(55 days)
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No
The summary describes a standard ELISA kit for quantitative determination of IgE in human serum, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic test for the quantitative determination of immunoglobulin E in human serum, used for assessing hypersensitive and allergic reactions. It does not provide therapy or treatment.
Yes.
The device quantifies immunoglobulin E in human serum for the assessment of hypersensitive and allergic reactions, which is a diagnostic purpose.
No
The device description clearly states it is an "Enzyme Immunoassay Test Kit," which is a hardware-based laboratory test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the "quantitative determination of immunoglobulin E in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro).
- Purpose: The purpose is for the "assessment of hypersensitive and allergic reactions in patients," which is a diagnostic purpose.
- Device Description: The device is described as an "Enzyme Immunoassay Test Kit (IgE-ELISA)," which is a common type of in vitro diagnostic test.
Therefore, based on the provided information, the BioCheck IgE ELISA fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
DGC
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.
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 |