(26 days)
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No
The description focuses on a standard immunoassay technology (CMIA) and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
Explanation: The device is an in-vitro diagnostic assay used to measure free thyroxine levels, which aids in assessing thyroid status. It does not treat or alleviate a disease, but rather provides diagnostic information.
Yes
The device quantitatively determines free thyroxine (Free T4) in human serum and plasma, which is used "as an aid in the assessment of thyroid status." This indicates it provides information to assist in diagnosing a medical condition.
No
The device description clearly outlines a chemical immunoassay process involving reagents, microparticles, and an optical system to measure relative light units. This indicates a hardware-based laboratory analyzer system, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states the assay is for the "quantitative determination of free thyroxine (Free T4) in human serum and plasma." This involves testing human specimens in vitro (outside the body).
- Purpose: The assay is used "as an aid in the assessment of thyroid status," which is a medical purpose.
- Device Description: The description details a "two-step immunoassay" using "human serum and plasma," further confirming the in vitro nature of the testing.
- Calibrators and Controls: The description of the calibrators and controls also refers to their use in the "quantitative determination of values in the measurement of substances in human specimens."
All these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma. The ARCHITECT Free T4 assay is to be used as an aid in the assessment of thyroid status.
The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
Product codes (comma separated list FDA assigned to the subject device)
CEC, JIT, JJX
Device Description
The ARCHITECT Free T4 assay is a two-step immunoassay to determine the presence of free thyroxine (Free T4) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample and anti-T4 coated paramagnetic microparticles are combined. Free T4 (unbound) present in the sample binds to the anti-T4 coated microparticles. After washing. T3 acridinium labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of Free T4 in the sample and the RLUs detected by the ARCHITECT i optical system.
The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T4 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T4 measurements are used as an aid in the assessment of thyroid status.
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 nonclinical performance of the ARCHITECT Free T4 assay was demonstrated through the following studies:
- Accuracy by Correlation
- Accelerated Calibrator Stability
- Real Time Calibrator Stability - In-Use (Open Vial)
- Real Time Calibrator Stability - Intended Storage (Closed Vial)
- Limits of Blank/Detection/Quantitation (LoB/LoD/LoQ)
- Linearity
- 20-Day Precision at the Limits of the Measuring Interval
- 20-Day Precision to Verify the Product Requirements
- 20-Day Precision for Native Samples
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity: 0.4 ng/dL (replaced by LoQ)
LoB: 0.22 ng/dL
LoD: 0.28 ng/dL
LoQ: 0.4 ng/dL
Dynamic Range/Measuring Interval: 0.4–6.0 ng/dL
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
§ 862.1695 Free thyroxine test system.
(a)
Identification. A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II.
0
123379
NOV 2 7 2012
Attachment B 510(k) Summary (Summary of Safety and Effectiveness)
This summary of the 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Applicant Name:
Jacek Gorzowski, Regulatory Affairs Project Manager
Regulatory Affairs
Abbott Laboratories Diagnostics Division
Dept. 9VA, AP5N-2
100 Abbott Park Road
Abbott Park, IL 60064
Device Name:
Classification Name: Radioimmunoassay, Free Thyroxine
Trade Name: Abbott ARCHITECT Free T4
Common Name: Radioimmunoassay, Free Thyroxine
Governing Regulation: 862.1695
Device Classification: Class II
Classification Panel: Clinical Chemistry
Product Code: CEC/JIT/JJX
Legally marketed device to which equivalency is claimed:
K983417, Abbott ARCHITECT Free T4 (LN 7K65-01; 2-point calibration)
1
Intended Use of Device:
The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma. The ARCHITECT Free T4 assay is to be used as an aid in the assessment of thyroid status.
The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
Description of Device:
The ARCHITECT Free T4 assay is a two-step immunoassay to determine the presence of free thyroxine (Free T4) in human serum and plasma using CMIA technology with flexible assay protocols, referred to as Chemiflex.
In the first step, sample and anti-T4 coated paramagnetic microparticles are combined. Free T 4 (unbound) present in the sample binds to the anti-T4 coated microparticles. After washing. T3 acridinium labeled conjugate is added in the second step. Pre-Trigger and Trigger Solutions are then added to the reaction mixture; the resulting chemiluminescent reaction is measured as relative light units (RLUs). An inverse relationship exists between the amount of Free T4 in the sample and the RLUs detected by the ARCHITECT i optical system.
The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 4 assay test system to establish points of reference that are used in the quantitative determination of values in the measurement of substances in human specimens. Free T4 measurements are used as an aid in the assessment of thyroid status.
2
Modification of Device:
This Special 510(k) modification of the ARCHITECT Free T4 assay consisted of changing the calibration from a 2-point calibration to a 6-point calibration.
3
Similarities and Differences of Modified Device:
The table below compares the new device, ARCHITECT Free T4 (LN 7K65-02; 6-point calibration), with the predicate device, ARCHITECT Free T4 (LN 7K65-01; 2-point calibration) (K983417).
| Attribute | Predicate Device
ARCHITECT Free T4
(2-point calibration)
LN 7K65-01, K983417 | New Device
ARCHITECT Free T4
(6-point calibration)
LN 7K65-02 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Free T4 (FT4)
assay is a Chemiluminescent
Microparticle Immunoassay
(CMIA) for the quantitative
determination of free thyroxine
(Free T4) in human serum and
plasma. The ARCHITECT Free T4
assay is to be used as an aid in the
assessment of thyroid status. | Same |
| | The ARCHITECT Free T4
Calibrators are for the calibration of
the ARCHITECT i System when
used for the quantitative
determination of free thyroxine
(Free T4) in human serum and
plasma when using the
ARCHITECT Free T4 Reagent Kit. | |
| | The ARCHITECT Free T4 Controls
are for the verification of the
accuracy and precision of the
ARCHITECT i System when used
for the quantitative determination of
free thyroxine (Free T4) in human
serum and plasma when using the
ARCHITECT Free T4 Reagent Kit. | |
| | | |
| Instrumentation | ARCHITECT i System | Same |
| Attribute | Predicate Device
ARCHITECT Free T4
(2-point calibration)
LN 7K65-01, K983417 | New Device
ARCHITECT Free T4
(6-point calibration)
LN 7K65-02 |
| Assay Reagents | Microparticles: Anti-T4 (sheep)
coated microparticles in TRIS
buffer with sheep IgG stabilizers.
Minimum concentration: 0.08%
solids. Preservative: antimicrobial
agent.
Conjugate: T3 acridinium-labeled
conjugate in MES buffer with NaCl
and Triton X-100 stabilizers.
Minimum concentration: 0.2 ng/mL.
Preservative: ProClin. | • Same |
| Free T4 Calibrators | • 2 levels
• 0.5 and 6.0 ng/dL L-thyroxine
in human serum | • 6 levels
• 0.0, 0.5, 1.0, 2.0, 3.5,
6.0 ng/dL L-thyroxine in
human serum |
| Calibrator
Composition | • Calibrators 1-2: L-thyroxine,
sodium salt pentahydrate (HPLC
grade)
• Calibrators 1-2: Diluent: Human
Serum
• Calibrators 1-2: Preservative:
Sodium Azide | • Calibrators B-F: Same
• Calibrators A-F: Diluent: Same
• Calibrators A-F: Preservative:
Same |
| Standardization | The calibrators are matched to an
Abbott internal reference standard.
This internal reference standard is
manufactured by gravimetric
methods based on the Free
Thyroxine calculation (FT4c) using
L-Thyroxine, sodium salt
pentahydrate (HPLC grade), at each
concentration, which depends on the
amount of Total T4 found in the
serum and the serum's T4 binding
capacity. | Same |
| Calibrator Range | 0.0–6.0 ng/dL | Same |
| Attribute | Predicate Device
ARCHITECT Free T 4
(2-point calibration)
LN 7K65-01, K983417 | New Device
ARCHITECT Free T 4
(6-point calibration)
LN 7K65-02 |
| Analytical Sensitivity | 0.4 ng/dL | Analytical sensitivity replaced by
LoQ. |
| LoB
LoD
LoQ | Not applicable | LoB: 0.22 ng/dL
LoD: 0.28 ng/dL
LoQ: 0.4 ng/dL |
| Dynamic Range/
Measuring Interval | 0.4–6.0 ng/dL | Same |
| Control
Composition | • Controls L, M, H: L-thyroxine,
sodium salt pentahydrate (HPLC
grade)
• Controls L, M, H: Diluent:
Human Serum
• Controls L, M, H: Preservative:
Sodium Azide | • Controls L, M, H: Same
• Controls L, M, H: Diluent: Same
• Controls L, M, H: Preservative:
Same |
4
Similarities and Differences of Modified Device (Continued):
5
Similarities and Differences of Modified Device (Continued):
6
Verification/Validation of Modification:
The nonclinical performance of the ARCHITECT Free T4 assay was demonstrated through the following studies:
- . Accuracy by Correlation
- . Accelerated Calibrator Stability
- . Real Time Calibrator Stability - In-Use (Open Vial)
- . Real Time Calibrator Stability - Intended Storage (Closed Vial)
- ◆ Limits of Blank/Detection/Quantitation (LoB/LoD/LoQ)
- Linearity *
- 20-Day Precision at the Limits of the Measuring Interval .
- 20-Day Precision to Verify the Product Requirements •
- 20-Day Precision for Native Samples .
Conclusion:
Substantial equivalence for the modified device, ARCHITECT Free Ta (LN 7K65-02; 6-point calibration), is claimed to the predicate device cleared in K983417, ARCHITECT Free T4 (LN 7K65-01; 2-point calibration). The modification to the calibrators, which consisted of changing the calibration from a 2-point calibration to a 6-point calibration, has not changed the intended use, as described in the labeling, nor has it altered the fundamental scientific technology of the device.
7
DEPARTMENT OF HEALTH & HUM AN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. 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 representation of a human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans and provide essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 27, 2012
Abbott Laboratories c/o Jacek Gorzowski 100 Abbott Park Road Dept. 9VA, AP5N-2 Abbott Park, IL 60064-3500
Re: kl23379
Trade/Device Name: Abbott ARCHITECT Free T4 Regulation Number: 21 CFR 862.1695 Regulation Name: Free thyroxine test system Regulatory Class: Class II Product Code: CEC, JIT, JJX Dated: October 30, 2012 Received: November 1, 2012
Dear Jacek Gorzowski:
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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
8
Page 2 - Jacek Gorzowski
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benson for
Courtney H. Lias, Ph.D.
Director
Division of Chemistry and Toxicology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
9
Indications for Use
k 123379 510(k) Number (if known): Device Name: Abbott ARCHITECT Free T4 Indications for Use
The ARCHITECT Free T4 (FT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (Free T4) in human serum and plasma. The ARCHITECT Free T4 assay is to be used as an aid in the assessment of thyroid status.
The ARCHITECT Free T , Calibrators are for the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free Ta) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Yung Chan
Division Vitro Diagnostics and Radiological Health Office of 510(k)