510(k) Report

510(k) · Cleared

Cleared

AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge..

K112161510(k) TraditionalCleared Jan 20, 2012177-day reviewClass I21 CFR 862.2560

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

Radiometer Medical Aps · KHO Fluorometer, For Clinical Use

Cleared on Jan 20, 2012 as substantially equivalent to K042924 (Fisher Diagnostics, 2005) and 1 other predicate after a 177-day review. Its family tree reaches back 6 generations to 1996. 1 later device descends from it.

Decided
Jan 20, 2012
Review
177 days
Class
Class I
Product code
KHO
Recalls
None
Predicates
2

Its longest line of descent runs back 6 generations to K961828 (1996). 8 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 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: 1 other ancestor2 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 deviceK112161 AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…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)K112161AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC…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
199810
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
FIG. 1 — Lineage of K112161, 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 KHO? 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? (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
*K042924Architect Stat Myo Immunoassay
Summary page 2
…yed) (21 CFR 862.1660) Product code: JJY 2. Predicate device * ARCHITECT STAT Myoglobin, 510(k) number K(042924 o ARCHITECT STAT Myoglobin Calibrators, 510(k) number K042924 * Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537 3. Device description I test principle The AQT90 FLEX is a…
Fisher Diagnostics20052
*K050537Liquichek Cardiac Markers Plus Control, Liquichek Cardiac Markers Plus Control LT…
Summary page 2
…RCHITECT STAT Myoglobin, 510(k) number K(042924 o ARCHITECT STAT Myoglobin Calibrators, 510(k) number K042924 * Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537 3. Device description I test principle The AQT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence us…
Bio-Rad2005—

Also cleared against K042924: 1 other device →

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 8 ancestors have a recall of any class.
  • Of its descendants, K163462 (Radiometer Medical Aps, 2017) has gone furthest, with 0 descendants of its own.
  • 1 other device also cites its predicate K042924.

How does its category compare?

All KHO devices

KHO Fluorometer, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.

FDA decisions per year · KHO

1in 2012

2012: 1
2007high 1 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KHO

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

Recalls per year · KHO

7in 2018

2011: 22012: 12014: 22017: 42018: 7
2007high 7 (2018) · low 0 (2007)2026

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

Adverse event reports per year · KHO

178in 2025

2007: 52008: 12009: 242010: 492011: 292012: 682013: 532014: 652015: 302016: 352017: 1522018: 2,1232019: 4402020: 2572021: 2132022: 2242023: 2602024: 1682025: 178
2007high 2,123 (2018) · low 1 (2008)2025

MAUDE reports naming product code KHO, 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—05
20080—01
20090—024
20100—049
20110—229
20121—168
20130—053
20140—265
20150—030
20160—035
20170—4152
20180—72,123
20190—0440
20200—0257
20210—0213
20220—0224
20230—0260
20240—0168
20250—0178
20260—0—

What is it indicated for?

AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument 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. AQT90 FLEX Myo Test is an in vitro diagnostic assay for the quantitative…

Read the full statement (180 words)

AQT90 FLEX analyzer is for in vitro diagnostic use. The instrument 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.

AQT90 FLEX 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 indicated for use as an aid in the rapid diagnosis of heart disease, e.g. acute myocardial infarction.

AQT90 FLEX Myo CAL cartridge is for in vitro diagnostic use. For calibration adjustment of the Myo Test, as indicated on the cartridge, on the AQT90 FLEX analyzer.

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.

Also cleared against K042924

1 other device cites the same predicate.

  • K120326AQT90 Flex CKMB Test Kit, AQT90 Flex LQC Multi-Check, Levels 1-3, AQT90 Flex CKMB Cal CartridgeRadiometer Medical Aps · 2012

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 KHO

The KHO category page

  • K973547Triage StatmeterBiosite Incorporated · 1998
  • K971103Aia Nexia-Automated Enzyme Immunoassay SystemTosoh Medics, Inc. · 19972 recalls
  • K962919Vitros Immunodiagnostic SystemJohnson & Johnson Clinical Diagnostics, Inc. · 19965 recalls
  • K952719Biocircuits Ios (in-Office System)Biocircuits Corp. · 1995
  • K950415Fluoroscan NeonatalIsolab, Inc. · 1995

https://510kreport.com/device/K112161 · printed Nov 3, 2026

Cite this page

510(k) Report. “K112161: AQT90 Flex Analyzer, AQT90 Flex Myoglobin Test Kit, AQT90 Flex LQC Multi-Check, LVLS 1-3, AQT90 Flex Myo Cal Cartridge...” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112161

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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