510(k) Report

510(k) · Cleared

Cleared

Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H

K071980510(k) TraditionalCleared Sep 11, 200755-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 11, 2007 as substantially equivalent to K063663 (Dade Behring, Inc., 2007) after a 55-day review. Its family tree reaches back 3 generations to 2000. 2 later devices descend from it.

Decided
Sep 11, 2007
Review
55 days
Class
Class I
Product code
JJY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K002852 (2000). 7 ancestors in all, the oldest K860894 (1986). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2001: 1 other ancestor2000: 1 other ancestor1986: 1 other ancestor2008: 2 descendants clearedK002852 · N/T Protein Control SL · Dade Behring, Inc. · 2000K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001K063663 · Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H · Dade Behring, Inc. · 20071990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors3 generations back: 2 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K063663 · Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M and H · Dade Behring, Inc. · 2007K012468 · Modification to N/T Protein Control SL · Dade Behring, Inc. · 2001K002852 · N/T Protein Control SL · Dade Behring, Inc. · 20000
  1. Root · 3 generations backK002852 N/T Protein Control SLDade Behring, Inc. · 2000
  2. 2 generations backK012468 Modification to N/T Protein Control SLDade Behring, Inc. · 2001
  3. 1 generation backK063663 Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator…Dade Behring, Inc. · 2007
  4. This deviceK071980 Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc. · 2007
  5. Descendant · cites it directly · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  6. Descendant · 2 generations on · 0 of its ownK081161 Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista…Dade Behring, Inc. · 2008

Most influential descendants

Showing 2 of 2 · See all
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · cites it directly1descendant
  • K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System Protein 1…Dade Behring, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002852N/T Protein Control SLDade Behring, Inc.2000—
−2K012468Modification to N/T Protein Control SLDade Behring, Inc.2001—
−1K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and…Dade Behring, Inc.2007—
0 (this device)K071980Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,HDade Behring, Inc.2007—
+1K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+2K081161Dimension Vista System Igg Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
200010
200110
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
FIG. 1 — Lineage of K071980, 2000–2008Source: 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), 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
Get a 510(k) Report

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
*K063663Dimension Vista STFR Flex Reagent Cartridge and Protein 1 Calibrator and Control L, M…
Summary page 1
…Clinical Chemistry (75) 3. Identification of the Legally Marketed Device: Dimension Vista® Protein 1 Calibrator K063663 Dimension Vista® Protein 1 Control L K063663 Dimension Vista® Protein 1 Control M…
Dade Behring, Inc.2007—

Also cleared against K063663: 1 other device →

What descends from it? (2)

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

NumberDeviceApplicantDecidedDescendants
K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc.20081

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?

  • The line of descent spans 7 years and passes through 1 company; a new generation was cleared every 9 months on median.
  • 1 of the 7 ancestors has a recall of any class.
  • Of its descendants, K073561 (Dade Behring, Inc., 2008) has gone furthest, with 1 descendant of its own.
  • 1 other device also cites its predicate K063663.

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. 2007, this device’s year, is highlighted.

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?

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a,-Acid Glycoprotein (A1AG); a,-Antitrypsin (A1AT); B.-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G…

Read the full statement (362 words)

PROT1 CAL is an in vitro diagnostic product for the calibration of the Dimension Vista® System for: a,-Acid Glycoprotein (A1AG); a,-Antitrypsin (A1AT); B.-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF)

PROT1 CON L is an assayed, low level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: a,-Acid Glycoprotein (AlAG); o1 -Antitrypsin (AlAT); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (1GM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF)

PROT1 CON M is an assayed, mid-level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista ® System in the quantitative determination of: a,-Acid Glycoprotein (A1AG); ao-Antitrypsin (A1AT); P 2-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF)

PROT1 CON H is an assayed, high level, intralaboratory quality control for assessment of precision and analytical bias on the Dimension Vista® System in the quantitative determination of: ao-Acid Glycoprotein (A1AG); a1 -Antitrypsin (A1AT); 132-Microglobulin (B2MIC); C3 Complement (C3); C4 Complement (C4); Ceruloplasmin (CER); Haptoglobin (HAPT); Hemopexin (HPX); Homocysteine (HCYS); Immunoglobulin A (IGA); Immunoglobulin E (IGE); Immunoglobulin G (IGG); Immunoglobulin G Subclass 1 (IGG1); Immunoglobulin G Subclass 2 (IGG2); Immunoglobulin G Subclass 3 (IGG3); Immunoglobulin G Subclass 4 (IGG4); Immunoglobulin M (IGM); Prealbumin (PREALB); Retinol Binding Protein (RBP); soluble Transferrin Receptor (STFR); Transferrin (TRF)

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

Also cleared against K063663

1 other device cites the same predicate.

  • K072435Dimension Vista Protein 3 Calibrator, 3 Control,1 Control L, 1 Control M, 1 Control HDade Behring, Inc. · 2007

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/K071980 · printed Nov 6, 2026

Cite this page

510(k) Report. “K071980: Dimension Vista Protein 1 Calibrator, PROTEIN1 Control L,M,H.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071980

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026