CARDIOMPO TEST
Device Facts
| Record ID | K050029 |
|---|---|
| Device Name | CARDIOMPO TEST |
| Applicant | Prognostix, Inc. |
| Product Code | NTV · Immunology |
| Decision Date | May 10, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5600 |
| Device Class | Class 2 |
Intended Use
The CardioMPO™ Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit. 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 PrognostiX CardioMPO Calibrator Kit is intended for use with the CardioMPO Reagent Kit to establish a calibration curve that is used to determine MPO concentration. The PrognostiX CardioMPO Control Kit is intended for use with the CardioMPO Reagent Kit as an assayed quality control sample to monitor and evaluate the precision and accuracy of the CardioMPO Test.
Device Story
CardioMPO is a sandwich ELISA for quantitative measurement of myeloperoxidase (MPO) in lithium heparin human plasma. Input: plasma sample added to microtiter plate coated with monoclonal anti-MPO antibody; primary polyclonal rabbit anti-MPO antibody; secondary HRP-labeled goat anti-rabbit IgG antibody. Transformation: enzymatic turnover of TMB substrate produces color change proportional to MPO concentration. Output: spectrophotometric absorbance at 450 nm (with 630 nm correction) converted to MPO concentration via calibration curve. Used in professional clinical laboratories by technicians. Results assist physicians in assessing MACE risk for chest pain patients, including those Troponin T negative. Benefits include improved risk stratification for cardiac events.
Clinical Evidence
Retrospective analysis of 560 banked plasma samples from chest pain patients (Brennan et al., 2003). Primary endpoint: MACE (myocardial infarction, revascularization, death) at 30 days and 6 months. Results showed MACE risk increased with MPO quartiles. Adjusted odds ratios for MACE at 30 days ranged from 1.0 (ref) to 3.3 (p<0.001) for all patients, and up to 6.9 (p<0.001) for Troponin T negative patients.
Technological Characteristics
Sandwich ELISA; mouse monoclonal and rabbit polyclonal anti-MPO antibodies; goat anti-rabbit IgG conjugate. Measures optical density at 450 nm. Linear range: 13-5223 pM. Sample type: lithium heparin plasma. Standards referenced: NCCLS EP5-A (precision), EP6-A (linearity), EP7-A (interference).
Indications for Use
Indicated for patients presenting with chest pain, aged 23-96 years, to evaluate risk of major adverse cardiac events (MACE) including myocardial infarction, revascularization, or death. Used in conjunction with clinical history, ECG, and cardiac biomarkers.
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
- diaDexus PLAC™ Test (k030477)
Related Devices
- K071474 — DIMENSION CLINICAL CHEMISTRY SYSTEM MPO FLEX REAGENT CARTRIDGE, CALIBRATOR,CONTROL, MODEL RF425, RC425,RC426 · Siemens Healthcare Diagnostics · Dec 10, 2008
- K030477 — DIADEXUS PLAC TEST · Diadexus, Inc. · Jul 18, 2003
- K970343 — MMB METHOD · Dade Chemistry Systems, Inc. · Feb 14, 1997
Submission Summary (Full Text)
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K050029
## 510(k) Summary
# PrognostiX CardioMPO™ Test
This 510(k) summary is being submitted in accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
#### General Information
| Name and Address of Applicant: | PrognostiX, Inc.<br>10265 Carnegie Avenue<br>Cleveland, OH 44106<br>216-445-7469<br>Thomas M. Jackson, Ph.D. |
|--------------------------------|--------------------------------------------------------------------------------------------------------------|
| Date Prepared: | January 5, 2005 |
| Device Trade Name: | CardioMPO™ Test |
| Common Name: | Myeloperoxidase Test |
#### Identification of Legally Marketed Device
diaDexus PLAC™ Test 510(k) number K030477 diaDexus, Inc. 343 Oyster Point Blvd. South San Francisco, CA 94080
#### Intended Use
The CardioMPO Test 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.
#### Device Description
The CardioMPO Test is a sandwich enzyme immunoassay that uses two highly specific antibodies, one monoclonal and one polyclonal, and an enzyme labeled anti-rabbit IgG antibody for the measurement of MPO concentration in human plasma. The CardioMPO Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit.
The CardioMPO Reagent Kit contains the following: a microtiter plate coated with a monoclonal anti-MPO antibody; a solution of primary polyclonal rabbit anti-MPO antibody; a solution of secondary goat anti-rabbit IgG antibody labeled with horseradish peroxidase solution; TMB substrate solution; Stop Solution; Wash Buffer Concentrate; Assay Buffer; and plate sealers.
The CardioMPO Calibrator Kit contains six Calibrators comprised of human MPO in a phosphatebuffered matrix containing proteins, detergents, and stabilizers. Calibrators are intended to establish a calibration curve that is used to determine MPO concentration. Calibrator values are provided on individual Calibrator labels. Calibrators are provided ready-to-use.
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The CardioMPO Control Kit contains three Controls comprised of human MPO in a human plasma matrix. Controls are intended to monitor and evaluate the precision and accuracy of the CardioMPO Test. Ranges are provided on individual Control labels. Controls are freated in the same manner as patient samples.
Calibrators are added directly to the appropriate wells of the Microtiter Plate. Assay Buffer is added to all wells that are intended for Control or sample analysis. Aliquots of Controls or samples are added to the appropriate wells and the plate is incubated for 60 minutes at 20-26°C. The wells are then washed with Wash Buffer to remove antigens not specifically bound to the immobilized antibody.
A yellow primary polyclonal rabbit anti-MPO antibody is added to each well and incubated for 60 minutes at 20-26°C. This antibody binds to the MPO captured on the plate. The plate is again washed with Wash Buffer to remove unbound primary antibody.
A blue secondary goat anti-rabbit IgG antibody, labeled with the enzyme horseradish peroxidase (HRP), is then added to each well and incubated for 30 minutes at 20-26°C. This antibody binds to the primary antibody, and the MPO in the sample is "sandwiched" between the monoclonal antibody on the solid phase and a complex of the rabbit anti-MPO and the HRP-goat anti-rabbit IgG antibody. The wells are washed with Wash Buffer to remove unbound HRP-labeled antibody.
The substrate, tetramethylbenzidine (TMB), is then added to each well and incubated for 10 minutes at 20-26°C resulting in the development of a blue color. Color development is stopped with the addition of Stop Solution, changing the color to yellow.
The enzymatic turnover of the substrate is determined spectrophotometrically at 450 nm, preferably with correction at 630 nm, and is directly proportional to the concentration of MPO. The absorbances of the Calibrators are used to plot a standard curve of absorbance versus MPO concentration from which the MPO concentration in the Controls or samples can be determined.
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#### Comparison of New Device to Predicate Device
The chart below identifies the similarities and differences between the PrognostiX CardioMPO Test and the predicate device, the diaDexus PLAC™ Test.
| Characteristic | PrognostiX CardioMPO Test<br>(Proposed) | diaDexus PLAC™ Test<br>(K030477) |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Quantitative in vitro diagnostic test to detect 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. | Quantitative in vitro diagnostic test for the determination of Lp-PLA2 in human plasma, to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk for coronary heart disease. |
| Analyte | Myeloperoxidase | Lipoprotein-associated<br>phospholipase A2 |
| Sample | Lithium Heparin Plasma | EDTA Plasma |
| Methodology | ELISA | ELISA |
| Detection Method | Optical Density at 450 nm | Optical Density at 450 nm |
| Risk to Patients | Minimal Risk | Minimal Risk |
| Laboratory<br>Environment | Professional Laboratory | Professional Laboratory |
| Precision in plasma,<br>Total | <9% | <8% |
| Within-run | <6% | <6% |
| Interferences | No interference observed at the suggested NCCLS test concentrations of triglycerides, cholesterol, bilirubin, and albumin.<br>No interference up to 1500 mg/L hemoglobin. | No interference observed at the suggested NCCLS test concentrations of hemoglobin, triglycerides, cholesterol, bilirubin, and albumin. |
| Clinical study results | Odds ratio increases from 1.0 to a max. of 5.2 across 4 quartiles | Risk ratio increases from 1.0 to a max. of 2.5 across 3 tertiles |
#### Performance Characteristics
#### Sensitivity
The minimum detection limit, as calculated by interpolation of the mean plus two standard deviations of 24 replicates of the 0 pM MPO Calibrator (F), is 13 pM MPO.
#### Assay Precision
Total and within-run precision were determined by testing four Matrix Controls, containing human MPO in Calibrator matrix, and five Plasma Controls, containing human MPO in human lithium heparin plasma, with MPO concentrations distributed throughout the calibration range of the assay, according to NCCLS guidelines EP5-A. The nine samples were assayed in duplicate, using a single lot of reagents and Calibrators, on two separate plates per day, for twenty days. A new calibration curve was run in duplicate on each plate. Total precision in plasma samples was 8.2% and within-run precision was 5.5%.
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#### Linearity
Lithium heparin plasma samples spiked to high MPO levels were intermixed with neat plasma samples with low MPO levels to create nine MPO concentrations across and exceeding the anticipated linear range. Linearity of the MPO levels measured in the mixtures was assessed using the polynomial evaluation of linearity as recommended in NCCLS guidelines EP6-A. The CardioMPO Test was linear from 13 pM to 5223 pM MPO, within 60 pM or 9% in this interval.
#### Interfering Substances
The following substances, when tested in plasma containing 3000 pM and 1000 pM MPO, according to NCCLS guidelines EP7-A, were found not to interfere up to the concentrations indicated. Bias of 10% or less was not considered interference.
| Substance tested | Test concentration<br>(mg/L) | Comments |
|-------------------------|------------------------------|----------------------|
| Acetylsalicylic acid | 600 | Toxic dose |
| Albumin | 50000 | High* |
| Amoxicillin | 75 | 3x therapeutic dose |
| Bilirubin, conjugated | 50 | High* |
| Bilirubin, unconjugated | 150 | High* |
| Captopril | 5 | Toxic dose |
| Ceruloplasmin | 600 | High |
| Cholesterol | 1000 | High* |
| DNA | 16.7 | High |
| Fenofibrate | 45 | 3x therapeutic dose |
| Hemoglobin | 1500 | Hemolysis ** |
| Heparin, lithium | 3000 U/L | 3x therapeutic dose |
| Hydrochlorothiazide | 6 | 3x therapeutic dose |
| Hydrocortisone | 0.69 | Toxic dose |
| Ibuprofen | 500 | Toxic dose |
| Indomethacin | 36 | 2x therapeutic dose |
| Isosorbide dinitrate | 0.15 | 3x therapeutic dose |
| Lovastatin | 53 | 2x therapeutic dose |
| Methotrexate | 160 | Therapeutic dose |
| Metoprolol | 5 | Toxic dose |
| Naproxen | 500 | 4x therapeutic dose |
| Niacin | 0.5 | 5x therapeutic dose |
| Nifedipine | 0.4 | 2x therapeutic dose |
| Salicylic acid | 600 | Toxic dose |
| Sodium azide | 0.50% | 5x preservative dose |
| Triglycerides | 5000 | Lipemia |
* High level of interfering substance per NCCLS EP7-A
** Hemoglobin levels of 5000 mg/L produced a bias of >10%. A doseresponse series showed a bias of <10% at <1500 mg/L hemoglobin within a 95% prediction interval.
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#### Interfering Antibodies
Twenty-one plasma samples known to have elevated levels of heterophilic or other potentially interfering antibodies, such as HAMA, RF, anti-MPO p-ANCA, etc., were analyzed for interference in the CardioMPO Test. The mean recovery of MPO from samples containing heterophilic antibodies was 108% with individual recoveries ranging from 89 to 118%. Therefore, no evidence of significant interference was observed due to the heterophilic antibodies tested in the CardioMPO Test.
#### Cross-reactivity
The following potential cross-reactants, tested in both a plasma pool containing MPO and Assay Buffer according to NCCLS guidelines EP7-A, showed no significant cross-reaction in the assay up to the concentrations indicated.
| Substance tested | Concentrations<br>tested (nM) |
|---------------------------|-------------------------------|
| α-1 antrypsin, human | 1250, 125, 12.5 |
| C-reactive protein, human | 543, 54.3, 5.43 |
| Lysozyme, human | 4464, 446.4, 44.64 |
| IgA, human | 417, 41.7, 4.17 |
| Elastase, human | 2500, 250, 25 |
| Lactoperoxidase, bovine | 801, 80.1, 8.01 |
| Lactoferrin, human | 781, 78.1, 7.81 |
| COX1, ovine | 893, 89.3, 8.93 |
| COX2, human | 868, 86.8, 8.68 |
| Thyroid peroxidase, human | 595, 59.5, 5.95 |
| Troponin I, human | 2155, 215.5, 21.55 |
#### Spiking recovery
Fourteen lithium heparin plasma samples were spiked with 509.9, 1016, and 1500 pM MPO and analyzed for recovery. The percent recovery was calculated by dividing the mean measured MPO concentration of the spiked sample by the expected MPO concentration, where the expected MPO concentration was the sum of the measured MPO concentration in the neat plasma sample and the concentration of the MPO spike. The overall recovery of spiked MPO ranged from 89% to 105% with a mean of 97%.
#### Dilution recovery
Thirteen lithium heparin plasma samples were spiked with 1500 pM MPO and diluted 1:2, 1:4, 1:8, and 1:16 with Assay Buffer. The percent recovery was calculated by dividing the mean MPO concentration of the pre-diluted sample multiplied by the dilution factor by the mean MPO concentration of the sample with no pre-dilution. The mean recovery of a 1:2 dilution was 116%, with recoveries ranging from 102% to 131%. The mean recovery at dilutions of 1:4 through 1:16 rose from 132% to 145% due to decreased plasma matrix effects. The PrognostiX CardioMPO Test is formulated to account for matrix effects associated with a 5 µL human plasma sample. PrognostiX does not recommend further dilution of samples with MPO levels exceeding the value of the highest Calibrator should be reported as greater than that level, e.g. > 5000 pM.
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#### Hook Effect
There is no evidence of hook effect in the CardioMPO Test up to 800,000 pM MPO, roughly 150 times greater than the upper end of the reportable range and 500 times greater than the median level of patients in the clinical study.
#### Reference Interval
Plasma samples from a population of apparently healthy blood donors, were evaluated with the CardioMPO Test. A two-stage outlier detection scheme, a Box-Cox transformation followed by a robust outlier detection method, was used to eliminate six outliers. Since there was no significant difference in MPO levels between males (n=145) and females (n=149) after adjustment for outliers, the reference range was estimated from the adjusted normal subject population.
The median MPO level for subjects in the adjusted normal subject population was 193 pM and the range of results was 48 to 924 pM. The non-parametric distribution of mveloperoxidase levels in this normal population vields a two-tailed central 95% reference interval, corrected for the influence of outlier rejection, of 78 - 708 pM. However, in this application the more appropriate single-tailed lower 95% reference interval, again corrected for the influence of the outlier rejection method, is < 539 pM.
#### Summary of Clinical Study
To determine the efficacy of the PrognostiX CardioMPO Test as a predictor of risk for major adverse cardiac events (MACE), MPO levels were measured in 560 banked plasma samples from a prior study of patients presenting to the Emergency Department within 24 hours of the onset of chest pain (Brennan, et al, N Engl J Med 2003; 349:1595-1604). Patients were followed for the development of myocardial infarction, need for revascularization, or death over the next 30-day and 6 month interval. Samples assayed with the PrognostiX CardioMPO Kits were from patients aged 23 to 96 years. Median age was 64. The incidence of MACE was assessed by follow up phone calls at 30 davs and 6 months.
Multivariate logistic-rearession models (SAS version 8.0, SAS Institute) were developed to calculate odds ratios and 95% confidence intervals. The adjusted covariates were age, gender, race, Troponin T (≤0.03 ng/mL vs. >0.03 ng/mL) (McErlean et al. Am J Cardiol 2000;85:421-426), C-reactive Protein (<1 mg/L. >3 mg/L. >3 mg/L) (Brennan et al. N Engl J Med 2003;349:17, 1595-1604), CK-MB (≤8.8 ng/mL vs. >8.8 ng/mL) (McErlean et al. Am J Cardiol 2000;85:421-426), history of smoking, history of diabetes, history of hypertension, and history of high cholesterol. Missing covariate information on some subjects reduced the study population. The risk of MACE in all patients in the ensuing 30-day period increased with increasing quartiles of myeloperoxidase levels. Adjusted odds ratios and the percentage of patients within an MPO quartile with and without MACE at 30 days are shown in the following graph and table.
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### Risk of MACE in All Patients
Image /page/7/Figure/1 description: This image is a bar graph that shows the percentage of patients within a quartile. The x-axis shows the MPO by Quartile (pM) with the ranges <1082, 1082-1853, 1854-2990, and >2990. The y-axis shows the percentage of patients within a quartile, ranging from 0 to 100. The graph compares the percentage of patients with MACE and without MACE in each quartile.
| MPO (pM) | MACE at 30 days, All Patients (n=523) | | | |
|------------|---------------------------------------|-----------|------------|-----------|
| | <1082 | 1082-1853 | 1854-2990 | >2990 |
| Odds Ratio | 1.0 | 2.5 | 2.8 | 3.3 |
| 95% CI | NA | 1.3-4.8 | 1.5-5.6 | 1.7-6.4 |
| p value | | p = 0.007 | p = 0.0021 | p < 0.001 |
*In each analysis the first quartile served as the reference group
Similar analysis of patients that were persistently negative for Troponin T (≤0.03 ng/mL) also revealed a significantly higher risk of MACE for patients with plasma MPO levels in higher quartiles.
Image /page/7/Figure/5 description: This bar graph shows the percentage of patients within a quartile. The x-axis shows the MPO by Quartile (pM) with values of <1082, 1082-1853, 1854-2990, and >2990. The y-axis shows the percentage of patients within a quartile from 0 to 100. The graph compares the percentage of patients with MACE and No MACE for each quartile.
Risk of MACE in Patients Persistently Negative for Troponin T
| | MACE at 30 days, TnT negative Patients (n=304) | | | |
|------------|------------------------------------------------|------------|-----------|-----------|
| MPO (pM) | <1082 | 1082-1853 | 1854-2990 | >2990 |
| Odds Ratio | 1.0 | 3.4 | 4.1 | 6.9 |
| 95% CI | NA | 1.2-9.4 | 1.5-11.4 | 2.5-19.2 |
| p value | | p = 0.0194 | p = 0.007 | p < 0.001 |
*In each analysis the first quartile served as the reference group
It should be noted that different cut-off points may be appropriate for different clinical populations.
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#### Conclusions
The PrognostiX CardioMPO Test is acceptably precise, linear, accurate, and is not subject to appreciable cross-reactivity or interference. The detection limit of 13 pM is acceptable for the intended use of this test. The test is reproducible across several reagent lots, several instruments and multiple operators and should provide reliable and reproducible results when used by professional clinical laboratories.
The clinical evaluation of the CardioMPO Test involved re-analysis of 560 banked lithium heparin plasma samples from an earlier study of patients with chest pain. The results of this study demonstrate that plasma levels of MPO are associated with risk of myocardial infarction, revascularization, and death. The performance testing and clinical data support the safety and effectiveness of the CardioMPO Test as an aid in evaluating patients presenting with chest pain that are at risk for major adverse cardiac events, including myocardial infarction, need for revascularization, or death.
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Image /page/9/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 perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, represented by three curved lines that suggest wings or feathers.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
MAY 1 0 2005
Thomas M Jackson, Ph.D. Director of Product Development Prognostix, Inc. 10265 Carnegie Avenue Cleveland, OH 44106
k050029 Re:
Trade/Device Name: CardioMPO™M Test Regulation Number: 21 CFR 866.5600 Regulation Name: Low- density lipoprotein immunological test system Regulatory Class: Class II Product Code: NTV, JJX, JIS Dated: April 19, 2005 Received: April 20, 2005
Dear Dr. Jackson:
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,
Jean M. Cooper, MS, DUM
Jean M. Cooper, MS, 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
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# PrognostiX, Inc. 510(k) Notification for CardioMPO
# Indications for Use
510(k) Number (if known): K050029
Device Name:__CardioMPO™ Test
Indications for Use:
The CardioMPO™ Test is comprised of the CardioMPO Reagent Kit, the CardioMPO Calibrator Kit, and the CardioMPO Control Kit.
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 PrognostiX CardioMPO Calibrator Kit is intended for use with the CardioMPO Reagent Kit to establish a calibration curve that is used to determine MPO concentration.
The PrognostiX CardioMPO Control Kit is intended for use with the CardioMPO Reagent Kit as an assayed quality control sample to monitor and evaluate the precision and accuracy of the CardioMPO Test.
Prescription Use _ X (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)
nce of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
**Division Sign-Off**
Office of In Vitro Diagnostic
Device Evaluation and Safety
51000 K050029
Submitted on: 05 January 2005
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