510(k) Report

510(k) · Cleared

Cleared

N Protein Standard UY Calibrator

K003501510(k) TraditionalCleared Mar 15, 2001122-day reviewClass II21 CFR 862.1150

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

Dade Behring, Inc. · JIT Calibrator, Secondary

Cleared on Mar 15, 2001 after a 122-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.

Decided
Mar 15, 2001
Review
122 days
Class
Class II
Product code
JIT
Recalls
None
Predicates
0

12 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2004: 1 descendant cleared2009: 1 descendant cleared2008: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2018: 1 descendant cleared200020052010201520202025
  1. This deviceK003501 N Protein Standard UY CalibratorDade Behring, Inc. · 2001
  2. Descendant · cites it directly · 8 of its ownK041627 Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004
  3. Descendant · 2 generations on · 5 of its ownK080811 Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C…Roche Diagnostics Corp. · 2008
  4. Descendant · 3 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 · 4 generations on · 1 of its ownK171072 N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017
  6. Descendant · 4 generations on · 1 of its ownK161817 Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2004: 12007: 22008: 22009: 12012: 12014: 12016: 12017: 12018: 12025: 1
2004high 2 (2007) · low 0 (2005)2026

Most influential descendants

Showing 5 of 12 · See all
  • K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S · 2004 · cites it directly8descendants
  • K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin C Control…Roche Diagnostics Corp. · 2008 · 2 generations on5descendants
  • K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator, Cystatin C…Roche Diagnostics · 2014 · 3 generations on4descendants
  • K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH · 2017 · 4 generations on1descendant
  • K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo) · 2016 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003501N Protein Standard UY CalibratorDade Behring, Inc.2001—
+1K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S2004—
+2K080811Tina-Quant Cystatin C, Calibrator F.a.S. Cystatin C and Cystatin C Andcystatin…Roche Diagnostics Corp.2008—
+3K141143Cobas C Tina-Quant Cystatin C Gen.2 Assay, C.F.a.S. Cystatin C Calibrator…Roche Diagnostics2014—
+4K171072N Latex Cystatin C; N Protein Standard UYSiemens Healthcare Diagnostics Products GmbH2017—
+4K161817Tina-quant Cystatin C Gen.2Roche Diagnostics Operations (Rdo)2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200720
200820
200910
201210
201410
201610
201710
201810
202510
FIG. 1 — Lineage of K003501, 2001–2025Source: 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 JIT? 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
Get a 510(k) Report

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? (12)

See all 12

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

NumberDeviceApplicantDecidedDescendants
K041627Cystatin C Immunoparticles, Control Set, CalibratorDako A/S20048
K083906Advia Chemistry Cystatin C Reagent, Advia Chemistry Cystatin C Calibrator, Models P/N…Siemens Healthcare Diagnostics20090
K080662Genzyme Cystatin C Reagent Anf Genzyme Cystatin C CalibratorGenzyme Corporation20080
K063351Dimension Vista Cysc Flex Reagent Cartridge, Protein 3 Calibrator and Cystatin Control…Dade Behring, Inc.20070

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, K041627 (Dako A/S, 2004) has gone furthest, with 8 descendants of its own.

How does its category compare?

All JIT devices

JIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JIT

7in 2017

2007: 52008: 62009: 22010: 62011: 72012: 22013: 52014: 102015: 42016: 42017: 7
2007high 10 (2014) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JIT

28in 2017

2007: 78 days median2008: 46 days median2010: 65 days median2011: 48 days median2013: 140 days median2014: 33 days median2015: 30 days median2016: 33 days median2017: 28 days median
2007high 140 (2013) · low 28 (2017)2026

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

Recalls per year · JIT

1in 2023

2007: 12009: 22011: 32012: 32014: 22015: 12018: 52020: 22023: 12026 (partial year): 1
2007high 5 (2018) · low 0 (2008)2026

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

Adverse event reports per year · JIT

7in 2025

2010: 32011: 22012: 102013: 432014: 92015: 62016: 32017: 72018: 82019: 2152020: 122021: 32022: 42023: 62024: 172025: 7
2007high 215 (2019) · low 0 (2007)2025

MAUDE reports naming product code JIT, 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
200757810
200864600
20092—20
201066503
201174832
20122—310
20135140043
2014103329
201543016
201643303
201772807
20180—58
20190—0215
20200—212
20210—03
20220—04
20230—16
20240—017
20250—07
20260—1—

More from Dade Behring, Inc.

347 FDA decisions under this applicant name. See the company

  • K093848PT-Multi-Calibrator, Model OPAT07Dade Behring, Inc. · 2010
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, and…Dade Behring, Inc. · 2008
  • K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1 Calibrator, Dimension…Dade Behring, Inc. · 2008
  • K071603Dimension Vista Carcinoembryonic Antigen Flex Reagent Cartridge (Cea)Dade Behring, Inc. · 2008
  • K071597Dimension Vista (R) Afp Flex (R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci 5 Calibrator…Dade Behring, Inc. · 2008

Recent decisions in JIT

The JIT category page

  • K171168VITROS Immunodiagnostic Products Insulin CalibratorsOrtho Clinical Diagnostics · 2017
  • K170938CalSet IGF-1Roche Diagnostics · 2017
  • K170160Abbott ARCHITECT Free T3Abbott Laboratories · 2017
  • K163546Lumipulse G Progesterone-N CalibratorsFujirebio Diagnostics,Inc. · 2017
  • K163534Lumipulse G FSH-N CalibratorsFujirebio Diagnostics,Inc. · 2017

https://510kreport.com/device/K003501 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003501: N Protein Standard UY Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003501

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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