LIQUICHEK TUMOR MARKER CONTROL

K141073 · Bio-Rad Laboratories · JJY · Jun 23, 2014 · Clinical Chemistry

Device Facts

• Record ID: K141073
• Device Name: LIQUICHEK TUMOR MARKER CONTROL
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liguichek Tumor Marker Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Tumor Marker Control is a trilevel liquid quality control serum derived from human source material with added animal-derived constituents, stabilizers, and preservatives. It is used in clinical laboratories to monitor the precision of testing procedures for various tumor marker analytes. The control is provided in a liquid form and is designed for use with specific instrumentation, such as the Siemens Dimension Vista Systems. Laboratory personnel use the control by running it alongside patient samples; the resulting values are compared against the provided mean values and ±3SD ranges to verify the performance and precision of the testing system. By identifying potential variations caused by reagents, instrumentation, or technique, the device helps ensure the reliability of clinical test results, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish thawed opened, thawed unopened, and shelf-life stability claims. Acceptance criteria were met for all stability parameters.

Technological Characteristics

Trilevel liquid control; human source material with animal-derived constituents, stabilizers, and preservatives. Formulated for specific use with Siemens Dimension Vista Systems. Storage requirements: -20 to -50 °C (unopened). Stability: 10 days thawed/opened, 15 days thawed/unopened at 2-8 °C. No software or electronic components.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific tumor marker analytes (AFP, B2-M, CA 15-3, CA 19-9, CA 125, CEA, Ferritin, hCG, Prolactin, Total PSA, Free PSA) in clinical laboratory settings.

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) #: k141073

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.