K Number

Device Name

THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY

Manufacturer

MICROGENICS CORP.

Date Cleared

2013-08-20

(344 days)

Product Code

OUF

Regulation Number

862.3840

Intended Use

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

Device Description

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations. R1 Antibody Reagent: <1.0% Anti-Everolimus polyclonal antibody (rabbit) in a buffer as stabilizer and <0.09% sodium azide as preservative. 1 x 22 mL R2 Microparticle Reagent: <0.6% Everolimus-coated microparticles in buffer containing <0.05% sodium azide as preservative. 1 x 8 mL Precipitation Reagent: Precipitating reagent, and <0.09% sodium azide as preservative. 1 x 8 mL The reagents are supplied ready-to-use in liquid form in plastic HDPE bottles, for storage at 2 to 8°C. The reagent set is sufficient for 100 tests.

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

K100144

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard in vitro diagnostic assay based on antibody-microparticle technology. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on analytical characteristics like sensitivity, precision, and method comparison, not on algorithmic performance metrics.

Therapeutic

No
This device is an in vitro diagnostic assay used to quantify Everolimus in blood, aiding in patient management, but it does not directly treat or prevent a disease.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states, "This in vitro diagnostic device is intended for clinical laboratory use only." Additionally, it quantifies a substance in human whole blood to aid in the management of transplant patients, which is a diagnostic purpose.

SaMD (Software as a Medical Device)

The device description explicitly details physical reagents (liquids in bottles) which are hardware components, not software.

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 assay is designed for the "quantitative determination of Everolimus in human whole blood." This is a diagnostic test performed in vitro (outside the body) on a biological sample (whole blood) to provide information for patient management.
Clinical Context: The results are used "as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy." This indicates the test provides information relevant to clinical decision-making.
Device Description: The description details reagents used to perform a test on a biological sample, which is characteristic of an IVD.

The document clearly identifies the device as an IVD and describes its function and intended use in a way that aligns with the definition of an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

OUF

Device Description

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations.

Component	Description	Configuration
R1 Antibody Reagent

Regulation Number and Section

§ 862.3840 Sirolimus test system.

(a)
Identification. A sirolimus test system is a device intended to quantitatively determine sirolimus concentrations in whole blood. Measurements are used as an aid in management of transplant patients receiving therapy with sirolimus.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Sirolimus Test Systems.” See § 862.1(d) for the availability of this guidance document.

Summary

K122766

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:

Company / Contact Person

Karen Lee Regulatory Affairs Specialist Thermo Fisher Scientific, Clinical Diagnostics Division 46360 Fremont Blvd. Fremont, CA 94538 Phone: (510) 979-5000 x31814 (510) 979-5422 Fax: E-mail: karen.lee@thermofisher.com

AUG 2 0 2013

Date Prepared

September 7, 2012

Common / Usual Name	QMS® Everolimus Assay
Trade / Proprietary Name	Thermo Scientific QMS® Everolimus Assay
Classification Regulation	21 CFR 862.3840
Device Class	Class II
Device Regulation Panel	Clinical Chemistry and Clinical Toxicology
Product Code	OUF

Regulatory Declarations

Intended Use

QMS® Everolimus Reagents

Legally Marketed Device to Which Equivalency is Claimed

The Thermo Scientific QMS® Everolimus Assay is substantially equivalent to the previously cleared QMS® Everolimus Assay (K100144).

Device Description

The QMS® Everolimus Assay consists of separately packaged reagents (R1, R2, and Precipitation Reagent) with the following contents and configurations.

Component	Description	Configuration
R1 Antibody
Reagent