IDS-ISYS IGF-I CALIBRATION VERIFIERS

K122141 · Immunodiagnostic Systems , Ltd. · JJX · Aug 7, 2012 · Clinical Chemistry

Device Facts

• Record ID: K122141
• Device Name: IDS-ISYS IGF-I CALIBRATION VERIFIERS
• Applicant: Immunodiagnostic Systems , Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 7, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The IDS-iSYS IGF-I Calibration Verifier is a device intended for the verification of calibration of the IDS-iSYS IGF-I assay when performed on the IDS-iSYS multi-disciplined automated analyzer.

Device Story

The IDS-iSYS IGF-I Calibration Verifier is a lyophilized matrix composed of a buffer solution, bovine serum albumin, sodium azide preservative, and IGF-I peptide. It is used on the IDS-iSYS multi-disciplined automated analyzer to verify the calibration of the IDS-iSYS IGF-I assay. The device is intended for clinical laboratory use. The operator performs a calibration run using the assay reagent cartridge, calibrators, and control set, followed by testing the verifiers in triplicate. The analyzer calculates the mean value of valid runs; the healthcare provider compares this result against a customer acceptance range (8% standard deviation) to confirm assay calibration accuracy. This process ensures the reliability of IGF-I measurements, which are critical for clinical decision-making regarding growth hormone-related disorders.

Clinical Evidence

No clinical data. Bench testing only. Performance evaluated through value assignment (minimum 15 runs across 3 independent analyzers) and stability testing. Accelerated shelf-life stability supports 6 months at 2-8°C; real-time stability testing is ongoing. Reconstituted stability on-board the analyzer is validated for up to 2.5 hours. Traceability established to NIBSC code 02/254 international standard.

Technological Characteristics

Lyophilized buffered protein matrix containing bovine serum albumin and sodium azide. 4 levels. Traceable to NIBSC 02/254. Designed for use on the IDS-iSYS automated analyzer. Stability: 6 months shelf-life at 2-8°C; 2.5 hours on-board stability after reconstitution.

Indications for Use

Indicated for verification of calibration of the IDS-iSYS IGF-I assay on the IDS-iSYS multi-disciplined automated analyzer. For prescription use only.

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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Decision Summary, k122141

This 510(k) was reviewed under OIVD’s Pilot Triage 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.