(30 days)
Not Found
No
The description focuses on the chemical composition and stability testing of calibrators for a laboratory assay, with no mention of AI or ML.
No.
This device is a diagnostic calibrator used for the quantitative determination of thyroxine, not for treating a condition.
No
This device is a calibrator, used to establish reference points for quantitative determination of substances. It aids in the assessment of thyroid status by providing values for the Total T4 assay, but it does not directly diagnose a condition itself.
No
The device description clearly states the calibrators are physical substances (human serum with different concentrations of T4) packaged in vials, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the calibrators are for the "quantitative determination of thyroxine (Total T4) in human serum and plasma." This involves testing human specimens in vitro (outside the body).
- Device Description: The description further clarifies that the calibrators are "intended for medical purposes for use in the ARCHITECT Total 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." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Clinical Context: The description mentions that "Total T4 measurements are used as an aid in the assessment of thyroid status," indicating a clinical application for the results obtained using these calibrators.
- Components: The calibrators themselves contain human serum and different concentrations of T4, which are components used in an in vitro assay.
Therefore, based on the provided information, the ARCHITECT Total T4 Calibrators meet the criteria for being an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ARCHITECT Total T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of thyroxine (Total T4) in human serum and plasma.
Product codes
JIT
Device Description
The calibrators are devices intended for medical purposes for use in the ARCHITECT Total 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. Total T4 measurements are used as an aid in the assessment of thyroid status. The calibrators are designed to be used on the ARCHITECT i System (i 2000, and i 1000SR) with the ARCHITECT Total T4 Reagents. ARCHITECT Total T4 Calibrator kit contains:
Calibrator A (Cal A) 1 × 4 mL
Calibrator B (Cal B) 1 × 4 mL
Calibrator C (Cal C) 1 × 4 mL
Calibrator D (Cal D) 1 × 4 mL
Calibrator E (Cal E) 1 × 4 mL
Calibrator F (Cal F) 1 × 4 mL
ARCHITECT Total T4 Calibrator A contains human serum. Preservative: Sodium Azide.
ARCHITECT Total T4 Calibrators B-F contain different concentrations of T4 prepared in human serum. Preservative: Sodium Azide.
The ARCHITECT Total T4 Calibrators are prepared to target the following concentrations:
Calibrator A (Cal A) 0.0 ug/dL (0.0 nmol/L)
Calibrator B (Cal B) 3.0 ug/dL (38.6 nmol/L)
Calibrator C (Cal C) 6.0 ug/dL (77.2 nmol/L)
Calibrator D (Cal D) 12.0 ug/dL (154.4 nmol/L)
Calibrator E (Cal E) 18.0 ug/dL (231.7 nmol/L)
Calibrator F (Cal F) 24.0 ug/dL (308.9 nmol/L)
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies for the ARCHITECT Total T4 calibrators were performed based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP25-A.
In-Use Condition (Open Vial): Stability of the ARCHITECT Total T4 Calibrators was evaluated. At the baseline time point (0) and each subsequent time point (1, 2, 3, 4, 6, 9 and 12 months) the on-test calibrator vials are opened and squeezed to ensure good air exchange, then inverted and squeezed to release a minimum of 8 drops of material from each vial. The vials are then closed and stored at 2 to 8°C until the next time point. In-use testing was performed using a minimum of 10 replicates each of the on-test calibrators, reference controls, and reference panel with the designated reference reagents. The time point results were evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 12 months at 2 - 8°C.
Intended Storage Condition (Closed Vial): The stability for the ARCHITECT Total T4 Calibrators was evaluated using real-time stability study. For the real time stability study, three lots of test materials are stored at 2 – 8°C. Samples at time-points 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 months were tested and evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 14 months at 2 – 8°C.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 10, 2015
ABBOTT LABORATORIES LISA LUKOWSKI REGULATORY AFFAIRS PROJECT MANAGER 100 ABBOTT PARK ROAD, DEPT 9VA, AP8-I ABBOTT PARK IL 60064
Re: K151566
Trade/Device Name: ARCHITECT Total T4 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: June 9, 2015 Received: June 10, 2015
Dear Lisa Lukowski:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 Parts 801 and 809); 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.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Courtney
Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K151566
Device Name ARCHITECT Total T4 Calibrators
Indications for Use (Describe)
The ARCHITECT Total T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of thyroxine (Total T4) in human serum and plasma.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
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.
I. Applicant Name
Abbott Laboratories Dept. 9V6, AP8-1 100 Abbott Park Road Abbott Park, IL 60064
Primary contact person:
Lisa Lukowski, ADD, Regulatory Affairs Project Manager Phone: (224) 668-8849 Fax: (224) 667-4836 E-Mail: lisa.lukowski@abbott.com
Secondary contact person:
Mary Caren Murawski, Associate Director of Regulatory Affairs Phone: (224) 667-2817 Fax: (224) 667-4836 E-Mail: mary.murawski@abbott.com
Date Summary prepared: July 9, 2015
II. Device Name
Trade Name: ARCHITECT Total T4 Calibrators Device Classification: Class II Classification Name: Calibrator, Secondary Governing Regulation: 862.1150 Code: JIT
Classification Panel: Clinical Chemistry
510(k) Number: K151566
III. Predicate Device
ARCHITECT Total T4 Calibrators (K983440)
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IV. Description of the Device
The calibrators are devices intended for medical purposes for use in the ARCHITECT Total 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. Total T4 measurements are used as an aid in the assessment of thyroid status.
The calibrators are designed to be used on the ARCHITECT i System (i 2000, and i 10005R) with the ARCHITECT Total T4 Reagents.
ARCHITECT Total T4 Calibrator kit contains:
| Component | Number of Bottles × Volume |
|---|---|
| Calibrator A (Cal A) | 1 × 4 mL |
| Calibrator B (Cal B) | 1 × 4 mL |
| Calibrator C (Cal C) | 1 × 4 mL |
| Calibrator D (Cal D) | 1 × 4 mL |
| Calibrator E (Cal E) | 1 × 4 mL |
| Calibrator F (Cal F) | 1 × 4 mL |
- . ARCHITECT Total T4 Calibrator A contains human serum. Preservative: Sodium Azide.
- . ARCHITECT Total T4 Calibrators B-F contain different concentrations of T4 prepared in human serum. Preservative: Sodium Azide.
The ARCHITECT Total T4 Calibrators are prepared to target the following concentrations:
| Component | Concentration
(ug/dL) | Concentration
(nmol/L) |
|----------------------|--------------------------|---------------------------|
| Calibrator A (Cal A) | 0.0 | 0.0 |
| Calibrator B (Cal B) | 3.0 | 38.6 |
| Calibrator C (Cal C) | 6.0 | 77.2 |
| Calibrator D (Cal D) | 12.0 | 154.4 |
| Calibrator E (Cal E) | 18.0 | 231.7 |
| Calibrator F (Cal F) | 24.0 | 308.9 |
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Value Assignment:
The ARCHITECT Total T4 (TT4) calibrators are prepared using a stock solution and then value assigned using primary calibrators (Abbott internal reference standards prepared using USP material). The TT4 calibrator values must meet the sponsor's predetermined acceptance criteria within a set specification, determined by the manufacturer. Each new TT4 calibrator lot is value assigned prior to use. Before each lot is released, the TT 4 calibrators are run on 3 instruments, 1 run per instrument 15 replicates per run. The observed values must meet the manufacture's acceptance criteria.
V. Intended Use of the Device
The ARCHITECT Total T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of thyroxine (Total T4) in human serum and plasma.
VI. Summary of Technological Characteristics
The following table provides the similarities and differences between the candidate (ARCHITECT Total T4) and the predicate device (ARCHITECT Total T4, K983440).
| Attribute | Predicate Device
ARCHITECT Total T4 Calibrators
(2-Point Calibration)
K983440 | Candidate Device
ARCHITECT Total T4 Calibrators
(6-Point Calibration)
K151566 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Total T4
Calibrators are for the calibration
of the ARCHITECT i System
when used for the quantitative
determination of thyroxine (Total
T4) in human serum and plasma. | Same |
| Instrumentation | ARCHITECT i System ( i 2000SR,
i 2000, and i 1000SR) | Same |
| Attribute | Predicate Device
ARCHITECT Total T4 Calibrators
(2-Point Calibration)
K983440 | Candidate Device
ARCHITECT Total T4 Calibrators
(6-Point Calibration)
K151566 |
| Total T4
Calibrators | 2 levels 0.0 and 18.0 µg/dL L-Thyroxine in human serum | 6 levels 0.0, 3.0, 6.0, 12.0, 18.0, and 24.0 µg/dL L-Thyroxine in human serum |
| Calibrator
Composition | Calibrator 1:
Analyte: None
Diluent: Human Serum
Preservative: Sodium Azide Calibrator 2:
Analyte: L-Thyroxine
Diluent: Human Serum
Preservative: Sodium Azide | Calibrator A:
Analyte: None
Diluent: Human Serum
Preservative: Sodium Azide Calibrators B-F:
Analyte: L-Thyroxine
Diluent: Human Serum
Preservative: Sodium Azide |
| Standardization | The calibrators are matched to an
Abbott internal reference standard.
This internal reference standard is
manufactured by gravimetric
methods using USP reference
L-Thyroxine. | Same |
| Storage and
Stability | The calibrators are stable until the
expiration date when stored and
handled as directed at 2-8°C. | The expiration date is 12 months
from the date opened when stored
and handled as directed. Do not
exceed the lot expiration date
printed on the bottle.
The calibrators are stable until the
expiration date when stored and
handled as directed. |
| Preparation for
Use | Ready to use | Same |
Comparison of ARCHITECT Total T4 to Predicate ARCHITECT Total T4 Calibrators
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Comparison of ARCHITECT Total T4 to Predicate ARCHITECT Total T4 Calibrators
Stability Results:
Stability studies for the ARCHITECT Total T4 calibrators were performed based on guidance from the Clinical Laboratory and Standards Institute (CLSI) document EP25-A.
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In-Use Condition (Open Vial):
Stability of the ARCHITECT Total T4 Calibrators was evaluated. At the baseline time point (0) and each subsequent time point (1, 2, 3, 4, 6, 9 and 12 months) the on-test calibrator vials are opened and squeezed to ensure good air exchange, then inverted and squeezed to release a minimum of 8 drops of material from each vial. The vials are then closed and stored at 2 to 8°C until the next time point. In-use testing was performed using a minimum of 10 replicates each of the on-test calibrators, reference controls, and reference panel with the designated reference reagents. The time point results were evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 12 months at 2 - 8°C.
Intended Storage Condition (Closed Vial):
The stability for the ARCHITECT Total T4 Calibrators was evaluated using real-time stability study. For the real time stability study, three lots of test materials are stored at 2 – 8°C. Samples at time-points 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 months were tested and evaluated against the stability limit evaluation criteria. The results support the following stability claim for the ARCHITECT Total T4 Calibrators: 14 months at 2 – 8°C.
Standardization
The calibrators are matched to an Abbott internal reference standard. This internal reference standard is manufactured by gravimetric methods using USP reference L-Thyroxine.
VII. Conclusion
Substantial equivalence for the candidate device, ARCHITECT Total T4 Calibrators, is claimed to the predicate device cleared in K983440, ARCHITECT Total T4 Calibrators. The modifications to the calibrators have not changed the intended use, as described in its labeling, nor have the modifications altered the fundamental scientific technology of this device.