(14 days)
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No
The summary describes a chemiluminescent immunoassay system for quantitative determination of triiodothyronine. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is a standard immunoassay.
No.
The device is an in vitro diagnostic (IVD) immunoassay system used for the quantitative determination of triiodothyronine levels in human serum, which aids in the diagnosis of thyroid disorders, rather than treating them.
Yes
The device is used for the quantitative determination of triiodothyronine levels, and its clinical importance is explicitly stated for the "diagnosis of thyroid disorders." This directly indicates its role in identifying or classifying a disease or condition.
No
The device description explicitly states that the system comprises "reagents and the ACCESS® Immunoassay Analyzer," indicating the presence of physical components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the device is for the "quantitative determination of triiodothyronine levels in human serum." This involves testing a biological sample (serum) in vitro (outside the body).
- Clinical Importance: The clinical importance is described as being "in the diagnosis of thyroid disorders," which is a typical application for IVD devices.
- Device Description: The description mentions "reagents" and an "Immunoassay Analyzer," which are components of an IVD system used for laboratory testing.
- Performance Studies: The document includes performance studies like precision, accuracy, and correlation, which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (Ciba Corning ACS™ T3) is common in regulatory submissions for IVD devices, indicating a comparison to an already cleared device.
All these elements strongly indicate that the ACCESS® Total T3 Assay is an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACCESS® Total T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of triiodothyronine levels in human serum using the ACCESS® Immunoassav System. The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.
Product codes (comma separated list FDA assigned to the subject device)
CDP, JIS
Device Description
The ACCESS® Total T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of triiodothyronine in human serum.
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)
Precision studies: Within run precision ranges from 3.22% CV (high control) to 5.22% CV (low control). Total imprecision ranges from 4.74% CV (high control) to 9.12% CV (low control). Accuracy: Dilution recovery studies performed by diluting two patient samples containing Total T3 with Total T3 Calibrator S0 range from 85.6% to 107.7% recovery. Spiking recovery studies performed by adding T3 to two patient samples containing low levels of T3 range from 87.7% to 112.1 % recovery. Correlation: A comparison of Total T3 values from 153 samples run in both the ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay gives the following statistical data using deming calculations: r = 0.978, v = 1.020x + 0.077. Analytical Sensitivity: The lowest detectable level of total T3 distinguishable from zero (Total T3 Calibrator S0) with 95% confidence is 0.1 ng/ml.
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.
Ciba Corning ACS™ T3
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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§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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510(k) Premarket Notification Confidential
OCT 31 1997
1. General Information
Device Generic Name: Device Trade Name: Applicant's Name and Address:
Enzyme Immunoassav, Total T3 ACCESS® Total T3 assay Beckman Instruments, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318
2. Predicate Device
Ciba Corning ACS™ T3 Ciba Corning Diagnostics Corp. Medfield, MA 02052
APPENDIX 4: Summary of Safety and Effectiveness Information
3. Device Description
The ACCESS® Total T3 reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of triiodothyronine in human serum.
4. Indications for Use
The ACCESS® Total T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of trijodothyronine levels in human serum using the ACCESS® Immunoassav System.
5. Comparison of Technological Characteristics
Both the ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay measure triiodothyronine in human serum. The ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay are competitive binding immunoassays. Both assays utilize microparticle technology. The ACCESS® Total T3 binds streptavidin to paramagnetic particles and Ciba Corning ACS™ T3 binds T3 analogue to paramagnetic particles. Both assays use light generated from a chemiluminescent reaction which is measured in a luminometer. Both assavs use a T3 analoque and an alkaline phosphatase coniugated monoclonal anti-T3 antibody. The ACCESS® Total T3 assay uses a monoclonal anti-T3 antibody conjugated to alkaline phosphatase which acts on a dioxetane based chemiluminescent substrate to produce light. The Ciba Corning ACS™ T3 assay uses a monoclonal anti-T3 antibody coniugated to acridinium ester which when activated by hydrogen peroxide and weak sodium peroxide produces light. The ACCESS® Total T3 assay uses a six point calibration while the Ciba Corning ACS™ T3 assay uses a two point calibration. The ACCESS® Total T3 assay utilizes a T3 analogue coupled to biotin while the Ciba Corning ACS™ utilizes a T3 analoque coupled to particles.
6. Summary of Studies
Precision studies: Within run precision ranges from 3.22% CV (high control) to 5.22% CV (low control). Total imprecision ranges from 4.74% CV (high control) to 9.12% CV (low control). Accuracy: Dilution recovery studies performed by diluting two patient samples containing Total T3 with Total T3 Calibrator S0 range from 85.6% to 107.7% recovery. Spiking recovery studies performed by adding T3 to two patient samples containing low levels of T3 range from 87.7% to 112.1 % recovery.
Correlation: A comparison of Total T3 values from 153 samples run in both the ACCESS® Total T3 assay and the Ciba Corning ACS™ T3 assay gives the following statistical data using deming calculations: r = 0.978, v = 1.020x + 0.077.
Analytical Sensitivity: The lowest detectable level of total T3 distinguishable from zero (Total T3 Calibrator S0) with 95% confidence is 0.1 ng/ml.
7. Conclusion
The ACCESS® Total T3 reagents when used with the ACCESS® Immunoassay Analyzer are substantially equivalent to another test for the measurement of Total T3 commercial distribution.
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, with three lines representing the feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is simple and recognizable, and it is often used on official documents and websites related to the department.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 31 1997
Shellie Gust Requlatory Specialist Beckman Instruments, Inc. 100 Lake Hazeltine Drive Chaska, Minnesota 55318-1084
K973966 Re: Enzyme Immunoassay, Total T3 ACCESS® Total T3 Assay Regulatory Class: II Product Code: CDP, JIS Dated: October 16, 1997 October 17, 1997 Received:
Dear Ms. Gust:
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 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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, qood 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 Requlations, 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 requlatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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/dsmamain.html".
Sincerely yours,
Steven Gutman
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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INDICATIONS FOR USE STATEMENT
10(k) Number ( if known): K973966
bevice Name: ACCESS® Total T3 Reagents on the ACCESS® Immunoassay Analyzer
ndications For Use:
The ACCESS® Total T3 Assay is a paramagnetic particle, chemiluminescent immunoassay for the guantitative determination of triiodothyronine levels in human serum, using the ACCESS® mmunoassay System.
The clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto's thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Clinical Laboratory
510(k) Number K973966
✓ Prescription Use