(23 days)
Not Found
No
The summary describes a laboratory assay for measuring thyroid-stimulating hormone and does not mention any AI or ML components.
No
The device is an in vitro diagnostic assay used for quantitative measurement of hTSH to assess thyroid status, which is a diagnostic purpose, not a therapeutic one.
Yes
The device provides "in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma" and is "indicated for use with patients where an assessment of their thyroid status is desired." This direct measurement and assessment for diagnosis make it a diagnostic device.
No
The device description explicitly states it consists of a "reagent pack and calibrators," which are 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 the human thyroid-stimulating hormone (hTSH) in human serum or plasma." The term "in vitro" is the key indicator of an IVD.
- Sample Type: The assay is performed on human serum or plasma, which are biological samples taken from the body and analyzed outside of it.
- Purpose: The assay is used for "assessment of their thyroid status," which is a diagnostic purpose.
Therefore, based on the provided information, the Access HYPERsensitive hTSH Assay clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Access®
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 the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.
Product codes (comma separated list FDA assigned to the subject device)
JLW
Device Description
The Access® hTSH assay consists of the reagent pack and
calibrators. Other items needed to perform the assay include the
diluent, 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
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
The assay has been modified to allow performance of a "2nd
generation" test (≤ 20% CV at 0.1 µlU/mL) in addition to the
exiting "3rd generation" test (≤ 20% CV at 0.01-0.02 µlU/mL).
The 2nd generation test requires a smaller sample size, has a
shorter incubation time and provides results in less time than the
3rd generation test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
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.
0
SEP 1 6 2004
Attachment D: 510(k) Summary
Image /page/0/Picture/2 description: The image shows the logo for Beckman Coulter. The logo consists of a black circle with two white curved lines inside, followed by the words "BECKMAN" and "COULTER" stacked on top of each other. The text is in a bold, sans-serif font.
lmmunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
| Applicant: | Beckman Coulter, Inc.
Immunodiagnostics Development Center
1000 lake Hazeltine Drive
Chaska, MN 55318 |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Barbara Stegmeier, RAC
Principal Consultant
Phone: 952.368.7648
Fax: 952.368.7610 |
| Date Prepared: | August 23, 2004 |
| Trade Name: | Access® HYPERsensitive hTSH Assay |
| Product Classification
and Code: | II - JLW |
| Predicate Device: | Access® HYPERsensitive hTSH Assay - K023093, K954825,
K925637 |
| Device Description: | The Access® hTSH assay consists of the reagent pack and
calibrators. Other items needed to perform the assay include the
diluent, substrate and wash buffers. |
| Intended Use: | The Access®
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. |
| Summary of
Technological
Characteristics: | The assay has been modified to allow performance of a "2nd
generation" test (≤ 20% CV at 0.1 µlU/mL) in addition to the
exiting "3rd generation" test (≤ 20% CV at 0.01-0.02 µlU/mL).
The 2nd generation test requires a smaller sample size, has a
shorter incubation time and provides results in less time than the
3rd generation test. |
| Conclusion: | The modified Access® hTSH assay is substantially equivalent to
the previously cleared Access® hTSH assays. |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 6 2004
Ms. Barbara Stegmeier Principal Consultant Beckman Coulter, Inc. Immunodiagnostic Development Center 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
K042281 Re:
Trade/Device Name: Access HYPERsensitive hTSH Assay Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW Dated: August 23, 2004 Received: August 24, 2004
Dear Ms. Stegmeier:
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).
2
Page 2
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, Ir Joursens on the promotion and advertising of your device, please contact the Office of Jn 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). You may obtain other general information on your responsibilities under the Act 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,
Jean M. Cooper, U.S., DVM.
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K042281
Device Name: Access HYPERsensitive hTSH Assay
Indications for Use:
The Access HYPERsensitive hTSH Assay provides in vitro quantitative measurement of the human thyroid-stimulating hormone (hTSH) in human serum or plasma. The Access HYPERsensitive hTSH Assay is indicated for use with patients where an assessment of their thyroid status is desired. This assay is capable of providing 3rd generation (HYPERsensitive hTSH) and/or the 2nd generation (Fast hTSH) results.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Carol C. Benson
Division Sign Off
Division Sign-On
Office of In Vitro Dlagn Device Evaluation an
5166K K04228