(68 days)
Not Found
No
The summary describes a quantitative immunoassay for measuring hTSH levels and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic assay used to measure hTSH levels, which aids in evaluating thyroid status. It does not provide treatment or therapy.
Yes
The device measures human thyroid stimulating hormone (hTSH) for "evaluation of their thyroid status," which is a diagnostic purpose.
No
The device description explicitly states it consists of a reagent pack, calibrators, diluent, substrate, and wash buffers, which are all physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the assay provides "in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma." The term "in vitro" means "in glass" or "in the lab," indicating that the test is performed outside of the living body using biological samples.
- Device Description: The description lists components like "reagent pack, calibrators, and diluent," which are typical components of laboratory assays used for diagnostic testing.
- Performance Studies: The mention of a "method correlation study" using "paired plasma and serum samples" further confirms that this is a test performed on biological samples in a laboratory setting.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.
The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.
Product codes
JLW, JIS
Device Description
The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
Not Found
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
To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access HYPERsensitive hTSH assay.
Key Metrics
Study results demonstrate good correlation between the plasma and serum samples.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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510(k) Summary
[As required by 21 CFR 807.92]
510(k) Number K023093
Date Prepared:
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, Inc | |
| Diagnostics Division | |
| 1000 Lake Hazeltine Drive | |
| Chaska, MN 55318 | Denise Thompson |
| Regulatory Affairs Specialist | |
| Phone: 952-368-1202 | |
| Fax: 952-368-7610 |
General Information
| Trade Name | Access® HYPERsensitive hTSH assay |
|---|---|
| Common Name | Thyroid stimulating hormone assay |
| Classification Name | Thyroid stimulating hormone test system (21 CFR 862.1690) |
Device Description
The Access® HYPERsensitive hTSH assay consists of the reagent pack, calibrators, and diluent. Consumables required for the assay include substrate and wash buffers.
Intended Use
The Access HYPERsensitive hTSH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, hTSH) levels in human serum and plasma using the Access® Immunoassay Systems.
Substantial Equivalence Comparison
The Access HYPERsensitive hTSH assay is substantially equivalent to the previously cleared Access HYPERsensitive hTSH assay (K925637 and K954825). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays include the same components. The only difference between the two assays is that the sample type has been expanded to include human plasma samples.
Supporting Data
To demonstrate substantial equivalence, a method correlation study, using paired plasma and serum samples, was conducted using the Access HYPERsensitive hTSH assay. Study results demonstrate good correlation between the plasma and serum samples.
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Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access HYPERsensitive hTSH assay.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 to the right, arranged in a way that suggests forward movement or progress.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Denise Thompson Regulatory Affairs Specialist Beckman Coulter, Inc. · 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K023093
Trade/Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW; JIS Dated: September 17, 2002 Received: September 18, 2002
Dear Ms. Thompson:
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 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 Butman
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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510(k) Number: K023093
Device Name: Access® HYPERsensitive hTSH on the Access® Immunoassay Systems
Indications:
The Access HYPERsensitive hTSH assay provides in vitro quantitative measurement of human thyroid stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH assay is indicated for use with patients where an evaluation of their thyroid status is desired.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
510ck) Number ___
Prescription Use (Per 21 CFR 801.109)
Over-The-CounterUse
(Optional Format 1-2-96)
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Division of Clinical Laboratory Devices