(263 days)
No
The description focuses on standard immunoassay technology and automated laboratory system functions, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is an in vitro diagnostic test system used for quantitative measurement of an enzyme in human body fluids to aid in the confirmation of acute myocardial infarction. It does not provide any treatment or therapy.
Yes
The text explicitly states that the "MMB method is an in vitro diagnostic test" and the "Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device."
No
The device description clearly details a physical instrument system (Dimension Vista® 1500 System) that performs analytical procedures using various detection technologies (photometric, turbidimetric, chemiluminescence, nephelometric, multisensor, ion selective technology). The MMB assay is a reagent used with this hardware system. This is not a software-only device.
Yes, both the Dimension Vista® MMB Assay and the Dimension Vista® 1500 System are explicitly stated to be In Vitro Diagnostic (IVD) devices.
Here's why:
- Dimension Vista® MMB Assay: The "Intended Use / Indications for Use" section clearly states: "The MMB method is an in vitro diagnostic test for the quantitative measurement of mass creatine kinase MB isoenzyme in human serum and plasma..."
- Dimension Vista® 1500 System: The "Intended Use / Indications for Use" section clearly states: "The Siemens Healthcare Diagnostics Dimension Vista® 1500 System is an in vitro diagnostic device intended to duplicate manual analytical procedures..."
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JHY, JJE
Device Description
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 isoenzymebiotinylated 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
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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).
Results: For MMB (Passing Bablok) slope was 0.99 (95% CI: 0.98 - 0.99) and intercept was -0.16 ng/dL (95% CI: -0.20 - -0.10). For MMB (linear regression) slope was 0.97 and intercept was 0.64, with a correlation coefficient of 0.999.
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.
Results: For QC1 (mean 8.66 ng/mL), repeatability SD was 0.15 (%CV 1.72) and within-lab precision SD was 0.22 (%CV 2.59). For QC2 (mean 24.13 ng/mL), repeatability SD was 0.36 (%CV 1.50) and within-lab precision SD was 0.56 (%CV 2.30). For QC3 (mean 70.73 ng/mL), repeatability SD was 0.91 (%CV 1.28) and within-lab precision SD was 1.27 (%CV 1.80). For Plasma Pool 1 (mean 3.26 ng/mL), repeatability SD was 0.15 (%CV 4.71) and within-lab precision SD was 0.19 (%CV 5.99). For Plasma Pool 2 (mean 6.15 ng/mL), repeatability SD was 0.15 (%CV 2.45) and within-lab precision SD was 0.21 (%CV 3.40).
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.
Results: For the range 0 – 313.5 ng/mL, the slope was 1.004, intercept was 0.170, and correlation coefficient was 0.999.
LoB, LoD and LoQ:
The Limit of Blank (LoB) was calculated to be 0.4 ng/mL [0.4 µg/L]. 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].
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are stacked slightly on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
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
1
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
2
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 Drive
Newark, DE 19714 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Siemens Healthcare Diagnostics Inc.
P.O. Box 6101
Newark, DE 19714
Attn: Kathleen Dray-Lyons
Tel: 781-826-4551
Email: 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
4
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.
5
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 | Predicate
Dimension Vista® MMB Flex®
reagent cartridge | Proposed
Dimension Vista® MMB Flex®
reagent cartridge |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| 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. | 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 and
antibody | Biotinylated monoclonal
antibody, mass creatine kinase
MB isoenzyme Chemibeads,
Streptavidin Sensibeads, assay
buffer | Same |
Dimension Vista® MMB Assay Similarities and Differences
6
| Predicate | Propose Device | |
|---|---|---|
| Feature | Dimension Vista® 1500 | |
| Integrated System | ||
| (Current) | Dimension Vista® 1500 System | |
| (Modified with new PMT) | ||
| Dimension Vista® 1500 Integrated | ||
| System | ||
| Intended Use | The Siemens Healthcare | |
| Diagnostics Dimension Vista® | ||
| Integrated 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® chemical | ||
| and immunochemical applications | ||
| use photometric, turbidimetric, | ||
| chemiluminescence, nephelometric | ||
| and integrated ion-selective | ||
| multisensor technology for clinical | ||
| use. | Same | |
| System Control | Fully automated and controlled by | |
| microprocessors | Same | |
| User Interface | Contains graphical user interface | |
| screens | Same | |
| Detection | ||
| Technologies | Contains a photometer and a | |
| multisensor electrode for | ||
| performing photometric tests, and | ||
| electrolyte tests. It also has a | ||
| LOCI® module for immunoassay | ||
| tests. | Same | |
| Reagents | Uses pre-packaged Flex® reagent | |
| cartridges. Reagents are hydrated | ||
| and 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 tube | ||
| used to count the | ||
| signal in the | ||
| chemiluminescent | ||
| methods | Contains a faceplate | |
| ❖ Contains a photocathode | ||
| ❖ Contains an anode at end | Same |
Similarities between the predicate Dimension Vista® 1500 System and the
7
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 | Predicate
Dimension Vista® 1500
Integrated System (Current) | Propose Device
Dimension Vista® 1500
(Modified with new PMT) |
|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------|
| Photomultiplier tube
used to count the
signal in the
chemiluminescent
methods | Vendor: Excelitas
Multiplier channel: Enhanced Glass
Single Surface Tube | Vendor: Hamamatsu
Multiplier channel: multiple dynodes |
| Component Area
Network (CAN
Board) | Included in current Dimension
Vista® 1500 Integrated System | Updated to also be compatible with
new 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 | Predicate
Sample
Range
(ng/mL) | Slope
(95% CI) | Intercept ng/dL
(95% CI) | Correlation
Coefficient
(std linear
regression) | n |
|-------------------------------|-----------------------------------------|-----------------------|-----------------------------|----------------------------------------------------------|-----|
| MMB
(Passing
Bablok) | 1.0 - 274.0 | 0.99
(0.98 - 0.99) | -0.16
(-0.20 - -0.10) | Not
applicable | 111 |
| MMB
(linear
regression) | 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 | Mean
ng/mL | Repeatability | | Within-Lab Precision | |
|-----------------------------------------------------------------|---------------|---------------|------|----------------------|------|
| | | SD | %CV | SD | %CV |
| Thermo Cardiolmmune XL Liquid
Assayed 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 |
| Plasma
Pool 1 | 3.26 | 0.15 | 4.71 | 0.19 | 5.99 |
| Plasma
Pool 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 of
Samples | Slope | Intercept | Correlation
Coefficient. | 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.