Product code DKZ: 510(k) clearances and predicates
Product code DKZ covers DRI Ecstasy Plus Assay. FDA lists 225 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
225 clearances on file under product code DKZ. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 0 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 0 |
| 2026 so far | 0 |
Recent clearances
Newest DKZ clearances in the FDA index, with applicant and decision date:
- K240670, DRI Ecstasy Plus Assay, applicant Microgenics Corporation, decided 2024-10-30. FDA record
- K233019, AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx, applicant Hangzhou AllTest Biotech Co., Ltd., decided 2023-12-13. FDA record
- K231137, Xenta Drug Screen Cup, Xenta Drug Screen Dipcard, applicant Xenta Biomedical Science Co., Ltd., decided 2023-05-19. FDA record
- K200363, Quidel Triage® TOX Drug Screen, 94600, applicant Quidel Cardiovascular, Inc., decided 2020-03-11. FDA record
- K191099, Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel, applicant Atlas Medical, decided 2019-10-03. FDA record
- K182719, Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro, applicant Quidel Cardiovascular, Inc., decided 2019-06-19. FDA record
- K182738, Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine), applicant Hangzhou AllTest Biotech Co., Ltd., decided 2019-03-27. FDA record
- K180879, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use, applicant Shanghai Venture Bio-Tech Co., Ltd., decided 2018-12-14. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx, Xenta Drug Screen Cup, Xenta Drug Screen Dipcard. Watch new DKZ clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code DKZ?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent DKZ clearances include DRI Ecstasy Plus Assay.
How many 510(k) clearances use product code DKZ?
225 at the time this page was generated, from openFDA records.
How do I find a predicate device under DKZ?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new DKZ clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.