VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT

K133550 · Maine Standards Company, LLC · JJX · Feb 5, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133550
• Device Name: VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT
• Applicant: Maine Standards Company, LLC
• Product Code: JJX · Clinical Chemistry
• Decision Date: Feb 5, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit solutions are intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range for the following analyte, ferntin, on automated instrument systems. The product is intended for use with quantitative assays on the indicated analyzers specified in the labeling.

Device Story

VALIDATE® FERRITIN Calibration Verification / Linearity Test Kit consists of five liquid, ready-to-use levels of purified ferritin in a human serum base. Levels 1 and 5 are prepared independently; intermediate levels 2, 3, and 4 are prepared via equal-part dilutions. Used in clinical laboratory settings on automated instrument systems to verify assay performance across the reportable range. Healthcare providers run the kit as a sample; the instrument produces quantitative results for each level. Providers compare these results against expected target ranges to confirm linearity and calibration. This process ensures the accuracy of patient ferritin testing, supporting clinical decision-making regarding iron status and related conditions.

Clinical Evidence

Bench testing only. Linearity and stability were evaluated on Roche Cobas 6000 and Beckman Coulter Access II analyzers. Linearity performance demonstrated for 431 days. Freeze/thaw stability confirmed for 6 cycles. Acceptance criteria for all levels were 90-110% of the day-of-manufacture value.

Technological Characteristics

Liquid, ready-to-use human serum base containing purified ferritin. Five levels with equal-part dilution relationship (CLSI EP6-A). Storage: -10 to -25°C. Shelf life: 12 months. No electronic components; standalone test kit.

Indications for Use

Indicated for in vitro diagnostic use to verify linearity, calibration, and reportable range of ferritin assays on automated instrument systems.

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) #: k133550

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.