510(k) Report

510(k) · Cleared

Cleared

Modification to Emit 2000 Theophylline Assay, Model Osr 4P229

K011166510(k) SpecialCleared May 10, 200124-day reviewClass II21 CFR 862.3880

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. · KLS Enzyme Immunoassay, Theophylline

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
KLS
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K011166Source: 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 KLS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • 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 KLS devices

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

FDA decisions per year · KLS

FDA has decided no KLS device since 2007.

Median 510(k) review, days · KLS

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

Recalls per year · KLS

2in 2013

2012: 22013: 2
2007high 2 (2012) · low 0 (2007)2026

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

Adverse event reports per year · KLS

1in 2025

2007: 12009: 22011: 12016: 22025: 1
2007high 2 (2009) · low 0 (2008)2025

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

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—01
20080—00
20090—02
20100—00
20110—01
20120—20
20130—20
20140—00
20150—00
20160—02
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—01
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 KLS

The KLS category page

  • K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2004
  • K042407Emit Caffeine AssayDade Behring, Inc. · 2004
  • K020740Roche Online TheophyllineRoche Diagnostics Corp. · 2002
  • K011771Randox TheophyllineRandox Laboratories, Ltd. · 2002
  • K013272Acs: 180 and Advia Centaur Theophylline 2 AssayBayer Corp. · 2001

https://510kreport.com/device/K011166 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011166: Modification to Emit 2000 Theophylline Assay, Model Osr 4P229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011166

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