510(k) Report

510(k) · Cleared

Cleared

Cystatin C Immunoparticles, Control Set, Calibrator

K041627510(k) TraditionalCleared Sep 3, 200479-day reviewClass II21 CFR 862.1225

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

Dako A/S · NDY Test, Cystatin C

Cleared on Sep 3, 2004 as substantially equivalent to K003503 (Dade Behring, Inc., 2001) and 2 other predicates after a 79-day review. Its family tree reaches back 1 generation to 1995. 8 later devices descend from it.

Decided
Sep 3, 2004
Review
79 days
Class
Class II
Product code
NDY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K953239 (1995). 3 ancestors in all. 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2007: 1 descendant cleared2012: 1 descendant cleared2008: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant clearedK953239 · Boehringer Mannheim/Hitachi 917 Analyzer · Boehringer Mannheim Corp. · 1995 · recalled1995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 3 descendants2 generations forward: 1 descendant3 generations forward: 2 descendants4 generations forward: 2 descendants K953239 · Boehringer Mannheim/Hitachi 917 Analyzer · Boehringer Mannheim Corp. · 1995 · recalled0
  1. Root · 1 generation backK953239 Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp. · 1995 · Recalled
  2. This deviceK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
  3. Descendant · cites it directly · 5 of its ownK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
  4. Descendant · 2 generations on · 4 of its ownK141143 Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C…Roche Diagnostics · 2014
  5. Descendant · 3 generations on · 1 of its ownK171072 N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017
  6. Descendant · 3 generations on · 1 of its ownK161817 Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016
  7. Descendant · 4 generations on · 0 of its ownK242585 Cystatin CSENTINEL CH. SpA · 2025

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12012: 12014: 12016: 12017: 12018: 12025: 1
2007high 1 (2007) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp. · 2008 · cites it directly5descendants
  • K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics · 2014 · 2 generations on4descendants
  • K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017 · 3 generations on1descendant
  • K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016 · 3 generations on1descendant
  • K242585Cystatin CSENTINEL CH. SpA · 2025 · 4 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953239Boehringer Mannheim/Hitachi 917 AnalyzerBoehringer Mannheim Corp.199518
0 (this device)K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S2004—
+1K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin…Roche Diagnostics Corp.2008—
+2K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator…Roche Diagnostics2014—
+3K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH2017—
+3K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)2016—
+4K242585Cystatin CSENTINEL CH. SpA2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201210
201410
201610
201710
201810
202510
FIG. 1 — Lineage of K041627, 1995–2025Source: 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), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NDY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NDY device

  1. #1 K242585 Cystatin Cscore 10.5 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K003503N Latex Cystatin C
Summary page 1
…ator, Secondary (21 CFR 862.1150) Predicate Devices For Cystatin C Immunoparticles: N Latex Cystatin C Test Kit, Dade Behring, Inc. (K003503) Creatinine Plus, Roche Diagnostics Corp. (K953239) For Cystatin C Control Set: N…
Dade Behring, Inc.2001—
*K953239Boehringer Mannheim/Hitachi 917 Analyzer
Summary page 1
…For Cystatin C Immunoparticles: N Latex Cystatin C Test Kit, Dade Behring, Inc. (K003503) Creatinine Plus, Roche Diagnostics Corp. (K953239) For Cystatin C Control Set: N Cystatin C Control, Dade Behring, Inc. (K003503)…
Boehringer Mannheim Corp.199518
*K003501N Protein Standard UY Calibrator
Summary page 1
…N Cystatin C Control, Dade Behring, Inc. (K003503) For Cystatin C Calibrator: N Protein Standard UY, Dade Behring, Inc. (K003501) Cystatin C Immunoparticles - Cystatin C Control Set - Cystatin C Calibrator DakoCytomation Denmark A/S…
Dade Behring, Inc.2001—

Also cleared against K003503: 2 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp.20085
K121588Randox Cystatin C Control Level 2 Randox Cystatin C Control Level 3Randox Laboratories, Ltd.20120
K063647Cystatin C Antiserum, Calibrator, Control and Control HighThermo Electron OY20070

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?

  • 1 of the 3 ancestors has a recall of any class.
  • Of its descendants, K080811 (Roche Diagnostics Corp., 2008) has gone furthest, with 5 descendants of its own.
  • 2 other devices also cite its predicate K003503.

How does its category compare?

All NDY devices

NDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NDY

1in 2025

2007: 32008: 62009: 12010: 32012: 12014: 12016: 12017: 12018: 12025: 1
2007high 6 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NDY

265in 2010

2007: 95 days median2008: 101 days median2010: 265 days median
2007high 265 (2010) · low 95 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NDY

1in 2020

2020: 1
2007high 1 (2020) · low 0 (2007)2026

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

Adverse event reports per year · NDY

10in 2025

2015: 12016: 12017: 22019: 12023: 22024: 32025: 10
2007high 10 (2025) · low 0 (2007)2025

MAUDE reports naming product code NDY, 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
200739500
2008610100
20091—00
2010326500
20110—00
20121—00
20130—00
20141—00
20150—01
20161—01
20171—02
20181—00
20190—01
20200—10
20210—00
20220—00
20230—02
20240—03
20251—010
20260—0—

What is it indicated for?

For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. For In Vitro Diagnostic Use. For Professional Use Only. Cystatin C Control Set is an assayed bi-level control intended to monitor and…

Read the full statement (120 words)

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Immunoparticles are intended for the quantitative determination of cystatin C in human serum, heparinized plasma and EDTA plasma by turbidimetry and nephelometry. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Control Set is an assayed bi-level control intended to monitor and evaluate the precision and accuracy of the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

For In Vitro Diagnostic Use. For Professional Use Only.

Cystatin C Calibrator is intended for establishing calibration curves for the quantitative immunological determination of human cystatin C by turbidimetry or nephelometry.

Indications for use as stated in the FDA summary.

Also cleared against K003503

2 other devices cite the same predicate.

  • K071388Gentian Cystatin C ImmunoassayGentian AS · 20071 recall
  • K041878N Latex CystatinDade Behring, Inc. · 2004

More from Dako A/S

2 FDA decisions under this applicant name. See the company

  • K032692Dakocytomation Beta-2-Microglobulin Kit, Code NO. OA 368Dako A/S · 2004

Recent decisions in NDY

The NDY category page

  • K242585Cystatin CSENTINEL CH. SpA · 2025
  • K181082ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)Siemens Healthcare Diagnostics, Inc. · 2018
  • K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017
  • K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016
  • K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C Gen.2 Control SetRoche Diagnostics · 2014

https://510kreport.com/device/K041627 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041627: Cystatin C Immunoparticles, Control Set, Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041627

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026