K Number

Device Name

MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer

Manufacturer

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD

Date Cleared

2017-07-14

(290 days)

Product Code

JLW

Regulation Number

862.1690

Intended Use

The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum. The measurement of TSH is used in the diagnosis of thyroid disorders. The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.

Device Description

The MAGLUMI 2000 system is a floor model, fully automated instrument system that utilizes chemiluminescent technology and uses pre-packaged reagent packs to measure a variety of analytes in human body fluids. It is controlled through a combination of custom and off-the-shelf software. MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(<0.1%) and ProClin® 300; Calibrator Low-TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Calibrator High- TSH antigen (human origin), phosphate buffer, bovine serum, NaN3(<0.1%) and ProClin® 300; Buffer- tris buffer, HAMA Blocker, BSA, NaN3(<0.1%) and ProClin® 300; ABEI Label- labeled with anti-TSH monoclonal antibody (mouse), tris buffer, containing BSA, NaN3(<0.1%) and ProClin® 300; Control 1- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 2- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300; Control 3- TSH antigen (human origin), phosphate buffer, bovine serum NaN3(<0.1%) and ProClin® 300.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K083844, K151792

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard automated immunoassay system and its associated reagents. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The software is described as "custom and off-the-shelf," which does not inherently imply AI/ML.

Therapeutic

No
This device is an in vitro diagnostic (IVD) test used for the quantitative determination of TSH in human serum to assist in the diagnosis of thyroid disorders; it does not provide any treatment or therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the assay is "for in vitro diagnostic use" and that "The measurement of TSH is used in the diagnosis of thyroid disorders." It also identifies the system as an "automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens."

SaMD (Software as a Medical Device)

The device description clearly states it is a "floor model, fully automated instrument system" that utilizes hardware components (instrument, reagent packs) in addition to software.

IVD (In Vitro Diagnostic)

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

Here's why, based on the provided text:

Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The MAGLUMI 2000 TSH assay is for in vitro diagnostic use in the quantitative determination of thyroid-stimulating hormone (TSH) in human serum."
Purpose of the Device: The device is designed to perform tests on clinical serum specimens to measure analytes (TSH in this case) for the diagnosis of thyroid disorders. This is a core function of an IVD.
Nature of the Reagents: The description of the reagents includes components like antibodies, antigens, buffers, and controls, which are typical for in vitro diagnostic assays.
Performance Studies: The document describes analytical and comparison studies using patient serum samples, which are conducted to validate the performance of an IVD.
Predicate Devices: The mention of predicate devices (other IVD systems) further confirms the device's classification as an IVD.

The definition of an In Vitro Diagnostic (IVD) is a medical device that is used to perform tests on samples such as blood, urine, or tissue, taken from the human body, to detect diseases, conditions, or infections. The MAGLUMI 2000 system and its TSH assay fit this definition perfectly.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MAGLUMI 2000 Immunoassay system is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical serum specimens. The MAGLUMI 2000 Immunoassay system's assay application utilizes chemiluminescents technology for clinical use.

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

JLW, JJE

Device Description

MAGLUMI 2000 TSH kit consists of the following reagents: Magnetic Microbeads-coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(

Regulation Number and Section

§ 862.1690 Thyroid stimulating hormone test system.

(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.

Summary

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 an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 14, 2017

SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD c/o JOE SHIA, DIRECTOR LSI INTERNATIONAL INC. 504E DIAMOND AVE., SUITE F GAITHERSBURG MD 20877

Re: K162698

Trade/Device Name: MAGLUMI 2000 TSH. MAGLUMI 2000 Immunoassay Analyzer Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: II Product Code: JLW. JJE Dated: May 29, 2017 Received: June 5, 2017

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. 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 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,

Kellie B. Kelm -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

Indications for Use

510(k) Number (if known) K162698

Device Name MAGLUMI 2000 TSH

Indications for Use (Describe)

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)

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."

Indications for Use

510(k) Number (if known) K162698

Device Name MAGLUMI 2000 Immunoassay Analyzer

Indications for Use (Describe)

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)	☐

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.

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."

K162698

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:	July 12, 2017
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 TSH MAGLUMI 2000 Immunoassay System Classification: Class II (assay); Class I (instrument)

| Product Code | CFR # | Product
Abbreviation | Product Name |
|--------------|----------|-------------------------|---------------------------------------------------------------|
| JLW | 862.1690 | TSH | Thyroid Stimulating Hormone |
| JJE | 862.2160 | | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |

1. Predicate Devices: K083844, Siemens ADVIA Centaur TSH3 K151792, Siemens Trinidad Immunoassay (IM) System
1. Intended Use:

1. Device Description:

MAGLUMI 2000 System:

MAGLUMI 2000 TSH assay:

MAGLUMI 2000 TSH kit consists of the following reagents:

Magnetic Microbeads- coated with anti-TSH monoclonal antibody, phosphate buffer, NaN3(