(90 days)
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Not Found
No
The 510(k) summary describes a standard immunoassay for measuring TSH levels and contains no mention of AI or ML technology.
No
Explanation: This device is for diagnostic purposes (quantitative determination of thyrotropin in human serum for diagnosis of thyroid or pituitary disorders), not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that the assay is "useful in the diagnosis of thyroid or pituitary disorders."
No
The 510(k) summary describes an immunoassay (EIA) for measuring TSH in human serum, which is a laboratory test involving physical reagents and samples, not a software-only device.
Yes, based on the provided information, the BioCheck S-TSH EIA is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum." This involves testing a biological sample (human serum) outside of the body (in vitro) to obtain diagnostic information.
- Purpose: The assay is described as "useful in the diagnosis of thyroid or pituitary disorders." This clearly indicates a diagnostic purpose.
These are key characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BioCheck S-TSH EIA is intended for the quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders.
Product codes (comma separated list FDA assigned to the subject device)
JLW
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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§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
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 features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
JUN 2 2 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Biocheck, Inc. c/o Ms. Robin J. Hellen, M.S. Ilellen Professional Services 9418 Lasaine Avenue Northridge, California 91325
Re: K990993
Trade Name: Biocheck Sensitive Thyroid Stimulating Hormone (S-TSH) Enzyme Immunoassay Test Kit Regulatory Class: II Product Code: JLW Dated: March 22, 1999 Received: March 24, 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 (I'remarket 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 Under the Clinical Laboratory Improvement Amendments of 1988 (CEIA-10), Microsoft
require a CLIA complexity categorization. To determine if it does, you should contact the require a CLIA complexity categorization. 10 december 2011 at 1770) 488-7655.
Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
Chicks to Liseans Course of Substantial equivalence as described in your 10(k) prematice
This letter will allow of substantial equivalence of your device to a legally marked This letter will allow you to begin marketing your device to a legally harketed a
notification. The FDA finding of substantial equivalence of your device to I his letter will and with the of substantial equivalence of your device to as anyally
predicate device results in a classification for your device and thus, permits your dev proceed to the market.
pfoceed to the mainter.
If you desire specific advice for your device on our labeling regulation (21 CFR, Part 801 and If you desire specific advice for your devices), please contact the Office of Cyour device at
additionally 809.10 for in vitro diagnostic devices), please contact the Office (301) 594-458. Additionally, for questions on the promotion and advise.
(301) 594-458. Additionally, for questions on the promotion and advice.
(301) 594-4588. Additionall (301) 594-4588. Additionally, for questions on the promotion and also, please of the regulation
(301) 594-4588. Additionally, for questions on the regulation (501) 394-5500: 1122. States to permarket notification"(21 CFR 807). Chhe Collected Collected on States of Stices of Stical of Stical of Stical of Sinali
entitled, "Misbrandi please connact the best of premarket notification (21 CFR 001. For and Comments of Sunal)
entitled, "Misbranding by refects" to premarket from the Division of Sunall information on your responsibilities under the Act may be oblamber (801) 443-6597, or at its
Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-659 Manufacturers Assistance at its ton-free hances (117)
internet address "http://www.fda.gov/cdrl/dsmaldsmamain.html".
Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.h
Sincerely yours,
Steven Autman
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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PART I - 510(k) Information
Statement for Indications for Use lll.
| 510(k) Number (if known): | K990993 |
|---|---|
| Device Name: | BioCheck, Inc. Sensitive TSH EIA |
| Indications for Use: | The BioCheck S-TSH EIA is intended for the quantitative determination of thyrotropin, of thyroid stimulating hormone (TSH) in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. |
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K990993 |
Concurrence of the CDRH, Office of Device Evaluation (ODE)
| Prescription Use: | OR | Over the Counter Use: |
|---|---|---|
| ------------------- | ---- | ----------------------- |
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