The Microgenics Cyclosporine Controls, consisting of levels 1 through 5, are in-vitro diagnostic medical devices intended for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.

Device Description

The Microgenics Cyclosporine Controls are prepared from whole human blood, with pure chemicals stabilizers added. The control kit includes five separate controls known as C1, C2, C3, C4 and C5 with target concentrations of approximately 70, 200, 350, 700 and 1600 ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.

AI/ML Overview

The provided text is a 510(k) summary for the Microgenics Cyclosporine Controls, focusing on demonstrating substantial equivalence to predicate devices rather than detailed performance studies with acceptance criteria in the manner typical for AI/ML device evaluations.

Therefore, many of the requested sections below cannot be fulfilled directly from the provided document as it does not contain information on: a test set for performance evaluation against ground truth, expert involvement for ground truth establishment, adjudication methods, MRMC studies, standalone performance studies, training set details, or explicit acceptance criteria in a quantitative sense for device performance.

Instead, the document focuses on comparing the new device's characteristics and intended use to legally marketed predicate devices to establish substantial equivalence.

Here's an attempt to extract and infer information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance (e.g., specific accuracy, precision, or bias targets) that would typically be evaluated in a study for a novel diagnostic device. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to existing predicate devices based on shared characteristics and intended use.

Acceptance Criteria Category	Specific Criteria (Inferred from Substantial Equivalence)	Reported Device Performance (Comparison to Predicates)
Intended Use	Must be for use as assayed quality control material to monitor the precision of laboratory testing procedures for cyclosporine.	Matches the intended use of the CEDIA® Cyclosporine Plus High Range Controls and Lyphochek® Whole Blood Control.
Matrix	Processed Human Whole Blood.	Matches the matrix of both predicate devices.
Form	Lyophilized.	Matches the form of both predicate devices.
Analytes	Cyclosporine.	Matches the primary analyte of both predicate devices (Lyphochek includes additional analytes but the common one is cyclosporine).
Reconstituted Vial Claim	14 days at 2°C to 8°C.	Matches the claim of both predicate devices.
Storage	2°C to 8°C until expiration date.	Matches the storage conditions of both predicate devices.
Stability	Until expiration date noted on vial label.	Matches the stability claim of both predicate devices.
Manufacturing Methods	Manufactured using methods virtually identical to predicate.	Stated that manufacturing methods are "virtually identical" to CEDIA® predicate.
Safety and Effectiveness	Provide reasonable assurance of safety and effectiveness for the stated intended use.	This is the overarching conclusion of the 510(k) based on the substantial equivalence argument, without specific quantitative performance data presented.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. The document describes a comparison to predicate devices, not a study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "data" provided is a comparison of product characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This type of information is pertinent to AI/ML or image-based diagnostic devices where ground truth often requires expert labeling or interpretation. This document describes a quality control material.

4. Adjudication Method for the Test Set

Not applicable. There is no test set or adjudication process described.

5. 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 not an AI/ML device and therefore, MRMC studies are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established characteristics and performance of the predicate devices themselves, deemed safe and effective. The new device demonstrates substantial equivalence by matching these characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no training set mentioned or implied.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

Summary

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K032842

OCT 17 2003

510(k) SUMMARY

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 Facsimile: (510) 979-5002

Contact Person:

David Casal, Ph.D. Vice-President, Clinical, Regulatory and Quality Affairs Telephone: (510)-979-5012 Facsimile: (510) 979-5212

Preparation Date:

September 10, 2003

Device Information:

Device Classification Name:	Drug Specific Contr
Common/Usual Name:	Cyclosporine Immu
Proprietary Name:	Microgenics Cyclos
Regulation Number:	21 CFR§862.3280
Regulatory Name:	Clinical toxicology
Product Code:	LAS
Regulatory Class:	Class I

trol Materials unosuppressive Drug Control sporine Controls control material

Predicate Devices:

CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) Lyphochek Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories.

Device Description:

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ng cyclosporine/mL. The Microgenics Cyclosporine Controls are provided in lyophilized form for increased stability.

Intended Use:

Comparison to Predicate Device(s):

The Microgenics Cyclosporine Controls are substantially equivalent to the CEDIA® Cyclosporine Plus High Range Controls 4 and 5 (K030616) and the Lyphochek® Whole Blood Control (K022041) manufactured by Bio-Rad Laboratories. Moreover, the Microgenics Cyclosporine Controls are manufactured using methods virtually identical to those used for manufacture of the CEDIA® Cyclosporine Plus High Range Controls 4 and 5.

DeviceCharacteristics	Subject Device	Predicate Device(K030616)	Predicated Device(K022041)
Intended Use	Microgenics Cyclospor-ine Controls, consistingof levels 1 through 5, arein-vitro diagnosticmedical devices intendedfor use as assayed qualitycontrol material tomonitor the precision oflaboratory testingprocedures forcyclosporine.	CEDIA® CyclosporinePlus High Range Controlsare intended for use as anassayed quality controlmaterial to monitor theprecision of laboratoryprocedures forcyclosporine.	Lyphochek® WholeBlood Control is intendedfor use as an assayedquality control material tomonitor the precision oflaboratory testingprocedures forcyclosporine.
Matrix	Processed Human WholeBlood	Processed Human WholeBlood	Processed Human WholeBlood
Form	Lyophilized	Lyophilized	Lyophilized
Analytes	Cyclosporine	Cyclosporine	Cyclosporine, Lead, RedCall Folate, andTacrolimus
Levels	Five (5) Levels	Two (2) Levels	Three (3) Levels
Reconstituted VialClaim	14 days at 2°C to 8°C	14 days at 2°C to 8°C	14 days at 2°C to 8°C.Exception: Red cell folateis stable for 3 days at 2°Cto 8°C
Storage	2°C to 8°C untilexpiration date	2°C to 8°C untilexpiration date	2°C to 8°C untilexpiration date
Stability	Until expiration datenoted on vial label	Until expiration datenoted on vial label	Until expiration datenoted on vial label

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Summary:

The information provided in this pre-market notification demonstrates that the Microgenics Cyclosporine Controls (Assayed and Unassayed) 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 pre-market notification provides reasonable assurance the Microgenics Cyclosporine Controls are safe and effective for the stated intended use.

CEDIA® is a registered trademark of Roche Diagnostics.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with wavy lines below them.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 17 2003

David Casal, Ph.D. Vice President, Clinical, Regulatory and Quality Affairs Microgenics Corporation 46360 Fremont Blvd. Fremont, CA 94538

Re: K032842

Trade/Device Name: Microgenics Cyclosporine Controls Regulation Number: 21 CFR 862.3280 Regulation Name: Clinical toxicology control material Regulatory Class: Class I Product Code: LAS Dated: September 10, 2003 Received: September 16, 2003

Dear Dr. Casal:

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 (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

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INDICATIONS FOR USE STATEMENT

Ko32842

510(k) Number (if known):

Microgenics Cyclosporine Controls Device name:

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the Counter Use_

(per 21 CFR §801.109

9
(Optional Format 1-2-96)

Albert Cooper
Division Sign-Off for Tear Cooper

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 303 2842

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.