510(k) · Cleared
ClearedOntrak Testcard 9
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · DKZ Enzyme Immunoassay, Amphetamine
Cleared on Nov 5, 2001 as substantially equivalent to K973784 (Biosite Incorporated, 1997) and 1 other predicate after a 101-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.
- Decided
- Nov 5, 2001
- Review
- 101 days
- Class
- Class II
- Product code
- DKZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K973784 (1997). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K051235ON Trak TestcardVarian, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other… | Biosite Incorporated | 1997 | 4 |
| 0 (this device) | K012396 | Ontrak Testcard 9 | Roche Diagnostics Corp. | 2001 | — |
| +1 | K051235 | ON Trak Testcard | Varian, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K973784 | Triage Panel for Drugs of Abuse, Plus Tricyclic Antidepressants and Other Triage Drug…Summary page 1…Regulation Predicate Device Date Predicate | Predicate Name Code Number Name Cleared 510(k) OnTrak TesTcard 9 | Amphetamines test 91DKZ 862.3100 Triage® Panel 12/03/97 K973784 system ‘ OnTrak TesTcard 9 | Barbiturates test 91DIS 862.3150 Triage® Panel 12/03/97 K973784 system OnTrak TesTcard 9 | Benzodi… | 1997 |
| * | K000096 | Ontrak Teststik for Methamphetamine, Cat. 1986686Summary page 1…OnTrak TesTcard 9 | Cocaine test 91DIO 862.3250 Triage® Panel 12/03/97 K973784 systems OnTrak TesTcard 9 | Methamphetamines 91LAF 862.3610 | OnTrak TesTstik™ 04/26/00 K000096 test system Methamphetamines OnTrak TesTcard 9 | Morphine test 91DJJ 862.3640 Triage® Panel 12/03/97 K973784 systems OnTrak Tes… | 2000 |
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 |
|---|---|---|---|
| K051235 | ON Trak Testcard | 2005 | 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?
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 Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300…
Read the full statement (141 words)
The Roche Diagnostics Corporation OnTrak TesTcard 9 is an in vitro diagnostic test intended for use by health care professionals only for the qualitative detection of drug or drug metabolites in urine. OnTrak TesTcard 9 simultaneously tests for the presence of multiple drugs or drug metabolites. The OnTrak TesTcard 9 profile (cutoff) consists of amphetamines (1000 ng/ml), barbiturates (200 ng/ml), benzodiazepines (100 ng/ml), cocaine metabolite (300 ng/ml), methamphetamine (500 ng/ml), morphine (300 ng/ml), PCP (25 ng/ml), tricyclic antidepressants (TCA-1000 ng/ml) and THC (50 ng/ml).
OnTrak TesTcard 9 provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmation method. Clinical consideration and professional judgment should be applied to any drug abuse test result, particularly when preliminary positive results are used.
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/K012396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012396: Ontrak Testcard 9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012396
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026