UA-Cellular Complete

K170091 · Streck · JJW · Feb 9, 2017 · Clinical Chemistry

Device Facts

• Record ID: K170091
• Device Name: UA-Cellular Complete
• Applicant: Streck
• Product Code: JJW · Clinical Chemistry
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

UA-Cellular® Complete is an assayed chemistry and cellular urine control for evaluating the accuracy and precision of automated procedures that measure urinary sediment and chemistry parameters on the following instruments and testing methods: Sysmex® UF-1000i™ Automated Urine Particle Analyzer: Siemens® Clinitek Atlas Automated Urine Chemistry Analyzer utilizing the Clinitek Atlas 10 Reagent Pak; the Arkray AUTION HYBRID™ AU-4050 fullyautomated integrated urine analyzer: utilizing the Aution sticks 10EA Reagent strips: Siemens Clinitek Status® line of automated chemistry strip reader analyzers; Manual Reading of Urine Refractive Index; Manual Reading of the Siemens Multistix® 10SG Reagent Strips, and the Siemens Clinitest® hCG Pregnancy test.

Device Story

UA-Cellular Complete is a three-level, in-vitro diagnostic control; contains stabilized mammalian red/white blood cells, stabilized bacteria, and simulated urine sediments in preservative medium. Analyte levels adjusted with chemicals. Packaged in 4 oz amber plastic bottle with foil-lined flip-top cap. Used in clinical laboratories to verify performance of automated urine particle analyzers, chemistry strip readers, and manual testing methods (refractive index, hCG pregnancy tests). Healthcare providers use control results to assess instrument accuracy and precision before patient sample analysis. Ensures reliability of urinalysis results; aids in maintaining quality control standards.

Clinical Evidence

Bench testing only. Multi-site and single-site precision studies conducted per CLSI EP05-A3 guidelines across multiple instruments (Sysmex UF-1000i, Arkray AU-4050, Siemens Clinitek Atlas/Status). Open-vial (30-day) and closed-vial (100-day) stability studies performed. All data met pre-established acceptance criteria for accuracy and precision.

Technological Characteristics

Three-level liquid control; stabilized mammalian RBCs/WBCs, stabilized bacteria, and simulated urine sediments in preservative medium. Storage 2-10°C. 30-day open-vial stability; 100-day closed-vial stability. No electronic components; non-software device.

Indications for Use

Indicated for use as an assayed chemistry and cellular urine control to evaluate accuracy and precision of automated and manual urinalysis procedures. Intended for clinical laboratory use.

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) #: k170091

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.