VITROS Immunodiagnostic Products Insulin Calibrators

K171168 · Ortho Clinical Diagnostics · JIT · May 16, 2017 · Clinical Chemistry

Device Facts

• Record ID: K171168
• Device Name: VITROS Immunodiagnostic Products Insulin Calibrators
• Applicant: Ortho Clinical Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: May 16, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

For in vitro diagnostic use only. For use in the calibration of the VITROS ECVECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System for the quantitative measurement of insulin in human serum and plasma (Li Heparin).

Device Story

VITROS Immunodiagnostic Products Insulin Calibrators are liquid, three-level calibrators (1, 25, 250 µIU/mL) containing recombinant human insulin in a BSA-buffered solution with antimicrobial agents. Used in clinical laboratory settings to calibrate VITROS ECi/ECiQ, 3600, and 5600 systems. The calibration process establishes a valid curve for the quantitative measurement of insulin in human serum and plasma samples. Healthcare providers use the resulting insulin measurements to aid in clinical decision-making regarding patient metabolic status. The device ensures analytical accuracy by providing traceability to the WHO 1st International Reference Preparation 66/304.

Clinical Evidence

Bench testing only. No clinical data provided. Stability and traceability were validated per CLSI EP25-A and FDA guidance for IVD calibrators. Value assignment is traceable to WHO 1st International Reference Preparation 66/304.

Technological Characteristics

Liquid calibrator kit containing three levels (1, 25, 250 µIU/mL). Composition: recombinant human insulin, BSA buffer, antimicrobial agent. Traceability: WHO 1st International Reference Preparation 66/304. Stability: 13 weeks opened, stored at 2-8°C. Standard: CLSI EP25-A.

Indications for Use

Indicated for use in the calibration of VITROS Immunodiagnostic systems for the quantitative measurement of insulin in human serum and plasma (Li Heparin). For prescription use.

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) #: k171168

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.