Set Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: II Product Code: MRG, JJX Dated: September 30, 2016 Received: October 4, 2016
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 (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/Resourcesfor You/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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Indications for Use
510(k) Number (if known) K161831
Device Name IDS-iSYS 25VitDy IDS-iSYS 25VitDS Control Set
Indications for Use (Describe)
The IDS iSYS 25 VilD assay is intended for the quantitative determination of total 25-hydroxyvitamin D (125(OH)D) in hyman serum or plasma on the IDS iSYS Multi-Discipline Automated System. Results are to be used in conjunction with other clinical and laboratory data to assist the clinician in the assessment of vitamin D sufficiency in an adult population.
The IDS-iSYS 25 VitD Control Set is used for quality control of the IDS-iSYS 25 VitD 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)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Immunodiagnostic Systems (IDS). The logo features the letters "ids" in a stylized, connected script, with a red circle above the "i". Below the letters, the words "immunodiagnosticsystems" are written in a smaller, red font. The overall design is modern and clean, suggesting a company focused on diagnostics.
510(k) SUMMARY
| 510k Number | K161831 |
|---|---|
| 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: Alexandra Bennett | |
| Phone: +44 191 5190660 | |
| Fax: +44 191 5190760 | |
| Email: alexandra.bennett@idsplc.com | |
| Date prepared: 11th November 2016 | |
| Device Name | Proprietary names: IDS-iSYS 25VitDS |
| IDS-iSYS 25VitDS Control Set | |
| Common names: As above | |
| Classification: 21CFR862.1825 Vitamin D Test System, | |
| Class II | |
| 21CFR862.1660 Quality Control Material | |
| (Assayed and Unassayed), | |
| Class I, reserved | |
| Product Code: MRG | |
| IIX |
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Image /page/4/Picture/0 description: The image shows the 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 gray 'ids' is the text 'immunodiagnosticsystems' in red, presented in a smaller, sans-serif font.
Predicate Device The IDS-iSYS 25 VitDS is substantially equivalent to other products in commercial distribution intended for similar use. We claim equivalency to the currently marketed IDS-iSYS 25-Hydroxy Vitamin DS (K140554).
IDS-iSYS 25 VitDS Device Description
The IDS-iSYS 25 VitDs reagent kit consists of one (1) Immunoassay Cartridge, one (1) vial each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis.
IDS-iSYS 25 VitDS Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. IDS-iSYS 25 VitDS Cartridge contains the following ready to use reagents:
- Magnetic particles coated with streptavidin in a phosphate . buffer containing sodium azide.
- . Sodium hydroxide solution.
- . 25(OH)D labelled with an acridinium ester derivative, in buffer containing bovine serum albumin with sodium azide.
- . Anti-25(OH)D sheep polyclonal antibody labelled with an biotin, in buffer containing bovine, sheep and mouse proteins and sodium azide.
- . Assay buffer containing proprietary displacing compounds, methanol and sodium azide.
The IDS-iSYS 25 VitD® Calibrators are included in the reagent kit. The ready to use calibrators contains human serum buffer matrix with two defined concentrations of 25(OH)D and sodium azide as preservative (