(263 days)
Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.
The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology
The Siemens Healthcare Diagnostics Dimension Vista® MMB Assay is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma for confirmation of acute myocardial infarction. The K143720 submission describes the modification of the Dimension Vista® 1500 System with a new photomultiplier tube (PMT) and its impact on the MMB assay.
Here's an analysis of the acceptance criteria and study data:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a separate section with pass/fail thresholds. Instead, it presents performance characteristics (method comparison, precision, linearity, LoB, LoD, LoQ) for the modified system and implicitly assumes that these demonstrate substantial equivalence to the predicate device. For this response, I will interpret the performance data provided as the "reported device performance" and infer the implied "acceptance criteria" based on the comparison to the existing predicate and typical performance expectations for such devices.
| Performance Characteristic | Implicit Acceptance Criteria (Inferred) | Reported Device Performance (Modified System) |
|---|---|---|
| Method Comparison | Close agreement with predicate device (slope near 1, intercept near 0, high correlation). | Passing-Bablok Regression: Slope = 0.99 (95% CI: 0.98 - 0.99), Intercept = -0.16 ng/dL (95% CI: -0.20 - -0.10). Linear Regression: Slope = 0.97, Intercept = 0.64, Correlation Coefficient = 0.999. (Range: 1.0 - 274.0 ng/mL) |
| Precision (Repeatability) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.15, %CV = 1.72. QC2 (24.13 ng/mL): SD = 0.36, %CV = 1.50. QC3 (70.73 ng/mL): SD = 0.91, %CV = 1.28. Plasma Pool 1 (3.26 ng/mL): SD = 0.15, %CV = 4.71. Plasma Pool 2 (6.15 ng/mL): SD = 0.15, %CV = 2.45. |
| Precision (Within-Lab) | Low coefficient of variation (CV) at various concentration levels. | QC1 (8.66 ng/mL): SD = 0.22, %CV = 2.59. QC2 (24.13 ng/mL): SD = 0.56, %CV = 2.30. QC3 (70.73 ng/mL): SD = 1.27, %CV = 1.80. Plasma Pool 1 (3.26 ng/mL): SD = 0.19, %CV = 5.99. Plasma Pool 2 (6.15 ng/mL): SD = 0.21, %CV = 3.40. |
| Linearity | Demonstrated linearity across the assay range (slope near 1, intercept near 0, high correlation). | Range: 0 – 313.5 ng/mL. Slope = 1.004, Intercept = 0.170, Correlation Coefficient = 0.999. |
| Limit of Blank (LoB) | Acceptably low. | 0.4 ng/mL. |
| Limit of Detection (LoD) | Acceptably low (proportion of false positives/negatives < 5%). | 0.8 ng/mL (α < 5%, β < 5%, based on 260 determinations). |
| Limit of Quantitation (LoQ) | CV ≤ 20% at a low concentration. | CV ≤ 20% at a mass creatine kinase MB isoenzyme concentration ≤ 1.0 ng/mL. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 111 native de-identified human serum and plasma samples were used for the method comparison study.
- Data Provenance: The samples were described as "native de-identified human serum and plasma samples," implying they were clinical samples. The country of origin is not explicitly stated, but given the manufacturer (Siemens Healthcare Diagnostics Inc. Newark, DE) and the submission to the FDA, it is likely the studies were conducted in the US or using samples relevant to the US market. The study is prospective in the sense that the samples were analyzed on both the predicate and modified devices specifically for this comparison study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A - This device is an in vitro diagnostic assay that provides a quantitative measurement of an analyte (CK-MB). The "ground truth" for method comparison and performance evaluation is typically established by comparing the device's results to a legally marketed predicate device, a reference method, or by analyzing samples with known concentrations (e.g., in linearity or precision studies using controls or spiked samples). There are no human "experts" establishing a "ground truth" diagnosis for the purpose of validating the assay's analytical performance; rather, the predicate device serves as the comparator.
4. Adjudication Method for the Test Set
N/A - No human adjudication was performed or is relevant for this type of analytical performance study. The comparison is objective, based on quantitative measurements against a predicate device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for devices where human interpretation of images or other qualitative data is involved, and the AI's role is to assist human readers. The Dimension Vista® MMB Assay is an IVD device that provides quantitative measurements, not requiring interpretation by multiple readers in an MRMC setting for its analytical validation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Yes, the studies presented are effectively "standalone" performance evaluations of the Dimension Vista® MMB Assay on the modified Dimension Vista® 1500 System. The device's performance (accuracy, precision, linearity, limits) is assessed purely analytically, without human intervention in the measurement process itself, beyond sample loading and general system operation. The comparison is between two automated systems (predicate vs. modified).
7. The Type of Ground Truth Used
The "ground truth" for the test set (111 samples) in the method comparison study was the measurements obtained from the predicate device (Dimension Vista® MMB assay on the Dimension Vista® 1500 Integrated System K051087). For precision, linearity, LoB, LoD, and LoQ studies, the ground truth was established by using characterized control materials, pooled plasma samples, or serially diluted samples with known theoretical concentrations.
8. The Sample Size for the Training Set
N/A - This device is not an AI/ML-driven algorithm that requires a "training set" in the conventional sense of machine learning. The system is based on chemiluminescent immunoassay technology and instrumental measurements, not a learned algorithm that processes data like images. Therefore, the concept of a "training set" for an algorithm is not applicable here.
9. How the Ground Truth for the Training Set Was Established
N/A - As explained above, there is no "training set" for this type of IVD device.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2015
SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN DRAY-LYONS REGULATORY AND CLINICAL AFFAIRS SPECIALIST 500 GBC DRIVE, P.O. BOX 6101 NEWARK, DE 19714
Re: K143720
Trade/Device Name: Dimension Vista MMB Assay, Dimension Vista 1500 System Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHY, JJE Dated: July 31, 2015 Received: August 3, 2015
Dear Ms. Kathleen Dray-Lyons:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the
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electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerelv vours.
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143720
Device Name
· Dimension Vista® MMB (Mass creatine kinase MB isoenzyme) Assay
- · Dimension Vista® 1500 System
Indications for Use (Describe)
Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass
creatine kinase MB isoenzyme in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Siemens Healthcare Diagnostics
Dimension® Vista MMB Assay on the Dimension® Vista 1500 System 510(k) Premarket Notification
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 510(k) number is: K143720
-
- Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation
| Manufacturer: | Siemens Healthcare Diagnostics Inc.500 GBC DriveNewark, DE 19714 |
|---|---|
| Contact Information: | Siemens Healthcare Diagnostics Inc.P.O. Box 6101Newark, DE 19714Attn: Kathleen Dray-LyonsTel: 781-826-4551Email: kathleen.a.dray-lyons@siemens.com |
| Date of Preparation: | September 15, 2015 |
2. Device Names:
- o Dimension Vista® MMB (Mass creatine kinase MB isoenzyme)
- Dimension Vista® 1500 System o
Classifications:
- 21 CFR §862.1215; Creatine phosphokinase/creatine kinase or o isoenzymes test system, Class II
- 21 CFR §862.2160; Analyzer, chemistry (photometric, discrete), For o Clinical Use, Class I
Product Codes:
- o JHY
- o JJE
Panels:
- o Chemistry
3. Identification of the Predicate Devices:
Dimension Vista® MMB (Mass creatine kinase MB isoenzyme) - K970343 Dimension Vista® 1500 Integrated System - K051087
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Siemens Healthcare Diagnostics
Dimension® Vista MMB Assay on the Dimension® Vista 1500 System 510(k) Premarket Notification
Device Description: 4.
Dimension Vista® MMB Assay:
The MMB method is a homogeneous sandwich chemiluminescent immunoassay based on LOCI® technology. LOC10 reagents include two synthetic bead reagents and a biotinylated antimass creatine kinase MB isoenzvme monoclonal antibody fragment. The first bead reagent (Sensibeads) is coated with streptavidin and contains photosensitive dye. The second bead reagent (Chemibeads) is coated with a second anti-mass creatine kinase MB isoenzyme monoclonal antibody and contains chemiluminescent dye. Sample is incubated with Chemibeads and biotinylated antibody to form a beadmass creatine kinase MB isoenzyme-biotinylated antibody sandwich. Sensibeads are added and bind to the biotin to form bead-pair immunocomplexes. Illumination of the complex by light at 680 nm generates singlet oxygen from Sensibeads which diffuses into the Chemibeads, triggering a chemiluminescent reaction. The resulting signal is measured at 612 nm and is a direct function of the mass creatine kinase MB isoenzyme concentration in the sample.
The Dimension Vista® 1500 System:
The Dimension Vista® 1500 System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged Flex reagent test cartridges to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric, turbidimetric, chemiluminescence, nephelometric, and integrated ion selective multisensor detection technologies for clinical use. The Dimension Vista® 1500 System can analyze up to 1500 tests/hour (typical, depending on the method mix) using a variety of analytical detection capabilities. Dimension Vista® 1500 System detection technologies are: Photometric, Turbidimetric, Chemiluminescent, Nephelometric, Multisensor, ion selective technology
5. Device Intended Use:
Dimension Vista® MMB Assay:
The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme (EC 2.7.3.2) in human serum and plasma on the Dimension Vista® System for confirmation of acute myocardial infarction.
Dimension Vista® 1500 System:
The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista® 1500 System chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use.
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6. Medical device to which equivalence is claimed:
The modified Dimension Vista® MMB test system for use on the Dimension Vista® 1500 System with the new photomultiplier tube (PMT) is substantially equivalent to the currently marketed Dimension Vista®MMB assay (K970343) on the Dimension Vista® 1500 Integrated System (K051087).
A comparison of the similarities and differences between the devices is provided in the following tables:
| Feature | PredicateDimension Vista® MMB Flex®reagent cartridge | ProposedDimension Vista® MMB Flex®reagent cartridge |
|---|---|---|
| Intended Use | Dimension Vista®MMB Assay:The MMB method is an in vitrodiagnostic test for thequantitative measurement ofmass creatine kinase MBisoenzyme (EC 2.7.3.2) inhuman serum and plasma onthe Dimension Vista® System forconfirmation of acute myocardialinfarction. | Same |
| Assay Range | 0.5–300 ng/mL | 1.0 – 300 ng/mL |
| Sample Type | Human serum and plasma | Same |
| Technology | LOCI® technology | Same |
| Sample size | 5 µL | Same |
| Reagents andantibody | Biotinylated monoclonalantibody, mass creatine kinaseMB isoenzyme Chemibeads,Streptavidin Sensibeads, assaybuffer | Same |
Dimension Vista® MMB Assay Similarities and Differences
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| Predicate | Propose Device | |
|---|---|---|
| Feature | Dimension Vista® 1500Integrated System(Current) | Dimension Vista® 1500 System(Modified with new PMT) |
| Dimension Vista® 1500 IntegratedSystem | ||
| Intended Use | The Siemens HealthcareDiagnostics Dimension Vista®Integrated System is an in vitrodiagnostic device intended toduplicate manual analyticalprocedures such as pipetting,mixing, heating, and measuringspectral intensities to determine avariety of analytes in human bodyfluids. Dimension Vista® chemicaland immunochemical applicationsuse photometric, turbidimetric,chemiluminescence, nephelometricand integrated ion-selectivemultisensor technology for clinicaluse. | Same |
| System Control | Fully automated and controlled bymicroprocessors | Same |
| User Interface | Contains graphical user interfacescreens | Same |
| DetectionTechnologies | Contains a photometer and amultisensor electrode forperforming photometric tests, andelectrolyte tests. It also has aLOCI® module for immunoassaytests. | Same |
| Reagents | Uses pre-packaged Flex® reagentcartridges. Reagents are hydratedand stored on-board the instrument | Same |
| Temperature | Reagents are stored at 2 - 8°C.Reactions are controlled at 37°C. | Same |
| Operating System | Windows Operating System | Same |
| Photomultiplier tubeused to count thesignal in thechemiluminescentmethods | Contains a faceplate❖ Contains a photocathode❖ Contains an anode at end | Same |
Similarities between the predicate Dimension Vista® 1500 System and the
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Siemens Healthcare Diagnostics
Dimension® Vista MMB Assay on
the Dimension® Vista 1500 System 510(k) Premarket Notification
Differences between the predicate Dimension Vista® 1500 System and the Modified Dimension Vista® 1500 Integrated System with new PMT:
| Feature | PredicateDimension Vista® 1500Integrated System (Current) | Propose DeviceDimension Vista® 1500(Modified with new PMT) |
|---|---|---|
| Photomultiplier tubeused to count thesignal in thechemiluminescentmethods | Vendor: ExcelitasMultiplier channel: Enhanced GlassSingle Surface Tube | Vendor: HamamatsuMultiplier channel: multiple dynodes |
| Component AreaNetwork (CANBoard) | Included in current DimensionVista® 1500 Integrated System | Updated to also be compatible withnew PMT |
7. Performance Characteristics
Method Comparison:
A split sample method comparison between the Dimension Vista® MMB assay (K970343) on the modified Dimension Vista® 1500 System with the new PMT and the predicate Dimension Vista® 1500 Integrated System (K051087), was performed with 111 native de-identified human serum and plasma samples across the assay range (1.0 to 300 ng/mL). Analysis of the results yielded the following:
| Method | PredicateSampleRange(ng/mL) | Slope(95% CI) | Intercept ng/dL(95% CI) | CorrelationCoefficient(std linearregression) | n |
|---|---|---|---|---|---|
| MMB(PassingBablok) | 1.0 - 274.0 | 0.99(0.98 - 0.99) | -0.16(-0.20 - -0.10) | Notapplicable | 111 |
| MMB(linearregression) | 1.0 - 274.0 | 0.97 | 0.64 | 0.999 | 111 |
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Precision:
Reproducibility testing was conducted in accordance with the CLSI/NCCLS Approved Guideline for User Evaluation of Precision Performance of Clinical Chemistry Devices EP5-A2. For each test level, a single test from two independent cups was analyzed twice per day for 20 days. The repeatability and within-lab standard deviations were calculated by the analysis of variance method.
Typical precision observed on the modified Dimension Vista® 1500 System is summarized below:
| Material | Meanng/mL | Repeatability | Within-Lab Precision | ||
|---|---|---|---|---|---|
| SD | %CV | SD | %CV | ||
| Thermo Cardiolmmune XL LiquidAssayed Cardiac Marker Control | |||||
| QC1 | 8.66 | 0.15 | 1.72 | 0.22 | 2.59 |
| QC2 | 24.13 | 0.36 | 1.50 | 0.56 | 2.30 |
| QC3 | 70.73 | 0.91 | 1.28 | 1.27 | 1.80 |
| PlasmaPool 1 | 3.26 | 0.15 | 4.71 | 0.19 | 5.99 |
| PlasmaPool 2 | 6.15 | 0.15 | 2.45 | 0.21 | 3.40 |
Modified Dimension Vista® 1500 System (new PMT)
Linearity
Linearity across the assay range (1.0 to 300 ng/mL) was confirmed according to CLSI EP6-A. Evaluation of the Linearity of Quantitative Measurement, by testing a sample with a high concentration of MMB. This sample was serially diluted with a low concentration sample producing ten test samples ranging from 0 to 313.5 ng/mL. Each dilution was assayed in replicates of five. Data were analyzed using linear regression analysis [x-axis: theoretical concentration versus y-axis: measured concentration]. 200 - and 3rd -order polynomial regressions of the mean observed analyte values vs. expected concentrations were generated. A summary of the linearity data is presented below.
| Range ofSamples | Slope | Intercept | CorrelationCoefficient. | N |
|---|---|---|---|---|
| 0 – 313.5 ng/mL | 1.004 | 0.170 | 0.999 | 10 |
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LoB, LoD and LoQ
The Limit of Blank (LoB) was calculated to be 0.4 ng/mL [0.4 µg/L]. LoD is the lowest concentration of analyte that can be detected reliably, while LoB is the highest concentration that is likely to be observed for a blank sample. The Limit of Detection (LoD) was determined to be 0.8 ng/mL [0.8 µg/L]. The proportions of false positives (α) was less than 5% and false negatives (β) less than 5%, based on 260 determinations, with 60 blank replicates and 200 low level replicates.
The limit of quantitation (LoQ) corresponds to a within-laboratory imprecision coefficient of variation (CV) of ≤ 20% at a mass creatine kinase MB isoenzyme concentration ≤ 1.0 ng/mL [1.0 µg/L]. Refer to Attachment 1 and 2 for a copy of the LOB, LOD and LOQ protocol and line data respectively.
Specificity
Specificity studies were not performed, because specificity is antibody dependent and there were no changes to the MMB assay antibody or concentration of the antibody conjuqates. In addition, the Dimension Vista® 1500 System new photomultiplier tube, which is used to count the signal, would not impact assay specificity. Refer to the original 510(k) clearance, K970343 for the specificity data.
8. Conclusion:
The proposed modified Dimension Vista® MMB test system for use on the Dimension Vista® 1500 System is substantially equivalent to the current legally marketed device based on intended use, principle and the performance characteristics above.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.