510(k) Report

510(k) · Cleared

Cleared

Cobas Reagent for Lidocaine & Calibrators

K853010510(k) TraditionalCleared Aug 7, 198522-day reviewClass II21 CFR 862.3555

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

Roche Diagnostic Systems, Inc. · KLR Enzyme Immunoassay, Lidocaine

Cleared on Aug 7, 1985 after a 22-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
Aug 7, 1985
Review
22 days
Class
Class II
Product code
KLR
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2003: 1 descendant cleared2009: 1 descendant cleared1990200020102020
  1. This deviceK853010 Cobas Reagent for Lidocaine & CalibratorsRoche Diagnostic Systems, Inc. · 1985
  2. Descendant · cites it directly · 1 of its ownK031856 Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK091617 QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009

Most influential descendants

Showing 2 of 2 · See all
  • K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp. · 2003 · cites it directly1descendant
  • K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific · 2009 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853010Cobas Reagent for Lidocaine & CalibratorsRoche Diagnostic Systems, Inc.1985—
+1K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.20032
+2K091617QMS Lidocaine Calibrators, Model 0374678Thermo Fisher Scientific2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200910
FIG. 1 — Lineage of K853010, 1985–2009Source: 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 KLR? 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)

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

NumberDeviceApplicantDecidedDescendants
K031856Preciset TDM I and Preciset TDM II CalibratorsRoche Diagnostics Corp.20031

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, K031856 (Roche Diagnostics Corp., 2003) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KLR devices

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

FDA decisions per year · KLR

1in 2009

2009: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KLR

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

Recalls per year · KLR

1so far in 2026, the most since 2007

2026 (partial year): 1
2007high 1 (2026) · low 0 (2007)2026

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

Adverse event reports per year · KLR

2in 2020

2020: 2
2007high 2 (2020) · low 0 (2007)2025

MAUDE reports naming product code KLR, 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—00
20080—00
20091—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—02
20210—00
20220—00
20230—00
20240—00
20250—00
20260—1—

More from Roche Diagnostic Systems, Inc.

296 FDA decisions under this applicant name. See the company

  • K983698Modification to Abuscreen Online BarbituratesRoche Diagnostic Systems, Inc. · 1999
  • K983702Modification to Abuscreen Online for BenzoidiazepinesRoche Diagnostic Systems, Inc. · 1999
  • K983704Modification to Abuscreen Online for PhencyclidineRoche Diagnostic Systems, Inc. · 1999
  • K983556Abuscreen Online Benz 300 CalibratorsRoche Diagnostic Systems, Inc. · 1998
  • K983555Abuscreen Online Benz 200 CalibratorsRoche Diagnostic Systems, Inc. · 1998

Recent decisions in KLR

The KLR category page

  • K090282QMS LidocaineThermo Fisher Scientific, Inc. · 2009
  • K033809Dimension Lidocaine (Lido) Flex Reagent Cartridge Method, Dimension Drug Calibrator II, Models DF113. DC49DDade Behring, Inc. · 2004
  • K032334Roche Online TDM LidocaineRoche Diagnostics Corp. · 2004
  • K973102Lidocaine Eia AssayDiagnostic Reagents, Inc. · 1997
  • K881116Easy-Test Emit (R) Lidocaine Lido Item NO. 16641Diagnostic Systems · 1988

https://510kreport.com/device/K853010 · printed Nov 4, 2026

Cite this page

510(k) Report. “K853010: Cobas Reagent for Lidocaine & Calibrators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853010

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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