DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)

K130698 · Siemens Healthcare Diagnostics · JIT · Apr 5, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130698
• Device Name: DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
• Applicant: Siemens Healthcare Diagnostics
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The PROG CAL is an in vitro diagnostic product for the calibration of the Progesterone method on the Dimension Vista® System.

Device Story

Dimension Vista® Progesterone Calibrator (PROG CAL) is a liquid, frozen, human serum-based product containing progesterone and preservatives. Used in clinical laboratory settings to calibrate the Progesterone assay on the Dimension Vista® System. The calibrator is provided in ten vials across five concentration levels (0 to 44.0 ng/mL). Values are assigned using multiple Dimension Vista instruments and reagent lots, traceable to the Isotope Dilution Gas Chromatography Mass Spectrometry (ID/GC/MS) reference method. The healthcare provider uses the calibrator to establish the calibration curve on the instrument, ensuring accurate quantification of progesterone levels in patient samples. This process supports clinical decision-making regarding patient hormone status.

Clinical Evidence

Bench testing only. Stability studies confirmed 12-month shelf life at -15°C to -25°C and 15-day stability for opened vials at 2-8°C. Value assignment was validated using 45 replicates per level across multiple instruments and reagent lots.

Technological Characteristics

Human serum-based liquid calibrator; frozen storage (-15°C to -25°C); five concentration levels (0, 1.00, 8.00, 20.0, 44.0 ng/mL); traceable to ID/GC/MS reference method; used on Dimension Vista® 1500 Clinical Chemistry System.

Indications for Use

Indicated for the calibration of the Progesterone (PROG) assay on the Dimension Vista® System. For prescription use only.

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) #: k130698

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.