510(k) Report

510(k) · Cleared

Cleared

Access CK-MB

K234005510(k) TraditionalCleared Feb 16, 202459-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

Beckman Coulter, Inc. · JHX Fluorometric Method, Cpk Or Isoenzymes

Cleared on Feb 16, 2024 as substantially equivalent to K030012 (Beckman Coulter, Inc., 2003) after a 59-day review. Its family tree reaches back 2 generations to 2000.

Decided
Feb 16, 2024
Review
59 days
Class
Class II
Product code
JHX
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K000716 (2000). No later device cites it as a predicate yet.

K000716 · Access CK-MB on the Access Immunoassay Analyzer · Beckman Coulter, Inc. · 2000K030012 · CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372 · Beckman Coulter, Inc. · 2003200020052010201520202025
K030012 · CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372 · Beckman Coulter, Inc. · 2003K000716 · Access CK-MB on the Access Immunoassay Analyzer · Beckman Coulter, Inc. · 20000
  1. Root · 2 generations backK000716 Access CK-MB on the Access Immunoassay AnalyzerBeckman Coulter, Inc. · 2000
  2. 1 generation backK030012 CK-MB and CK-MB Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2003
  3. This deviceK234005 Access CK-MBBeckman Coulter, Inc. · 2024
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K000716Access CK-MB on the Access Immunoassay AnalyzerBeckman Coulter, Inc.2000—
−1K030012CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371…Beckman Coulter, Inc.2003—
0 (this device)K234005Access CK-MBBeckman Coulter, Inc.2024—
FIG. 1 — Lineage of K234005, 2000–2024Source: 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 JHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new JHX device

  1. #1 K212648 VITROS Immunodiagnostic Products CK-MB Reagent…score 3.1 · 2 generations · no Class I recall
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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
*K030012CK-MB and CK-MB Calibrators on the Access Immunoassay Systems, Models 386371 and 386372
Summary page 4
…zyme Immunoassay Trade Name: Access CK-MB Classification Code: JHX Classification Regulation: 21 CFR 862.1215 Predicate Device Device Name: Access CK-MB 510(k) Numbers: K030012 Device Description The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determi…
Beckman Coulter, Inc.2003—

What descends from it?

No later submission names this one as a predicate yet.

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 24 years and passes through 1 company; a new generation was cleared every 21.1 years on median.
  • None of the 2 ancestors has a recall.

How does its category compare?

All JHX devices

JHX Fluorometric Method, Cpk Or Isoenzymes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · JHX

1in 2024

2009: 12012: 12017: 12022: 12024: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JHX

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

Recalls per year · JHX

2in 2015

2008: 12009: 12012: 42015: 2
2007high 4 (2012) · low 0 (2007)2026

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

Adverse event reports per year · JHX

1in 2025

2007: 22008: 62009: 402010: 272011: 42012: 182013: 82014: 172015: 82016: 102017: 32018: 162019: 72020: 32021: 102022: 22023: 22024: 22025: 1
2007high 40 (2009) · low 1 (2025)2025

MAUDE reports naming product code JHX, 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
20070—02
20080—16
20091—140
20100—027
20110—04
20121—418
20130—08
20140—017
20150—28
20160—010
20171—03
20180—016
20190—07
20200—03
20210—010
20221—02
20230—02
20241—02
20250—01
20260—0—

What is it indicated for?

The Access CK-MB assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination

of CK-MB levels in human serum and plasma using the Access Immunoassay Systems to aid in the diagnosis and

treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Indications for use as stated in the FDA summary.

More from Beckman Coulter, Inc.

456 FDA decisions under this applicant name. See the company

  • K262597Access BNP IIBeckman Coulter, Inc. · 2026
  • K261109Access MeMed BVBeckman Coulter, Inc. · 2026
  • K262109Access NT-proBNPBeckman Coulter, Inc. · 2026
  • K252169Access BNP IIBeckman Coulter, Inc. · 2026
  • K254059Access anti-HBc IgMBeckman Coulter, Inc. · 2026

Recent decisions in JHX

The JHX category page

  • K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal CartridgeRadiometer Medical Aps · 2012
  • K081360Pathfast CK-MB-II, Pathfast Myo-IIMitsubishi Kagaku Iatron · 20091 recall
  • K051650Stratus CS Acute Care MB Isoenzyme of Creatine Kinase (CKMB) Test Pak; Stratus CS Acute Care CKMB Testpak.Dade Behring, Inc. · 200511 recalls

https://510kreport.com/device/K234005 · printed Nov 6, 2026

Cite this page

510(k) Report. “K234005: Access CK-MB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K234005

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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