510(k) · Cleared

Cleared

Ethanol

K013538510(k) TraditionalCleared Dec 14, 200151-day reviewClass II21 CFR 862.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Abbott Laboratories · DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method

Cleared on Dec 14, 2001 as substantially equivalent to K993980 (Syva Co., 2000) after a 51-day review. Its family tree reaches back 2 generations to 1990.

Decided: Dec 14, 2001
Review: 51 days
Class: Class II
Product code: DML
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K903153 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK903153 Emit Ethyl Alcohol AssaySyva Co. · 1990
1 generation backK993980 Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULSyva Co. · 2000
This deviceK013538 EthanolAbbott Laboratories · 2001

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K903153	Emit Ethyl Alcohol Assay	Syva Co.	1990	—
−1	K993980	Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL	Syva Co.	2000	—
0 (this device)	K013538	Ethanol	Abbott Laboratories	2001	—

FIG. 1 — Lineage of K013538, 1990–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 DML? 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

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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	Applicant	Decided	Recalls
*	K993980	Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409UL Summary page 1 …tional to the concentration of alcohol in the specimen. Substantial Equivalence: The Ethanol assay is substantially equivalent to the Emit® II Plus Ethyl Alcohol assay (K993980) on the SYVA®-30R Analyzer. ETHANOL 510(k) Section lI October 23, 2001 Page 12 Ethan_S_Rl.doc 0000011 Both assa…	Syva Co.	2000	—

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?

The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 9.5 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All DML devices

DML Nad-Nadh, Specific Reagent For Alcohol Enzyme Method: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DML

FDA has decided no DML device since 2007.

Median 510(k) review, days · DML

Too few DML 510(k)s in any year since 2007 to give a median.

Recalls per year · DML

No recall names DML since 2007.

Adverse event reports per year · DML

2in 2024

2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code DML, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	2
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	1
2019	—	0
2020	—	1
2021	—	1
2022	—	1
2023	—	2
2024	—	2
2025	—	0
2026	—	—

What is it indicated for?

The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.

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/K013538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K013538: Ethanol.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013538

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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