Predicate Devices

Qualigen FastPack® TSH (K052301)

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a magnetic lateral flow immunoassay and an associated instrument for quantitative determination of TSH. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the provided text. The performance studies focus on method comparison and analytical sensitivity/specificity, not AI/ML model performance.

Therapeutic

No
The device is described as an in-vitro diagnostic immunoassay for the quantitative determination of TSH, used in the diagnosis of thyroid or pituitary disorders, not for treating them.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that "The measurements of thyroid stimulating hormone (TSH) ... are used in the diagnosis of thyroid or pituitary disorders." This directly indicates its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components like a nitrocellulose membrane device, antibodies, and paramagnetic particles, indicating it is a hardware-based immunoassay system, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The "Intended Use / Indications for Use" section explicitly states "for the in-vitro quantitative determination of TSH in human serum." The term "in-vitro" means "in glass" or "in the lab," referring to tests performed outside of the living body.
Purpose: The purpose of the test is to aid in the "diagnosis of thyroid or pituitary disorders," which is a diagnostic purpose.
Sample Type: The test uses "human serum," which is a biological sample taken from a human.
Setting: The device is intended for use in "clinical laboratories," which are typical settings for IVD testing.

All of these points align with the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.

Product codes

JLW, JJQ

Device Description

The MICT® TSH Immunoassay for the quantitative determination of TSH in human serum is designed for use on MICT® Instrument.
MICT® TSH Device Reagents

Solid phase nitrocellulose membrane device with two detection zones:
a. Control line region containing a polyclonal goat anti-rabbit IgG antibody, and
b. Test line region containing a monoclonal anti-TSH antibody
Lyophilized conjugate tube containing the monoclonal anti-TSH antibody covalently coupled to 300 nm super paramagnetic particles.
The MICT® Immunoassay is a "sandwich" magnetic chromatographic assay:

Step 1: Sample or control (100 uL) is added to the lyophilized . conjugate tube and mixed using an up and down motion in the pipet.
Set 2: Transfer the entire contents of the sample/conjugate to the ● sample port on the nitrocellulose test cassette.
Step 3: The sample/conjugate will chromatograph along the . nitrocellulose membrane for 30 minutes, but not longer than 45 minutes after starting the test..
Step 4: Insert the test cassette into the MICT magnetic Instrument . and press start after barcode is read.
Results will automatically print. ●

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

Not Found

Intended User / Care Setting

clinical laboratories.

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)

Precision:
MICT® TSH (Within Lab %CV):
Site 1: 0.191 µIU/mL (14.1%), 0.29 µIU/mL (9.4%), 0.83 µIU/mL (9.4%), 3.7 µIU/mL (7.8%), 46.7 µIU/mL (8.8%)
Site 2: 0.191 µIU/mL (13.3%), 0.29 µIU/mL (10.1%), 0.87 µIU/mL (7.8%), 4.1 µIU/mL (9.1%), 46.6 µIU/mL (9.5%)
Site 3: 0.187 µIU/mL (14.4%), 0.29 µIU/mL (9.5%), 0.87 µIU/mL (7.6%), 3.95 µIU/mL (9.1%), 48.4 µIU/mL (7.5%)

FastPack® TSH (Total Within Lab %CV):
0.54 µIU/mL (20.0%), 1.54 µIU/mL (9.7%), 4.69 µIU/mL (7.0%), 46.30 µIU/mL (9.5%)

Sensitivity:
MICT® TSH: LOB = 0.04 µIU/mL, LOD = 0.077 µIU/mL, LOQ = 0.077 µIU/mL
FastPack® TSH: Analytical = 0.043 µIU/mL, Functional = 0.13 µIU/mL

Method Comparison: Three site performance evaluation of MICT vs. Qualigen FastPack TSH Method.
Site 1: MICT = 0.97 FastPack -0.27 (n=66, r = 0.99)
Site 2: MICT = 0.93 FastPack -0.07 (n=74, r = 0.99)
Site 3: MICT = 0.98 FastPack 0.00 (n=64, r = 0.99)
Pooled: MICT = 0.96 FastPack -0.12 (n=204, r = 0.99)

Interfering Substances (No interference up to):
Bilirubin: MICT® TSH 40 mg/dL, FastPack® TSH 40 mg/dL
Hemoglobin: MICT® TSH 1000 mg/dL, FastPack® TSH 1000 mg/dL
Triglycerides: MICT® TSH 3200 mg/dL, FastPack® TSH 1000 mg/dL
Phospholipid: MICT® TSH 800 mg/dL, FastPack® TSH --

Specificity (n.d.):
MICT® TSH: 500 mIU/mL LH, 500 mIU/mL FSH
FastPack® TSH: 500 mIU/mL LH, 500 mIU/mL FSH

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Sensitivity: LOB = 0.04 µIU/mL, LOD = 0.077 µIU/mL, LOQ = 0.077 µIU/mL
Specificity: 500 mIU/mL LH, 500 mIU/mL FSH

Predicate Device(s)

Qualigen FastPack® TSH (K052301)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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

0

K110761

MAR - 9 2012

510(k) Summary

MICT® TSH Using the MICT® Instrument

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| 1. | Submitter
name, address,
contact | MagnaBioSciences LLC
6325 Lusk Blvd.
San Diego, CA 92121 | |
|----|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| | | Telephone:
Fax: | (858)481-4400
(858-481-7410 |
| | | Contact Person: | James L. Wyatt |
| | | Date Prepared: | February 2012 |
| 2. | Device name | Proprietary name: | MICT® TSH
Using the MICT® Instrument |
| | | Common name: | Magnetic ImmunoChomatographyic Test for the
determination of TSH |
| | | Classification Name: | Quantitative Determination of TSH in Human
Serum |
| 3. | Predicate
device | Qualigen FastPack® TSH (K052301) | |
| 4. | Device
description | The MICT® TSH Immunoassay for the quantitative determination of TSH
in human serum is designed for use on MICT® Instrument. | |
| | MICT® TSH Device Reagents | | |
| | | 1. Solid phase nitrocellulose membrane device with two detection
zones:
a. Control line region containing a polyclonal goat anti-rabbit
IgG antibody, and
b. Test line region containing a monoclonal anti-TSH
antibody | |

1

MagnaBioSciences, LLC

510(k) Summary (continued)

1. Lyophilized conjugate tube containing the monoclonal anti-TSH antibody covalently coupled to 300 nm super paramagnetic particles.
  The MICT® Immunoassay is a "sandwich" magnetic chromatographic assay:
Step 1: Sample or control (100 uL) is added to the lyophilized . conjugate tube and mixed using an up and down motion in the pipet.
Set 2: Transfer the entire contents of the sample/conjugate to the ● sample port on the nitrocellulose test cassette.
Step 3: The sample/conjugate will chromatograph along the . nitrocellulose membrane for 30 minutes, but not longer than 45 minutes after starting the test..
Step 4: Insert the test cassette into the MICT magnetic Instrument . and press start after barcode is read.
Results will automatically print. ●
The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro ડ. Intended use quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT TSH immunoassay is designed for use with the MCIT instrument. The MICT System is intended for use in clinical laboratories.
The following tables compare the MICT® TSH with the Qualigen Comparison to 6. Predicate Device FastPack® TSH.

2

510(k) Summary (continued)

MagnaBioSciences, LLC

Feature	MICT® TSH	FastPack® TSH
Intended Use.	The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.	FastPack® TSH Immunoassay is a paramagnetic particle immunoassay for the in-vitro quantitative determination of TSH in human plasma. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The FastPack TSH Immunoassay is designed for use with the FastPack System
Assay Methodology:	Sandwich immunoassay	Sandwich immunoassay
Storage Condition:	1 - 30°C	2-8 °C
Data Analysis	Internal data reduction via microcomputer	Internal data reduction via microcomputer
Test Processing	Semi-Automated	Semi-Automated
Sample Type:	Serum	Plasma
Detector:	Magnetic Instrument	Photomultiplier Tube (PMT)
Label	Super Magnetic Particles	Alkaline Phosphatase -
Lucegine
Sample Volume	100 µL	100 µL
Assay Range	0.13 to 100 µIU/mL	0.13 to 100 µIU/mL
Instrument Required	MICT® Instrument	Qualigen FastPack® System
Antibody	Monoclonal/Monoclonal	Monoclonal/Monoclonal
Solid Phase	Nitrocellulose Membrane	Magnetic Particles
Detection	Magnetic Moment	Chemiluminescence
Calibration	Factory generated master curve with single calibration per lot, calibration is stable until expiration of the assay lot.	Factory generated calibration curve using 6 standards.
Recalibration required 14 day at the customer site.
Throughput	Single Sample	Single Sample
Time to Result	30 minutes	15 minutes
Reagents Supplied as	Box of 20 reagent cassettes with lyophilized conjugate tubes	Box of 50 individual Tests

3

MagnaBioSciences, LLC

1

Performance Characteristics:	MICT® TSH
Feature	Mean
µIU/mL
Within Lab	%CV	Mean
µIU/mL
Total Within Lab	%CV
Precision	Site 1
	1
0.191	14.1	1
0.54	20.0
	2
0.29	9.4	2
1.54	9.7
	3
0.83	9.4	3
4.69	7.0
	4
3.7
5
46.7	7.8
8.8	4
46.30	9.5
	Site 2
	1
0.191	13.3
	2
0.29	10.1
	3
0.87	7.8
	4
4.1
5
46.6	9.1
9.5
	Site 3
	1
0.187	14.4
	2
0.29	9.5
	3
0.87	7.6
	4
3.95
5
48.4	9.1
7.5
Sensitivity	LOB = 0.04 µIU/mL
LOD = 0.077 µIU/mL
LOQ = 0.077 µIU/mL		Analytical = 0.043 µIU/mL
Functional = 0.13 µIU/mL
Method
Comparison	Three site performance evaluation of MICT vs. Qualige
FastPack TSH Method.

Site 1: MICT = 0.97 FastPack -0.27 (n=66, r = 0.99)
Site 2: MICT = 0.93 FastPack -0.07 (n=74, r = 0.99)
Site 3: MICT = 0.98 FastPack 0.00 (n=64, r = 0.99)

4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the circle is a stylized image of an eagle or other bird with outstretched wings. The bird is facing to the left.

Food and Drug Administration

10903 New Hampshire Avenue Silver Spring, MD 20993

MagnaBioSciences, LLC. c/o James Wyatt, PhD Chief Technical Officer 6325 Lusk Blvd. San Diego, CA 92121 .

MAR - 9 2012

K110761 Re:

Trade Name: MICT® TSH and MICT® Instrument Regulation Number: 21 CFR §862.1690 Regulation Name: Thyroid Stimulating Hormone Test System Regulatory Class: II Product Codes: JLW, JJQ Dated: February 28, 2012 Received: March 6, 2012

Dear Dr. Wyatt:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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). .

5

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.gov/Medical

Devices/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/Resourcesfor You/Industry/default.htm

Sincerely yours,

V

Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices

Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

6

Indications for Use Form

510(k) Number: K110761

Device Name: MICT®TSH

Indications for Use:

The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.

Prescription Use) × (Part 21 CFR 801. Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Autie Charles

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 110761

2 Page 1 of

7

Indications for Use Form

510(k) Number (if known): K110761 ·

Device Name: MICT® Instrument

Indications for Use:

The MICT® TSH is a magnetic lateral flow immunoassay for the in-vitro quantitative determination of TSH in human serum. The measurements of thyroid stimulating hormone (TSH) produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The MICT System is intended for use in clinical laboratories.

Prescription Use) (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qute Chuler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 110761

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