(56 days)
No
The summary describes a standard chemiluminescence immunoassay kit and its performance characteristics. There is no mention of AI or ML in the device description, intended use, or performance studies.
No
Explanation: This device is an in vitro diagnostic (IVD) immunoassay designed to measure 25-OH Vitamin D levels. It aids in assessing vitamin D sufficiency but does not provide any therapeutic treatment or intervention.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for "quantitative determination of 25-OH Vitamin D in human serum" and "is to be used as an aid in the assessment of vitamin D sufficiency," which are diagnostic purposes.
No
The device description clearly states it is a "kit" consisting of various reagents (Magnetic Microbeads, Calibrators, Displacing Reagent, ABEI Label, Controls). These are physical components, not software. The device is an in vitro diagnostic (IVD) assay that is run on a separate analyzer (MAGLUMI 2000), which is also a hardware device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states it is an "in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum". This clearly indicates it is used to test samples outside of the body (in vitro) to diagnose or assess a condition (vitamin D sufficiency).
- Device Description: The description lists reagents used to perform a test on a biological sample (human serum).
- Performance Studies: The document details various performance studies (Precision, Linearity, Stability, Detection Limit, Interference, Comparison Studies) which are standard for evaluating the performance of an IVD.
- Predicate Device: The mention of a "Predicate Device" (DiaSorin LIAISON 25-OH VITAMIN D Total Assay) is common in regulatory submissions for IVDs, where a new device is compared to an already approved device.
- Reference Device: The mention of a "Reference Device" (MAGLUMI 2000 instrument) indicates the instrument on which the assay is performed, which is typical for an IVD kit designed for a specific analyzer.
All of these elements strongly indicate that the MAGLUMI 2000 25-OH Vitamin D is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.
Product codes (comma separated list FDA assigned to the subject device)
MRG
Device Description
MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (
§ 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
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August 1, 2019
Shenzhen New Industries Biomedical Engineering Co., Ltd % Joe Shia. Director LSI International Inc 504E Diamond Ave., Suite F Gaithersburg, MD 20877
Re: K191499
Trade/Device Name: MAGLUMI 2000 25-OH Vitamin D Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D test system Regulatory Class: Class II Product Code: MRG Dated: June 2, 2019 Received: June 6, 2019
Dear Joe Shia:
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. 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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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,
Kellie B. Kelm, Ph.D. Acting Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191499
Device Name MAGLUMI 2000 25-OH Vitamin D
Indications for Use (Describe)
MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.
| 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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K191499
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR 807.92
-
- Date: July 26, 2019
-
- Submitter: Shenzhen New Industries Biomedical Engineering Co., Ltd. No.16, Jinhui Road, Pingshan New District, Shenzhen China 518122
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- Contact person: Joe Shia LSI International Inc. 504 East Diamond Ave., Suite F Gaithersburg, MD 20878 Telephone: 240-505-7880 Fax: 301-916-6213 Email:shiajl(@yahoo.com
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- Device Name: MAGLUMI 2000 25-OH VITAMIN D
Classification: Class II (assay)
| Product Code | CFR # | Product Name |
|---|---|---|
| MRG | 862.1825 | Vitamin D Test System |
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- Predicate Devices:
K 112725, DiaSorin LIAISON 25-OH VITAMIN D Total Assay
- Predicate Devices:
-
- Device Description:
MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (
- Device Description: