The Dimension® Mycophenolic Acid Flex® reagent cartridge is an in vitro diagnostic test for the quantitative measurement of Mycophenolic acid (MPA) in human plasma on the Dimension® clinical chemistry system. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic, and cardiac transplant patients.
The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

Device Description

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.
The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.
The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

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Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence rather than defining explicit acceptance criteria for a new clinical performance study. The core of the evidence relies on a split-sample comparison to demonstrate agreement with existing, validated methods.

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance (Dimension® MPAT vs. Reference)
Correlation Coefficient (r)	High correlation (e.g., > 0.95 or 0.98) between new device and reference methods	0.98
Slope	Close to 1.0 (indicating proportional agreement)	1.04
Intercept (µg/mL)	Close to 0 (indicating minimal systematic bias)	-0.02

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

Sample Size: 109 clinical samples
Data Provenance: Clinical samples from kidney, heart, and liver transplant patients. The country of origin is not specified but is implied to be clinical data. The study is retrospective, as it involves a "split sample comparison" with existing methods, suggesting these samples were collected and then tested by both new and reference methods.

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

This study does not involve "experts" in the traditional sense of clinicians or radiologists establishing ground truth. Instead, the ground truth is established by reference methods (HPLC/LC-MS assays). The qualifications of the personnel performing these reference assays are not detailed, but it's assumed they are trained laboratory professionals.

4. Adjudication Method for the Test Set

There was no explicit "adjudication method" described as this was a quantitative comparison against established laboratory reference methods (HPLC/LC-MS). Discrepancies between the new device and the reference method would be analyzed through statistical comparison rather than a consensus process involving multiple human adjudicators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic (IVD) test system, not an imaging or diagnostic AI system that would typically involve human readers. The performance is assessed by comparing quantitative results to a gold standard, not by evaluating human reader performance with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance described is effectively "standalone" for the device, meaning it's the performance of the automated assay itself. There is no human-in-the-loop component in the measurement of mycophenolic acid by the Dimension® MPAT system. The device produces a quantitative result without human interpretation of the assay's execution, though a human would interpret the clinical significance of the numerical result.

7. The Type of Ground Truth Used

Reference Method Assays: The ground truth was established by HPLC/LC-MS assays. These are considered gold standard methods for quantitative measurement of analytes like mycophenolic acid in clinical chemistry.

8. The Sample Size for the Training Set

The document does not provide information regarding a separate "training set" or its size. For an IVD assay like this, the development process likely involves extensive internal optimization and verification using various samples, but these are generally not described as a distinct "training set" in the context of a 510(k) submission for an immunoassay. The presented data is for the validation of the finalized device.

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

Since a specific "training set" is not detailed, this information is not provided. If such a phase existed, the ground truth would similarly be established by robust reference methods or gravimetric preparation of known concentration samples.

Summary

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

Submitter's Name: Helen M. Lee Siemens Healthcare Inc. P.O. Box 6101 Newark, DE 19714-6101 Phone 302.631.8706 Fax 302.631.6299

Date of Preparation: October 6, 2011

Name of Product: 1. Dimension® Mycophenolic Acid Flex® Reagent Cartridge 2. Dimension® Mycophenolic Acid Calibrator

FDA Classification Name: 1. Immunoassay, Mycophenolic Acid (MPA) 2. Calibrator

Predicate Device:

The following table describes the predicate devices, device classification, regulation and product code associated with this pre-market notification:

NewProduct	PredicateDevice	510(k)number	DeviceClass	Regulation	ProductCode
Dimension® MPATFlex® ReagentCartridge	Roche Total MPA assay forthe COBAS INTEGRAsystem	K063520	II	21 CFR862.3840	OAV
Dimension® MPATCalibrator	Roche Total MPACalibrators for the COBASINTEGRA system	K063520	II	21 CFR862.3200	DLJ

Device Description:

MPAT

The liquid reagents are configured in an eight well "Flex®"; the content of each Flex® well is described in the Instructions for Use.

The methodology for the Dimension® MPAT assay is based on a homogenous particle enhanced turbidimetric inhibition immunoassay (PETINIA) technique, which uses a latex particle

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mycophenolic acid conjugate (PR) and monoclonal mycophenolic acid specific antibody (Ab). Mycophenolic acid present in the sample competes with the mycophenolic acid on the particles for available antibody, thereby decreasing the rate of aggregation. Hence, the rate of aggregation is inversely proportional to the concentration of mycophenolic acid in the sample. The rate of aggregation is measured using bichromatic turbidimetric readings at 340 nm and 700 nm.

The concentration is determined by means of a mathematical function:

Mycophenolic acid + PR + Ab --------------------------------------------------------------------------------------------------------------------------------------------------(scatters light at 340 nm)

To perform the MPAT assay, a sample cup containing the plasma or serum sample to be analyzed and a Dimension® MPAT reagent Flex® Reagent Cartridge are placed appropriately on the Dimension® analyzer.

Calibrator

The Dimension MPAT Calibrator is used to calibrate the MPAT assay on the Dimension system. The calibrator is a five level aqueous BSA matrix product containing Mycophenolic acid. The typical calibration levels for levels 1 through 5 respectively, are 0.0, 0.7, 2.3, 6.7 and 30.0 µg/mL. Level 1 is a zero level, and can be used to dilute samples that exceed 30 µg/mL.

Intended Use:

MPAT

The MPAT assay is an in vitro diagnostic test for the quantitative measurement of mycophenolic acid (MPA) in human serum and plasma on the Dimension® Clinical Chemistry System. Measurements of MPA are used as an aid in the management of mycophenolic acid therapy in renal, hepatic and cardiac transplant patients.

Calibrator

The MPAT calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid (MPAT) method on the Dimension® clinical chemistry system.

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Comparison to Predicate Device:

Both the Dimension® Mycophenolic Acid Flex® Reagent Cartridge and the predicate Roche Total MPA assay for the COBAS INTEGRA system employ prepackaged reagents for use on automated clinical chemistry test systems. A comparison of the important similarities and differences of these methods is provided in the following table:

Feature	Dimension® Mycophenolic AcidFlex® Reagent Cartridge	Roche Total MPA assay forthe COBAS INTEGRAsystem
Intended Use	in vitro diagnostic use; quantitativemeasurement of Mycophenolic Acidin human serum and plasma as an aidin the management of MPA therapyin renal, hepatic and cardiactransplant patients.	in vitro diagnostic use;quantitative measurement ofMycophenolic Acid in humanserum or plasma as an aid inthe management of MPAtherapy in renal and cardiactransplant patients.
Sample Type	EDTA Plasma	Serum, EDTA Plasma
Assay Range	0.2 - 30.0 µg/mL[0.62 - 93.60 µmol/L]	0.4 - 15 µg/mL, extendablewith post-dilution to 50 µg/mL
Technology	Homogenous particle enhancedturbidimetric inhibition immunoassay(PETINIA) technique with the MPArate of aggregation inverselyproportional to the MPAconcentration in the sample.	Enzyme-mimicking assay withMPA concentration inverselyproportional to the formationof NADH.
Detection	Bichromatic turbidimetric readings at340 nm and 700 nm.	Spectrophotometric readings
Sample Size	5 µL	3 µL
BindingProtein	monoclonal mycophenolic acidspecific antibody	N/A

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Both the Dimension® Mycophenolic Acid Calibrator and the predicate Roche Total MPA Calibrators for the COBAS INTEGRA system have similar intended use. A comparison of the important similarities and differences is provided in the following table:

Feature	Dimension® Mycophenolic AcidCalibrator	Roche Total MPA Calibrators forthe COBAS INTEGRA system
IntendedUse	Calibrate MPAT on theDimension® clinical chemistrysystem	Calibrate MPA on the COBASINTEGRA system
Analytes	MPA	MPA
Matrix	Bovine Serum Albumin	Negative human serum
Traceableto:	Gravimetric preparation	Gravimetric preparation
Form	Liquid, stored at 2-8°C	Liquid
Volume	Vial containing Level 1 with 5.0mL and Levels 2-5 have 2.0 mLper vial.	Levels A- F with 5.0 mL each andone vial of diluents (10.0 mL)
Levels	5 levels (0, 0.7, 2.3, 6.7, and30.0 µg/mL)	6 levels (0, 1, 3, 5, 10, 15 µg/mL)

Comments on Substantial Equivalence:

Split sample comparison between the Dimension® Mycophenolic Acid Flex® Reagent Cartridge and HPLC/LC-MS assays gave the following correlation statistics, when tested with clinical samples from kidney, heart and liver transplant patients:

Dimension®	ReferenceMethod	Slope	Intercept(µg/mL)	CorrelationCoefficient (r)	n
MPAT	HPLC/LC-MS	1.04	-0.02	0.98	109

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Conclusion:

The Dimension® Mycophenolic Acid Flex® Reagent Cartridge with the associated Dimension® MPAT Calibrator are substantially equivalent in principle and performance to the Roche COBAS INTEGRA system based on the split sample comparison versus HPLC and HPLC/LC-MS reference methods discussed above.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Siemens Healthcare Diagnostics, Inc. c/o Ms. Helen Lee 500 GBC Drive M/S 514 Newark. DE 19714-6101

OCT - 7 2011

Re: K102772

Trade Name: Dimension®Mycophenolic Acid Flex® reagent cartridge Dimension® Mycophenolic Acid Calibrator Regulation Number: 21 CFR 862.3840 Regulation Name: Sirolimus test system Regulatory Class: Class II Product Code: OAV, DLJ Dated: September 30, 2011 Received: October 4, 2011

Dear Ms. Lee:

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Virro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the responing of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 for (1 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/de{autt.html

Sincerely yours,

Courtney H. Lias, Ph.D. 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 Form

510(k) Number (if known): K102772

Device Name: Dimension® Mycophenolic Acid Flex® reagent cartridge

Indications for Use:

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart C) - ,

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

xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) | 02772

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Indications for Use Form

1,02772 510(k) Number (if known): _

Device Name: Dimension® Mycophenolic Acid Calibrator

Indications for Use:

The Dimension® Mycophenolic Acid Calibrator is an in vitro diagnostic product for the calibration of the Mycophenolic Acid method on the Dimension® clinical chemistry system.

Prescription Use X Prescription Use X__________________________________________________________________________________________________________________________________________________________

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

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

Rudd Chesler

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 102772

Page 2 of 1

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.