LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS

K133710 · Lin-Zhi International, Inc. · DKB · Feb 21, 2014 · Clinical Toxicology

Device Facts

• Record ID: K133710
• Device Name: LZI MULTIPLE ANALYTE SET A;B;C DRUGS OF ABUSE CONTROLS
• Applicant: Lin-Zhi International, Inc.
• Product Code: DKB · Clinical Toxicology
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Indications for Use

The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers. The LZI Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for in vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, and Secobarbital. The controls are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.

Device Story

Device consists of liquid, ready-to-use calibrators and controls for drugs of abuse testing. Input: processed, drug-free human urine matrix spiked with known concentrations of specific drug analytes. Operation: used by laboratory technicians on automated clinical chemistry analyzers to calibrate assays and monitor performance. Output: calibration curves and quality control results used by clinicians to verify assay accuracy. Clinical context: preliminary analytical results; requires confirmation by GC/MS or LC/MS. Benefit: ensures accuracy and reliability of drug screening assays, supporting clinical decision-making in toxicology.

Clinical Evidence

Bench testing only. Stability studies conducted at 2-8°C, room temperature, and 30°C; results showed <10% variation. Real-time stability confirmed for at least 12 months at 2-8°C. Value assignment verified gravimetrically using NIST-traceable weights and confirmed by GC/MS to be within ±10% of target concentrations.

Technological Characteristics

Liquid, ready-to-use human urine matrix containing drug analytes and 0.09% sodium azide preservative. Analyte concentrations verified by GC/MS. Storage at 2-8°C. Compatible with automated clinical chemistry analyzers using homogeneous enzyme immunoassay technology.

Indications for Use

Indicated for in vitro diagnostic calibration and performance monitoring of homogeneous enzyme immunoassays for drugs of abuse (Benzoylecgonine, Methamphetamine, Methadone, 6-acetylmorphine, MDMA, Morphine, Oxazepam, Secobarbital) in human urine. For prescription use on automated clinical chemistry analyzers.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k133710

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.