510(k) Report

510(k) · Cleared

Cleared

AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge

K120326510(k) TraditionalCleared Nov 21, 2012293-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

Radiometer Medical Aps · JHX Fluorometric Method, Cpk Or Isoenzymes

Cleared on Nov 21, 2012 as substantially equivalent to K962549 (Biomerieux Vitek, Inc., 1996) and 2 other predicates after a 293-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.

Decided
Nov 21, 2012
Review
293 days
Class
Class II
Product code
JHX
Recalls
None
Predicates
3

Its longest line of descent runs back 6 generations to K961828 (1996). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor1996: 1 other ancestor1998: 1 other ancestor2017: 1 descendant clearedK961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 1996K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 2002K040277 · Liquichek Cardiac Marker Control LT · Bio-Rad Laboratories, Inc. · 2004K050537 · Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus · Bio-Rad · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 1 descendant K050537 · Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT, Liquichek Cardiac Markers Plus · Bio-Rad · 2005K040277 · Liquichek Cardiac Marker Control LT · Bio-Rad Laboratories, Inc. · 2004K021498 · Liquichek Cardiac Markers Control LT Level 1, 2, 3, and Trilevel · Bio-Rad · 2002K012656 · Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648 · Bio-Rad · 2001K980556 · Liquichek Cardiac Markers Control LT · Bio-Rad · 1998K961828 · Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688) · Bio-Rad · 1996−50
  1. Root · 6 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. 5 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. 4 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. 3 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. 2 generations backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. 1 generation backK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. This deviceK120326 AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3…Radiometer Medical Aps · 2012
  8. Descendant · cites it directly · 0 of its ownK163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017

Most influential descendants

Showing 1 of 1 · See all
  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad1996—
−5K980556Liquichek Cardiac Markers Control LTBio-Rad1998—
−4K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad2001—
−3K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad2002—
−2K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.2004—
−1K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control…Bio-Rad2005—
0 (this device)K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex…Radiometer Medical Aps2012—
+1K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199810
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K120326, 1996–2017Source: 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 K234005 Access CK-MBscore 7.2 · 2 generations · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*K962549Vidas Creatine Kinase MB Assay 30-421
Summary page 2
…ame: quality control material (assayed and unassayed) (21 CFR 862.1660) Product code: JJY 2. Predicate device *VIDAS Creatine Kinase MB (CKMB) Assay, 510(k) number K962549 *VIDAS Creatine Kinase MB (CKMB) Calibrators, 510(k) number K962549 *Liquicheck Cardiac Markers Plus Control LT, 510(k) number…
Biomerieux Vitek, Inc.1996—
*K042924Architect Stat Myo Immunoassay
Summary page 9
…duct code JHX AQT90 FLEX CKMB CAL Cartridge. Class II. VIDAS Creatine Kinase MB (CKMB) Calibrators, Classification name: calibrator, secondary, 510(k) number K042924 (21 CFR. 862.1150), product code ]IT AQT90 FLEX LQC Multi-CHECK, Levels 1, 2 Liquicheck Cardiac Markers Plus Control LT…
Fisher Diagnostics20052
*K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…
Summary page 2
…e MB (CKMB) Assay, 510(k) number K962549 *VIDAS Creatine Kinase MB (CKMB) Calibrators, 510(k) number K962549 *Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537 3. Device description / test principle The AQT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence us…
Bio-Rad2005—

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps20170

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 16 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 9 ancestors have a recall of any class.
  • Of its descendants, K163462 (Radiometer Medical Aps, 2017) has gone furthest, with 0 descendants of its own.

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. 2012, 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?

AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction. AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by…

Read the full statement (128 words)

AQT90 FLEX CKMB Test is an in vitro diagnostic assay for the quantitative determination of creatine kinase isoform MB in EDTA or lithium-heparin whole blood or plasma specimens on the AQT90 FLEX analyzer in point of care and laboratory settings. It is intended for use as an aid in the diagnosis of myocardial infarction.

AQT90 FLEX CKMB CAL cartridge is for in vitro diagnostic use for the calibration of the CKMB Test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.

AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for in vitro diagnostic use. For use with the AQT90 FLEX analyzer as a liquid quality control serum (LQC) to monitor the precision of laboratory testing procedures for the analytes listed on the specification insert.

Indications for use as stated in the FDA summary.

More from Radiometer Medical Aps

28 FDA decisions under this applicant name. See the company

  • K163462AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
  • K170882ABL90 Flex, ABL90 Flex PlusRadiometer Medical Aps · 2017
  • K160153ABL90 Flex PlusRadiometer Medical Aps · 20165 recalls
  • K142898ABL800 FLEX with AQURE connectivityRadiometer Medical Aps · 20153 recalls
  • K150226Hematocrit and Metabolite QUALICHECKRadiometer Medical Aps · 2015

Recent decisions in JHX

The JHX category page

  • K234005Access CK-MBBeckman Coulter, Inc. · 2024
  • 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
  • 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/K120326 · printed Nov 6, 2026

Cite this page

510(k) Report. “K120326: AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal Cartridge.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120326

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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