(368 days)
Not Found
Not Found
No
The summary describes a standard automated immunoassay analyzer and assay kit, with no mention of AI or ML capabilities in the intended use, device description, or other sections.
No
The device is an in vitro diagnostic analyzer used for quantitative determination of vitamin D metabolites in human serum, which aids in assessment rather than direct treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states "The IDS-iSYS Multi-Discipline Automated Analyser... is for in vitro diagnostic use" and that "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." These statements clearly indicate its role in diagnosis.
No
The device description explicitly states it is an "Automated Analyser," which is a hardware device used for in vitro diagnostic testing. The software is part of the overall system, but the system itself is not software-only.
Yes, this device is an IVD (In Vitro Diagnostic).
The provided text explicitly states multiple times that the device is for "in vitro diagnostic use". The intended use is to analyze human serum to assist in the assessment of vitamin D sufficiency, which is a classic example of an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use. The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. 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 kit is for in vitro diagnostic use only. The IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin D Assay.
Product codes
MRG, JJX, JJE
Device Description
Not Found
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
Adult population
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features an eagle-like emblem with three stylized lines representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem. The seal is printed in black and white.
Immunodiagnostic Systems, Inc. c/o Mr. Ken Gibbs 17029 East Enterprise Drive, Suite 1 Fountain Hills, Arizona 85268
Re: K091849
Trade/Device Name: IDS-iSYS 25-Hydroxy Vitamin D Assay Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG, JJX, JJE Dated: June 21, 2010 Received: June 22, 2010
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUN ? 5 2010
Dear Mr. Gibbs:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
1
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/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 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Signature
Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): K091849
IDS-iSYS 25-Hydroxy Vitamin D Assay Device Name:
Indications For Use: The IDS-iSYS Multi-Discipline Automated Analyser is a discrete continuous loading chemiluminescent immunoassay analyzer for in vitro diagnostic use
The IDS-iSYS 25-Hydroxy Vitamin D Assay is intended for the quantitative determination of 25-hydroxyvitamin D (25-OH D) and other hydroxylated metabolites in human serum on the IDS-iSYS Multi-Discipline Automated Analyser. 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 kit is for in vitro diagnostic use only.
The IDS-iSYS 25-Hydroxy Vitamin D Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the IDS-iSYS 25-Hydroxy Vitamin D Assay.
Prescription Use × (Part 21 CFR 801 Subpart D)
··
AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Visitor Sign Off
ivision Sian-Of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091849