510(k) · Cleared
ClearedModification to Abuscreen Online for Phencyclidine
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Roche Diagnostic Systems, Inc. · JCM Control, Hemoglobin, Abnormal
Cleared on Feb 10, 1999 as substantially equivalent to K920935 (Roche Diagnostic Systems, Inc., 1992) after a 112-day review. Its family tree reaches back 1 generation to 1992. 1 later device descends from it.
- Decided
- Feb 10, 1999
- Review
- 112 days
- Class
- Class II
- Product code
- JCM
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K920935 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK920935 Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1992
- This deviceK983704 Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK043305 Online Dat Phencyclidine PlusRoche Diagnostics Corp. · 2005
Most influential descendants
Showing 1 of 1 · See all- K043305Online Dat Phencyclidine PlusRoche Diagnostics Corp. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920935 | Abuscreen Online for Phencyclidine | Roche Diagnostic Systems, Inc. | 1992 | — |
| 0 (this device) | K983704 | Modification to Abuscreen Online for Phencyclidine | Roche Diagnostic Systems, Inc. | 1999 | — |
| +1 | K043305 | Online Dat Phencyclidine Plus | Roche Diagnostics Corp. | 2005 | — |
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 JCM? 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 |
|---|---|---|---|
| * | K920935 | Abuscreen Online for PhencyclidineSummary page 2…nostic Systems, Inc. claims equivalence. Table 2 Product Name Predicate Product 510(k) Number and Date Name Predicate Cleared Abuscreen ONLINE for Abuscreen ONLINE for K920935 3/18/92 Phencyclidine Phencyclidine 13 Roche Diagnostic Systems, Inc. Abuscreen ONLINE® Phencyclidine Somervill… | 1992 |
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 |
|---|---|---|---|
| K043305 | Online Dat Phencyclidine Plus | 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?
- Its one ancestor has no recall.
- Of its descendants, K043305 (Roche Diagnostics Corp., 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JCM devicesJCM Control, Hemoglobin, Abnormal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JCM
FDA has decided no JCM device since 2007.
Median 510(k) review, days · JCM
Too few JCM 510(k)s in any year since 2007 to give a median.
Recalls per year · JCM
No recall names JCM since 2007.
Adverse event reports per year · JCM
No MAUDE report names JCM since 2007.
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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the
qualitative and semiquantitative detection of phencyclidine and its metabolites in
human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 ng/mL.
Semiquantitative test results may be obtained that permit laboratories to assess
assay performance as part of a quality control program. Measurements obtained
by this device are used in the diagnosis of phencyclidine use or abuse.
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/K983704 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983704: Modification to Abuscreen Online for Phencyclidine.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983704
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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