510(k) Report

510(k) · Cleared

Cleared

Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229

K011164510(k) SpecialCleared May 10, 200124-day reviewClass II21 CFR 862.3630

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

Syva Co., Dade Behring, Inc. · KXS Radioimmunoassay, Methaqualone

Cleared on May 10, 2001 after a 24-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
May 10, 2001
Review
24 days
Class
Class II
Product code
KXS
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K011164Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KXS? 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All KXS devices

KXS Radioimmunoassay, Methaqualone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KXS

FDA has decided no KXS device since 2007.

Median 510(k) review, days · KXS

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

Recalls per year · KXS

No recall names KXS since 2007.

Adverse event reports per year · KXS

No MAUDE report names KXS since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Syva Co., Dade Behring, Inc.

19 FDA decisions under this applicant name. See the company

  • K011920Emit 2000 Digoxin Assay, Model OSR4H229Syva Co., Dade Behring, Inc. · 2001
  • K011620Emit 2000 N-Acetylprocainamide Assay, Model OSR4N229Syva Co., Dade Behring, Inc. · 2001
  • K011605Emit 2000 Quinidine Assay, Model OSR4Q229Syva Co., Dade Behring, Inc. · 20011 recall
  • K011300Emit II Plus Cannabinoid Assay, Model OSR9N229Syva Co., Dade Behring, Inc. · 2001
  • K011306Emit II Plus Benzodiazepine Assay, Model 0SR9F229Syva Co., Dade Behring, Inc. · 2001

Recent decisions in KXS

The KXS category page

  • K993986Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULSyva Co. · 2000
  • K955676Synchron Systems Methaqualone ReagentBeckman Instruments, Inc. · 1996
  • K945187Roche Abuscreen Online for MethaqualoneRoche Diagnostic Systems, Inc. · 1995
  • K940123Methaqualone Enzyme ImmunoassayDiagnostic Reagents, Inc. · 1994
  • K921013Syva Emit II Methaqualone AssaySyva Co. · 1992

https://510kreport.com/device/K011164 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011164: Modification to the Emit II Plus Methaqualone Assay, Model OSR9Q229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011164

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026