K Number
K182423
Device Name
MAGLUMI 2000 FT4
Date Cleared
2018-10-04

(28 days)

Product Code
Regulation Number
862.1695
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.
Device Description
MAGLUMI 2000 FT4 kit consists of the following reagents: Magnetic Microbeads- coated with T4 antigen, BSA, NaN3(<0.1%) Calibrator Low-Containing BSA and T4 antigen, NaN3 (<0.1%) Calibrator High- Containing BSA and T4 antigen, NaN3 (<0.1%) Buffer- Containing BSA and NaN3 (<0.1%) ABEI Label- Anti-T4 monoclonal antibody labeled with ABEI, containing BSA, NaN3(<0.1%) Control 1- Containing BSA and T4 antigen, NaN3 (<0.1%) Control 2- Containing BSA and T4 antigen, NaN3 (<0.1%)
More Information

Not Found

No
The summary describes a standard in vitro diagnostic 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) assay designed to measure free thyroxine levels to aid in the diagnosis of thyroid disorders, not to treat them.

Yes

The product's "Intended Use / Indications for Use" states that the assay is for "in vitro diagnostic use" and that "The measurement of FT4 is used in the diagnosis of thyroid disorders."

No

The device description clearly outlines a kit containing various reagents (Magnetic Microbeads, Calibrators, Buffer, ABEI Label, Controls). This indicates a physical, in vitro diagnostic assay kit, not a software-only device. The mention of the MAGLUMI 2000 instrument (a hardware device) as a reference device further supports this.

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use".
  • Device Description: The description details reagents used to perform a test on human serum, which is a biological sample tested in vitro (outside the body).
  • Intended User / Care Setting: This section also states "in vitro diagnostic use".

All of these points clearly indicate that the MAGLUMI 2000 FT4 assay is designed and intended for diagnostic testing performed outside of a living organism.

N/A

Intended Use / Indications for Use

The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

Product codes (comma separated list FDA assigned to the subject device)

CEC

Device Description

MAGLUMI 2000 FT4 kit consists of the following reagents: Magnetic Microbeads- coated with T4 antigen, BSA, NaN3(

§ 862.1695 Free thyroxine test system.

(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

October 4, 2018

Shenzhen New Industries Biomedical Engineering Co., Ltd % Joe Shia Scientific Reviewer LSI International Inc 504E Diamond Ave., Suite F Gaithersburg, MD 20877

Re: K182423

Trade/Device Name: MAGLUMI 2000 FT4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC Dated: August 31, 2018 Received: September 6, 2018

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

1

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S

Courtney H. Lias, Ph.D. for Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K182423

Device Name MAGLUMI 2000 FT4

Indications for Use (Describe)

The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

K182423

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR 807.92

    1. Date: October 2, 2018 2. Submitter: Shenzhen New Industries Biomedical Engineering Co., Ltd. No.16, Jinhui Road, Pingshan New District, Shenzhen China 518122 3. 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
    1. Device Name: MAGLUMI 2000 FT4

Classification:

Class II (assay)

| Product Code | CFR # | Product
Abbreviation | Product Name |
|--------------|----------|-------------------------|----------------------------|
| CEC | 862.1695 | FT4 | Free Thyroxine Test System |

  1. Predicate Devices: K080167, Siemens ADVIA Centaur FT4

6. Intended Use:

The MAGLUMI 2000 FT4 assay is for in vitro diagnostic use in the quantitative determination of free thyroxine (FT4) in human serum. The measurement of FT4 is used in the diagnosis of thyroid disorders.

7. Device Description:

MAGLUMI 2000 FT4 kit consists of the following reagents: Magnetic Microbeads- coated with T4 antigen, BSA, NaN3(