DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426

Q: Who is the manufacturer of DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426?

Siemens Healthcare Diagnostics filed the 510(k) submission for DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474).

Q: What is the FDA product code for DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426?

NTV. It is classified under 21 CFR 866.5600 as a Class 2 device in the Immunology panel.

Q: What is the regulatory pathway for DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426?

510(k) clearance (submission type: Traditional).

Q: Does DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 use AI or machine learning?

Yes. DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 (K071474) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: Who can help prepare an FDA 510(k) submission like DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Q: Can an AI/ML device like DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K071474 · Siemens Healthcare Diagnostics · NTV · Dec 10, 2008 · Immunology

Device Facts

Record ID	K071474
Device Name	DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426
Applicant	Siemens Healthcare Diagnostics
Product Code	NTV · Immunology
Decision Date	Dec 10, 2008
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 866.5600
Device Class	Class 2
Attributes	AI/ML

Intended Use

The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.

Device Story

The Dimension MPO Flex reagent cartridge is an in vitro diagnostic immunoassay for quantitative MPO measurement in human plasma. It utilizes a one-step sandwich enzyme immunoassay principle on the Dimension clinical chemistry system. The process involves incubating patient samples with chromium dioxide particles coated with MPO-specific monoclonal antibodies and a beta-galactosidase-labeled conjugate. Magnetic separation removes unbound conjugate; the remaining sandwich is reacted with a chromogenic substrate (CPRG). Hydrolysis releases a chromophore (CPR), with color change measured at 577 nm. The concentration of MPO is directly proportional to the rate of color change. The device is used in clinical laboratory settings by trained personnel. Results are provided to physicians to assist in risk stratification for MACE in patients presenting with chest pain, alongside other clinical data. It aids in identifying patients at higher risk for cardiac events, potentially guiding clinical management decisions.

Clinical Evidence

Clinical study of 400 patients presenting with chest pain or ACS symptoms. MACE (myocardial infarction, revascularization, or death) assessed at 30 days and 6 months. Logistic regression showed MPO concentration correlates with MACE risk; odds ratios increased with MPO quartiles. MPO provided statistically significant incremental value (p<0.05) over race, gender, hyperlipidemia, and hsCRP in predicting MACE. MPO levels >633 pmol/L identified patients at higher risk for MACE even when Troponin I was <0.07 ng/mL.

Technological Characteristics

Sandwich enzyme immunoassay; chromium dioxide particles; beta-galactosidase label; chromogenic substrate (CPRG); 577 nm photometric detection. Compatible with Dimension clinical chemistry system (heterogeneous immunoassay module). Sample types: EDTA, lithium heparin, or sodium heparin plasma. Analytical specificity: <0.15% cross-reactivity with common cardiac markers (Troponin I, CRP, etc.).

Indications for Use

Indicated for quantitative measurement of myeloperoxidase (MPO) in human plasma to evaluate patients presenting with chest pain at risk for major adverse cardiac events (MACE), including myocardial infarction, revascularization, or death. Used in conjunction with clinical history, ECG, and cardiac biomarkers. Prescription use only.

Regulatory Classification

Identification

A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

Predicate Devices

PrognostiX MPO

Related Devices

K984191 — MYOGLOBIN FLEX REAGENT CARTRIDGE · Dade Behring, Inc. · Dec 10, 1998
K050029 — CARDIOMPO TEST · Prognostix, Inc. · May 10, 2005
K053109 — DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE · Dade Behring, Inc. · Dec 23, 2005

Submission Summary (Full Text)

{0}------------------------------------------------ KO)/474 DEC 10 2008 #### MPO 510K 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. | Submitter's Name: | George M. Plummer Siemens Healthcare Diagnostics P.O. Box 6101 Newark, DE 19714-6101 | |-----------------------------|-----------------------------------------------------------------------------------------------| | Date of Preparation: | May 22, 2007 | | Name of Product(s): | Dimension MPO Flex® reagent cartridge | | FDA Classification Name(s): | Myeloperoxidase, Immunoassay, System, Test (866.5600) | | FDA Guidance Documents: | None applicable | | Predicate Device(s): | PrognostiX CardioMPO™ Enzyme Immunoassay (K050029) | #### Device Description(s): The MPO method is a one-step enzyme immunoassay based on the "sandwich" principle. The sample is incubated with chromium dioxide particles coated with monoclonal antibodies specific for MPO, and conjugate reagent (13-galactosidase labeled monoclonal antibodies specific for MPO). A particle/MPO/conjugate sandwich forms during the incubation period. Unbound conjugate is removed by magnetic separation and washing. The sandwich bound fl-galactosidase is combined with the chromogenic substrate chlorophenol red-ß-D-galactopyranoside (CPRG). Hydrolysis of CPRG releases a chromophore (CPR). The concentration of MPO present in the patient sample is directly proportional to the rate of color change due to formation of CPR measured at 577 nm. #### Intended Use: #### MPO Flex® reagent cartridge: The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. {1}------------------------------------------------ ## MPO Calibrator: The MPO Calibrator is an in vitro diagnostic product intended to be used to calibrate the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. ### MPO Control: The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. #### Substantial Equivalence A summary of the performance attributes of the Siemens Healthcare Diagnostics MPO Flex® reagent cartridge and the predicate PrognostiX CardioMPO™ Enzyme Immunoassay (K050029) is provided in the following charts. | Item | PrognostiX MPO | Dimension® MPO | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The CardioMPO™ Reagent Kit is an enzyme immunoassay intended for the quantitative determination of myeloperoxidase in human plasma, to be used in conjunction with clinical history, ECG and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. | The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. | | Assay Type | Sandwich enzyme immunoassay | Sandwich enzyme immunoassay | | Reportable Range | 13 to 5000 pmol/L | 20 to 5000 pmol/L | | Hook Effect | No high dose effect up to 800,000 pmol/L | No high dose effect up to 800,000 pmol/L | | Clinical study results | Odds ratio increases from 1.0 to a max. of 3.3 across 4 quartiles | Odds ratio increases from 1.0 to a max. of 2.3 across 4 quartiles | #### Table of Similarities {2}------------------------------------------------ | Expected Values | ≤ 539 pmol/L | 20 - 633 pmol/L | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Analytical Specificity | < 0.15% cross-reactivity at high and low MPO concentrations for the following: a-1 Antitrypsin (1250 nmol/L), C-reactive protein (550 nmol/L), Lysozyme (4500 nmol/L), Immunoglobin A (400 nmol/L), Elastase (2500 nmol/L), Lactoperoxidase (800 nmol/L), Lactoferrin 800 nmol/L), COX1 (900 nmol/L), COX2 (900 nmol/L), Thyroid peroxidase (600 nmol/L) | < 0.15% cross-reactivity at high and low MPO concentrations for the following: a-1 Antitrypsin (1250 nmol/L), C-reactive protein (550 nmol/L), Lysozyme (4500 nmol/L), Immunoglobin A (400 nmol/L), Elastase (2500 nmol/L), Lactoperoxidase (800 nmol/L), Lactoferrin 800 nmol/L), COX1 (900 nmol/L), COX2 (900 nmol/L), Thyroid peroxidase (600 nmol/L), Troponin I (2150 nmol/L); < 0.4% cross-reactivity for Eosinophil Peroxidase (922 nmol/L) | # Table of Differences · | Item | PrognostiX MPO | Dimension® MPO | |----------------------|-------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Antibody | PrognostiX polyclonal rabbit and goat monoclonal | Siemens Healthcare Diagnostics mouse monoclonal | | Calibration Interval | Calibration curve using six levels updated for each run. | Calibration curve updated for each lot, using five levels every 30 days with the same reagent lot. | | Sample Volume | 5 uL | 30 uL | | Sample | Lithium Heparin Plasma | EDTA, Li or Na sodium heparin plasma | | Controls | 3 level; human MPO in lithium heparin plasma | 2 level; human MPO in BSA | # Method performance Summary: ## Analytical Results ## Method Comparison A split, lithium heparin patient sample method comparison demonstrated good agreement between the A spit, minuti nepartir panetiveanipe stion® MPO method and the predicate PrognostiX CardioMPO™ Enzyme Immunoassay. | PrognostiX Sample Range | Dimension® Sample Range | n | Slope | Intercept | Correlation Coefficient | |-------------------------------|-------------------------------|-----|-------|-----------|----------------------------| | 154-4869 | 189-4678 | 139 | 1.03 | 91.8 | 0.88 | {3}------------------------------------------------ The model equation for the Passing Bablok regression statistics is: fresults for Dimension® MPO] = slope x [comparative method results] + intercept. #### Plasma Study Results Comparison of matched EDTA, sodium heparin and lithium heparin plasma samples were tested with the Dimension® MPO method. The following table summarizes the Passing Bablok regression from the study. | Comparative Specimen | Slope | Intercept | Correlation Coefficient | N | |---------------------------------------|-------|-----------|----------------------------|----| | Lithium Heparin vs. EDTA | 1.01 | -19.3 | 0.997 | 59 | | Lithium Heparin vs. Sodium Heparin | 0.96 | -7.2 | 0.999 | 49 | ## Reproducibility Typical precision observed for the Dimension MPO method is summarized below: | | Sample | Mean (ng/mL) | Repeatability | | Within Lab | | |--|---------------------------------------------------|-----------------|---------------|------------|------------|-----| | | | SD (ng/mL) | %CV | SD (ng/mL) | %CV | | | | Siemens Healthcare Diagnostics Level 1 Control | 428.4 | 16.3 | 3.8 | 20.4 | 4.8 | | | Siemens Healthcare Diagnostics Level 2 Control | 3643.7 | 121 | 3.3 | 131.6 | 3.6 | | | EDTA Plasma Pool | 494.1 | 10.9 | 2.2 | 17.2 | 3.5 | | | Heparin Plasma Pool | 1465 | 43.6 | 3 | 53.3 | 3.6 | The reproducibility testing was conducted in accordance with the CLSI Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EPS-A2. For each test level, a single test from two independent cups was analyzed twice per day. The repeatability and within-lab standard deviations were calculated by the analysis of variance method. ## Clinical Study Results EDTA plasma samples were obtained from 400 patients who presented to the Emergency Department or acutely to out-patient facilities with chest pain or equivalent symptoms suggestive of ACS. Patients enrolled in the study were assessed for major adverse cardiac events (MACE) defined as myocardial infarction, revascularization (defined as coronary artery bypass graft, percutaneous coronary intervention, or placement of cardiac stent), or death. Incidence of MACE was assessed at 30 days and 6 months. Logistic-regression models were used to calculate odds ratios and 95th percentile confidence {4}------------------------------------------------ intervals. Odds ratios were calculated for MPO separately and after adjustment for age, gender, Troponin I, NT-proBNP, C-reactive protein, white blood cell count, ST-segment depression, history of hypertension, history of hypercholesterolemia, history of diabetes, and smoking status. The risk of MACE in all patients in the ensuing 30 day and 6 month period increased with increasing quartiles of myeloperoxidase concentration as shown in the following tables, demonstrating that MPO is an important predictor of MACE alone and in combination with other indicators of cardiovascular health. | | MACE at 30 Days+ | | | | |------------------------|------------------|-------------|-------------|--------------| | | Q1* | Q2 | Q3 | Q4 | | MPO (pmol/L) | 94 - 581 | 582 - 894 | 895 - 1657 | 1658 - 5000 | | Odds Ratio | 1.00 | 1.36 | 2.63 | 4.29 | | 95% CI | NA | 0.55 - 3.40 | 1.14 - 6.06 | 1.91 - 9.61 | | Adjusted Odds Ratio | 1.00 | 1.41 | 3.03 | 4.31 | | 95% CI | NA | 0.51 - 3.89 | 1.19 - 7.76 | 1.62 - 11.50 | | | MACE at 6 Months+ | | | | |------------------------|-------------------|-------------|-------------|-------------| | | Q1* | Q2 | Q3 | Q4 | | MPO (pmol/L) | 94 – 581 | 582 – 894 | 895 – 1657 | 1658 – 5000 | | Odds Ratio | 1.00 | 0.99 | 2.10 | 4.12 | | 95% CI | NA | 0.41 – 2.40 | 0.95 – 4.63 | 1.95 – 8.73 | | Adjusted Odds Ratio | 1.00 | 0.98 | 2.21 | 3.66 | | 95% CI | NA | 0.37 – 2.56 | 0.93 – 5.26 | 1.50 – 8.94 | + The 95% CI's do not account for the random variation in the quartile values. * In each analysis the first quartile served as the reference group for calculation of odds ratio Logistic regression analysis was used to examine the added effect of MPO over various clinical and demographic covariates, one covariate at a time. A statistically significant effect of MPO was observed after separate adjustment for the effects of race, gender, hyperlipidemia and CRP. MPO did not have a statistically significant effect over troponin I. {5}------------------------------------------------ | Model† | 0 days | 30 days | 180 days | |----------------------|------------------------|------------------------|------------------------| | Race | 0.62 | 0.61 | 0.62 | | Race & MPO | 0.72 | 0.71 | 0.71 | | Difference (95% CI) | -0.10 (-0.15 to -0.04) | -0.10 (-0.15 to -0.04) | -0.09 (-0.14 to -0.04) | | p-value | 0.0010 | 0.0011 | 0.0004 | | Sex | 0.59 | 0.60 | 0.59 | | Sex & MPO | 0.73 | 0.74 | 0.73 | | Difference (95% CI) | -0.14 (-0.21 to -0.07) | -0.14 (-0.20 to -0.08) | -0.14 (-0.20 to -0.08) | | p-value | <0.0001 | <0.0001 | <0.0001 | | hsCRP | 0.51 | 0.51 | 0.54 | | hsCRP & MPO | 0.69 | 0.68 | 0.68 | | Difference (95% CI) | -0.17 (-0.26 to -0.09) | -0.17 (-0.26 to -0.08) | -0.14 (-0.22 to -0.06) | | p-value | 0.0001 | 0.0002 | 0.0003 | | Hyperlipidemia | 0.63 | 0.64 | 0.62 | | Hyperlipidemia & MPO | 0.73 | 0.73 | 0.71 | | Difference (95% CI) | -0.10 (-0.15 to -0.04) | -0.09 (-0.14 to -0.04) | -0.09 (-0.14 to -0.04) | | p-value | 0.0004 | 0.0003 | 0.0003 | +Values for covariate and covariate plus MPO correspond to area under the ROC curve (AUC) Further analysis of the clinical data was made by stratifying patients using the upper limit of the I uniter and of the 11633 pmol/L) and Dimension Troponin I at the 99th percentile (0.07 ng/mL). The analysis shows that patients at risk for MACE within 30 and 180 days were identified significantly more often for MPO>633 pmol/L than for MPO 633 pmol/L when Troponin < 0.07 ng/mL. Image /page/5/Figure/3 description: The image contains the title "MPO Provides Improved Stratification for MACE When Combined With Troponin I+". The title is written in a bold, sans-serif font. The text is centered on the image. Image /page/5/Figure/4 description: This image is a bar graph that shows the percentage of MACE (Major Adverse Cardiovascular Events) in patients with Troponin I levels less than or equal to 0.07 ng/mL. The graph compares two groups: patients with MPO (Myeloperoxidase) levels less than or equal to 633 pmol/L and patients with MPO levels greater than 633 pmol/L. The percentage of MACE is approximately 5% in the group with lower MPO levels and approximately 15% in the group with higher MPO levels. * p = 0.008 vs. MPO ≤ 633 pmol/L. One sided p values were calculated using Fisher's Exact test {6}------------------------------------------------ - * Data shown represents incidence of MACE at 30 days; incidence of MACE at 180 days was similar #### Comments on Substantial Equivalence: Both the predicate PrognostiX MPO reagent cartridge and the Siemens Healthcare Diagnostics Dimension® MPO immunoassays are intended for the quantitative determination of myeloperoxidase. Comparative data for plasma samples demonstrate good analytical agreement between the methods. The clinical results with the Siemens Healthcare Diagnostics MPO assay demonstrates that Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. #### Conclusion: The Siemens Healthcare Diagnostics Dimension® MPO and the predicate PrognostiX MPO immunoassays (K050029) are substantially equivalent based on their intended use and performance characteristics as described above. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, oriented diagonally from the upper right to the lower left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 Siemens Healthcare Diagnostics c/o Mr. George M. Plummer Regulatory Affairs Director P.O. Box 6101 Newark, DE 19714-6101 DEC 1 0 2008 Re: k071474 > Trade Name: Dimension® MPO Flex® reagent cartridge, Dimension® MPO Calibrator, Dimension® MPO Control Regulation Number: 21 CFR 866.5600 Regulation Name: Low-density lipoprotein immunological test system. Regulatory Class: Class II Product Codes: NTV, JIT, JIT, JJX Dated: November 26, 2008 Received: December 02, 2008 Dear Mr. Plummer: 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 vour 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). {8}------------------------------------------------ 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) 276-0490. 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 (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Jean M. Cooper, M.S., D.V.M. Sean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ #### INDICATIONS FOR USE STATEMENT # 510(k) Number (If Known): Device(s) Name(s): Dimension® MPO Flex® reagent cartridge Dimension® MPO Calibrator Dimension® MPO Control Indications for Use: MPO Flex® reagent cartridge: The MPO method is an in vitro diagnostic test for the quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system with the heterogeneous immunoassay module. Myeloperoxidase measurements may be used in conjunction with clinical history, ECG, and cardiac biomarkers to evaluate patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death. #### MPO Calibrator: The MPO Calibrator is an in vitro diagnostic product intended to calibrate the Myeloperoxidase (MPO) method on the Dimension o clinical chemistry system with the heterogeneous immunoassay module. MPO Control: The myeloperoxidase control is an in vitro diagnostic product intended for use as an assayed quality control product to monitor the performance of the Myeloperoxidase (MPO) method on the Dimension ® clinical chemistry system with the heterogeneous immunoassay module. Prescription Use (Part 21 CFR 801 Subpart D) and/or Over-the-counter Use (21 CFR 801 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) Carol Benem Sign-Off Tice of In Vitro Diagnostic Device K071474