# K033866: Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)

- Pathway: 510(k) (Traditional)
- Applicant: Lin-Zhi International, Inc.
- Decided: Apr 7, 2004 after 117 days
- Product code: DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites)
- Device class: 2
- Regulation: 21 CFR 862.3250
- 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 K960187 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020763: Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit), Lin-Zhi International, Inc. (2002) Summary page 2.
- K020368: Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit), Lin-Zhi International, Inc. (2002) Summary page 2.
- K020254: Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011, Lin-Zhi International, Inc. (2002) Summary page 2.

## Cited in the summary but kept off the family tree
- K020369: Elecsys Anti-TG Calcheck, Roche Diagnostics Corp. (2002). Our reading of the summary gave K020369, FDA’s number for Elecsys Anti-TG Calcheck (Roche Diagnostics Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Amphetamines Enzyme Immunoassay”. Kept off the family tree. Summary page 2.

## Indications for use
The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay is a homogeneous enzyme immunoassay with 300 ng/mL cutoff for cocaine metabolite, 1000 ng/mL cutoff for amphetamines, 300 ng/mL cutoff for opiates, and 25 ng/mL cutoff for phencyclidine. The assay will produce a positive result if any of the four analyte are present at a concentration at or above their respective cutoffs but will not identify which drug is present. The assay is solely intended for the qualitative screening of human urine for these analytes. Measurements obtained by this device are used in the diagnosis and treatment of individuals who have used cocaine, amphetamines, opiates, or phencyclidine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method for the individual drugs must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly, when preliminary positive results are used.

Source page: https://510kreport.com/device/K033866
Methodology: https://510kreport.com/methodology