510(k) · Cleared
ClearedON Trak Testcard
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian, Inc. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Jun 8, 2005 as substantially equivalent to K012396 (Roche Diagnostics Corp., 2001) and 1 other predicate after a 26-day review. Its family tree reaches back 2 generations to 1997.
- Decided
- Jun 8, 2005
- Review
- 26 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K973784 (1997). 4 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other… | Biosite Incorporated | 1997 | 4 |
| −1 | K012396 | Ontrak Testcard 9 | Roche Diagnostics Corp. | 2001 | — |
| 0 (this device) | K051235 | ON Trak Testcard | Varian, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K012396 | Ontrak Testcard 9Summary page 1…I 1 3) Predicate We claim substantial equivalence to this currently marketed device: Device On Trak TesTcard 9, K012396, 11/05/2001 On Trak TesTcard 9, K050321, 04/18/2005 4) Device The OnTrak TesTcard assays contained in… | 2001 |
| * | K050321 | Ontrak Testcard 9Summary page 1…claim substantial equivalence to this currently marketed device: Device On Trak TesTcard 9, K012396, 11/05/2001 On Trak TesTcard 9, K050321, 04/18/2005 4) Device The OnTrak TesTcard assays contained in this submission are in vitro Description diagnostic… | 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 8 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 4 ancestors has a recall of any class.
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 OnTrak TesTcard menus are various combinations of the different drugs that are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. It simultaneously tests for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following: Cutoff Concentrations: Amphetamines (d,l-amphetamine): 1000 ng/mL Barbiturates (secobarbital): 200 ng/mL…
Read the full statement (122 words)
The OnTrak TesTcard menus are various combinations of the different drugs that are listed below. The TesTcard products are in vitro diagnostic tests for the qualitative detection of drug or drug metabolite in urine. It simultaneously tests for the presence of multiple drugs or drug metabolites. The TesTcard profile (cutoff) consists of the following:
Cutoff Concentrations:
Amphetamines (d,l-amphetamine): 1000 ng/mL
Barbiturates (secobarbital): 200 ng/mL
Benzodiazepines (oxazepam): 100 ng/mL
Cocaine metabolite (benzoylecgonine): 300 ng/mL
Methamphetamine (d-methamphetamine): 500 ng/mL
Morphine (morphine): 300 ng/mmL
PCP (phencyclidine): 25 ng/rmL
Tricyclic Antidepressants (TCA)(Imipramine): 1000 ng/mL
THC (II -nor-A 9-THC-9-carboxylic acid): 50 ng/mL
TesTcard products provide only preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051235 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051235: ON Trak Testcard.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051235
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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