(60 days)
For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.
Not Found
Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:
The provided document is an FDA 510(k) clearance letter for the "Spectral's 2 in 1 (TnI-Myo) test." This type of document primarily confirms substantial equivalence to a predicate device and provides regulatory information. It does not typically contain the detailed study results, acceptance criteria, or ground truth establishment methods that would be found in a clinical study report or a 510(k) submission itself.
Therefore, much of the requested information cannot be directly extracted from the provided text. I will explicitly state if the information is "Not available in the provided text."
Acceptance Criteria and Device Performance (Based on available information and typical device regulation)
Since the document is an FDA clearance letter for a diagnostic test, the "acceptance criteria" generally refer to the performance characteristics that render the device substantially equivalent to a legally marketed predicate device. While specific numerical acceptance criteria are not in this document, the overall acceptance standard is "substantial equivalence."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Inferred) | Reported Device Performance (Inferred from 510(k) clearance) |
|---|---|
| Qualitative Determination | Device performs qualitative determination of cTnI and myoglobin. |
| Sample Types | Validated for whole blood, plasma, or serum. |
| Indications for Use | "Aid in the diagnosis of Myocardial Infarction (MI) at the bedside, point-of-care, and hospital settings." |
| Substantial Equivalence | Found substantially equivalent to legally marketed predicate devices. (This is the overarching "acceptance criterion" for 510(k) clearance). |
| Accuracy / Performance | Not available in the provided text. (Specific sensitivity, specificity, or agreement rates are not detailed here, but would have been part of the 510(k) submission that led to this clearance). |
| Precision / Reproducibility | Not available in the provided text. |
| Interference | Not available in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not available in the provided text.
- Data Provenance: Not available in the provided text (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not available in the provided text. This information would typically be in the clinical study section of the 510(k) submission. For a diagnostic cardiac marker test, the "ground truth" (e.g., diagnosis of MI) is often established by a combination of clinical assessment, ECG changes, and serial biomarker measurements using a laboratory reference method, not necessarily by a panel of "experts" in the same way an imaging study might be.
4. Adjudication Method for the Test Set
- Not available in the provided text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is typically for imaging devices where human readers interpret images with and without AI assistance. This device is an in-vitro diagnostic (IVD) test, where a machine or visual reading (depending on the format) produces a result. Human interpretation of the test result occurs, but it's not an MRMC study in the traditional sense of comparing human reader performance on complex cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. For an IVD device like this, the device itself provides a result (qualitative determination of cTnI and myoglobin). The performance metrics (e.g., sensitivity, specificity, analytical accuracy) would represent the "standalone" performance of the test kit against a reference standard. While the document doesn't provide these specific metrics, they are a fundamental part of the 510(k) submission for IVD devices.
7. The Type of Ground Truth Used
- Not explicitly stated in the provided text. For cardiac biomarker IVDs, the "ground truth" for a positive MI diagnosis in clinical studies usually involves a composite endpoint, which may include:
- Expert Consensus: A panel of cardiologists reviewing all available clinical data (symptoms, ECG, imaging, clinical course).
- Outcomes Data: Definitive diagnosis of MI based on all clinical evidence and patient outcomes.
- Validated Reference Method: Comparison against a highly accurate laboratory-based immunoassay for cTnI and Myoglobin as a primary reference for analytical performance, and then correlated with clinical outcomes for diagnostic performance.
8. The Sample Size for the Training Set
- Not available in the provided text. (IVD devices typically refer to "development" or "validation" sets rather than "training" sets in the context of traditional machine learning, though modern IVDs can incorporate AI/ML).
9. How the Ground Truth for the Training Set Was Established
- Not available in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Nisar A. Shaikh Director of Quality Systems Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario M9C 1C2 CANADA
MAY 2 4 2002
K020950 Re:
Trade/Device Name: Spectral's 2 in 1 (TnI-Myo) test Regulation Numbers: 21 CFR 862.1215; 21 CFR 866.5680 Regulation Names: Creatine phosphokinase/creatine kinase or isoenzymes test system; Myoglobin immunological test system Regulatory Class: Class II; Class II Product Code: MMI; DEA Dated: March 22, 2002
Dear Dr. Shaikh:
Received: March 25, 2002
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 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed notification. The I Dri imating of succion for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (2) CFR Part 801 and 1 II you desire specific acrice for your astic devices), please contact the Office of Compliance at additionally 807.10 for in viue allestions on the promotion and advertising of your device, (301) 594-4536. Truditional ) , IST 453-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Information on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/odrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Spectral Diagnostics Inc. Spectral's 2 in 1 (TnI-Myo) Test 510(k) Notification
510(k) Number (if Known) : Not Known at this time
Device Name : Spectral's 2 in 1 (TnI-Myo) test
Indications for Use: For the qualitative determination of cardiac troponin I
ndications for the top the belocked blood, plasma or serum as an aid in the Indications for Use: For the quality coocorative coocorative as an aid in the (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.
Jean Cooper
(Division Sign-
Division of Clin.
vices
510(k) Number.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use: X
OD
Over the counter use: (Optional Format 1-2-96)
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Prescription Use: X (Per 21 CFR 801.109) OR
SDI Ref #: R-003/2002-510K
§ 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.