(7 days)
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No
The document describes a calibrator set for an immunoassay system, which is a chemical-based measurement method. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on equivalence to a predicate calibrator, not on algorithmic performance.
No
The device is a calibrator used to establish reference points for measuring free T3 levels; it does not directly treat or diagnose a condition.
No
The device is a calibrator set, which establishes points of reference for the measurement of free T3 levels. While it is used in the process of determining diagnostic values, the calibrator itself does not diagnose a condition; it aids in the accurate measurement by another device (immunoassay system).
No
The device description explicitly states it is a "Calibrator set" and "kit" containing "6 X 2.5 mL bottles," indicating it is a physical product with chemical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma." This clearly indicates it's used to analyze biological samples (human serum and plasma) in vitro (outside the body) to provide diagnostic information (free T3 levels).
- Device Description: The description further supports this by explaining its use with the "Access Free T3 Reagent for generation of the Free T3 assay calibration curve." This describes a process performed in vitro to prepare for diagnostic testing.
- Performance Studies: The performance studies compare it to a predicate device which is also a calibrator used in an immunoassay system, a common type of IVD.
The core function of this device is to provide a standard for measuring an analyte (free T3) in biological samples, which is a defining characteristic of an In Vitro Diagnostic device.
No.
A Predetermined Change Control Plan (PCCP) authorizes future modifications to a device without needing a new 510(k) submission, provided these changes fall within the scope of the pre-specified plan. This clearance letter does not contain any language or information indicating that a PCCP has been authorized for this device. The information provided describes a standard 510(k) clearance based on substantial equivalence to a predicate device.
Intended Use / Indications for Use
The Access Free T3 Calibrators are intended to calibrate the Access Free T3 The Access ITEE 15 Oalibrators are internets of free triiodothyronine levels in human assay for the qualifising the Access Immunoassay Systems.
The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.
Product codes
JIT
Device Description
The Access Free T3 Calibrators are designed for use with the Access Free T3 Reagent for generation of the Free T3 assay calibration curve on Beckman Coulter's Access Immunoassay Systems. The Access Free T3 Calibrator kit contains 6 X 2.5 mL bottles, one for each of six calibrator levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
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)
The Access Free T3 Calibrators have been demonstrated to be equivalent to the The Access Product. Based on the results of the performance characteristics predioute product: "Product claims and specifications and specifications.
Performance data from validation testing supports a finding of substantial renomance to the Beckman Coulter Access Ultrasensitive hGH Calibrators already in commercial distribution.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(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.
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DC1 5 - 2004
Access Free T3 Calibrator 510(k) Summary
1.0 Submitted By:
Valynda Machen Senior Regulatory Affairs Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 (952) 368-1383 Telephone: (952) 368-7610 FAX:
2.0 Date Submitted
September 27, 2004
3.0 Device Name(s):
-
Proprietary Names 3.1
Access® Free T3 Calibrators -
3.2 Classification Names
Calibrator (21 CFR § 862.1150)
4.0 Legally Marketed Device
The Access Free T3 Calibrators claim substantial equivalence to the Beckman Coulter Access Ultrasensitive hGH Calibrators currently in commercial distribution, FDA 510(k) Number K003098.
5.0 Device Description
The Access Free T3 Calibrators are designed for use with the Access Free T3 Reagent for generation of the Free T3 assay calibration curve on Beckman Coulter's Access Immunoassay Systems. The Access Free T3 Calibrator kit contains 6 X 2.5 mL bottles, one for each of six calibrator levels. The Access Immunoassay Systems utilize a competitive binding immunoenzymatic method for quantitative analyte measurement.
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Intended Use 6.0
The Access Free T3 Calibrators are intended to calibrate the Access Free T3 The Access ITEE 15 Oalibrators are internets of free triiodothyronine levels in human assay for the qualifising the Access Immunoassay Systems.
Comparison to the Predicate 7.0
The Access Free T3 Calibrators and the predicate calibrator utilize the same test The Access ITEE 15 Oalbratore and mo productions . Each calibrator is intended for use in a different analyte test system. The Access Free T3 intentied for use in a different are provided in a stabilized bovine serum callurators and the prodicate device contains somatropin (human growth albumin Thum. - The preatedie T3 calibrator contains 3', 3, 5-triiodothyronine. homone) while the Access for are liquid stable while the predicate calibrator is lyophilized and requires preparation.
Summary of Performance Data 8.0
The Access Free T3 Calibrators have been demonstrated to be equivalent to the The Access Product. Based on the results of the performance characteristics predioute product: "Product claims and specifications and specifications.
Performance data from validation testing supports a finding of substantial renomance to the Beckman Coulter Access Ultrasensitive hGH Calibrators already in commercial distribution.
Beckman Coulter, Inc. Access Free T3 Calibrators
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 5 - 2004
Ms. Valynda Machen Senior Regulatory Specialist Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318-1084
Re: K042651
K042031
Trade/Device Name: Free T3 Calibrators on the Access Immunoassay System Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: September 27, 2004 Received: September 28, 2004
Dear Ms. Machen:
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 for the enated of 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, do noos mat hat (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 I va may) attols 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 or any I 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) I ms lotter will and wy a the FDA finding of substantial equivalence of your device to a legally premaince notification " assessification 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, ar you store on the promotion and advertising of your device, please contact the Office of or Yatodollo en atte provise 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, MS, 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
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Indications for Use
510(k) Number (if known): ___ K042651
Device Name: Free T3 Calibrators on the Access Immunoassay Systems
Indications For Use: The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Albert Satz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K042651
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