(561 days)
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 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.
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.
The provided text describes the Siemens Healthcare Diagnostics Dimension MPO Flex® reagent cartridge and its associated calibrator and control. The information focuses on demonstrating substantial equivalence to a predicate device, the PrognostiX CardioMPO™ Enzyme Immunoassay. The study does not involve an AI device, therefore, some of the requested information such as MRMC study, and number of experts to establish ground truth is not applicable.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria (from predicate device) and Reported Device Performance:
| Feature | Predicate Device (PrognostiX MPO) Acceptance Criteria (as reported) | Dimension® MPO Flex® (Reported Performance) |
|---|---|---|
| Intended Use | Quantitative determination of myeloperoxidase in human plasma to evaluate patients at risk for major adverse cardiac events (MACE). | Quantitative measurement of myeloperoxidase (MPO) in human plasma on the Dimension® clinical chemistry system, for evaluating patients at risk for MACE. |
| 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 |
| Odds Ratio (Clinical) | Increases from 1.0 to a max. of 3.3 across 4 quartiles | Increases from 1.0 to a max. of 4.29 across 4 quartiles (30 days MACE) |
| Expected Values | ≤ 539 pmol/L (presumably a reference range) | 20 - 633 pmol/L (presumably a reference range) |
| Analytical Specificity | < 0.15% cross-reactivity for listed substances | < 0.15% cross-reactivity for most listed substances, < 0.4% for Eosinophil Peroxidase |
2. Sample Size Used for the Test Set and Data Provenance:
- Method Comparison (Split-sample):
- Sample Size: 139 patient samples.
- Data Provenance: Not explicitly stated, but the mention of "patient samples" and "lithium heparin patient sample" suggests a collection from clinical settings. The type of study design for this (e.g., retrospective vs. prospective) is not specified.
- Plasma Study (Comparative Specimen):
- Sample Size: 59 samples for Lithium Heparin vs. EDTA, 49 samples for Lithium Heparin vs. Sodium Heparin.
- Data Provenance: Not explicitly stated, but implies patient samples as different plasma types are being compared.
- Reproducibility: Not applicable for a test set in the same way as clinical validation.
- Clinical Study Results:
- Sample Size: 400 patients.
- Data Provenance: EDTA plasma samples obtained from patients who presented to the Emergency Department or acutely to out-patient facilities with chest pain or equivalent symptoms suggestive of ACS. This appears to be a prospective collection tied to patient enrollment, followed by a retrospective analysis of MACE at 30 days and 6 months.
- Country of Origin: Not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not Applicable. This is an in vitro diagnostic device measuring a biomarker (MPO). The "ground truth" for the clinical study is the occurrence of Major Adverse Cardiac Events (MACE), defined as myocardial infarction, revascularization, or death, which are objective clinical outcomes, not interpretations by experts.
4. Adjudication Method for the Test Set:
- Not Applicable. As mentioned above, the "ground truth" (MACE occurrence) is based on objective clinical outcomes, not subjective interpretations requiring adjudication.
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 an in vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting images or data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device itself is a standalone immunoassay for quantitative measurement of MPO. There is no "algorithm" in the sense of AI performing a diagnostic task. The clinical study evaluates the performance of the MPO measurement in predicting MACE, which is an inherent property of the biomarker itself, not an algorithmic interpretation.
7. The Type of Ground Truth Used:
- Clinical Outcomes/Pathology:
- For the clinical study, the ground truth was defined by Major Adverse Cardiac Events (MACE) at 30 days and 6 months. MACE was specifically defined as:
- Myocardial infarction
- Revascularization (coronary artery bypass graft, percutaneous coronary intervention, or placement of cardiac stent)
- Death
- These are objective, outcome-based clinical endpoints.
- For the clinical study, the ground truth was defined by Major Adverse Cardiac Events (MACE) at 30 days and 6 months. MACE was specifically defined as:
8. The Sample Size for the Training Set:
- Not Applicable. This filing describes an in vitro diagnostic device based on an immunoassay. There is no concept of a "training set" in the context of an immunoassay, as there is with machine learning or AI models. The device's performance characteristics (e.g., reportable range, specificity, reproducibility) are established through analytical studies, and its clinical utility is demonstrated through a clinical study.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for this type of device, ground truth establishment for a training set is not relevant.
{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. PlummerSiemens Healthcare DiagnosticsP.O. Box 6101Newark, 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 Kitis an enzyme immunoassayintended for the quantitativedetermination ofmyeloperoxidase in humanplasma, to be used inconjunction with clinicalhistory, ECG and cardiacbiomarkers to evaluate patientspresenting with chest pain thatare at risk for major adversecardiac events, includingmyocardial infarction, need forrevascularization, or death. | The MPO method is an in vitrodiagnostic test for the quantitativemeasurement of myeloperoxidase(MPO) in human plasma on theDimension® clinical chemistry systemwith the heterogeneous immunoassaymodule. Myeloperoxidasemeasurements may be used inconjunction with clinical history, ECG,and cardiac biomarkers to evaluatepatients presenting with chest pain thatare at risk for major adverse cardiacevents, 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 effectup to 800,000 pmol/L | No high dose effectup to 800,000 pmol/L |
| Clinical study results | Odds ratio increases from 1.0 toa 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 rabbitand goat monoclonal | Siemens HealthcareDiagnostics mousemonoclonal |
| Calibration Interval | Calibration curve using sixlevels updated for each run. | Calibration curve updated foreach lot, using five levelsevery 30 days with the samereagent lot. |
| Sample Volume | 5 uL | 30 uL |
| Sample | Lithium Heparin Plasma | EDTA, Li or Na sodiumheparin plasma |
| Controls | 3 level; human MPO inlithium 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.
| PrognostiXSampleRange | Dimension®SampleRange | n | Slope | Intercept | CorrelationCoefficient |
|---|---|---|---|---|---|
| 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 | CorrelationCoefficient | 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 HealthcareDiagnostics Level 1 Control | 428.4 | 16.3 | 3.8 | 20.4 | 4.8 | |
| Siemens HealthcareDiagnostics 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 OddsRatio | 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 OddsRatio | 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
§ 866.5600 Low-density lipoprotein immunological test system.
(a)
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.(b)
Classification. Class II (performance standards).