510(k) Report

510(k) · Cleared

Cleared

MMB Method

K970343510(k) TraditionalCleared Feb 14, 199716-day reviewClass II21 CFR 862.1215

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. · JHY Colorimetric Method, Cpk Or Isoenzymes

Cleared on Feb 14, 1997 after a 16-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.

Decided
Feb 14, 1997
Review
16 days
Class
Class II
Product code
JHY
Recalls
None
Predicates
0

7 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2005: 1 descendant cleared2004: 1 descendant cleared2008: 2 descendants cleared2006: 1 descendant cleared1995200020052010201520202025
  1. This deviceK970343 MMB MethodDade 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 · cites it directly · 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 7 descendants. See all descendants

Descendants cleared per year

2004: 12005: 12006: 12008: 22015: 2
2004high 2 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 7 · 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 · cites it directly0descendants
  • 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)K970343MMB MethodDade 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
+1K143720Dimension 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
200410
200510
200610
200820
201520
FIG. 1 — Lineage of K970343, 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 JHY? 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
Named without a submission number
—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K051087Dimension Vista Integrated SystemDade Behring, Inc.20055
K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics20150
K033747Ramp CK-MB AssayResponse Biomedical Corp.20040

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, K051087 (Dade Behring, Inc., 2005) has gone furthest, with 5 descendants of its own.

How does its category compare?

All JHY devices

JHY Colorimetric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JHY

1in 2015

2007: 12013: 12014: 22015: 1
2007high 2 (2014) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHY

Too few JHY 510(k)s in any year since 2007 to give a median.

Recalls per year · JHY

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

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

Adverse event reports per year · JHY

3in 2023

2012: 12014: 32015: 22016: 42017: 112018: 52019: 22020: 22022: 12023: 3
2007high 11 (2017) · low 0 (2007)2025

MAUDE reports naming product code JHY, 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
20071—00
20080—00
20090—00
20100—10
20110—00
20120—01
20131—00
20142—03
20151—02
20160—04
20170—011
20180—05
20190—02
20200—02
20210—00
20220—01
20230—03
20240—00
20250—00
20260—0—

What is it indicated for?

The MMB Method for the Dimension® RxL Clinical Chemistry System with the heterogeneous immunoassay module is used to quantitatively measure CKMB in human serum and plasma.

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
  • K973099Prostate Specific Antigen ControlDade Chemistry Systems, Inc. · 1997
  • K973100Prostate Specific Antigen (Psa) CalibratorDade 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 JHY

The JHY category page

  • K143720Dimension Vista MMB AssaySiemens Healthcare Diagnostics · 20155 recalls
  • K130080Easyra CK-MB Reagent, Easyra CRP Reagent, Easy Cal CRP Calibrator Kit, Easyqc CRP Quality Control MaterialMedica Corporation · 2014
  • K140404Elecsys CK-MB Stat ImmunoassayRoche Diagnostics · 2014
  • K132571Elecsys CK-MB Stat Immunoassay, Elecsys CK-MB ImmunoassayRoche Diagnostics · 2013
  • K070835Olympus CK-MB ReagentOlympus Life & Material Science Europa GmbH (Irish · 2007

https://510kreport.com/device/K970343 · printed Nov 3, 2026

Cite this page

510(k) Report. “K970343: MMB Method.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K970343

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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