(132 days)
The BioCheck Myoglobin ELISA is intended for the quantitative determination of myoglobin in human serum. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.
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The provided text is a 510(k) premarket notification letter for a Myoglobin Enzyme Immunoassay Test Kit. It focuses on regulatory approval and substantial equivalence to a predicate device, rather than detailed performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth cannot be extracted from this document.
Here's a breakdown of what can be inferred or what is explicitly missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in this document. The 510(k) process focuses on demonstrating "substantial equivalence" to a predicate device, meaning the new device is as safe and effective as a legally marketed device. Specific performance acceptance criteria are typically detailed in the full 510(k) submission, not in the FDA's decision letter.
- Reported Device Performance: Not included in this document. The letter confirms review and determination of substantial equivalence, but it doesn't present the actual performance data (e.g., sensitivity, specificity, accuracy, precision) that led to that determination.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned in this document.
- Data Provenance: Not mentioned 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)
- Number of Experts: Not mentioned in this document.
- Qualifications of Experts: Not mentioned in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned 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
- This device is an in-vitro diagnostic (IVD) immunoassay test kit, not an AI-assisted diagnostic imaging device. Therefore, a multi-reader multi-case (MRMC) study involving human readers and AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is an immunoassay test kit, not an algorithm. Its performance is inherent to the assay chemistry and instrumentation, not an "algorithm only" in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For an immunoassay for myoglobin, the "ground truth" would typically be established by a reference method for myoglobin quantification or clinical diagnosis of heart or renal disease, confirmed by other established clinical markers or gold standard diagnostic procedures. However, the specific method used is not mentioned in this document.
8. The sample size for the training set
- This device is an immunoassay, not a machine learning model. Therefore, the concept of a "training set" in the context of AI/ML is not applicable.
9. How the ground truth for the training set was established
- This question is not applicable as the device is an immunoassay, not a machine learning model.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.
Food and Drug Administratio 2098 Gaither Read Rockville MD 20850
BioCheck, Inc. c/o Ms. Robin J. Hellen, M.S. Hellen Professional Services 9418 Lasaine Avenue Northridge, CA 91325
K022660 Re: Trade/Device Name: BioCheck, Inc. Myoglobin Enzyme Immunoassay Test Kit Regulation Number: 21 CFR 866.5680 Regulation Name: Myoglobin immunological test system Regulatory Class: Class II Product Code: DRR Dated: November 14, 2002 Received: November 15, 2002
Dear Ms. Hellen:
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 Sutman
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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BIOCHECK, Inc. Myoglobin Immunoassay Test Kit BC-1117 Premarket Notification
PART I - 510(k) Information
III. STATEMENT FOR INDICATIONS FOR USE
510(k) Number (if known): K022660
Device Name: BioCheck, Inc. Myoglobin
Enzyme Immunoassay Test Kit
Indications for Use:
The BioCheck Myoglobin ELISA is intended for the quantitative
determination of myoglobin in human serum. Measurement of myoglobin
aids in the rapid diagnosis of heart or renal disease.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Dean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K022660
Prescription Use: ✓ OR Over the Counter Use: __
§ 870.2050 Biopotential amplifier and signal conditioner.
(a)
Identification. A biopotential amplifier and signal conditioner is a device used to amplify or condition an electrical signal of biologic origin.(b)
Classification. Class II (performance standards).