510(k) · Cleared
ClearedOntrak Teststik for PCP, Cat. 07 6654 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostics Corp. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Jan 27, 2000 as substantially equivalent to K973075 (Roche Diagnostic Systems, Inc., 1997) after a 62-day review. Its family tree reaches back 2 generations to 1988.
- Decided
- Jan 27, 2000
- Review
- 62 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K881817 (1988). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK881817 Abuscreen (R) Ontrak (TM) for AmphetaminesRoche Diagnostic Systems, Inc. · 1988
- 1 generation backK973075 Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine…Roche Diagnostic Systems, Inc. · 1997
- This deviceK994020 Ontrak Teststik for PCP, Cat. 07 6654 2Roche Diagnostics Corp. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K881817 | Abuscreen (R) Ontrak (TM) for Amphetamines | Roche Diagnostic Systems, Inc. | 1988 | — |
| −1 | K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik… | Roche Diagnostic Systems, Inc. | 1997 | — |
| 0 (this device) | K994020 | Ontrak Teststik for PCP, Cat. 07 6654 2 | Roche Diagnostics Corp. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 2 | 0 |
| 1990 | 2 | 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 LCM? 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 LCM device
- #1 K212952 Psychemedics Homogeneous Enzyme Immunoassay…score 3.5 · 2 generations · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K973075 | Ontrak Teststik for Amphetamines, Ontrak Teststik for Cocaine, Ontrak Teststik for…Summary page 1…Product CFR Predicate Date Predicate Name Name Code Classification Device Predicate 510(k) Name Name Cleared Number OnTrak Enzyme 91LCM | Unassigned | OnTrak 10/9/97 | K973075 TesTstik Immunoassay TesTstik for for PCP Phencyclidine PCP 3) Predicate We claim substantial equivalence to the currently market… | 1997 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- None of the 6 ancestors has a recall.
- 2 other devices also cite its predicate K973075.
How does its category compare?
All LCM devicesLCM Enzyme Immunoassay, Phencyclidine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCM
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · LCM
Too few LCM 510(k)s in any year since 2007 to give a median.
Recalls per year · LCM
No recall names LCM since 2007.
Adverse event reports per year · LCM
2in 2019
MAUDE reports naming product code LCM, 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 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 2 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Roche Diagnostics Corporation OnTrak TesTstik™ for PCP is an in vitro diagnostic test intended for professional use for the qualitative detection of PCP in urine at or above a cutoff concentration of 25 ng/mL
OnTrak TesTstik provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.
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/K994020 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994020: Ontrak Teststik for PCP, Cat. 07 6654 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994020
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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