IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers

K161082 · Immunodiagnostic Systems , Ltd. · JJX · May 17, 2016 · Clinical Chemistry

Device Facts

• Record ID: K161082
• Device Name: IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: May 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IDS-iSYS 17-OH Progesterone Control Set is for in vitro diagnostic use, for the quality control of the IDS-iSYS 17-OH Progesterone on the IDS-iSYS Multi-Discipline Automated System. Rx Only. The IDS-iSYS 17-OH Progesterone Calibration Verifiers are an in vitro diagnostic device intended for medical purposes in the quantitative verification of assay calibration and measuring range of the IDS-iSYS 17-OH Progesterone assay, when performed on the IDS-iSYS Multi Discipline Automated System. Rx Only.

Device Story

IDS-iSYS 17-OH Progesterone Control Set and Calibration Verifiers are liquid human serum-based reagents containing 17-OH Progesterone and sodium azide preservative. Used on IDS-iSYS Multi-Discipline Automated System; operated by laboratory personnel. Controls monitor assay performance; calibration verifiers confirm assay calibration and measuring range. Value assignment performed gravimetrically and confirmed via immunologic analysis on the IDS-iSYS system. Healthcare providers use results to ensure analytical accuracy of patient sample testing. Benefits include reliable quality assurance and verification of assay measuring range, supporting accurate clinical diagnostic results.

Clinical Evidence

Bench testing only. Value assignment performed on three IDS-iSYS systems over 21 runs (controls) or five runs (verifiers). Stability validated via accelerated studies (CLSI EP25-A) supporting 9-month shelf life at 2-8°C; real-time studies ongoing. Open-vial stability confirmed for 49 days; on-board stability confirmed for 4 hours. Precision acceptance criteria: CV ≤ 10% for low concentration, ≤ 8% for middle/high concentrations.

Technological Characteristics

Liquid human serum matrix with <0.1% sodium azide preservative. Analyte: 17-OH Progesterone. System: IDS-iSYS Multi-Discipline Automated System. Storage: 2-8°C. Stability testing per CLSI EP25-A. No electronic or software components integral to the reagent itself; functions as a consumable for the automated analyzer.

Indications for Use

Indicated for in vitro diagnostic quality control and calibration verification of the IDS-iSYS 17-OH Progesterone assay on the IDS-iSYS Multi-Discipline Automated System.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

510(k) #: k161082

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.