(68 days)
For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
Not Found
This document is limited in the information it provides regarding the acceptance criteria and the study that proves the device meets them. It is a 510(k) clearance letter for the "Spectral's Cardiac Status™ CK-MB Rapid Test," indicating that it has been determined substantially equivalent to a legally marketed predicate device. This type of clearance generally implies that the new device performs as well as, or is as safe and effective as, an existing device.
However, the letter itself does not contain the detailed study results, acceptance criteria, or performance data. These would typically be found in the 510(k) submission itself, which is not provided here.
Therefore,Based on the provided document, I cannot fully answer your request. The document is a 510(k) clearance letter, confirming that the "Spectral's Cardiac Status™ CK-MB Rapid Test" has been found substantially equivalent to a predicate device. This letter does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of the 510(k) submission.
Here's what can be inferred or stated as missing:
1. A table of acceptance criteria and the reported device performance:
* Not present in this document. The 510(k) clearance letter itself does not include performance data or specific acceptance criteria. These would have been part of the original 510(k) submission.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
* Not present in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not present in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
* Not applicable/Not present. This device is an in vitro diagnostic test for CK-MB, not an AI-assisted diagnostic imaging device requiring human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, implicitly. As an in vitro diagnostic test, the "Spectral's Cardiac Status™ CK-MB Rapid Test" would perform its analysis (qualitative determination of CK-MB) independently, without a human "in-the-loop" once the sample is applied and the test is run. Its performance would be evaluated in a standalone manner. No specific study details are given here, but the nature of the device implies a standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated in this document. For an in vitro diagnostic device like this, the ground truth for CK-MB levels would typically be established using a reference laboratory method (e.g., a highly sensitive and specific quantitative CK-MB assay) or clinical diagnosis based on a combination of symptoms, ECG, and other lab markers as part of MI diagnosis.
8. The sample size for the training set:
* Not present in this document. This device, being a rapid diagnostic test, might not use a "training set" in the same way a machine learning algorithm would. It would likely be validated against clinical samples with known concentrations/statuses.
9. How the ground truth for the training set was established:
* Not present in this document.
Summary of what's provided by the document:
- Device Name: Spectral's Cardiac Status™ CK-MB Rapid Test
- Intended Use: For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
- Regulatory Status: Class II device, cleared via 510(k) as substantially equivalent to a predicate device.
To obtain the detailed study information, acceptance criteria, and performance data, one would need to refer to the actual 510(k) submission (K022409) filed with the FDA, rather than just the clearance letter.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 3 0 2002
Nisar Shaikh, Ph.D. Director of Quality Systems Spectral Diagnostics, Inc. 135-2 The West Mall Toronto. Ontario Canada M9C 1C2
K022409 Re:
Trade/Device Name: Spectral's Cardiac Status™ CK-MB Rapid Test Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHT Dated: July 22, 2002 Received: July 24, 2002
Dear Dr. Shaikh:
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. Iisting 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 predicate device results in a classification 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 (21 CFR Part 801 and 1 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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 Cardiac Status™ CK-MB Rapid Test 510(k) Notification
510(k) Number (if Known): Not Known at this time
Device Name: Spectral's Cardiac Status™ CK-MB Rapid test
Indications for Use: For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
Sean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K022469
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Professional Use:
Prescription Use:
(Per 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.