CANNABINOID URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS— 510(k) K021449

Clearance details

Applicant

Lin-Zhi International, Inc.

Product code

Code DLJ

Device class

Class 2

Regulation

21 CFR 862.3200

Advisory panel

Clinical Toxicology

Date received

2002-05-06

Decision date

2002-06-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

San Jose, CA, US

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• Z-1178-2014 — Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,¿ 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers.Class II·Terminated·Lin-Zhi International Inc·20140206

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021449.