510(k) Report

510(k) · Cleared

Cleared

Emit 2000 Carbamazepine Assay, Model OSR4F229

K010814510(k) SpecialCleared Apr 13, 200125-day reviewClass II21 CFR 862.3645

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. · KLT Enzyme Immunoassay, Carbamazepine

Cleared on Apr 13, 2001 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Apr 13, 2001
Review
25 days
Class
Class II
Product code
KLT
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared200020052010201520202025
  1. This deviceK010814 Emit 2000 Carbamazepine Assay, Model OSR4F229Syva Co., Dade Behring, Inc. · 2001
  2. Descendant · cites it directly · 0 of its ownK153596 ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite…Ark Diagnostics, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010814Emit 2000 Carbamazepine Assay, Model OSR4F229Syva Co., Dade Behring, Inc.2001—
+1K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator…Ark Diagnostics, Inc.2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K010814, 2001–2016Source: FDA 510(k) summaries, read by 510(k) Report · 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 KLT? 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? (1)

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

NumberDeviceApplicantDecidedDescendants
K153596ARK Oxcarbazepine Metabolite Assay, ARK Oxcarbazepine Metabolite Calibrator, ARK…Ark Diagnostics, Inc.20160

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, K153596 (Ark Diagnostics, Inc., 2016) has gone furthest, with 0 descendants of its own.

How does its category compare?

All KLT devices

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

FDA decisions per year · KLT

1in 2015

2007: 12011: 12013: 12015: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLT

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

Recalls per year · KLT

1in 2013

2013: 1
2007high 1 (2013) · low 0 (2007)2026

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

Adverse event reports per year · KLT

4in 2025

2009: 22010: 12011: 12012: 12013: 12014: 32015: 92016: 32017: 12018: 42019: 62020: 12021: 22022: 72023: 32024: 12025: 4
2007high 9 (2015) · low 0 (2007)2025

MAUDE reports naming product code KLT, 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
20071—00
20080—00
20090—02
20100—01
20111—01
20120—01
20131—11
20140—03
20151—09
20160—03
20170—01
20180—04
20190—06
20200—01
20210—02
20220—07
20230—03
20240—01
20250—04
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 KLT

The KLT category page

  • K151578Carbamazepine Gen 4Roche Diagnostics Operations (Rdo) · 2015
  • K123518Abbott Carbamazepine AssayMicrogenics Corporation · 2013
  • K103627Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine CalibratorsAbbott Laboratories · 2011
  • K063131Carbamazepine, Valproic Acid, TDM Calibration Set B and Abtrol, Nortrol ControlsThermo Electron OY · 2007
  • K042808Advia Ims Carbamazepine MethodBayer Healthcare, LLC · 2005

https://510kreport.com/device/K010814 · printed Nov 5, 2026

Cite this page

510(k) Report. “K010814: Emit 2000 Carbamazepine Assay, Model OSR4F229.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010814

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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