(55 days)
The BioCheck IgE ELISA is intended for the quantitative determination of immunoglobulin E in human serum. This assay is to be used for the assessment of hypersensitive and allergic reactions in patients.
BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)
The provided text is a 510(k) clearance letter from the FDA for the BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA). This document primarily focuses on regulatory approval and does not contain the detailed study information typically found in a clinical study report or a scientific publication.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, and specific study designs (like MRMC or standalone performance) is not available in the provided text.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not specified in this document. The FDA letter states the device is "substantially equivalent" to legally marketed predicate devices, implying it meets established performance characteristics, but the specific criteria are not listed.
- Reported Device Performance: Not included in this regulatory letter. This information would typically be in a separate study report submitted to the FDA as part of the 510(k) application.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text.
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 applicable/available. This device is an in vitro diagnostic (IVD) test kit, not an imaging AI device that typically relies on expert interpretation for ground truth. The "ground truth" for an IVD kit would likely be established through reference methods or clinical diagnosis, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/available. Adjudication methods like 2+1 are typically used in studies involving human interpretation (e.g., radiology readers) where there might be disagreement. For an IVD kit, performance is usually assessed against a reference standard.
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. MRMC studies are used for evaluating AI-assisted human performance, primarily in imaging. This device is an immunoassay test kit, which is a standalone diagnostic test performed in a lab, not an AI assisting a human reader.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. As an in vitro diagnostic test kit, the BioCheck IgE ELISA operates as a standalone diagnostic tool. Its performance (e.g., sensitivity, specificity, accuracy, precision, linearity) would have been assessed independently. However, the details of such a standalone performance study are not provided in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For an IgE assay, the ground truth would likely be established through:
- Clinical diagnosis of hypersensitive/allergic reactions: Based on patient history, symptoms, other diagnostic tests, and potentially positive responses to allergy testing (e.g., skin prick tests, challenge tests).
- Reference methods: Comparison to a legally marketed predicate device or a well-established laboratory method for IgE quantification.
- Not explicitly stated in the provided text.
8. The sample size for the training set
- Not applicable/available. This device is a chemical immunoassay kit, not an AI algorithm that requires a "training set" in the machine learning sense. Its development would involve analytical and clinical validation studies, but not a training set.
9. How the ground truth for the training set was established
- Not applicable/available for the same reasons as point 8.
In summary, the provided FDA 510(k) clearance letter confirms the device's regulatory approval as "substantially equivalent" but does not contain the detailed technical and clinical study data requested. That information would be found in the applicant's 510(k) submission, specifically in the performance data sections.
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SEP 2 1 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
BioCheck, Inc. c/o Ms. Robin J. Hellen Hellen Professional Service 9418 Lasaine Avenue Northridge, California 91325
Re: K992528
Trade Name: BioCheck, Inc. Immunoglobulin E (IgE) Enzyme Immunoassay Test Kit (IgE-ELISA)
Regulatory Class: II Product Code: DGC Dated: July 27, 1999 Received: July 28, 1999
Dear Ms. Hellen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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lll. Statement for Indications for Use
510(k) Number (if known): K992528
Device Name: BioCheck, Inc. Immunoglobulin E (IgE)
Enzyme Immunoassay Test Kit (IgE-ELISA)
Indications for Use:
The BioCheck IgE ELISA is intended for the quantitative determination of
immunoglobulin E in human serum. This assay is to be used for the
assessment of hypersensitive and allergic reactions in patients.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
[Signature]
(Division Sign-Off)
Division of Clinical Laboratory Devices K992528
510(k) Number __
| Labels | Values |
|---|---|
| Prescription Use: | ✓ |
| Over the Counter Use: | _ |
| OR |
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).