(62 days)
The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems. The Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.
The Access® Total T4 assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffers.
Here's an analysis of the provided text regarding the Access® Total T4 assay's acceptance criteria and studies:
Based on the provided 510(k) summary, the device Access Total T4 is being cleared based on substantial equivalence to a previously cleared Access Total T4 assay (K926475). The primary change in this new submission is the expansion of sample type to include human plasma samples. Therefore, the acceptance criteria and the study focus primarily on demonstrating that the performance of the assay with plasma samples is comparable to its performance with serum samples.
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state specific numerical acceptance criteria (e.g., correlation coefficient thresholds, bias limits, or ranges of agreement) for the method correlation study. It only states a qualitative outcome.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Good correlation between plasma and serum samples in method comparison study (implied for substantial equivalence). | "Study results demonstrate good correlation between the plasma and serum samples." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The exact number of paired plasma and serum samples used in the method correlation study is not specified in the provided document. It only states "paired plasma and serum samples."
- Data Provenance: The country of origin is not specified. The study is a prospective method correlation study where paired samples were collected and tested.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the study described is a method correlation study for an in vitro diagnostic (IVD) assay, not a study requiring expert readers to establish ground truth for image or clinical interpretation. The ground truth for this type of assay is derived from the established analytical performance of the predicate device and the new device.
4. Adjudication Method for the Test Set
This information is not applicable for a method correlation study of an IVD assay. Adjudication methods are typically associated with studies involving human interpretation or subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging or diagnostic aids that involve human interpretation. This submission concerns an in vitro diagnostic assay with a quantitative output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in spirit. The study described is an analytical performance study of the device itself (the Access Total T4 assay) generating quantitative results. There is no human interpretation involved in the final result generation by the device. The study demonstrates the device's performance in analyzing plasma and comparing it to serum.
7. The Type of Ground Truth Used
The ground truth for the method correlation study is implicitly the results obtained from the predicate device (or the same device running on the serum sample). The objective is to show the new sample type (plasma) yields results comparable to the established sample type (serum) using the same assay.
8. The Sample Size for the Training Set
This information is not applicable as the Access Total T4 assay described is an IVD assay (a chemical assay), not an AI/ML algorithm that requires a "training set" in the computational sense. The device is a direct measurement system.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
{0}------------------------------------------------
510(k) Summarv
[As required by 21 CFR 807.92]
510(k) Number K023369
Date Prepared: 10/07/2002
| Submitter | Contact Person |
|---|---|
| Beckman Coulter, IncDiagnostics Division1000 Lake Hazeltine DriveChaska, MN 55318 | Denise ThompsonRegulatory Affairs SpecialistPhone: 952-368-1202Fax: 952-368-7610 |
General Information
| Trade Name | Access® Total T4 |
|---|---|
| Common Name | Total thyroxine assay |
| Classification Name | Total thyroxine test system (21 CFR 862.1700) |
Device Description
The Access® Total T4 assay consists of the reagent pack and calibrators. Consumables required for the assay include substrate and wash buffers.
Intended Use
The Access Total T4 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access® Immunoassay Systems.
Substantial Equivalence Comparison
The Access Total T4 assay is substantially equivalent to the previously cleared Access Total T4 assay (K926475). 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 Total T4 assay. Study results demonstrate good correlation between the plasma and serum samples.
Conclusion
The information provided in this submission supports a substantial equivalence determination, and therefore 510(k) premarket notification clearance of the Access Total T4 assay.
{1}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.
Food and Drug Administratio 2098 Gaither Road ockville MD 20850
Ms. Denise Thompson Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re:
K023369 Trade/Device Name: Access® Total T4 on the Access® Immunoassay Systems Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI: JIS Dated: October 7, 2002 Received: October 8, 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 anv 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, 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
{3}------------------------------------------------
Indications Statemer
Page 1 of 1
510(k) Number: K023369
Device Name:
Access® Total T4 on the Access® Immunoassay Systems
Indications:
The Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.
coops
(Division Sign-Off)
Division of Clinical Laboratory Devices
$10(k) Number K023369
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rx ✓
OIT C -
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.