Abbott ARCHITECT Total T4 Calibrators

K151566 · Abbott Laboratories · JIT · Jul 10, 2015 · Clinical Chemistry

Device Facts

• Record ID: K151566
• Device Name: Abbott ARCHITECT Total T4 Calibrators
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

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.

Device Story

ARCHITECT Total T4 Calibrators are liquid, ready-to-use human serum-based calibrators containing L-Thyroxine at six specific concentrations (0.0 to 24.0 µg/dL). Used in clinical laboratory settings on ARCHITECT i System analyzers (i2000, i2000SR, i1000SR) to establish reference points for the quantitative measurement of Total T4. The healthcare provider uses the resulting assay values to assess patient thyroid status. The device provides standardized reference material to ensure accurate quantification of patient samples.

Clinical Evidence

Bench testing only. Stability studies were conducted per CLSI EP25-A guidelines. Real-time stability for closed vials was validated up to 14 months at 2-8°C. In-use (open vial) stability was validated up to 12 months at 2-8°C. Value assignment was verified by running new lots on three instruments with 15 replicates per run, meeting predetermined acceptance criteria.

Technological Characteristics

Human serum-based calibrators containing L-Thyroxine and sodium azide preservative. Six-point calibration levels (0.0, 3.0, 6.0, 12.0, 18.0, 24.0 µg/dL). Standardized against Abbott internal reference standards derived from USP L-Thyroxine via gravimetric methods. Ready-to-use liquid form factor. Compatible with ARCHITECT i System analyzers.

Indications for Use

Indicated for the calibration of the ARCHITECT i System for the quantitative determination of thyroxine (Total T4) 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) #: k151566

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.