# K133710: Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Feb 21, 2014 after 79 days
- Product code: DKB (Calibrators, Drug Mixture)
- Device class: 2
- Regulation: 21 CFR 862.3200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983159 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051088: Multiple Analyte Urine Drugs of Abuse Calibrators and Controls, Lin-Zhi International, Inc. (2005) Summary page 3.

## Indications for use
The Lin-Zhi 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: Bcnzoylecgonine, Methaniphetanine, Methadone, 6-acetylmorphine. MVDMA, Morphine, Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers. The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for ini vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Bcnzoylecgonine, Methamphlamine, Methadone, 6-acetylmnorpliine, MDMA, Morphine, Oxazepamn, and Secobarbital. The controls are designed for prescription use wvith honiogeneous enzyme immunoassays on automated clinical chemistry analyzers.

Source page: https://510kreport.com/device/K133710
Methodology: https://510kreport.com/methodology