(231 days)
Not Found
No
The description focuses on automated immunoassay analysis using chemiluminescent technology and pre-packaged reagents. There is no mention of AI or ML in the device description, intended use, or performance studies. The performance studies are standard analytical and method comparison studies for an immunoassay.
No.
This device is an in vitro diagnostic (IVD) immunoassay analyzer used to quantitatively determine 25-OH Vitamin D levels in human samples, aiding in the assessment of vitamin D sufficiency. It does not provide treatment or directly affect the structure or function of the body.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "designed to perform in vitro diagnostic tests on clinical specimens" and is "used for an aid in assessment of vitamin D sufficiency."
No
The device description clearly outlines a hardware analyzer (MAGLUMI X3) and a reagent kit (MAGLUMI 25-OH Vitamin D assay) which are physical components, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens." and "The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma..."
- Device Description: The "Device Description" for both the analyzer and the assay kit describes components and functions specifically designed for performing tests on biological samples (serum and plasma) outside of the body.
- Performance Studies: The "Summary of Performance Studies" details analytical and comparison studies conducted on clinical specimens (human serum and plasma samples) to evaluate the performance of the assay for diagnostic purposes.
- Predicate Devices: The mention of predicate devices with K numbers (K191499 and K162698) indicates that this device is being compared to previously cleared IVD devices.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.
Product codes (comma separated list FDA assigned to the subject device)
MRG, JJE
Device Description
MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer:
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations.
MAGLUMI 25-OH Vitamin D assay:
MAGLUMI 25-OH Vitamin D kit consists of the following reagents:
Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, 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.
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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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 12, 2024
Shenzhen New Industries Biomedical Engineering Co., Ltd % Joe Shia Director LSI International Inc 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K232587
Trade/Device Name: MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully auto chemiluminescence immunoassay analyzer Regulation Number: 21 CFR 862.1825 Regulation Name: Vitamin D Test System Regulatory Class: Class II Product Code: MRG, JJE Dated: February 25, 2024 Received: February 26, 2024
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 (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 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" (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).
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Your device is also subject to, among other requirements, the Quality System (OS) 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-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 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.
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.
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. Acting Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics 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) K232587
Device Name MAGLUMI 25-OH Vitamin D MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
Indications for Use (Describe)
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens.
The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in 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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510(k) SUMMARY
K232587
This summary of 510(k) safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR 807.92
-
- Date: April 11, 2024
-
- Submitter: Shenzhen New Industries Biomedical Engineering Co., Ltd. No.23, Jinxiu East Road, Pingshan District, 518122 Shenzhen, P.R. China
- Joe Shia 3. Contact person: LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, MD 20877 Telephone: 240-505-7880 Email:shiajl(@yahoo.com
- MAGLUMI 25-OH Vitamin D 4. Device Name: MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer
| Classification: | Class II (assay) and Class I (instrument) |
|---|---|
| ----------------- | ------------------------------------------- |
| Product Code | CFR # | Product Name |
|---|---|---|
| MRG | 862.1825 | Vitamin D Test System |
| JJE | 862.2160 | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
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- Device Description:
MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer:
- Device Description:
The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations.
MAGLUMI 25-OH Vitamin D assay:
MAGLUMI 25-OH Vitamin D kit consists of the following reagents:
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Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, NaN3 (