510(k) · Cleared
ClearedChemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chemtron Biotech, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on May 17, 2012 as substantially equivalent to K102203 (Chemtron Biotech, Inc., 2011) after a 14-day review. Its family tree reaches back 2 generations to 2002. 5 later devices descend from it.
- Decided
- May 17, 2012
- Review
- 14 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K020771 (2002). 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK020771 Acon One Step Drug Screen Test CardACON Laboratories, Inc. · 2002
- 1 generation backK102203 Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsChemtron Biotech, Inc. · 2011
- This deviceK121339 Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsChemtron Biotech, Inc. · 2012
- Descendant · cites it directly · 4 of its ownK142580 Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK150602 CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK152643 EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK151557 EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard…Nantong Egens Biotech Co., Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK151478 Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015
Most influential descendants
Showing 5 of 5 · See all- K142580Chemtrue Multi-Panel DOA DIP Card TestsChemtron Biotech, Inc. · 2014 · cites it directly4descendants
- K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 2 generations on1descendant
- K152643EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…Nantong Egens Biotech Co., Ltd. · 2015 · 2 generations on0descendants
- K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine -…Nantong Egens Biotech Co., Ltd. · 2015 · 2 generations on0descendants
- K151478Wondfo CR3 Keyless Split Sample CupGuangzhou Wondfo Biotech Co., Ltd. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K020771 | Acon One Step Drug Screen Test Card | ACON Laboratories, Inc. | 2002 | — |
| −1 | K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card Tests | Chemtron Biotech, Inc. | 2011 | — |
| 0 (this device) | K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests | Chemtron Biotech, Inc. | 2012 | — |
| +1 | K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | Chemtron Biotech, Inc. | 2014 | — |
| +2 | K150602 | CR3 Keyless Split Sample Cup Morphine - Methamphetamine | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
| +2 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +2 | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine… | Nantong Egens Biotech Co., Ltd. | 2015 | — |
| +3 | K151478 | Wondfo CR3 Keyless Split Sample Cup | Guangzhou Wondfo Biotech Co., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 4 | 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 DKZ? 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 DKZ device
- #1 K233019 AllTest Multi-Drug Rapid Test Cup; AllTest…score 14.6 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsSummary page 6…tivity (Cutoff characteristics), precision (Reproducibility), specificity (Cross-reactivity and interference) and stability studies were established in k1 02203. 5 10(k) Summary was prepared By: Jane Zhang on May 02 n, 2012 S3 DEPARTMENT OF HEALTH & HUMAN SERVICES… | 2011 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142580 | Chemtrue Multi-Panel DOA DIP Card Tests | 2014 | 4 |
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 10 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K142580 (Chemtron Biotech, Inc., 2014) has gone furthest, with 4 descendants of its own.
- 1 other device also cites its predicate K102203.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · DKZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · DKZ
180in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DKZ
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKZ
2in 2025
MAUDE reports naming product code DKZ, 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 | — | 1 | 0 |
| 2008 | 2 | — | 3 | 12 |
| 2009 | 2 | — | 5 | 1 |
| 2010 | 4 | 233 | 0 | 1 |
| 2011 | 6 | 123 | 4 | 2 |
| 2012 | 5 | 55 | 0 | 0 |
| 2013 | 8 | 103 | 1 | 1 |
| 2014 | 8 | 128 | 3 | 9 |
| 2015 | 5 | 107 | 0 | 8 |
| 2016 | 5 | 215 | 0 | 8 |
| 2017 | 0 | — | 1 | 0 |
| 2018 | 3 | 128 | 0 | 0 |
| 2019 | 3 | 180 | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Chemtron Biotech, Inc.'s Chemntrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows: Analyte — Abbreviation — Calibrator — Cutoff Concentration Amphetamine — AMP — d-Amphetamine — 1000 ng/mL Cocaine — COC…
Read the full statement (204 words)
The Chemtron Biotech, Inc.'s Chemntrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are rapid lateral flow immunoassays for the qualitative detection of up to six of the following drugs in a variety of combinations in human urine. The designed cutoff concentrations and the calibrators used for these drugs are as follows:
Analyte — Abbreviation — Calibrator — Cutoff Concentration
Amphetamine — AMP — d-Amphetamine — 1000 ng/mL
Cocaine — COC — Benzoylecgonine — 300 ng/mL
Marijuana — THC — 11-nor-A 9-THC9-COOH — 50 ng/mL
Methamphetamine — MET — d-Methamphetamine — 1000 ng/mL
Opiates — OPI/MOR — Morphine — 300 ng/mL
Phencyclidine — PCP — Phencyclidine — 25 ng/mL
The Chemtrue® Single/Multi-Panel Drug Screen Cassette and Dip Card Tests are intended for the qualitative detection of drugs of abuse for health care professional, in vitro diagnostic and Over-the-Counter (OTC) use. These assays provide only a preliminary result. A more specific alternative chemical method must be used in order to obtain a confirmed assay result. Gas Chromatography / Mass Spectrometry (GC/MS) or Liquid Chromatography / Mass Spectrometry (LC/MS) are the preferred confirmatory methods.
Clinical consideration and professional judgment should be applied to any drugs of abuse test result, particularly when preliminary positive results are indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121339: Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette Tests.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121339
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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