510(k) · Cleared
ClearedCamp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Cleared on Apr 7, 2004 as substantially equivalent to K020763 (Lin-Zhi International, Inc., 2002) and 2 other predicates after a 117-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Apr 7, 2004
- Review
- 117 days
- Class
- Class II
- Product code
- DIO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K960187 (1996). 6 ancestors in all, the oldest K935320 (1993). No later device cites it as a predicate yet.
- Root · 2 generations backK960187 Cocaine Metabolite Eia TestDiagnostic Reagents, Inc. · 1996 · Recalled
- 1 generation backK020763 Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit)…Lin-Zhi International, Inc. · 2002
- This deviceK033866 Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 &…Lin-Zhi International, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K960187 | Cocaine Metabolite Eia Test | Diagnostic Reagents, Inc. | 1996 | 1 |
| −1 | K020763 | Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031… | Lin-Zhi International, Inc. | 2002 | — |
| 0 (this device) | K033866 | Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test… | Lin-Zhi International, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DIO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DIO device
- #1 K213211 Carolina Liquid Chemistries Cocaine and…score 3.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K020763 | Cocaine Metabolite Enzyme Immunoassay Models #0030 (500 Tests Kit), #0031 (5000 Tests Kit)Summary page 2…ay, Amphetamines Enzyme Immunoassay, Opiate Enzyme Immunoassay, and Phencyclidine Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under premarket notification K020763 (Cocaine Metabolite Enzyme Immunoassay), K020369 (Amphetamines Enzyme Immunoassay), K020368 (Opiate Enzyme Immunoassay), and K020… | 2002 |
| Kept off the family tree | K020369 | FDA’s K020369 is Elecsys Anti-TG Calcheck 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…e Immunoassay, and Phencyclidine Enzyme Immunoassay by Lin-Zhi International, Inc., cleared under premarket notification K020763 (Cocaine Metabolite Enzyme Immunoassay), K020369 (Amphetamines Enzyme Immunoassay), K020368 (Opiate Enzyme Immunoassay), and K020254 (Phencyclidine Enzyme Immunoassay). LZI's Si… | 2002 |
| * | K020368 | Opiate Enzyme Immunoassay, Catalog # 0020 (500 Tests Kit); Catalog # 0021 (5000 Tests Kit)Summary page 2…unoassay by Lin-Zhi International, Inc., cleared under premarket notification K020763 (Cocaine Metabolite Enzyme Immunoassay), K020369 (Amphetamines Enzyme Immunoassay), K020368 (Opiate Enzyme Immunoassay), and K020254 (Phencyclidine Enzyme Immunoassay). LZI's Simultaneous Cocaine-Amphetamines-Morphine-Ph… | 2002 |
| * | K020254 | Phencyclidine Enzyme Immunoassay, Catalog Numbers 0010 & 0011Summary page 2…cleared under premarket notification K020763 (Cocaine Metabolite Enzyme Immunoassay), K020369 (Amphetamines Enzyme Immunoassay), K020368 (Opiate Enzyme Immunoassay), and K020254 (Phencyclidine Enzyme Immunoassay). LZI's Simultaneous Cocaine-Amphetamines-Morphine-Phencyclidine Multiple Analyte Enzyme Immun… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 6 ancestors has a recall of any class.
- 2 other devices also cite its predicate K020763.
How does its category compare?
All DIO devicesDIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DIO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · DIO
267in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIO
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIO
1in 2023
MAUDE reports naming product code DIO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 5 | 65 | 0 | 4 |
| 2012 | 5 | 139 | 0 | 0 |
| 2013 | 2 | — | 1 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 2 | — | 0 | 7 |
| 2016 | 3 | 88 | 0 | 9 |
| 2017 | 3 | 267 | 0 | 16 |
| 2018 | 1 | — | 0 | 12 |
| 2019 | 0 | — | 0 | 22 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (181 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033866 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033866: Camp Multiple Analyte Enzyme Immunoassay, Cat.# 0510, 0511 (500 & 5000 Test Kits).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033866
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026