510(k) · Cleared
ClearedSingle Analyte Urine Drugs of Abuse Calibrators and Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DLJ Calibrators, Drug Specific
Cleared on Dec 16, 2002 as substantially equivalent to K983159 (Diagnostic Reagents, Inc., 1998) after a 74-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Dec 16, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- DLJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983159 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK983159 Drugs of Abuse Urine Calibrators and ControlsDiagnostic Reagents, Inc. · 1998
- This deviceK023316 Single Analyte Urine Drugs of Abuse Calibrators and ControlsLin-Zhi International, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983159 | Drugs of Abuse Urine Calibrators and Controls | Diagnostic Reagents, Inc. | 1998 | — |
| 0 (this device) | K023316 | Single Analyte Urine Drugs of Abuse Calibrators and Controls | Lin-Zhi International, Inc. | 2002 | — |
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 DLJ? 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 |
|---|---|---|---|
| * | K983159 | Drugs of Abuse Urine Calibrators and ControlsSummary page 1…ially equivalent to the Drugs of Abuse Urine Calibrators A and Controls A (Diagnostic Reagents,inc., now Microgenics Corporation), cleared under premarket notifications (K983159) for Drugs of Abuse Urine Calibrators and Controls. Device Description All of the Single Analyte Urine DAU Calibr… | 1998 |
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?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K983159.
How does its category compare?
All DLJ devicesDLJ Calibrators, Drug Specific: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DLJ
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · DLJ
Too few DLJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DLJ
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DLJ
3in 2025
MAUDE reports naming product code DLJ, 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 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 2 | 6 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Methadone or Proposyphene Urine Drugs of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of their respective enzyme immunoassays to detect methadone or propoxyphene in human urine.
The Methadone or Propoxyphene Urine Drugs of Abuse Controls are intended for in vitro diagnostic use for the validation of their respective enzyme immunoassays to detect methadone or proposyphene in human urine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023316 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023316: Single Analyte Urine Drugs of Abuse Calibrators and Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023316
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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