(104 days)
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.
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.
The provided text is a 510(k) summary for the BioCentrex Cardiac Panel System. It details the device's technical specifications and performance characteristics, but does not explicitly lay out "acceptance criteria" in a structured table or specifically describe a "study that proves the device meets the acceptance criteria" in the way one might find in a clinical trial report.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through analytical studies. The performance metrics presented are common for in vitro diagnostic devices and are compared against the predicate devices for equivalency.
Here’s an interpretation of the available information structured to address your request, acknowledging the limitations of the provided document in explicitly defining "acceptance criteria" and a "single study report" in the typical sense.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit "acceptance criteria" are not listed in the document as such, I will infer what would likely be considered acceptable performance based on common standards for diagnostic assays and the predicate devices' performance. The reported device performance will be taken directly from the "Summary of Analytical Studies."
| Performance Metric | Inferred Acceptance Criteria (e.g., comparable to predicate device, within acceptable precision ranges) | Reported Device Performance |
|---|---|---|
| Cardiac Troponin I | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 3.1 to 4.7 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 5.6 to 8.3 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.04 ng/mL |
| Dilution Recovery | Near 100% recovery | 99.7 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.9953 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.992x + 0.316 (vs. predicate) |
| Functional Sensitivity (20% imprecision) | Defined limit for reliable detection | 0.15 ng cTnI/mL |
| CK-MB | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.3 to 7.8 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.7 to 8.9 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 0.41 ng/mL |
| Dilution Recovery | Near 100% recovery | 100.9 % (average) |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.995 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.995x + 0.313 (vs. predicate) |
| Myoglobin | ||
| Within-run Imprecision | Low %CV, comparable to predicate | 6.1 to 7.5 %CV |
| Total Imprecision | Low %CV, comparable to predicate | 7.0 to 7.8 %CV |
| Analytical Sensitivity (LOD) | Low detectable level, comparable to predicate | 2.8 ng/mL |
| Dilution Recovery | Near 100% recovery | No specific myoglobin recovery % given for dilution, but "average recoveries ... of 99.7 %, and 100.9 %" for cTnI and CK-MB are mentioned. It can be inferred that myoglobin also met similar linearity expectations. |
| Method Comparison (r) | High correlation (e.g., r > 0.95), comparable to predicate | r = 0.985 (vs. predicate) |
| Method Comparison (slope) | Slope near 1.0 | y = 0.965x + 6.5 (vs. predicate) |
| Analytical Specificity | No significant interference/cross-reactivity | No significant interference from therapeutic drugs, biological substances, heterophilic specimens, or cross-reactivity with other cardiac contractile proteins or CK isoenzymes. |
| Stability | Cartridge stable for stated period | 1 year at 2-8 °C (unopened); 24 hours at ambient (opened) |
2. Sample Size Used for the Test Set and Data Provenance
The document only provides sample sizes for the Method Comparison studies:
- Cardiac Troponin I: 101 specimens
- CK-MB: 73 specimens
- Myoglobin: 70 specimens
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "cardiac specimens," suggesting they were samples from patients, but further details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For in vitro diagnostic assays, "ground truth" (or reference method results) is typically established by comparative analysis with a legally marketed predicate device (as done here) or a recognized gold standard laboratory method, rather than expert consensus on individual cases. The "experts" in this context would be the technicians or laboratory personnel performing the predicate method tests.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies where expert consensus is needed to determine the true clinical status of a patient, especially when imaging or clinical assessment is subjective. For analytical performance studies of an IVD device, the "ground truth" is typically the result from the established predicate/reference method, and no human adjudication process for interpreting these results is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
This information is not applicable. The BioCentrex Cardiac Panel System is an in vitro diagnostic (IVD) device that measures biomarkers, not an AI-assisted diagnostic imaging or clinical decision support system that involves human readers interpreting cases. Therefore, an MRMC study or AI-related effect size data would not be relevant or expected for this type of device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not directly applicable in the context of an AI algorithm. However, the entirety of the analytical studies described (precision, sensitivity, linearity, method comparison, specificity, stability) represent the standalone performance of the BioCentrex Cardiac Panel System without human interpretation beyond standard laboratory procedures for running the assay and reporting results. The device is the "algorithm" and performs its measurements autonomously once the sample is loaded.
7. The Type of Ground Truth Used
The "ground truth" for the performance studies was established by comparison to predicate devices (Access® AccuTnI™, Access® CK-MB, and Access® Myoglobin) which are legally marketed immunoassays. This is a common and accepted method for demonstrating substantial equivalence for new IVD devices. The results from the predicate devices served as the reference standard.
8. The Sample Size for the Training Set
This information is not provided and is likely not relevant in the context of this device. The BioCentrex Cardiac Panel System is an immunoassay, not a machine learning or AI-driven system that requires a "training set" in the typical sense. Its performance is based on biochemical reactions and optical detection, calibrated by known standards or calibrators rather than a large dataset of patient samples used for algorithmic training.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" in the machine learning sense is not applicable for this immunoassay device. The device would be "calibrated" using manufacturer-provided calibrators, and quality control materials would be run to ensure ongoing performance. These calibrators would have known concentrations of the target analytes.
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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 myoglobinCardiac 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.
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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 diagnosticuse. To measure cardiactroponin I in wholeblood, plasma or serum | Same |
| Indications | Diagnosis of AMI. | Same |
| Measurement | Quantitative | Same |
| Method | 2-Site sandwich | Same |
| Principle | immunoassay | |
| MethodDetection | Fluorescence detectionon a planar waveguide. | Chemiluminescentenzyme immunoassay |
| Detector | CCD camera | Luminometer |
| Specimendilution | Not required | Same |
| Key Materials | Mouse monoclonal anti-human cTnI antibodies | Same |
| Test time | 12 minutes | 15 minutes |
| Sample Type | Anti-coagulated wholeblood, serum, or plasma | Serum and Plasma |
| Specimenvolume | 200 μL | 160 μL |
| Calibration | Calibration informationbar-coded. Newcalibration for each lot. | 6-level liquid calibrationevery 28 days |
| QualityControl | None | One level |
| ReportingUnits | ng/mL | Same |
| ReactionTemp. | 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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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).
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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 (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
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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)
§ 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.