(561 days)
Not Found
No
The device description and performance studies focus on a standard enzyme immunoassay method for measuring myeloperoxidase. There is no mention of AI or ML in the text.
No.
The device is an in vitro diagnostic test used to measure a biomarker (myeloperoxidase) in human plasma, which aids in evaluating patients' risk for cardiac events. It does not provide treatment or directly alleviate symptoms.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MPO reagent cartridge, calibrator, and control are "in vitro diagnostic tests" or "in vitro diagnostic products." Furthermore, it describes their use for the quantitative measurement of myeloperoxidase in human plasma to evaluate patients at risk for major adverse cardiac events, which is a clear diagnostic purpose.
No
The device description clearly outlines a "one-step enzyme immunoassay" involving reagents, particles, magnetic separation, washing, and measurement of color change at a specific wavelength. This indicates a physical, chemical, and optical process, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the MPO Flex® reagent cartridge, MPO Calibrator, and MPO Control are "in vitro diagnostic test" or "in vitro diagnostic product". This is the primary indicator that the device falls under the category of IVDs.
Furthermore, the description of the device and its use in measuring myeloperoxidase in human plasma for evaluating patients with chest pain aligns with the definition of an in vitro diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NTV, JIT, JIT, JJX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key 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.
Sample size: 139
Slope: 1.03
Intercept: 91.8
Correlation Coefficient: 0.88
Plasma Study Results (Comparison of matched EDTA, sodium heparin and lithium heparin plasma samples tested with the Dimension® MPO method):
Lithium Heparin vs. EDTA: Slope 1.01, Intercept -19.3, Correlation Coefficient 0.997, N 59
Lithium Heparin vs. Sodium Heparin: Slope 0.96, Intercept -7.2, Correlation Coefficient 0.999, N 49
Reproducibility:
Siemens Healthcare Diagnostics Level 1 Control (Mean 428.4 ng/mL): Repeatability SD 16.3 ng/mL, %CV 3.8; Within Lab SD 20.4 ng/mL, %CV 4.8
Siemens Healthcare Diagnostics Level 2 Control (Mean 3643.7 ng/mL): Repeatability SD 121 ng/mL, %CV 3.3; Within Lab SD 131.6 ng/mL, %CV 3.6
EDTA Plasma Pool (Mean 494.1 ng/mL): Repeatability SD 10.9 ng/mL, %CV 2.2; Within Lab SD 17.2 ng/mL, %CV 3.5
Heparin Plasma Pool (Mean 1465 ng/mL): Repeatability SD 43.6 ng/mL, %CV 3; Within Lab SD 53.3 ng/mL, %CV 3.6
Clinical Study Results:
Sample size: 400 patients who presented to the Emergency Department or acutely to out-patient facilities with chest pain or equivalent symptoms suggestive of ACS. Patients assessed for MACE (myocardial infarction, revascularization, or death) at 30 days and 6 months.
Logistic-regression models were used to calculate odds ratios and 95th percentile confidence intervals for MPO.
MACE at 30 Days:
MPO (pmol/L) Q1 (94 - 581): Odds Ratio 1.00, Adjusted Odds Ratio 1.00
MPO (pmol/L) Q2 (582 - 894): Odds Ratio 1.36 (95% CI 0.55 - 3.40), Adjusted Odds Ratio 1.41 (95% CI 0.51 - 3.89)
MPO (pmol/L) Q3 (895 - 1657): Odds Ratio 2.63 (95% CI 1.14 - 6.06), Adjusted Odds Ratio 3.03 (95% CI 1.19 - 7.76)
MPO (pmol/L) Q4 (1658 - 5000): Odds Ratio 4.29 (95% CI 1.91 - 9.61), Adjusted Odds Ratio 4.31 (95% CI 1.62 - 11.50)
MACE at 6 Months:
MPO (pmol/L) Q1 (94 – 581): Odds Ratio 1.00, Adjusted Odds Ratio 1.00
MPO (pmol/L) Q2 (582 – 894): Odds Ratio 0.99 (95% CI 0.41 – 2.40), Adjusted Odds Ratio 0.98 (95% CI 0.37 – 2.56)
MPO (pmol/L) Q3 (895 – 1657): Odds Ratio 2.10 (95% CI 0.95 – 4.63), Adjusted Odds Ratio 2.21 (95% CI 0.93 – 5.26)
MPO (pmol/L) Q4 (1658 – 5000): Odds Ratio 4.12 (95% CI 1.95 – 8.73), Adjusted Odds Ratio 3.66 (95% CI 1.50 – 8.94)
AUC values when examining added effect of MPO over clinical and demographic covariates:
Race: 0.62 (0 days), 0.61 (30 days), 0.62 (180 days)
Race & MPO: 0.72 (0 days), 0.71 (30 days), 0.71 (180 days)
Difference (95% CI): -0.10 (-0.15 to -0.04) (0 days), -0.10 (-0.15 to -0.04) (30 days), -0.09 (-0.14 to -0.04) (180 days)
p-value: 0.0010 (0 days), 0.0011 (30 days), 0.0004 (180 days)
Sex: 0.59 (0 days), 0.60 (30 days), 0.59 (180 days)
Sex & MPO: 0.73 (0 days), 0.74 (30 days), 0.73 (180 days)
Difference (95% CI): -0.14 (-0.21 to -0.07) (0 days), -0.14 (-0.20 to -0.08) (30 days), -0.14 (-0.20 to -0.08) (180 days)
p-value: 633 pmol/L than for MPO ≤ 633 pmol/L when Troponin
§ 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).
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 | 633 pmol/L than for MPO 633 pmol/L when Troponin 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).
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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