510(k) Report

510(k) · Cleared

Cleared

AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX

K163462510(k) TraditionalCleared Sep 21, 2017286-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 Sep 21, 2017 as substantially equivalent to K112161 (Radiometer Medical Aps, 2012) and 1 other predicate after a 286-day review. Its family tree reaches back 7 generations to 1996.

Decided
Sep 21, 2017
Review
286 days
Class
Class II
Product code
JHX
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K961828 (1996). 11 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2012: 1 other ancestor2005: 1 other ancestor1996: 1 other ancestor1998: 1 other ancestorK961828 · 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 · 2005K112161 · AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge.. · Radiometer Medical Aps · 201219952000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors3 generations back: 1 other ancestor K112161 · AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge.. · Radiometer Medical Aps · 2012K050537 · 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 · 7 generations backK961828 Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad · 1996
  2. 6 generations backK980556 Liquichek Cardiac Markers Control LTBio-Rad · 1998
  3. 5 generations backK012656 Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad · 2001
  4. 4 generations backK021498 Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad · 2002
  5. 3 generations backK040277 Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc. · 2004
  6. 2 generations backK050537 Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers…Bio-Rad · 2005
  7. 1 generation backK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps · 2012
  8. This deviceK163462 AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEXRadiometer Medical Aps · 2017
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K961828Liquichek Cardiac Markers Control (Cat. NO. 685,686,687,688)Bio-Rad1996—
−6K980556Liquichek Cardiac Markers Control LTBio-Rad1998—
−5K012656Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648Bio-Rad2001—
−4K021498Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelBio-Rad2002—
−3K040277Liquichek Cardiac Marker Control LTBio-Rad Laboratories, Inc.2004—
−2K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control…Bio-Rad2005—
−1K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…Radiometer Medical Aps2012—
0 (this device)K163462AQT90 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
201210
FIG. 1 — Lineage of K163462, 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? (2)

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
*K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS…
Summary page 8
…stantial Equivalence The AQT90 FLEX System devices are substantial equivalent in intended use, fundamental scientific technology, and characteristics to the predicates (K112161, K120326). Predicate devices Predicate name Device Manufacturer 510(k) number AQT90 FLE…
Radiometer Medical Aps2012—
*K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal…
Summary page 8
…Equivalence The AQT90 FLEX System devices are substantial equivalent in intended use, fundamental scientific technology, and characteristics to the predicates (K112161, K120326). Predicate devices Predicate name Device Manufacturer 510(k) number AQT90 FLEX Myo Tes…
Radiometer Medical Aps2012—

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 21 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
  • 2 of the 11 ancestors have a recall of any class.

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. 2017, 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 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. The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin in EDTA or lithium heparin whole-blood or plasma…

Read the full statement (161 words)

The 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.

The Myo Test is an in vitro diagnostic assay for the quantitative determination of myoglobin 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 rapid diagnosis of heart disease, for example, acute myocardial infarction.

For in vitro diagnostic use.

The AQT90 FLEX analyzer is an immunoassay instrument based on the quantitative determination of time-resolved fluorescence to estimate the concentrations of clinically relevant markers on whole-blood and plasma specimens to which a relevant anticoagulant has been added. It is intended for use in point-of-care and laboratory settings.

Indications for use as stated in the FDA summary.

More from Radiometer Medical Aps

28 FDA decisions under this applicant name. See the company

  • 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
  • K132691ABL90 FlexRadiometer Medical Aps · 2014

Recent decisions in JHX

The JHX category page

  • K234005Access CK-MBBeckman Coulter, Inc. · 2024
  • K212648VITROS Immunodiagnostic Products CK-MB Reagent PackOrtho Clinical Diagnostics · 2022
  • 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/K163462 · printed Nov 6, 2026

Cite this page

510(k) Report. “K163462: AQT90 FLEX Myo Test Kit, AQT90 FLEX CKMB Test Kit, AQT90 FLEX.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163462

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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