510(k) · Cleared

Recalled · 2011

Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit)

K032764510(k) TraditionalCleared Nov 3, 200359-day reviewClass II21 CFR 862.3150Recalls 1

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

Lin-Zhi International, Inc. · DIS Enzyme Immunoassay, Barbiturate

Cleared on Nov 3, 2003 as substantially equivalent to K010934 (Syva Co., Dade Behring, Inc., 2001) and 1 other predicate after a 59-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it. It has been recalled once.

Decided: Nov 3, 2003
Review: 59 days
Class: Class II
Product code: DIS
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K935101 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK935101 Urine Calibrators and Controls ModificationDiagnostic Reagents, Inc. · 1994
This deviceK032764 Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat#…Lin-Zhi International, Inc. · 2003
Descendant · cites it directly · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004

Most influential descendants

Showing 1 of 1 · See all

K033885BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935101	Urine Calibrators and Controls Modification	Diagnostic Reagents, Inc.	1994	—
0 (this device)	K032764	Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000…	Lin-Zhi International, Inc.	2003	—
+1	K033885	BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)	Lin-Zhi International, Inc.	2004	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0

FIG. 1 — Lineage of K032764, 1994–2004Source: 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 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

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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	Applicant	Decided	Recalls
*	K010934	Emit II Plus Barbituate Assay, Model 0SR9D0229	Syva Co., Dade Behring, Inc.	2001	—
*	K935101	Urine Calibrators and Controls Modification Summary page 6 …and controls included in the Multi- Drugs Urine Calibrators and Controls (Diagnostic Reagents, Inc., now Microgenics Corporation), cleared under premarket notifications (K935 101) for Drugs of Abuse Urine Calibrators and Controls.…	Diagnostic Reagents, Inc.	1994	—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K033885	BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)	Lin-Zhi International, Inc.	2004	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 8, 2011	Not classified	Z-0846-2012	Nonconforming Material/Component	Catalog #0140 and 0141 Barbiturate EIA small and large kits were not correctly made to specification such that the two antibodies used in production did not have curves that correctly aligned.

No ancestor or descendant has a Class I recall.

What does this lineage say?

None of the 2 ancestors has a recall.
Of its descendants, K033885 (Lin-Zhi International, Inc., 2004) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DIS devices

DIS Enzyme Immunoassay, Barbiturate: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DIS

1in 2016

2007high 3 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DIS

29in 2015

2007high 331 (2007) · low 29 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DIS

1in 2016

2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DIS

1in 2018

2007high 1 (2007) · low 0 (2009)2025

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 Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine. The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300…

Read the full statement (185 words)

The Barbiturate Drug of Abuse Calibrators are intended for in vitro diagnostic use for the calibration of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

The Barbiturate Drug of Abuse Controls are intended for in vitro diagnostic use for the validation of the Barbiturate Enzyme Immunoassay to detect barbiturates in human urine.

The Barbiturate Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 200 ng/mL and/or 300 ng/mL cutoffs. The assay is intended for use in the qualitative and semi-quantitative analyses of barbiturates in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.

Measurements obtained by this device are used in the diagnosis and treatment of barbiturate use or overdose and in monitoring levels of barbiturate to ensure appropriate therapy.

The Barbiturate Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K032764 · printed Nov 5, 2026

Cite this page

510(k) Report. “K032764: Barbiturate Enzyme Immunoassay, CA. # 0140 (500 Tests Kit); Cat# 0141 (5000 Tests Kit).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032764

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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