510(k) Report

510(k) · Cleared

Cleared

Modification to N/T Protein Control SL

K012468510(k) TraditionalCleared Sep 4, 200133-day reviewClass I21 CFR 862.1660

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

Dade Behring, Inc. · JJY Multi-Analyte Controls, All Kinds (Assayed)

Cleared on Sep 4, 2001 as substantially equivalent to K002852 (Dade Behring, Inc., 2000) after a 33-day review. Its family tree reaches back 1 generation to 2000. 26 later devices descend from it.

Decided
Sep 4, 2001
Review
33 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002852 (2000). 26 later devices descend from it, 14 citing it directly.

Descendants, by year cleared 2007: 10 descendants cleared2005: 1 descendant cleared2008: 4 descendants cleared2006: 6 descendants cleared2004: 1 descendant cleared2015: 2 descendants cleared2009: 1 descendant cleared2023: 1 descendant clearedK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 14 descendants2 generations forward: 7 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K002852 · N/T Protein Control SL · Dade Behring, Inc. · 20000
  1. Root · 1 generation backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
  2. This deviceK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
  3. Descendant · cites it directly · 7 of its ownK061338 Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006
  4. Descendant · cites it directly · 6 of its ownK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
  5. Descendant · 2 generations on · 6 of its ownK062055 Dimension Vista Protein 1 Calibrator, Control Low, Control Medium…Dade Behring, Inc. · 2006
  6. Descendant · 3 generations on · 5 of its ownK063508 Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2…Dade Behring, Inc. · 2007
  7. Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled

Showing 5 of 26 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 62007: 102008: 42009: 12015: 22023: 1
2004high 10 (2007) · low 0 (2010)2026

Most influential descendants

Showing 5 of 26 · See all
  • K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc. · 2006 · cites it directly7descendants
  • K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc. · 2007 · cites it directly6descendants
  • K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc. · 2006 · 2 generations on6descendants
  • K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator and…Dade Behring, Inc. · 2007 · 3 generations on5descendants
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002852N/T Protein Control SLDade Behring, Inc.2000—
0 (this device)K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—
+1K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.2006—
+1K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and…Dade Behring, Inc.2007—
+2K062055Dimension Vista Protein 1 Calibrator, Control Low, Control Medium, Control HighDade Behring, Inc.2006—
+3K063508Dimension Vista Protein 1 Calibrator and Control L, M, H; Protein 2 Calibrator…Dade Behring, Inc.2007—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.200532

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200510
200660
2007100
200840
200910
201520
202310
FIG. 1 — Lineage of K012468, 2000–2023Source: 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 JJY? 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? (1)

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
*K002852N/T Protein Control SL
Summary page 1
…otein Control SL: Quality Control Material (assayed) Classification Number: Class | (862.1660) 3. Identification of the Legally Marketed Device: N/T Protein Control SL (K002852) 4. Device Description: N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and preservative.…
Dade Behring, Inc.2000—

What descends from it? (26)

See all 26

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

NumberDeviceApplicantDecidedDescendants
K061338Dimension Vista Iga Flex Reagent Cartridge AssayDade Behring, Inc.20067
K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…Dade Behring, Inc.20076
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055
K063206Dimension Vista Hcys Flex Reagent Cartridge; Protein 1 Calibrator; Protein 1 Control…Dade Behring, Inc.20061
K082503Dimension Vista LG Light Chains, Type Kappa, Dimension Vista LG Light Chains, Type…Siemens Healthcare Diagnostics20080
K081249Dimension Vista System A2MAC Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc.20080
K063655Dimension Vista; Cer Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070
K063425Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control…Dade Behring, Inc.20070
K063272Dimension Vista B2MIC Flex Reagent Cartridge, Protein 1 Calibrator, Control Medium…Dade Behring, Inc.20070
K063322Dimension Vista TRF Flex Reagent Cartridge, Protein 1 Calibrator Protein 1 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?

  • Its one ancestor has no recall.
  • Of its descendants, K061338 (Dade Behring, Inc., 2006) has gone furthest, with 7 descendants of its own.

How does its category compare?

All JJY devices

JJY Multi-Analyte Controls, All Kinds (Assayed): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JJY

3in 2017

2007: 112008: 72009: 82010: 102011: 142012: 132013: 162014: 102015: 42016: 12017: 3
2007high 16 (2013) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JJY

78in 2017

2007: 49 days median2008: 54 days median2009: 80 days median2010: 109 days median2011: 120 days median2012: 40 days median2013: 82 days median2014: 49 days median2015: 153 days median2017: 78 days median
2007high 153 (2015) · low 40 (2012)2026

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

Recalls per year · JJY

2in 2025

2007: 52009: 22010: 62011: 12012: 32013: 22014: 22015: 12016: 32017: 42018: 32019: 42020: 62022: 32023: 32025: 22026 (partial year): 1
2007high 6 (2010) · low 0 (2008)2026

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

Adverse event reports per year · JJY

13in 2025

2007: 22008: 12009: 32010: 32011: 62012: 202013: 52014: 42015: 42016: 132017: 122018: 72019: 12020: 72021: 12023: 42024: 12025: 13
2007high 20 (2012) · low 0 (2022)2025

MAUDE reports naming product code JJY, 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
2007114952
200875401
200988023
20101010963
20111412016
20121340320
2013168225
2014104924
2015415314
20161—313
2017378412
20180—37
20190—41
20200—67
20210—01
20220—30
20230—34
20240—01
20250—213
20260—1—

What is it indicated for?

N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with BN™ Systems: IgG, 1gG1.4, IgA, IgM, C3c, C4, Transferrin, Albumin, ay-antitrypsin, oz-macroglobulin, Haptoglobin, a.4-acid glycoprotein, Prealbumin, Hemopexin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, p2-microglobulin, soluble Transferrin Receptor (sTfR), Ferritin, IgE, and Total protein; and by immunoturbidimetry with the TurbiTimeSystem: I1gG, IgA, IgM, C3c, C4, Transferrin, Albumin, Haptoglobin, a.4-acid glycoprotein.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

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 JJY

The JJY category page

  • K162530Multichem IA PlusTechno-Path Manufacturing · 2017
  • K163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd. · 2017
  • K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker…Bio-Rad Laboratories · 2017
  • K153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea…Radiometer America, Inc. · 2016
  • K150300Liquichek Cardiac Markers Plus Control LTBio-Rad Laboratories · 2015

https://510kreport.com/device/K012468 · printed Nov 5, 2026

Cite this page

510(k) Report. “K012468: Modification to N/T Protein Control SL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012468

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026