510(k) · Cleared
ClearedLzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Oct 30, 2006 as substantially equivalent to K992918 (OraSure Technologies, Inc., 2000) and 3 other predicates after a 28-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Oct 30, 2006
- Review
- 28 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K924446 (1992). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK924446 Micro-Plate Opiates AssaySolarcare Technologies Corp,Inc. · 1992
- 2 generations backK981341 STC Opiates Micro-Plate Eia (Orasure Application)OraSure Technologies, Inc. · 1998
- 1 generation backK050988 Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and…Lin-Zhi International, Inc. · 2006
- This deviceK063024 Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay…Lin-Zhi International, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK131653 Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K131653Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, ControlsLin-Zhi International, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924446 | Micro-Plate Opiates Assay | Solarcare Technologies Corp,Inc. | 1992 | — |
| −2 | K981341 | STC Opiates Micro-Plate Eia (Orasure Application) | OraSure Technologies, Inc. | 1998 | — |
| −1 | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and Controls | Lin-Zhi International, Inc. | 2006 | — |
| 0 (this device) | K063024 | Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi… | Lin-Zhi International, Inc. | 2006 | — |
| +1 | K131653 | Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls | Lin-Zhi International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2000 | 3 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992918 | STC Amphetamine-Specific Intercept Micro-Plate Eia, Model 1103ISummary page 2…rketed Predicate Device(s) The LZI Oral Fluid Amphetamine-Specific Enzyme Immunoassay is substantially equivalent to the Amphetamine-Specific Intercept® Micro-plate EIA (K992918) manufactured by OraSure Technologies Inc. (formerly known as STC Technologies, Inc) for its general intended use. The current su… | 2000 |
| * | K050945 | Oral Fluid Cocaine Metabolite Homogeneous Enzyme Immunoassays, Calibrators & ControlsSummary page 2…s, Inc) for its general intended use. The current subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K050945), Opiate (K050988), and Methadone (KO51058) Homogeneous Enzyme Immunoassay for its stated intended use. Device Description LZI'… | 2006 |
| * | K050988 | Opiate Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsSummary page 2…neral intended use. The current subject device is also substantially equivalent to other LZI test systems cleared by FDA, e.g., the Oral Fluid Cocaine (K050945), Opiate (K050988), and Methadone (KO51058) Homogeneous Enzyme Immunoassay for its stated intended use. Device Description LZI's Oral Fluid Amphe… | 2006 |
| * | K051058 | Methadone Oral Fluid Homogeneous Enzyme Immunoassay, Calibrators and ControlsSummary page 4…ice Predicate Device Predicate Device Characteristics (K050945) (K050988) (K051058) Intended Use The LZI Cocaine Metabolite The LZI Opiate Oral The LZI Methadone Oral… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131653 | Lzi Oral Fluid Amphetamine Enzyme Immunoassay, Calibrators, Controls | 2014 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 5.6 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K131653 (Lin-Zhi International, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K992918.
How does its category compare?
All DKZ devicesDKZ Enzyme Immunoassay, Amphetamine: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (d-amphetamine) are prepared with oral fluid buffer so that it can be used to verify and validate the…
Read the full statement (164 words)
The Amphetamine-Specific Enzyme Immunoassays for Drugs of Abuse in Oral Fluid is a homogeneous enzyme immunoassay system to detect amphetamine in human saliva with a cutoff of 45 ng/mL when testing oral fluid specimen collected with Salivette collector (manufactured by Sarstedt) and diluted with 1 mL of buffer. The calibrators and controls of the analyte (d-amphetamine) are prepared with oral fluid buffer so that it can be used to verify and validate the assay. The assay is intended for use in the qualitative determination for amphetamine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Oral Fluid Amphetamine-Specific Enzyme Immunoassay is a homogeneous enzyme immunoassay system provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) 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/K063024 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063024: Lzi Amphetamine-Specific Oral Fluid Homogeneous Enztme Immunoassay: Lzi Amphetamine Oral Fluid Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063024
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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