Abbott ARCHITECT Free T3

K170160 · Abbott Laboratories · JIT · Feb 15, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170160
• Device Name: Abbott ARCHITECT Free T3
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Feb 15, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for 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.

Device Story

ARCHITECT Free T3 Calibrators are liquid, ready-to-use human serum-based standards containing L-Thyroxine and L-Triiodothyronine; used to establish reference points for the ARCHITECT i System (i2000sr, i2000, i1000sr) during quantitative Free T3 assays. The kit consists of six levels (A-F) with concentrations ranging from 0.0 to 30.0 pg/mL. Calibrators are used by laboratory personnel in clinical settings to calibrate the assay system. By providing known concentrations, the device enables the system to generate a calibration curve, allowing for the accurate measurement of patient Free T3 levels. This measurement assists clinicians in assessing thyroid status. The device is stored at 2-8°C and is stable for 11-12 months.

Clinical Evidence

Bench testing only. Stability studies were performed per CLSI EP25-A guidelines. Real-time stability (closed vial) and in-use stability (open vial) were evaluated over 11-12 months at 2-8°C. Results support the claimed shelf life and in-use stability.

Technological Characteristics

Human serum-based calibrators; preservative: sodium azide. Six-level concentration range (0.0 to 30.0 pg/mL). Standardization via gravimetric methods using L-Triiodothyronine and L-Thyroxine (USP grade, >95% purity). Compatible with ARCHITECT i System. Storage: 2-8°C. Ready-to-use liquid form factor.

Indications for Use

Indicated for use with the ARCHITECT i System for the quantitative determination of free triiodothyronine (Free T3) in human serum and plasma to aid in the assessment of thyroid status.

Regulatory Classification

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.)

Special Controls

*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.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k170160

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.