The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

Device Description

MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called "MAS Immunosuppressant Controls." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics and acceptance criteria in the way one might expect for a novel diagnostic algorithm or clinical treatment device.

Therefore, many of the requested categories for defining acceptance criteria and study details cannot be directly extracted from this document, as they are not typically part of a 510(k) for a quality control material. Specifically, this submission does not contain information on device performance in terms of sensitivity, specificity, accuracy, or a clinical study with human readers or pathology ground truth.

However, I can extract the information that is present and indicate where the requested information is not applicable or not provided in this specific type of submission.

Acceptance Criteria and Device Performance

This 510(k) submission for MAS Immunosuppressant Controls does not present specific quantitative acceptance criteria or detailed performance data in the typical sense of a diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, substantial equivalence is claimed based on comparable intended use, physical properties, and a demonstration that the device is safe and effective for its stated purpose as a quality control material.

The implied acceptance criteria are that the control material performs similarly to the predicate device in its intended function: monitoring the precision of laboratory testing procedures for specific immunosuppressants. The study supporting this is a comparison to a predicate device, not an independent performance study against a clinical gold standard.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use: Assayed QC material for monitoring precision of lab testing for cyclosporine, sirolimus, tacrolimus.	Matches: The MAS Immunosuppressant Controls' intended use aligns directly with monitoring precision for these analytes.
Matrix: Processed Human Whole Blood.	Matches: Subject device uses Processed Human Whole Blood.
Analyte Inclusion: Cyclosporine, Sirolimus, Tacrolimus.	Matches: Subject device contains these three analytes.
Number of Levels: Three (3) levels.	Matches: Subject device offers three (3) levels.
Open Vial Claim: 14 days at 2°C to 8°C.	Matches: Subject device claims 14 days at 2°C to 8°C.
Storage: Stability until expiration date when stored at relevant temperature.	Matches: Subject device is stable until expiration date at -20°C (for the subject device) or 2°C to 8°C (for the predicate).

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated in terms of patient samples or a traditional test set. The comparison is between the control materials themselves. The submission does not detail any "test set" of patient data.
- Data Provenance: Not applicable. The study is a comparison of product characteristics and intended use, not based on clinical data or patient samples from a specific country or collected retrospectively/prospectively.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable: There is no "ground truth" expert review in the context of this 510(k) submission for a quality control material. The ground truth for individual analyte concentrations in control materials is established through a precise manufacturing and assaying process, not expert consensus on patient data.
Adjudication Method for the Test Set:
- Not Applicable: No adjudication method is mentioned as there is no test set in the conventional sense requiring expert review or adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable: This is a 510(k) for a quality control material, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable: This is not an algorithmic device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable in the traditional sense: For quality control materials, the "ground truth" for the declared values of the controls is established through the precise manufacturing process and subsequent validated analytical testing of the controls themselves, often against reference methods or certified reference materials, to assign the assayed values. It is not derived from clinical outcomes, pathology, or expert consensus on patient data.
The sample size for the training set:
- Not Applicable: This device does not involve a training set for an algorithm.
How the ground truth for the training set was established:
- Not Applicable: No training set is involved.

Summary

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K051074

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

510(k) Number:

Submitter:

Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538 Telephone: (510)-979-5000

Contact Person:

Lisa Charter Research and Development 46360 Fremont Blvd. Telephone: (510)-979-5142 Facsimile: (510) 979-5455

Preparation Date:

April 25, 2005

Device Information:

Device Classification Name:	Drug Specific Control Materials
Common/Usual Name:	Immunosuppressive Drug Control
Proprietary Name:	MAS® Immunosuppressant Controls
Regulation Number:	21 CFR§862.3280
Regulatory Name:	Clinical toxicology control material
Product Code:	LAS
Regulatory Class:	Class I

Predicate Devices:

Lyphochek® Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories.

Device Description:

MAS Immunosuppressant Controls is prepared from human whole blood, with pure chemicals and stabilizers. The control is provided in a liquid form containing Cyclosporine, Sirolimus, and Tacrolimus.

Intended Use:

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Comparison to Predicate Device(s):

The Microgenics Cyclosporine Controls are substantially equivalent to Lyphochek® Whole Blood
States and Children of States Also Die Rodd Charatariae The Microgenios Oyeloopenhoed by Bio-Rad Laboratories.

Device	Subject Device	Predicated Device
Characteristics		(K022041)
Intended Use	The MASImmunosuppressantControls, consistingof levels 1 through3, are in-vitrodiagnostic medicaldevices intended foruse as assayedquality controlmaterial to monitorthe precision oflaboratory testingprocedures forcyclosporine,sirolimus, andtacrolimus.	Lyphochek® WholeBlood Control isintended for use asan assayed qualitycontrol material tomonitor theprecision oflaboratory testingprocedures forcyclosporine, lead,red cell folate,tacrolimus, andsirolimus.
Matrix	Processed HumanWhole Blood	Processed HumanWhole Blood
Form	Liquid	Lyophilized
Analytes	Cyclosporine,Sirolimus,Tacrolimus	Cyclosporine,Lead, Red CellFolate, Tacrolimus,Sirolimus
Levels	Three (3) Levels	Three (3) Levels
Open VialClaim	14 days at 2°C to8°C	14 days at 2°C to8°C. Exception:Red cell folate isstable for 3 days at2°C to 8°C
Storage	-20°C untilexpiration date	2°C to 8°C untilexpiration date
Stability	Until expiration datenoted on vial label.	Until expirationdate noted on viallabel.

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Summary:

The information provided in this pre-market notification demonstrates that the MAS Immunosuppressant Controls are substantially equivalent to the previously cleared predicate devices. Substantial equivalence was demonstrated through comparison of intended use and physical properties to commercially available devices. The information supplied in this premarket notification provides reasonable assurance the MAS Immunosuppressant Controls are safe and effective for the stated intended use.

MAS® is a registered trademark of Medical Analysis Systems, Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 6 - 2005

Ms. Lisa Charter Research and Development Microgenics Corporation 46360 Fremont Blvd Fremont, CA 94538

K051074 Re: Trade/Device Name: MAS Immunosuppressant Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: April 25, 2005 Received: April 29, 2005

Dear Ms. Charter:

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).

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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 (240) 276-0484. 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/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Kos S 10 7 4

Device Name: MAS Immunosuppressant Controls

Indications For Use:

The MAS Immunosuppressant Controls, consisting of levels 1 through 3, are in-vitro The MAG inimal our less intended for use as assayed quality control material to ulughoutio modifical us no folaboratory testing procedures for cyclosporine, sirolimus, and tacrolimus.

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Q. Chalu

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K051074

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.