510(k) · Cleared
ClearedUrine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dade Behring, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Apr 6, 2000 after a 55-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Apr 6, 2000
- Review
- 55 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK000462 Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO.…Dade Behring, Inc. · 2000
- Descendant · cites it directly · 1 of its ownK163220 Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc. · 2017
- Descendant · cites it directly · 1 of its ownK062128 The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK222439 Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK102045 Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc. · 2017 · cites it directly1descendant
- K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc. · 2006 · cites it directly1descendant
- K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc. · 2023 · 2 generations on0descendants
- K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc. · 2011 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K000462 | Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A | Dade Behring, Inc. | 2000 | — |
| +1 | K163220 | Atellica CH Phencyclidine (Pcp) | Siemens Healthcare Diagnostics, Inc. | 2017 | — |
| +1 | K062128 | The Dimension Vista Flex Reagent Cartridges / Kit Assays | Dade Behring, Inc. | 2006 | — |
| +2 | K222439 | Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) | Siemens Healthcare Diagnostics, Inc. | 2023 | — |
| +2 | K102045 | Dimension Visa HBA1C, Model K3105A | Siemens Heatlhcare Diagnostics, Inc. | 2011 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
| 2023 | 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 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 |
|---|---|---|---|
| * | — | Abbott AxSYM System Phencyclidine II Assay Named without a submission number |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K163220 (Siemens Healthcare Diagnostics, Inc., 2017) has gone furthest, with 1 descendant of its own.
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 PCP Flex@ reagent cartridge used on the Dimension@clinical chemistry system provides reagents for an in vitro diagnostic test intended for the qualitative and semi-quantative determination of phency(;Iidine in human urine. Measurements obtained with the PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K000462 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000462: Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K000462
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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