THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS

• K Number: K123343
• Device Name: THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS
• Manufacturer: MICROGENICS CORP.
• Date Cleared: 2013-07-11 ( 253 days)
• Product Code: MLM JIT
• Regulation Number: 862.1678

Intended Use

The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS® Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

Device Description

The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1, Reagent 2 and Extraction Reagent) and calibrators (Calibrator A, B, C, D, E, and F). Reagent 1 (Antibody Reagent): <1.0% Anti-Tacrolimus monoclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. Configuration: 1 x 18 mL. Reagent 2 (Microparticle Reagent): <0.3% Tacrolimus-coated microparticles in buffer containing <0.09% sodium azide as preservative. Configuration: 1 x 12 mL. Extraction Reagent: 300 mM Zinc Sulfate and <0.09% sodium azide as preservative. Configuration: 1 x 50 mL. QMS® Tacrolimus Reagents are provided ready-to-use in liquid form and are to be stored at 2 to 8°C until the expiration date on the label. Calibrator Level, Target Concentration (ng/mL), Configuration: Calibrator A, 0.0, 1 x 4 mL Calibrator B, 2.0, 1 x 2 mL Calibrator C, 5.0, 1 x 2 mL Calibrator D, 10.0, 1 x 2 mL Calibrator E, 20.0, 1 x 2 mL Calibrator F, 30.0, 1 x 2 mL The QMS® Tacrolimus Calibrator kit is provided separately and packaged in amber glass bottles in a rectangular cardboard box with a 6-bottle divider. The calibrators are provided in liquid form and are to be stored at -20℃ ± 5℃ until the expiration date on the label. They are ready-to-use upon thawing.

Predicate Devices

K070820

Reference Devices

Abbott ARCHITECT® Tacrolimus assay

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on a traditional immunoassay method using antibodies and microparticles, with no mention of AI or ML.

Therapeutic

No

The device is an in vitro diagnostic immunoassay that quantifies tacrolimus levels in blood to aid in managing transplant patients. It does not directly treat or provide therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only."

SaMD (Software as a Medical Device)

No

The device is an in vitro diagnostic device consisting of physical reagents and calibrators used on automated clinical chemistry analyzers, not a software-only device.

IVD (In Vitro Diagnostic)

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

Here's why:

• Intended Use/Indications for Use: The document explicitly states "This in vitro diagnostic device is intended for clinical laboratory use only." This is a clear declaration of its intended use as an IVD.
• Purpose: The device is intended for the quantitative determination of tacrolimus in human whole blood. This is a test performed in vitro (outside the body) on a biological sample to provide information for medical purposes (managing transplant patients).
• Device Description: The description details reagents and calibrators used in a laboratory setting to perform the assay.
• Intended User/Care Setting: It is specified for "clinical laboratory use only," which is a typical setting for IVD testing.

All these factors align with the definition and characteristics of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

QMS® Tacrolimus Immunoassay

The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

QMS® Tacrolimus Calibrators

The QMS® Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

Product codes

MLM, JIT

Device Description

The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1, Reagent 2 and Extraction Reagent) and calibrators (Calibrator A, B, C, D, E, and F).

Component	Description	Configuration
Reagent 1 (Antibody Reagent)

Regulation Number and Section

§ 862.1678 Tacrolimus test system.

(a)
Identification. A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.(b)
Classification. Class II (special controls). The special control is “Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus Assays; Guidance for Industry and FDA.” See § 862.1(d) for the availability of this guidance document.

Summary

0

510(k) Summary

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

The assigned 510(k) number is: K123343

Company / Contact Person

Karen Lee Regulatory Affairs Specialist Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 Phone: [phone] x31814 Fax: [phone] [e-mail] E-mail:

Date Prepared

October 24, 2012

Common / Usual Name	QMS® Tacrolimus Immunoassay
Trade / Proprietary Name	Thermo Scientific QMS® Tacrolimus Immunoassay
Thermo Scientific QMS® Tacrolimus Calibrators
Classification Regulation	21 CFR 862.1678, Tacrolimus Test System
21 CFR 862. 1150, Calibrator
Device Class	Class II
Device Regulation Panel	Clinical Chemistry
Product Code	MLM, JIT

Regulatory Declarations

Intended Use

QMS® Tacrolimus Immunoassay

The QMS® Tacrolimus Immunoassay is intended for the quantitative determination of tacrolimus in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney, liver, and heart transplant patients receiving tacrolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only.

QMS® Tacrolimus Calibrators

The QMS® Tacrolimus Calibrator set is intended for use in calibration of the QMS® Tacrolimus Immunoassay.

1

Legally Marketed Device to Which Equivalency is Claimed

The Thermo Scientific QMS® Tacrolimus Immunoassay is substantially equivalent to the previously cleared Abbott ARCHITECT® Tacrolimus Assay (K070820).

Device Description

The QMS® Tacrolimus Immunoassay consists of separately packaged reagents (Reagent 1, Reagent 2 and Extraction Reagent) and calibrators (Calibrator A, B, C, D, E, and F).

Component	Description	Configuration
Reagent 1
(Antibody Reagent)