(28 days)
No
The document describes calibrators for a laboratory assay system and does not mention any AI or ML components.
No
The device is a calibrator used in an in-vitro diagnostic test to establish reference points for measurements, not to treat or diagnose a disease directly.
Yes
The device is described as "an aid in the assessment of thyroid status," which indicates its use in the diagnosis of a medical condition.
No
The device description clearly states the calibrators are physical substances (human serum with added components) intended for use with a specific hardware system (ARCHITECT i System). It describes the composition and packaging of the calibrator kit, indicating it is a tangible product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of free triiodothyronine (Free T3) in human serum and plasma." This involves testing human specimens in vitro (outside the body).
- Device Description: The description clarifies that the calibrators are "devices intended for medical purposes for use in the ARCHITECT Free T 3 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.
- Purpose: The description also states that "Free T3 measurements are used as an aid in the assessment of thyroid status." This indicates the results obtained using this device are intended to provide information for medical assessment, a key characteristic of IVDs.
The fact that it's a calibrator for an assay that measures a substance in human specimens for medical purposes clearly places it within the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ARCHITECT Free T3 Calibrators are for the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma.
Product codes
JIT
Device Description
The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T3 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 T3 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 2000gg, i 2000, and i 1000sR) with the ARCHITECT Free T3 Reagents. The ARCHITECT Free T3 Calibrator kit contains: Calibrator A (Cal A) 1 x 4 mL, Calibrator B (Cal B) 1 x 4 mL, Calibrator C (Cal C) 1 x 4 mL, Calibrator D (Cal D) 1 x 4 mL, Calibrator E (Cal E) 1 x 4 mL, Calibrator F (Cal F) 1 x 4 mL. ARCHITECT Free T3 Calibrator A contains human serum. Preservative: Sodium Azide. ARCHITECT Free T3 Calibrators B through F contain different concentrations of L-Thyroxine and L-Triiodothyronine prepared in human serum. Preservative: Sodium Azide. The ARCHITECT Free T3 Calibrators are prepared to target the following concentrations: Calibrator A (Cal A) at 0.0 pg/mL (0.0 pmol/L), Calibrator B (Cal B) at 1.4 pg/mL (2.15 pmol/L), Calibrator C (Cal C) at 3.5 pg/mL (5.38 pmol/L), Calibrator D (Cal D) at 7.0 pg/mL (10.75 pmol/L), Calibrator E (Cal E) at 17.2 pg/mL (26.42 pmol/L), Calibrator F (Cal F) at 30.0 pg/mL (46.08 pmol/L). The ARCHITECT Free T3 standardization follows a two-step assay standardization method, where market Free T3 Calibrator lots are matched to Primary Calibrators using sample/reference (S/C ratio) specifications. The Primary Calibrators are matched to Working Reference Calibrators (Abbott internal reference standards) using sample/reference (S/C ratio) specifications. The Working Reference Calibrators are manufactured by gravimetric methods using L-Triiodothyronine (Liothyronine USP) and L-Thyroxine (Levothyroxine USP).
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Intended User / Care Setting
Prescription Use
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
Stability studies for the ARCHITECT Free T3 Calibrators were performed based on guidance from the Clinical Laboratories and Standards Institute (CLSI) document EP25-A.
In-Use Condition (Open Vial) Study: The stability of the ARCHITECT Free T3 Calibrators was evaluated. At the baseline time point (0) and each subsequent time point (1, 2, 3, 4, 6, 8, and 11 months), the on-test calibrator vials were 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 were 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 a stability claim for the ARCHITECT Free T3 Calibrators of 11 months at 2 to 8°C. The in-use stability is an on-going study and is scheduled to continue for up to 18 months.
Intended Storage Condition (Closed Vial) Study: The stability of the ARCHITECT Free T3 Calibrators was evaluated using a real-time stability study. For the real time stability study, three lots of test material were stored at 2 to 8°C. Samples at time points 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months were tested and evaluated against the stability limit evaluation criteria. The results for the Intended Use stability support a stability claim of 12 months at 2 to 8°C.
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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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February 15, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ABBOTT LABORATORIES LINDA SOHN SR. REGULATORY SPECIALIST 100 ABBOTT PARK ROAD, DEPT 09AA, BLDG. AP08 ABBOTT PARK, IL 60064
Re: K170160
Trade/Device Name: ARCHITECT Free T3 Calibrators Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: January 17, 2017 Received: January 18, 2017
Dear Linda Sohn:
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.
Katherine Serrano -S
For : 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) K170160
Device Name ARCHITECT Free T3 Calibrators
Indications for Use (Describe)
The ARCHITECT Free T3 Calibrators are for the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T3) 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 (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.
I. Applicant Name
Abbott Laboratories Dept. 9AA, AP8-1 100 Abbott Park Road Abbott Park, IL 60064
Primary contact person for all communications:
Linda Sohn, ADD, Sr. Regulatory Affairs Specialist Phone: (224) 667-4846 Fax: (224) 667-4836 E-Mail: linda.sohn@abbott.com
Secondary contact person for all communications:
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: February 13, 2017
II. Device Name
Trade Name: ARCHITECT Free T3 Calibrators Device Classification: Class II Classification Name: Calibrator, Secondary Governing Regulation: 862.1150 Code: JIT
Classification Panel: Clinical Chemistry
510(k) Number: K170160
III. Predicate Device
ARCHITECT Free T3 Calibrators (K983439)
4
IV. Description of the Device
The calibrators are devices intended for medical purposes for use in the ARCHITECT Free T 3 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 T3 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 2000gg, i 2000, and i 1000sR) with the ARCHITECT Free T3 Reagents.
| 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 |
The ARCHITECT Free T3 Calibrator kit contains:
- . ARCHITECT Free T3 Calibrator A contains human serum. Preservative: Sodium Azide
- ARCHITECT Free T3 Calibrators B through F contain different concentrations . of L-Thyroxine and L-Triiodothyronine prepared in human serum. Preservative: Sodium Azide.
5
| Component | Concentration
(pg/mL) | Concentration
(pmol/L) |
|----------------------|--------------------------|---------------------------|
| Calibrator A (Cal A) | 0.0 | 0.0 |
| Calibrator B (Cal B) | 1.4 | 2.15 |
| Calibrator C (Cal C) | 3.5 | 5.38 |
| Calibrator D (Cal D) | 7.0 | 10.75 |
| Calibrator E (Cal E) | 17.2 | 26.42 |
| Calibrator F (Cal F) | 30.0 | 46.08 |
The ARCHITECT Free T3 Calibrators are prepared to target the following concentrations:
Value Assignment
The ARCHITECT Free T3 standardization follows a two-step assay standardization method, where market Free T3 Calibrator lots are matched to Primary Calibrators using sample/reference (S/C ratio) specifications. The Primary Calibrators are matched to Working Reference Calibrators (Abbott internal reference standards) using sample/reference (S/C ratio) specifications. The Working Reference Calibrators are manufactured by gravimetric methods using L-Triiodothyronine (Liothyronine USP) and L-Thyroxine (Levothyroxine USP).
V. Intended Use of the Device
The ARCHITECT Free T3 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free triiodothyronine (Free T2) in human serum and plasma.
VI. Summary of Technological Characteristics
The following table provides the similarities and differences between the candidate calibrators ARCHITECT Free T3 and the predicate calibrators (ARCHITECT Free T3, K983439).
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Comparison of ARCHITECT Free T3 to
Predicate ARCHITECT Free T3 Assay
| Attribute | Predicate Device
ARCHITECT Free T3 Calibrators
(2-Point Calibration), K983440 | Candidate Device
ARCHITECT Free T3 Calibrators
(6-Point Calibration) |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The ARCHITECT Free T3 Calibrators
are for the calibration of the
ARCHITECT i System when used for
the quantitative determination of free
triiodothyronine (Free T3) in human
serum and plasma. | Same |
| Instrumentation | ARCHITECT i System (i 2000gr,
i 2000, and i 1000sR) | Same |
| Free T3
Calibrators | 2 levels
●
1.4 and 30 pg/mL L-Thyroxine and
L-Triiodothyronine in human
serum | 6 levels
●
0.0, 1.4, 3.5, 7.0, 17.2, 30.0
pg/mL L-Thyroxine and L-
Triiodothyronine in human
serum |
| Calibrator
Composition | Calibrator 1:
Analyte: None
Diluent: Human Serum
Preservative: Sodium Azide
Calibrator 2:
Analyte: L-Thyroxine and L-
Triiodothyronine
Diluent: Human Serum
Preservative: Sodium Azide | Calibrator A:
Analyte: None
Diluent: Human Serum
Preservative: Sodium Azide
Calibrators B-F:
Analyte: L-Thyroxine and L-
Triiodothyronine
Diluent: Human Serum
Preservative: Sodium Azide |
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| Attribute | Predicate Device
ARCHITECT Free T3 Calibrators
(2-Point Calibration), K983440 | Candidate Device
ARCHITECT Free T3 Calibrators
(6-Point Calibration) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Standardization | The calibrators are matched to an
Abbott internal reference standard.
This internal reference standard is
manufactured by gravimetric methods
based on the Free Triiodothyronine
calculation (FT3c) using
L-Triiodothyronine (sodium salt, not
less than 95% pure by HPLC) and
L-Thyroxine (sodium pentahydrate,
not less than 95% pure by HPLC) at
each concentration level. The FT3c is
a calculation of the Free
Triiodothyronine hormone
concentration, which depends on the
amount of Total T3 and Total T4 found
in the serum as well as the serum 's
thyroid hormone binding capacity. | Same |
| Storage and
Stability | The calibrators are stable until the
expiration date when stored and
handled as directed at 2-8°C | Same |
| Preparation of
Use | Ready to use | Same |
Stability Results
Stability studies for the ARCHITECT Free T3 Calibrators were performed based on guidance from the Clinical Laboratories and Standards Institute (CLSI) document EP25-A.
In-Use Condition (Open Vial)
The stability of the ARCHITECT Free T3 Calibrators was evaluated. At the baseline time point (0) and each subsequent time point (1, 2, 3, 4, 6, 8, and 11 months), the ontest calibrator vials were 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 were 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.
8
The time point results were evaluated against the stability limit evaluation criteria. The results support a stability claim for the ARCHITECT Free T3 Calibrators of 11 months at 2 to 8°C. The in-use stability is an on-going study and is scheduled to continue for up to 18 months.
Intended Storage Condition (Closed Vial)
The stability of the ARCHITECT Free T3 Calibrators was evaluated using a real-time stability study. For the real time stability study, three lots of test material were stored at 2 to 8°C. Samples at time points 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12 months were tested and evaluated against the stability limit evaluation criteria. The results for the Intended Use stability support a stability claim of 12 months at 2 to 8°C.
The results for In-Use and Intended Storage stability studies support a stability claim for the ARCHITECT Free T3 Calibrators of 11 months at 2 to 8°C. The in-use and intended storage stability is an on-going study and is scheduled to continue for up to 18 months.
Standardization
The calibrators are matched to an Abbott internal reference standard. This internal reference standard is manufactured by gravimetric methods based on the Free Triiodothyronine calculation (FT3c) using L-Triiodothyronine (sodium salt, not less than 95% pure by HPLC) and L-Thyroxine (sodium pentahydrate, not less than 95% pure by HPLC) at each concentration level. The FT3c is a calculation of the Free Triiodothyronine hormone concentration, which depends on the amount of Total T3 and Total T4 found in the serum as well as the serum 's thyroid hormone binding capacity.
VII. Conclusion
Substantial equivalence for the candidate device, ARCHITECT Free T3 Calibrators, is claimed to the predicate device cleared in K983439, ARCHITECT Free T3 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.