510(k) · Cleared
ClearedBarbiturates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · DIS Enzyme Immunoassay, Barbiturate
Cleared on Mar 20, 2002 as substantially equivalent to K902580 (Syva Co., 1990) after a 195-day review. Its family tree reaches back 1 generation to 1990.
- Decided
- Mar 20, 2002
- Review
- 195 days
- Class
- Class II
- Product code
- DIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K902580 (1990). No later device cites it as a predicate yet.
- Root · 1 generation backK902580 Emit (R) II Barbiturate AssaySyva Co. · 1990
- This deviceK012996 BarbituratesAbbott Laboratories · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K902580 | Emit (R) II Barbiturate Assay | Syva Co. | 1990 | — |
| 0 (this device) | K012996 | Barbiturates | Abbott Laboratories | 2002 | — |
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? (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 |
|---|---|---|---|
| * | K902580 | Emit (R) II Barbiturate AssaySummary page 2…an be measured specl’rophotomctrical ly. Substantial Equivalence: The Barbituratcs assay is substantially equivalent to the Emit® IT Barbiturate assay (K902580) on the SYVA®-30R Analyzer. Both assays yield similar Performance Characteristics. Similarities: - Both assays are in vitro i… | 1990 |
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?
- Its one ancestor has no recall.
How does its category compare?
All DIS devicesDIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatraent of barbiturates use or overdose. The Barbiturates assay is calibrated with secobarbital and will detcct a variety of Barbiturates. The Barbiturates assay provides only a preliminary analytical test result. A more specific…
Read the full statement (114 words)
The Barbiturates assay is used for the qualitative analysis of barbiturates in human urine with a cutoff of 200 ng/mL for use in clinical laboratories. Measurements obtained by this device are used in the diagnosis and treatraent of barbiturates use or overdose. The Barbiturates assay is calibrated with secobarbital and will detcct a variety of Barbiturates.
The Barbiturates assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical resull. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse Lest result, particularly when preliminary positive results are used.
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/K012996 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012996: Barbiturates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012996
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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