510(k) Report

510(k) · Cleared

Cleared

Ferritin Calibrator

K983548510(k) TraditionalCleared Oct 27, 199818-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 Oct 27, 1998 as substantially equivalent to K963493 (Dade Chemistry Systems, Inc., 1996) after an 18-day review. Its family tree reaches back 1 generation to 1996. 6 later devices descend from it.

Decided
Oct 27, 1998
Review
18 days
Class
Class II
Product code
JIT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963493 (1996). 6 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2010: 2 descendants cleared2012: 1 descendant cleared2014: 1 descendant clearedK963493 · Ferritin Calibrator · Dade Chemistry Systems, Inc. · 19961995200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 1 descendant K963493 · Ferritin Calibrator · Dade Chemistry Systems, Inc. · 19960
  1. Root · 1 generation backK963493 Ferritin CalibratorDade Chemistry Systems, Inc. · 1996
  2. This deviceK983548 Ferritin CalibratorDade Behring, Inc. · 1998
  3. Descendant · cites it directly · 4 of its ownK071224 Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and…Dade Behring, Inc. · 2007 · Recalled
  4. Descendant · 2 generations on · 1 of its ownK121994 Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension…Siemens Healthcare Diagnostics, Inc. · 2012
  5. Descendant · 3 generations on · 0 of its ownK133512 Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia…Siemens Healthcare Diagnostics · 2014
  6. Descendant · 2 generations on · 0 of its ownK093645 Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010
  7. Descendant · 2 generations on · 0 of its ownK093631 B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642…Siemens Healthcare Diagnostics · 2010

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2007: 22010: 22012: 12014: 1
2007high 2 (2007) · low 0 (2008)2026

Most influential descendants

Showing 5 of 6 · See all
  • K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc. · 2007 · cites it directly4descendants
  • K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista Loci 4…Siemens Healthcare Diagnostics, Inc. · 2012 · 2 generations on1descendant
  • K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem Cal)Siemens Healthcare Diagnostics · 2014 · 3 generations on0descendants
  • K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics · 2010 · 2 generations on0descendants
  • K093631B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644Siemens Healthcare Diagnostics · 2010 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963493Ferritin CalibratorDade Chemistry Systems, Inc.1996—
0 (this device)K983548Ferritin CalibratorDade Behring, Inc.1998—
+1K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4…Dade Behring, Inc.20071
+2K121994Dimension Vista Vitamin B12 (VB12) Flex Reagent Cartridge, Dimension Vista…Siemens Healthcare Diagnostics, Inc.2012—
+3K133512Loci Vitamin B12 (VB12) Flex Reagent Cartridge, Loci Anemia Calibrator (Anem…Siemens Healthcare Diagnostics2014—
+2K093645Exl Anem Cal, Model RC640Siemens Healthcare Diagnostics2010—
+2K093631B12 Reagent Cartridge and Fol Flex Reagent Cartridge, Model RF642 and RF644Siemens Healthcare Diagnostics2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201020
201210
201410
FIG. 1 — Lineage of K983548, 1996–2014Source: 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 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
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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
*K963493Ferritin Calibrator
Summary page 1
…9714-6101 Date of Preparation: October 5, 1998 Name of Product: Ferritin Calibrator FDA Classification Name: Calibrator Predicate Device: Dimension® Ferritin Calibrator, K963493 Device Description: The Ferritin Calibrator is a liquid bovine albumin-based product. The Level 1 calibrator contains no detecta…
Dade Chemistry Systems, Inc.1996—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K071224Dimension Vista Vitamin B12 and Folate Flex Reagent Cartridges and Loci 4 CalibratorDade Behring, Inc.20074
K070552Dimension Vista Ferritin Flex Reagent Cartridge (Ferr)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, K071224 (Dade Behring, Inc., 2007) has gone furthest, with 4 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—

What is it indicated for?

The Ferritin Calibrator is intended to be used to calibrate the Ferritin (FERR) Method on the Dimension® RxL clinical chemistry system.

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 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/K983548 · printed Nov 6, 2026

Cite this page

510(k) Report. “K983548: Ferritin Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983548

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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