510(k) · Cleared
ClearedVitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, Iii, IV, & V
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics, Inc. · LCM Enzyme Immunoassay, Phencyclidine
Cleared on Nov 22, 2006 as substantially equivalent to K993983 (Syva Co., 2000) and 1 other predicate after a 121-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 22, 2006
- Review
- 121 days
- Class
- Class U
- Product code
- LCM
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K993983 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993983 Syva Emit II Plus Phencyclidine Assay, Model 9J029ULSyva Co. · 2000
- This deviceK062094 Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS…Ortho-Clinical Diagnostics, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993983 | Syva Emit II Plus Phencyclidine Assay, Model 9J029UL | Syva Co. | 2000 | — |
| 0 (this device) | K062094 | Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat… | Ortho-Clinical Diagnostics, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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? (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 |
|---|---|---|---|
| * | K993983 | Syva Emit II Plus Phencyclidine Assay, Model 9J029ULSummary page 4…DAT Performance Verifiers are substantially equivalent to the devices DADE BEHRING Syva® EMIT ® II Plus Phencyclidine Assay (K993983) and BIO-RAD Liquichek m Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the… | 2000 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 4…DADE BEHRING Syva® EMIT ® II Plus Phencyclidine Assay (K993983) and BIO-RAD Liquichek m Urine Toxicology Controls (K022707) (predicate devices) which were cleared by the FDA for in vitro diagnostic use. Th… | 2002 |
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?
- None of the 2 ancestors has a recall.
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?
For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose. The VITROS Chemistry Products PCP assay is intended for use by professional laboratory personnel.…
Read the full statement (215 words)
For in vitro diagnostic use only. VITROS Chemistry Products PCP Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of phencyclidine (PCP) in human urine using a cutoff of 25 ng/mL. Measurements obtained with the VITROS PCP method are used in the diagnosis and treatment of phencyclidine use or overdose.
The VITROS Chemistry Products PCP assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with this assay. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when evaluating a preliminary positive result.
For in vitro diagnostic use only. VITROS Chemistry Products Calibrator Kit 26 is used to calibrate VITROS 5,1 FS Chemistry Systems for the qualitative or semi-quantitative measurement of drugs of abuse.
For in vitro diagnostic use only. VITROS Chemistry Products FS Calibrator 1 is used in conjunction with VITROS Chemistry Products Calibrator Kits to calibrate VITROS 5,1 FS Chemistry Systems.
For in vitro diagnostic use only. VITROS Chemistry Products DAT Performance Verifiers are assayed controls used to monitor performance of urine drugs of abuse screening assays on VITROS 5,1 FS Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062094 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062094: Vitros Chemistry Products PCP Reagent, Calibrator Kit 26, FS Calibrator 1, Dat Performance Verifiers I, II, Iii, IV, & V.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062094
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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