510(k) Report

510(k) · Cleared

Cleared

Emit Caffeine Assay

K853872510(k) TraditionalCleared Jun 13, 1986269-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. · KLS Enzyme Immunoassay, Theophylline

Cleared on Jun 13, 1986 after a 269-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jun 13, 1986
Review
269 days
Class
Class II
Product code
KLS
Recalls
None
Predicates
0

2 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared1990200020102020
  1. This deviceK853872 Emit Caffeine AssaySyva Co. · 1986
  2. Descendant · cites it directly · 0 of its ownK042520 Vitros Chemistry Products Caffn Reagent Kit and TDM Performance…Ortho-Clinical Diagnostics, Inc. · 2004
  3. Descendant · cites it directly · 0 of its ownK042407 Emit Caffeine AssayDade Behring, Inc. · 2004

Most influential descendants

Showing 2 of 2 · See all
  • K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc. · 2004 · cites it directly0descendants
  • K042407Emit Caffeine AssayDade Behring, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853872Emit Caffeine AssaySyva Co.1986—
+1K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I…Ortho-Clinical Diagnostics, Inc.2004—
+1K042407Emit Caffeine AssayDade Behring, Inc.2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200420
FIG. 1 — Lineage of K853872, 1986–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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.

  • 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? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K042520Vitros Chemistry Products Caffn Reagent Kit and TDM Performance Verifiers I, II and IiiOrtho-Clinical Diagnostics, Inc.20040
K042407Emit Caffeine AssayDade Behring, Inc.20040

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?

  • Of its descendants, K042520 (Ortho-Clinical Diagnostics, Inc., 2004) has gone furthest, with 0 descendants of its own.

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.

448 FDA decisions under this applicant name. See the company

  • K011878Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators, Model 7S109ULSyva Co. · 2001
  • K012257Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229Syva Co. · 2001
  • K011947Emit 2000 Valproic Acid Assay, Model OSR4G229ULSyva Co. · 2001
  • K011528Emit 2000 Phenobarbital Assay, Model OSR4D229Syva Co. · 20013 recalls
  • K011347Emit 2000 Phenytoin Assay, Model 0SR4A229Syva Co. · 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/K853872 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853872: Emit Caffeine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853872

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