510(k) · Cleared
ClearedLzi Multiple Analyte Set a;B;C Drugs of Abuse Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DKB Calibrators, Drug Mixture
Cleared on Feb 21, 2014 as substantially equivalent to K051088 (Lin-Zhi International, Inc., 2005) after a 79-day review. Its family tree reaches back 2 generations to 1998.
- Decided
- Feb 21, 2014
- Review
- 79 days
- Class
- Class II
- Product code
- DKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K983159 (1998). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- 1 generation backK051088 Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2005 · Recalled
- This deviceK133710 Lzi Multiple Analyte Set a;B;C Drugs of Abuse ControlsLin-Zhi International, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| −1 | K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2005 | 3 |
| 0 (this device) | K133710 | Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls | Lin-Zhi International, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 DKB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K051088 | Multiple Analyte Urine Drugs of Abuse Calibrators and ControlsSummary page 3…nalyte Set A. B, and C Drugs of' Abuse Calibrators and Controls (k133)710) arc substantially equivalent to the Multiple Analvte Drugs of' Abuse Calibrators and Controls (k051088) mnanulactured by Lin-Zhi International. Inc. The 121 Multiple Analvte Set A. 13, anid C Drugs of Abuse Calibrators and Cont… | 2005 |
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 16 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 5 other devices also cite its predicate K051088.
How does its category compare?
All DKB devicesDKB Calibrators, Drug Mixture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DKB
2in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · DKB
Too few DKB 510(k)s in any year since 2007 to give a median.
Recalls per year · DKB
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DKB
1in 2017
MAUDE reports naming product code DKB, 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 | 2 | — | 3 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 2 | 1 |
| 2012 | 1 | — | 1 | 4 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Bcnzoylecgonine, Methaniphetanine, Methadone, 6-acetylmorphine. MVDMA, Morphine, Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers. The Lin-Zhi…
Read the full statement (121 words)
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of assays for the analytes currently listed in the package insert: Bcnzoylecgonine, Methaniphetanine, Methadone, 6-acetylmorphine. MVDMA, Morphine, Oxazepam, and Secobarbital. The calibrators are designed for prescription use with homogeneous enzyme immunoassays on automated clinical chemistry analyzers.
The Lin-Zhi Multiple Analyte Set A, B, and C Urine Drugs of Abuse Controls are intended for ini vitro diagnostic use to monitor the performance of assays for the analytes currently listed in the package insert: Bcnzoylecgonine, Methamphlamine, Methadone, 6-acetylmnorpliine, MDMA, Morphine, Oxazepamn, and Secobarbital. The controls are designed for prescription use wvith honiogeneous enzyme immunoassays on automated clinical chemistry analyzers.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133710: Lzi Multiple Analyte Set a;B;C Drugs of Abuse Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133710
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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