510(k) Report

510(k) · Cleared

Recalled · Class II · 2013

MMB Calibrator

K970336510(k) TraditionalCleared Mar 3, 199733-day reviewClass II21 CFR 862.1150Recalls 1

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

Dade Chemistry Systems, Inc. · JIT Calibrator, Secondary

Cleared on Mar 3, 1997 after a 33-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.

Decided
Mar 3, 1997
Review
33 days
Class
Class II
Product code
JIT
Recalls
1
Predicates
0

6 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2005: 1 descendant cleared2015: 2 descendants cleared2008: 2 descendants cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970336 MMB CalibratorDade Chemistry Systems, Inc. · 1997
  2. Descendant · cites it directly · 5 of its ownK051087 Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · Recalled
  3. Descendant · 2 generations on · 1 of its ownK073561 Dimension Vista System Immunoglobulin G Flex Reagent Cartridge…Dade Behring, Inc. · 2008
  4. Descendant · 2 generations on · 1 of its ownK061838 Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · Recalled
  5. Descendant · 2 generations on · 0 of its ownK143720 Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK140790 Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista…Siemens Healthcare Diagnostics · 2015 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 22015: 2
2005high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 6 · See all
  • K051087Dimension Vista Integrated SystemDade Behring, Inc. · 2005 · cites it directly5descendants
  • K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension Vista System…Dade Behring, Inc. · 2008 · 2 generations on1descendant
  • K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc. · 2006 · 2 generations on1descendant
  • K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 2015 · 2 generations on0descendants
  • K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…Siemens Healthcare Diagnostics · 2015 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K970336MMB CalibratorDade Chemistry Systems, Inc.1997—
+1K051087Dimension Vista Integrated SystemDade Behring, Inc.200532
+2K073561Dimension Vista System Immunoglobulin G Flex Reagent Cartridge, Dimension…Dade Behring, Inc.2008—
+2K061838Dimension Vista Chemistry 1 Calibrator, Model KC110Dade Behring, Inc.20063
+2K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics20155
+3K140790Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium…Siemens Healthcare Diagnostics20152

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200820
201520
FIG. 1 — Lineage of K970336, 1997–2015Source: 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
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
*—Abbott Laboratories IMx® Stat CK-MB Calibrator
Named without a submission number
—

What descends from it? (6)

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

NumberDeviceApplicantDecidedDescendants
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 5, 2013Class IIZ-1925-2013Material/Component ContaminationSiemens Healthcare Diagnostics has received complaints that the lyophilized cake is not fully dissolved after the stated time in the MMB calibrator Instructions For Use (IFU). The frequency of this occurrence is low but if it occurs…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 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 MMB Calibrator is intended to be used to calibrate the MMB method for the Dimension® RxL clinical chemistry system with the heterogeneous immunoassay module.

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 Chemistry Systems, Inc.

13 FDA decisions under this applicant name. See the company

  • K973650Troponin (Trop) MethodDade Chemistry Systems, Inc. · 1997
  • K973100Prostate Specific Antigen (Psa) CalibratorDade Chemistry Systems, Inc. · 1997
  • K973099Prostate Specific Antigen ControlDade Chemistry Systems, Inc. · 1997
  • K973101Prostate Specific Antigen MethodDade Chemistry Systems, Inc. · 1997
  • K971141FT4 Method for the Dimension RXL Clinical Chemistry SystemDade Chemistry Systems, Inc. · 1997

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/K970336 · printed Nov 4, 2026

Cite this page

510(k) Report. “K970336: MMB Calibrator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970336

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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