K Number

Device Name

FASTPACK FREE T4 IMMUNOASSAY

Manufacturer

Qualigen, Inc.

Date Cleared

2003-07-03

(153 days)

Product Code

CEC

Regulation Number

862.1695

Intended Use

The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

Device Description

The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay. ● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C. - . Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C. - . Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials. - . Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.

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

K902834

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard chemiluminescence immunoassay process and mentions no AI/ML components or algorithms.

Therapeutic

No
The device is an in vitro diagnostic immunoassay used to aid in the diagnosis and management of thyroid dysfunction, not to directly treat or prevent a disease.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction." This directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly outlines a chemical immunoassay process involving reagents, incubation steps, washing, and detection of a chemiluminescent signal. This is a hardware-dependent in vitro diagnostic assay, not a software-only device.

IVD (In Vitro Diagnostic)

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: "It is intended strictly for in vitro diagnostic use..."
Measurement of Biological Sample: The device measures free thyroxine (FT4) in "human serum," which is a biological sample taken from the body.
Purpose of Measurement: The measurement is for the "quantitative determination" of FT4, which is a diagnostic parameter used to "aid in the diagnosis and management of thyroid dysfunction." This aligns with the purpose of IVD devices.
Use with an Analyzer System: The device is designed for use with the "FastPack ® Analyzer System," which is a common setup for IVD assays.
Competitive Chemiluminescence Immunoassay: The "Device Description" details a laboratory-based assay method (chemiluminescence immunoassay) performed on a sample outside the body.

All these points strongly indicate that the FastPack ® Free T4 Immunoassay is an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FastPack® Free T4 Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of Free T4 in human serum. The FastPack® Free T4 Immunoassay is designed for use with the FastPack® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

The FastPack® Testo/Free T4 Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in human serum

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

CEC; JIX

Device Description

FastPack® Free T4 Immunoassay Reagents
The FastPack® Free T4 Immunoassay is a competitive chemiluminescense assay.
● Primary incubation: Sample, calibrator, or control (100 µL) is added to the antibody solution (100 µL) to start the sequence. The reaction time is 10 seconds at 37° C.
. Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C.
. Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
. Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.

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

Not Found

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)

Performance Characteristics:
Precision:
Between Run
1: Mean ng/dL 1.43, %CV 7.4
2: Mean ng/dL 3.51, %CV 6.2
Between Analyzer
1: Mean ng/dL 1.43, %CV 2.8
2: Mean ng/dL 3.51, %CV 1.8
Between Reagent Lot
1: Mean ng/dL 1.43, %CV 11.1
2: Mean ng/dL 3.51, %CV 4.8

Analytical Sensitivity: 0.4 ng T4/dL

Method Comparison:
versus Abbott IMx Free T4:
n = 131
Range of values (IMx): 0.61 to 5.52 ng T4/dL
Range of values (FastPack): 0.52 to 5.93 ng T4/dL
y = 1.07x - 0.17
r = 0.95

Interfering Substances:
Bilirubin: No interference up to 40 mg/dL
Hemoglobin: No interference up to 1000 mg/dL
Triglycerides: No interference up to 1000 mg/dL

Specificity: L-T3 ≤ 0.9%

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

Analytical Sensitivity: 0.4 ng T4/dL
Specificity: L-T3 ≤ 0.9%

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K902834

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

510(k) Summary K030329

FastPack® Free T4 Immunoassay on the FastPack® Analyzer System ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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 | Qualigen, Incorporated
2042 Corte del Nogal
Carlsbad, CA 92009 | | |
|----|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|--|
| | | Telephone:
Fax: | (760) 918-9165
(760) 918-9127 | |
| | | Contact Person: | Dorothy Deinzer | |
| | | Date Prepared: | January 28, 2003 | |
| 2. | Device name | Proprietary name: | FastPack® Free T4 Immunoassay
on the FastPack® Analyzer System | |
| | | Common name: | Chemiluminescense assay for the determination of
Free T4 | |
| | | Classification Name: | Quantitative Determination of Free T4 in Human
Serum | |
| 3. | Predicate
device | Abbott Laboratories IMx Free T4 (K902834) | | |
| 4. | Device
description | FastPack® Free T4 Immunoassay Reagents | | |
| | | The FastPack® Free T4 Immunoassay is a competitive chemiluminescense
assay. | | |
| | | ● Primary incubation: Sample, calibrator, or control (100 µL) is added
to the antibody solution (100 µL) to start the sequence. The reaction
time is 10 seconds at 37° C. | | |

. Secondary incubation: The initial reaction mixture (200 uL) is transferred to the magnetic particles with bound testosterone and competition between the sample testosterone and the beads continues for an additional 2.5 minutes at 37° C.
. Removal of unbound materials: The paramagnetic particles are washed three times with wash buffer (0.2 mL/wash cycle) to remove unbound materials.
. Substrate addition and detection: Chemiluminogenic substrate [140 uL] is added to the solid phase bound complex to form a chemiluminescent glow, which is measured by the FastPack® Analyzer System at 37° C.
Intended use న. The FastPack® Free Ta Immunoassay is a paramagnetic particle immunoassay intended for the in vitro quantitative determination of Free T4 in human serum. The FastPack® Free T4 Immunoassay is designed for use with the FastPack® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.
1. Comparison to The following tables compare the FastPack® Immunoassay System Predicate Device for Free T4 with the Abbott Laboratories Free T4 method.

Feature	FastPack® System	Abbott IMx® System
Intended Use	For the quantitative
measurement of free
thyroxine in human serum.	For the quantitative
measurement of free thyroxine
(FT4) in human serum and
heparinized plasma.
Assay
Methodology:	Competitive immunoassay	Competitive immunoassay
Storage
Condition:	2-8 °C	2-8 °C
Data Analysis	Internal data reduction via
microcomputer	Internal data reduction via
microcomputer
Temperature
Control	Required	Required
Test Processing	Automated	Automated
Sample Type:	Serum	Serum, Heparinized Plasma
Detector:	Photomultiplier Tube
(PMT)	Photomultiplier Tube (PMT)
Label	Alkaline Phosphatase	Alkaline Phosphatase

Sample Volume	100 µL	150 µL
Assay Range	0.4 to 6 ng/dL	0.4 to 6 ng/dL
Instrument
Required	FastPack® Analyzer
System	Abbott IMx® System
Control Levels	2(not supplied)	3
Antibody	Monoclonal	Polyclonal
Competing
component	T3 covalently coupled to
paramagnetic particles	T3-Alkaline Phosphatase
Conjugate
Solid Phase	Paramagnetic particles	Latex Microparticles
Substrate	ImmuGlow™ (Indoxyl -3-
phosphate and lucigenin)	4-Methylumbelliferyl
Phosphate
Detection	Chemiluminescense	Fluorescence
Calibration	Factory generated master
curve with single-level
calibration adjustment
every 14 days.	Full calibration curve (six
standards) with change in
reagents.
Throughput	Single Sample	Batch
Time to Result	7 minutes	45 minutes to first result
Reagents
Supplied as	Box of 50 disposable self
contained reagent packs	Free T4 Reagent Pack for 100
test, 6 vials of calibrator

Performance Characteristics:

Feature		FastPack® Free T4			Abbott IMx® Free T4
Precision		Mean
ng/dL	%CV		Mean
ng/dL	%CV
	Between Run			Run to Run
	1	1.43	7.4	1	1.18	4.47
	2	3.51	6.2	2	3.23	5.59
	Between Analyzer			Between Run
	1	1.43	2.8	1	1.18	3.80
	2	3.51	1.8	2	3.23	4.79
	Between Reagent Lot
	1	1.43	11.1
	2	3.51	4.8
Analytical
Sensitivity		0.4 ng T4/dL			0.4 ng T4/dL
Method
Comparison	versus Abbott IMx Free T4:
	n = 131
	Range of values (IMx): 0.61 to 5.52 ng T4/dL
	Range of values (FastPack): 0.52 to 5.93 ng T4/dL
	y = 1.07x - 0.17
	r = 0.95

Qualigen, Incorporated

| Interfering

Substances	No interference up to:	No interference up to:
Bilirubin	40 mg/dL	20 mg/dL
Hemoglobin	1000 mg/dL	1000 mg/dL
Triglycerides	1000 mg/dL	1200 mg/dL
Specificity	L-T3
≤ 0.9%	L-T3
≤ 0.5%

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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MC 20850

Ms. Dorothy Deinzer Vice President Quality and Regulatory Affairs Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92009

'JUL 0 3 2003

K030329 Re: Trade/Device Name: FastPack® Free T4 Immunoassay FastPack® Testo/Free T4 Calibrator Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system : Regulatory Class: Class II Product Code: CEC; JIX Dated: May 23, 2003 Received: May 28, 2003

Dear Ms. Deinzer:

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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

Page 2 --

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Page 1 of 2

Attachment 4

Indications for Use Statement

510(k) Number	K030329
Device Name	FastPack ® Free T4 Immunoassay
Indications for Use	The FastPack ® Free T4 Immunoassay is a paramagnetic particle, chemiluminescence immunoassay for the in vitro quantitative determination of free thyroxine (FT4) in human serum. The FastPack ® Free T4 Immunoassay is designed for use with the FastPack ® Analyzer System. It is intended strictly for in vitro diagnostic use as an aid in the diagnosis and management of thyroid dysfunction.

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)	K030329
--------	---------

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Page 2 of 2

Indications for Use Statement

510(k) Number	K030329
Device Name	FastPack® Testo/Free T4 Calibrator
Indications for Use	The FastPack® Testo/Free T4 Calibrator is intended to calibrate the FastPack® Analyzer system when used for the quantitative determination of Total Testosterone or Free T4 in human serum

Division Sign-Off

Office of In Vitro Diagnostic Device

Evaluation and Safety

510(k) K030329

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________