510(k) · Cleared
Recalled · Class II · 2017Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ortho-Clinical Diagnostics · DIS Enzyme Immunoassay, Barbiturate
Cleared on Jan 5, 2007 as substantially equivalent to K993987 (Syva Co., 2000) and 1 other predicate after a 161-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 5 times.
- Decided
- Jan 5, 2007
- Review
- 161 days
- Class
- Class II
- Product code
- DIS
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 1 generation to K993987 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK993987 Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULSyva Co. · 2000
- This deviceK062165 Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS…Ortho-Clinical Diagnostics · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129UL | Syva Co. | 2000 | — |
| 0 (this device) | K062165 | Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1… | Ortho-Clinical Diagnostics | 2007 | — |
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 DIS? 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? (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 |
|---|---|---|---|
| * | K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULSummary page 3…OS Chemistry Products predicate DAT Performance Verifiers are substantially equivalent to the Syva® EMIT II Plus devices: Barbiturate assay (K993987) and Bio-Rad Liquicheck TM Urine Toxicology Controls (K022707) predicate devices which were cleared by th… | 2000 |
| * | K022707 | Liquichek Urine Toxicology Control Level S1E, Model 438; Level S2E, Model 439Summary page 3…lly equivalent to the Syva® EMIT II Plus devices: Barbiturate assay (K993987) and Bio-Rad Liquicheck TM Urine Toxicology Controls (K022707) predicate devices which were cleared by the FDA for IVD use.… | 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 22, 2017 | Class II | Z-0911-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0913-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0912-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0914-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
| Sep 22, 2017 | Class II | Z-0915-2018 | Under Investigation by firm | This product is not meeting the current storage labeling for unopened VITROS DAT Performance Verifiers causing customers to obtain lower than expected VITROS BENZ results when using this control. |
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 DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · DIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · DIS
29in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DIS
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DIS
1in 2018
MAUDE reports naming product code DIS, 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 | 3 | 331 | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 2 | — | 1 | 0 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 3 | 29 | 0 | 0 |
| 2016 | 1 | — | 1 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 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?
For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose. The VITROS Chemistry Products BARB assay is intended for use by professional…
Read the full statement (219 words)
For in vitro diagnostic use only. VITROS Chemistry Products BARB Reagent is used on VITROS 5,1 FS Chemistry Systems for the semi-quantitative or qualitative determination of barbiturates (BARB) in human urine using a cutoff of either 200 ng/mL or 300 ng/mL. Measurements obtained with the VITROS BARB method are used in the diagnosis and treatment of barbiturates use or overdose.
The VITROS Chemistry Products BARB 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. VITRQS 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 ES Chemistry Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062165: Vitros Chemistry Products Barb Reagent; Calibrator Kit 26; FS Calibrator 1; Dat Performance Verifiers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062165
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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