510(k) · Cleared
Recalled · Class II · 2014Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, Iii, IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LDJ Enzyme Immunoassay, Cannabinoids
Cleared on Dec 28, 2006 as substantially equivalent to K011300 (Syva Co., Dade Behring, Inc., 2001) and 2 other predicates after a 71-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Dec 28, 2006
- Review
- 71 days
- Class
- Class II
- Product code
- LDJ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 1 generation to K993984 (2000). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993984 Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129ULSyva Co. · 2000
- This deviceK063164 Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993984 | Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129UL | Syva Co. | 2000 | — |
| 0 (this device) | K063164 | Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 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 LDJ? 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 LDJ device
- #1 K232732 Rapid Marijuana (THC) Test Strip 20, Rapid…score 9.4 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K011300 | Emit II Plus Cannabinoid Assay, Model OSR9N229 | 2001 |
| * | K993984 | Syva Emit II Plus Cannabinoid Assay, Models 9N029UL/9N129ULSummary page 4…S DAT Performance Verifiers are to predicate substantially equivalent to the SYVA® EMIT® II Plus Cannabinoid Assay devices (KOl 1300 and K993984) and BIO-RAD® Liquichek T Urine Toxicology Controls (K022707) (predicate deyices) which were cleared b… | 2000 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 4…he SYVA® EMIT® II Plus Cannabinoid Assay devices (KOl 1300 and K993984) and BIO-RAD® Liquichek T Urine Toxicology Controls (K022707) (predicate deyices) which were cleared by the FDA for in vitro diagnostic use.… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2014 | Class II | Z-1805-2014 | Process change control | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The validation process was not complete prior to calibrator… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 3 ancestors has a recall.
How does its category compare?
All LDJ devicesLDJ Enzyme Immunoassay, Cannabinoids: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDJ
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDJ
48in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LDJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDJ
1in 2015
MAUDE reports naming product code LDJ, 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 | 2 | — | 4 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 4 | 219 | 0 | 0 |
| 2012 | 4 | 193 | 0 | 0 |
| 2013 | 3 | 162 | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 48 | 0 | 1 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 1 | 0 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For in vitro diagnostic use only. VITROS Chemistry Products THC Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose. The VITROS Chemistry Products THC assay is intended for use by professional…
Read the full statement (218 words)
For in vitro diagnostic use only. VITROS Chemistry Products THC Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of cannabinoids (THC) in human urine using a cutoff of either 20 ng/mL or 50 ng/mL. Measurements obtained with the VITROS THC method are used in the diagnosis and treatment of cannabinoid use or overdose.
The VITROS Chemistry Products THC assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 30 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of cannabinoids (THC).
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063164: Vitros Chemistry Products THC Reagent, Calibrator Kit 30, FS Calibrator 1, and Dat Performance Verifiers I, II, Iii, IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063164
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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