(104 days)
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No
The summary describes a standard in vitro diagnostic device for measuring cardiac markers and does not mention any AI or ML components.
No
This device is an in vitro diagnostic (IVD) device used to measure biomarkers for diagnosis and treatment of myocardial infarction, not a device that directly treats a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use" and "to aid in the diagnosis and treatment of patients with myocardial infarction."
No
The device description explicitly states that the device is a "BioCentrex Cardiac Panel cartridge" used "with the BioCentrex Analyzer," indicating it is a hardware component (cartridge) used in conjunction with another hardware component (analyzer). The performance studies also focus on the analytical performance of the cartridge and its interaction with the analyzer, not on standalone software performance.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states "For in vitro diagnostic use". It also describes measuring analytes (cardiac troponin-I, creatine kinase MB, and myoglobin) in biological specimens (whole blood, serum, or plasma) to aid in the diagnosis and treatment of a specific condition (myocardial infarction). This aligns perfectly with the definition of an IVD.
- Device Description: The description confirms that the cartridges are used with an analyzer to measure these analytes in biological specimens.
- Performance Studies: The performance studies detail analytical characteristics like precision, sensitivity, linearity, and method comparison, which are standard evaluations for IVD devices.
- Predicate Devices: The listing of predicate devices with K numbers indicates that this device is being compared to other legally marketed IVD devices.
All of these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The BioCentrex Cardiac Panel cartridge is intended for in vitro diagnostic use with the BioCentrex Analyzer to quantitatively measure cardiac troponin-I, creatine kinase MB and myoglobin concentrations in anti-coagulated whole blood, serum or plasma.
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
Product codes
MYT, MMI, JHX, DDR
Device Description
BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (CTnI), creatine kinase-MB, and myoglobin concentrations in whole blood, serum or plasma specimens.
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
Precision:
Cardiac Troponin I - Within-run and total imprecision ranged from 3.1 to 4.7 %CV and 5.6 to 8.3 %CV, respectively, for levels ranging from 0.74 to 7.7 ng cTnI/mL.
CK-MB -- Within-run and total imprecision ranged from 6.3 to 7.8 %CV and 7.7 to 8.9 %CV, respectively, for levels ranging from 3.63 to 109.9 ng CK-MB/mL.
Myoglobin - Within-run and total imprecision ranged from 6.1 to 7.5 %CV and 7.0 to 7.8 %CV, respectively, for levels ranging from 36 to 376.2 ng myoglobin/mL.
Analytical Sensitivity: The lowest detectable levels of cardiac troponin I. CK-MB, and myoglobin distinguishable from zero with 95% confidence are 0.04, 0.41, and 2,8 ng/mL, respectively.
Dilution Recovery (Linearity): Linearity studies performed by diluting sodium heparin plasma samples with plasma containing normal endogenous level of analyte provided average recoveries for cardiac troponin I. CK-MB, and myoglobin of 99.7 %, and 100.9 %, respectively.
Method Comparison: Comparison of results obtained with 70 to 77 cardiac specimens to those obtained by the predicate methods yielded the following statistics:
Cardiac troponin I - for concentrations ranging from 0 to 99 ng cTnI/mL in 101 specimens, good agreement was obtained with the r = 0.9953 and y = 0.992x +0.316 ng/mL.
CK-MB - for concentrations ranging from 2.35 to 341 ng CK-MB/mL in 73 specimens, good agreement was obtained with the r = 0.995 and y = 0.995x +0.313 ng/mL.
Myoglobin - for concentrations ranging from 12 to 710 ng myoglobin/mL in 70 specimens, good agreement was obtained with the r = 0.985 and y = 0.965x + 6.5 ng/mL.
Analytical Specificity: There was no significant interference from therapeutic drugs, biological substances, or heterophilic specimens. There was no significant cross-reactivity with other potential cardiac contractile proteins or CK isoenzymes.
Stability: Accelerated stability studies indicate that unopened Cardiac Panel reagent cartridges are stable for one year when stored at 2-8 ℃. After opening, the reagent cartridges are stable for 24 hours at ambient temperature.
Reference Intervals: The 97.5" percentile upper range limit (URL) for troponin I is less than 0.15 ng/mL (functional sensitivity limit). Reference Intervals for CK-MB is 0.41 to 5.51 ng CK-MB/mL. For myoglobin, the Reference Interval for males is 8.2 to 101.5 ng myoglobin/mL and for females is 4.5 to 42.2 ng myoglobin/mL.
Cardiac Troponin I Functional Sensitivity: The functional sensitivity for cardiac troponin I at 20 % imprecision is 0.15 ng cTnImL.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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.
0
のではない。
この後にはなくて、いました。 この日は、10月には、10月には、10月には、10月には、同じので、10月には、10月には、10月には、10月には、1000万人には、1000円では、1000円では、1000円では、1000円では、1000円では、1000円以上には、1000円以上には、1000円以上には、1000円以上には、100
Image /page/0/Picture/1 description: The image contains the word "DUPLICATE" in all capital letters. The font is bold and sans-serif. The word is horizontally oriented and fills most of the frame. The letters are black against a white background.
entrex
6100 BRISTOL PARKWAY, CULVER CITY, CA 90230
TEL 310.258.9707 FAX 310.258.9707
00, 11:00
Cardiac Panel System 510(k) 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.
The assigned 510(k) number is: K033155
Submitters Name and Address
BioCentrex LLC 6100 Bristol Parkway Culver City, CA 90230 Telephone: 310-258-9702 Fax: 310-258-9707 Contact: Thomas Grove Ph.D.
Date Prepared: September 29, 2003
Device Names
Proprietary Name: BioCentrex Cardiac Panel System
Common Name:Cardiac Troponin I, CK-MB, and Myoglobin Immunoassays
| Classification Name: | Fluorometric method; cardiac troponin I, CK-MB, and myoglobin
Cardiac panel performed on the BioCentrex Analyzer |
| ---------------------- | --------------------------------------------------------------------------------------------------------------------- |
|---|
Predicate Device:
Access® AccuTnI™ for Use on the Access® Immunoassay Analyzer 510(k) Number: K021814
Access® CK-MB for Use on the Access® Immunoassay Analyzer 510(k) Number: K000716
Access® Myoglobin for Use on the Access® Immunoassay Analyzer 510(k) Number: K951634
Device Description:
BioCentrex Cardiac Panel cartridges are used with the BioCentrex Analyzer to measure cardiac troponin I (CTnI), creatine kinase-MB, and myoglobin concentrations in whole blood, serum or plasma specimens.
1
Intended Use:
The BioCentrex Cardiac Panel cartridge is intended for in vitro diagnostic use with the BioCentrex Analyzer to quantitatively measure cardiac troponin-I, creatine kinase MB and myoglobin concentrations in anti-coagulated whole blood, serum or plasma.
Comparison of Technological
| BioCentrex cTnI | Access® AccuTnI | |
|---|---|---|
| Intended Use | For in vitro diagnostic | |
| use. To measure cardiac | ||
| troponin I in whole | ||
| blood, plasma or serum | Same | |
| Indications | Diagnosis of AMI. | Same |
| Measurement | Quantitative | Same |
| Method | 2-Site sandwich | Same |
| Principle | immunoassay | |
| Method | ||
| Detection | Fluorescence detection | |
| on a planar waveguide. | Chemiluminescent | |
| enzyme immunoassay | ||
| Detector | CCD camera | Luminometer |
| Specimen | ||
| dilution | Not required | Same |
| Key Materials | Mouse monoclonal anti- | |
| human cTnI antibodies | Same | |
| Test time | 12 minutes | 15 minutes |
| Sample Type | Anti-coagulated whole | |
| blood, serum, or plasma | Serum and Plasma | |
| Specimen | ||
| volume | 200 μL | 160 μL |
| Calibration | Calibration information | |
| bar-coded. New | ||
| calibration for each lot. | 6-level liquid calibration | |
| every 28 days | ||
| Quality | ||
| Control | None | One level |
| Reporting | ||
| Units | ng/mL | Same |
| Reaction | ||
| Temp. | 30 °C | 37°C |
Summary of Analytical Studies:
Precision:
Cardiac Troponin I - Within-run and total imprecision ranged from 3.1 to 4.7 %CV and 5.6 to 8.3 %CV, respectively, for levels ranging from 0.74 to 7.7 ng cTnI/mL.
CK-MB -- Within-run and total imprecision ranged from 6.3 to 7.8 %CV and 7.7 to 8.9 %CV, respectively, for levels ranging from 3.63 to 109.9 ng CK-MB/mL.
Myoglobin - Within-run and total imprecision ranged from 6.1 to 7.5 %CV and 7.0 to 7.8 %CV, respectively, for levels ranging from 36 to 376.2 ng myoglobin/mL.
2
The lowest detectable levels of cardiac troponin I. CK-MB, and Analytical Sensitivity: myoglobin distinguishable from zero with 95% confidence are 0.04, 0.41, and 2,8 ng/mL, respectively.
Dilution Recovery (Linearity): Linearity studies performed by d iluting sodium heparin p lasma samples with plasma containing normal endogenous level of analyte provided average recoveries for cardiac troponin I. CK-MB, and myoglobin of 99.7 %, and 100.9 %, respectively.
Method Comparison: Comparison of results obtained with 70 to 77 cardiac specimens to those obtained by the predicate methods yielded the following statistics:
Cardiac troponin I - for concentrations ranging from 0 to 99 ng cTnI/mL in 101 specimens, good a greement was obtained with the r = 0.9953 and y = 0.992x +0.316 ng/mL.
CK-MB - for concentrations ranging from 2.35 to 341 ng CK-MB/mL in 73 specimens, good agreement was obtained with the r = 0.995 and y = 0.995x +0.313 ng/mL.
Myoglobin - for concentrations ranging from 12 to 710 ng myoglobin/mL in 70 specimens, good agreement was obtained with the r = 0.985 and y = 0.965x + 6.5 ng/mL.
Analytical Specificity: There was no significant interference from therapeutic drugs, biological substances, or heterophilic specimens. There was no significant cross-reactivity with other potential cardiac contractile proteins or CK isoenzymes.
Stability: Accelerated stability studies indicate that unopened Cardiac Panel reagent cartridges are stable for one year when stored at 2-8 ℃. After opening, the reagent cartridges are stable for 24 hours at ambient temperature.
Reference Intervals: The 97.5" percentile upper range limit (URL) for troponin I is less than 0.15 ng/mL (functional sensitivity limit). Reference Intervals for CK-MB is 0.41 to 5.51 ng CK-MB/mL. For myoglobin, the Reference Interval for males is 8.2 to 101.5 ng myoglobin/mL and for females is 4.5 to 42.2 ng myoglobin/mL.
Cardiac Troponin I Functional Sensitivity: The functional sensitivity for cardiac troponin I at 20 % imprecision is 0.15 ng cTnImL.
Conclusion
The BioCentrex Cardiac Panel test system is substantially equivalent to the Access® AccuTnTM. Access® CK-MB, and Access® Myoglobin on the Access® Immunoassay Systems for the measurement of cardiac troponin I, CK-MB, and myoglobin in human blood, plasma, and serum.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circle around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 1 2 2004
Thomas H. Grove, Ph.D. President BioCentrex LLC 6100 Bristrol Parkway Culver City, CA 90230
Re: K033155
Trade/Device Name: BioCentrex Cardiac Panel Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System Regulatory Class: Class II Product Code: MYT, MMI, JHX, DDR Dated: December 11, 2003 Received: December 12, 2003
Dear Dr. Grove:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE VI.
510(k) Number:
Device Name:
BioCentrex Cardiac Panel
Indications for use:
For in vitro diagnostic use with the BioCentrex Analyzer to measure cardiac troponin I, creatine kinase-MB, and myoglobin from whole blood, serum or plasma specimens to aid in the diagnosis and treatment of patients with myocardial infarction.
Carol C Benson Jr. Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K033155
(PLEAST WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Pcr 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)