ELECSYS CK-MB CALCHECK 5

K133284 · Roche Diagnostics · JJX · Nov 22, 2013 · Clinical Chemistry

Device Facts

• Record ID: K133284
• Device Name: ELECSYS CK-MB CALCHECK 5
• Applicant: Roche Diagnostics
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 22, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For use in calibration verification and for use in the verification of the assay range established by the Elecsys CK-MB reagent on the indicated Elecsys and cobas e immunoassay analyzers.

Device Story

Elecsys CK-MB CalCheck 5 is a lyophilized, human serum-based control containing human creatine kinase MB isoenzyme (CK-MB). Used in clinical laboratory settings by trained personnel to verify calibration and assay range of Elecsys CK-MB reagents on Roche immunoassay analyzers (Elecsys 2010, MODULAR ANALYTICS E170, cobas e 411, 601, 602). Product is reconstituted with distilled/deionized water before use. Healthcare providers use the resulting verification data to ensure analyzer performance remains within established specifications, supporting accurate clinical decision-making for cardiac diagnostic testing.

Clinical Evidence

No clinical data. Bench testing only. Value assignment conducted via duplicate runs on at least three Elecsys 2010 analyzers; median value used for assignment. Stability testing (real-time and open-vial) supports 36-month shelf-life at 2-8°C and 4-hour open-vial stability at 20-25°C.

Technological Characteristics

Lyophilized human serum matrix containing human CK-MB. Five-level concentration format. Reconstituted with 1.0 mL distilled/deionized water. Standardized against Elecsys CK-MB STAT assay (traceable to Abbott IMx assay). Compatible with Elecsys and cobas e immunoassay analyzers.

Indications for Use

Indicated for use as an assayed control for calibration verification and assay range verification of the Elecsys CK-MB reagent on Elecsys and cobas e immunoassay analyzers. 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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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k133284

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.