510(k) Report

510(k) · Cleared

Cleared

Sigma 610 for Protein in Urine & CSF

K853681510(k) TraditionalCleared Oct 28, 198554-day reviewClass II21 CFR 862.1635

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

Sigma Diagnostics, Inc. · CEK Biuret (Colorimetric), Total Protein

Cleared on Oct 28, 1985 after a 54-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
Oct 28, 1985
Review
54 days
Class
Class II
Product code
CEK
Recalls
None
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK853681 Sigma 610 for Protein in Urine & CSFSigma Diagnostics, Inc. · 1985
  2. Descendant · cites it directly · 1 of its ownK964457 Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 0 of its ownK060853 Online TDM TobramycinRoche Diagnostics Corp. · 2006 · Recalled

Most influential descendants

Showing 2 of 2 · See all
  • K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc. · 1997 · cites it directly1descendant
  • K060853Online TDM TobramycinRoche Diagnostics Corp. · 2006 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K853681Sigma 610 for Protein in Urine & CSFSigma Diagnostics, Inc.1985—
+1K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19972
+2K060853Online TDM TobramycinRoche Diagnostics Corp.20062

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200610
FIG. 1 — Lineage of K853681, 1985–2006Source: 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 CEK? 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
K964457Roche Cobas Ibtegra Reagent CassettesRoche Diagnostic Systems, Inc.19971

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, K964457 (Roche Diagnostic Systems, Inc., 1997) has gone furthest, with 1 descendant of its own.

How does its category compare?

All CEK devices

CEK Biuret (Colorimetric), Total Protein: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CEK

FDA has decided no CEK device since 2007.

Median 510(k) review, days · CEK

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

Recalls per year · CEK

2in 2021

2013: 12020: 22021: 2
2007high 2 (2020) · low 0 (2007)2026

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

Adverse event reports per year · CEK

6in 2025

2008: 12010: 82011: 102012: 22014: 12015: 32018: 12019: 32020: 22021: 12023: 122024: 332025: 6
2007high 33 (2024) · low 0 (2007)2025

MAUDE reports naming product code CEK, 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—01
20090—00
20100—08
20110—010
20120—02
20130—10
20140—01
20150—03
20160—00
20170—00
20180—01
20190—03
20200—22
20210—21
20220—00
20230—012
20240—033
20250—06
20260—0—

More from Sigma Diagnostics, Inc.

164 FDA decisions under this applicant name. See the company

  • K021162Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-EU, Amax Destiny Coagulation…Sigma Diagnostics, Inc. · 2002
  • K020109Sigma Diagnostics Accuclot LA ControlSigma Diagnostics, Inc. · 2002
  • K013549Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971Sigma Diagnostics, Inc. · 2001
  • K013544Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096Sigma Diagnostics, Inc. · 2001
  • K013545Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221Sigma Diagnostics, Inc. · 2001

Recent decisions in CEK

The CEK category page

  • K992846Hichem Total Protein ReagentElan Holdings, Inc. · 1999
  • K973108Total Protein (Micro) Assay, Catalogue Number 450-50Diagnostic Chemicals, Ltd. · 1998
  • K980042Careside Total ProteinExigent Diagnostics, Inc. · 1998
  • K971524Total Protein or TPCarolina Liquid Chemistries Corp. · 1997
  • K961864CSF/Urine Total ProteinTeco Diagnostics · 1996

https://510kreport.com/device/K853681 · printed Nov 6, 2026

Cite this page

510(k) Report. “K853681: Sigma 610 for Protein in Urine & CSF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853681

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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