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.

Device Description

The AOT90 FLEX is a cartridge-based immunoassay, based on time-resolved fluorescence using a europium (Eu) chelate as the fluorescent label. The test receptacles for the assay are 300 µL test cups, which contain the antibodies used for capture of the analyte, and the Eu chelate labeled antibodies used to trace the captured analyte. The sample is added to the test cup together with assay buffer. The cup is then incubated to allow formation of the immuno-complex, and subsequently washed to remove unbound antibodies and sample material. Finally, the cup is exposed to excitation light, and after a delay the emitted light generated by the fluorescent label is measured by single photon counting; this measurement cycle is repeated up to 3,300 times. The total count is then compared to an assay calibration curve to obtain a quantitative measurement of the analyte's concentration in the sample.

This technology uses dried reagents deposited in the test cups and in the calibration adjustment cups - no liquids other than the sample itself together with the assay buffer are required. Total assay time is less than 20 minutes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge, and LQC Multi-CHECK, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Predicate)	Reported Device Performance (AQT90 FLEX CKMB Test - in context of substantial equivalence to predicate)
Reportable/Calibration Range	0.8-300 ng/mL (VIDAS CKMB Assay)	1.5-300 ng/mL (µg/L)
Analytical Sensitivity	Limit of Detection is 0.8 ng/mL at the 95% level of confidence (VIDAS CKMB Assay)	Limit of Quantitation 1 ng/mL (µg/L)
Reference Range	99th percentile is 6.8 ng/mL (VIDAS CKMB Assay)	97.5th percentile for females is 6.9 ng/mL (µg/L), for males 11 ng/mL (µg/L). (Note: This is a direct comparison of reference ranges, not typically an acceptance criterion in the same way as analytical performance, but presented as a characteristic comparison)
Imprecision	CV(%) intraassay range is ≤ 6.2%; CV(%) interassay is ≤ 7.2%; CV(%) total is ≤ 16.7% (VIDAS CKMB Assay)	Across the reportable range, CV(%) within-run is ≤ 6.5% for plasma and ≤ 6.0% for whole blood; CV(%) total is ≤ 8.2% for plasma and ≤ 6.0% for whole blood.
Interference	No interference with CKBB and CKMM; no interference with hemoglobin, triglycerides and bilirubin (VIDAS CKMB Assay)	No interference with CKBB, CKMM, hemoglobin, triglycerides, bilirubin and other endogenous blood components. No interference with any of 52 drugs and solvents tested.
Comparison (Correlation with Predicate)	N/A (The predicate itself showed a comparison with Ciba-Corning Magic Lite CK-MB assay: y = 0.83x - 0.66, r = 0.97 for 175 samples in the range 0.8-300 ng/mL)	Whole blood vs VIDAS: POC Site 1 = 0.93x - 0.2; n = 43; r² = 0.99; POC Site 2 = 0.93x + 0.0; n = 46; r² = 0.98; POC Site 3 = 0.96x - 0.5; n = 48; r² = 0.95. Plasma vs VIDAS: POC Site 1 = 0.94x - 0.3; n = 44; r² = 0.99; POC Site 2 = 0.96x + 0.0; n = 46; r² = 0.99; POC Site 3 = 0.93x - 0.4; n = 48; r² = 0.95.

Study Proving Acceptance Criteria:

The study proving the device meets its acceptance criteria is a comparison study against a legally marketed predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (K962549). This is a common approach for 510(k) submissions to demonstrate substantial equivalence.

2. Sample Size and Data Provenance

Test Set Sample Size:
- Whole blood samples: n = 43 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 137 samples.
- Plasma samples: n = 44 (POC Site 1), n = 46 (POC Site 2), n = 48 (POC Site 3). Total = 138 samples.
- Overall total for the comparison study seems to be around 275 samples.
- The samples used in the comparison study were in the range of 2.1 - 217 ng/mL (µg/L) for plasma and 1.5 - 277 ng/mL (µg/L) for whole blood.
Data Provenance: Not explicitly stated regarding the country of origin. The study was performed at "POC Sites" (Point of Care Sites), suggesting it was conducted in a clinical or laboratory setting. It is a prospective study in the sense that samples were collected and tested on both the new device and the predicate for comparison.

3. Number of Experts and Qualifications for Ground Truth

This type of diagnostic test (quantitative immunoassay) relies on analytical performance rather than expert interpretation of images or clinical data for its primary ground truth establishment. Therefore, there were no "experts" in the traditional sense (e.g., radiologists) establishing ground truth for the test set. The ground truth for the comparison study is the result obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay).

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is an analytical comparison with a predicate device, not a human interpretation study requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is more relevant for imaging devices or devices where human interpretation directly influences the outcome and is being assisted by AI. This submission is for an in vitro diagnostic assay.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, the primary performance data presented is for the standalone algorithm/device performance in comparison to a predicate device. The results (concentration values) are generated directly by the AQT90 FLEX analyzer. There is no "human-in-the-loop" aspect to the CKMB measurement itself, and the study focuses on the analytical agreement between the new device and the predicate.

7. Type of Ground Truth Used

The ground truth used for the comparison study is the results obtained from the predicate device (VIDAS Creatine Kinase MB (CKMB) Assay). For analytical sensitivity and imprecision, the "ground truth" refers to established analytical methods and reference materials, often traceable to international standards (e.g., ERM-AD455/IFCC mentioned for traceability).

8. Sample Size for the Training Set

The provided document does not specify the sample size for a training set. This is typical for a 510(k) submission for a traditional in vitro diagnostic device, which usually involves development, verification, and validation studies but might not explicitly refer to "training sets" in the context of machine learning algorithms. The development of the assay reagents and calibration curve would have involved extensive testing, but not typically referred to as a "training set" as understood in AI/ML.

9. How the Ground Truth for the Training Set Was Established

Since no specific "training set" is mentioned in the context of AI/ML, this question is not directly applicable. For a traditional diagnostic assay, the "ground truth" for developing the assay's performance characteristics (e.g., calibration curve, analytical sensitivity, reference ranges) is established through:

Reference materials (e.g., ERM-AD455/IFCC mentioned for traceability).
Known concentrations of analyte in control samples.
Extensive laboratory testing using established analytical methods to define assay parameters.
Clinical studies to determine reference ranges in a healthy population.

Summary

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K120326

RADIOMETER 16

510(k) Premarket Notification Submission AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

510(k) Summary

AQT90 FLEX CKMB Test Kit AQT90 FLEX CKMB CAL Cartridge AQT90 FLEX LQC Multi-CHECK

Manufacturer

Radiometer Medical ApS Aakandevej 21, DK-2700 Bronshoj, Denmark

Contact_information

Radiometer Medical ApS Aakandevej 21 DK-2700 Bronshoj Denmark Att. Mrs Jana S. Hellmann Vice President, Global RA/QA Phone +45 3827 3827 Fax: +45 3827 2727 E-mail: jana.hellmann@radiometer.dk

Application correspondent

Radiometer Medical ApS Aakandevej 21 DK-2700 Bronshoj Denmark Att. Mrs Gitte Juel Frils Director, Regulatory Affairs · Phone +45 3827 3384 Fax: +45 3827 2727 E-mail: gitte.friis@radiometer.dk

Signature

Jau S. Her

Jana S. Hellmann 26 October, 2012

ﻳﺔ

Page 1 of 9

NOV 2 1 2012

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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

1.	Device names and classifications

2.	Predicate device
3.	Device description / test principle
4.	Device intended use
5.	Medical device to which substantial equivalence is claimed
6.	Technological characteristics in comparison to predicate device
7.	Conclusion

1. Device names and classifications

· Proprietary name: AQT90 FLEX CKMB Test Kit Class II Classification name: Creatine phosphokinase/creatine kinase or isoenzymes test system (21 CFR. 862.1215) Product code: JHX
· Proprietary name: AQT90 FLEX CKMB CAL Cartridge Class II Classification name: calibrator, secondary (21 CFR. 862.1150) Product code: JIT
· Proprietary name: AQT90 LQC FLEX Multi-CHECK, Levels 1, 2 and 3 Class I Classification name: 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 K050537

3. Device description / test principle

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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

1. Metering of an exact amount of sample and assay buffer and dispensing into a test cup
1. Incubating for 7-15 minutes at 37 °C
1. Washing of the test cup to remove unbound tracer antibodies and sample material
1. Drying the test cup
1. Measuring

4. Device intended use

AQT90 FLEX CKMB Test Kit includes 10 AQT90 FLEX CKMB Test cartridges and one AQT90 FLEX CKMB CAL cartridge. AQT90 FLEX CKMB 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 intended for the calibration of the CKMB test on the AQT90 FLEX analyzer by establishing points of reference to estimate CKMB values.

5. Medical device to which substantial equivalence is claimed

The AOT90 FLEX CKMB Test Kit and CKMB CAL cartridges are substantially equivalent in features and characteristics to the VIDAS Creatine Kinase MB (CKMB) Assay and the VIDAS Creatine Kinase MB (CKMB) Calibrator, 510(k) number K962549.

The AOT90 LOC FLEX Multi-CHECK, Levels 1, 2 and 3, is substantially equivalent in features and characteristics to the Liquicheck Cardiac Markers Plus Control LT, 510(k) number K050537.

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510(k) Premarket Notification Submission

. .

AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

6. Technological characteristics in comparison to predicate device

Comparison of features for AQT90 FLEX CKMB Test and predicate device

Item	AQT90 FLEX CKMB Test	VIDAS Creatine Kinase MB(CKMB) Assay
Intended use	The AQT90 FLEX CKMB is an invitro diagnostic assay for thequantitative determination ofcreatine kinase isoform MB inEDTA or lithium-heparinwhole-blood or plasmaspecimens on the AQT90 FLEXanalyzer in point of care andlaboratory settings. It isintended for use as an aid inthe diagnosis of myocardialinfarction. Currentinternational guidelines shouldalways be followed wheninterpreting CKMB results.	The VIDAS Creatine Kinase MB(CKMB) Assay is for in vitrodiagnosis and intended for useon the instruments of theVIDAS family (VitekImmunoDiagnostic AssaySystem) as an automatedenzyme-linked fluorescentimmunoassay (ELFA) for thequantitative determination ofcreatine kinase MB isoenzymeconcentration in human serumor plasma (heparin orEDTA). It is intended for useas an aid in the diagnosis ofacute myocardial infarctions.
Test format	Cartridge with 16 test cups,each coated with anti-CKMBcapture antibody andcontaining a separating layeras well as Eu-chelate anti-CKMB tracer. Sample andassay buffer are added to thecup. Assay buffer is located inthe Reagent Pack. The packalso receives the discardedcups and liquid waste. After anincubation period, a wash stepwith assay buffer removesunbound material from thecup, which is subsequentlydried. When exposed to anexcitation light the boundeuropium emits a fluorescence,which is measured in cycles ofsingle photon counting. Thetotal count is then compared toan assay calibration curve toobtain a quantitativemeasurement of the analyte'sconcentration in the sample.	The VIDAS Creatine Kinase MB(CKMB) assay is an enzyme-linked fluorescentimmunoassay that isperformed in an automatedinstrument. All assay steps andassay temperature arecontrolled by the instrument. Apipette tip-like disposabledevice, the Solid PhaseReceptacle (SPR), serves as asolid phase for the assay aswell as a pipetting device. TheSPR is coated at the time ofmanufacture with mousemonoclonal anti-CreatineKinase MB antibodies. TheVIDAS Creatine Kinase MB(CKMB) assay configurationprevents nonspecific reactionswith the SPR. Reagents for theassay are located in the sealedReagent Strips. A prewashstep prepares the SPR for thereaction then the sample istransferred into the wellcontaining the sample diluent.Wash steps remove unbound
Item	AQT90 FLEX CKMB Test	VIDAS Creatine Kinase MB(CKMB) Assay
		material. The conjugate is thencycled in and out of the SPR.This step allows the conjugateto attach to the CKMB alreadyfixed to the SPR: thus forminga "sandwich". Wash stepsremove unbound conjugate. Afluorescent substrate, 4-methylumbelliferyl phosphate,is cycled through the SPR.Enzyme remaining on the SPRwall will catalyze theconversion of the substrate tothe fluorescent product 4-methylumbelliferone. Theintensity of fluorescence ismeasured by the opticalscanner in the instrument; it isproportional to the CreatineKinase MB concentrationpresent in the sample. Whenthe VIDAS Creatine Kinase MB(CKMB) Assay is completed,the results are analyzedautomatically by theinstrument, and a report isprinted for each sample.
Traceability	ERM-AD455/IFCC	Not known
Antibodies	Mouse monoclonals for captureand tracer antibody	Mouse monoclonal for captureand goat polyclonal for tracerantibody
Sample type	Human whole blood andplasma	Human serum and plasma
Anticoagulants	EDTA, Li-heparin	EDTA, heparin
Controls	Recommended	Recommended
In-use stability	23 days on-board up to 32 °C	Solid Phase Receptacle not tobe left outside 2-8 °C forextended period of time.
Storage temperature	2-8 °C	2-8 °C
Reportable /calibration range	Reportable range 1.5-300 ng/mL (µg/L)	0.8-300 ng/mL
Item	AQT90 FLEX CKMB Test	VIDAS Creatine Kinase MB (CKMB) Assay
Analytical sensitivity	Limit of Quantitation 1 ng/mL(µg/L)	Limit of Detection is 0.8 ng/mLat the 95% level of confidence
Reference range	97.5th percentile for females is6.9 ng/mL (µg/L), for males 11ng/mL (µg/L).	99th percentile is 6.8 ng/mL
Imprecision	Across the reportable range,CV(%)within-run is ≤ 6.5% forplasma and ≤ 6.0% for wholeblood;CV(%)total is ≤ 8.2% forplasma and ≤ 6.0% for wholeblood.	CV(%)intraassay range is ≤ 6.2%;CV(%)interassay is ≤ 7.2%;CV(%)total is ≤ 16.7%
Interference	No interference with CKBB,CKMM, hemoglobin,triglycerides, bilirubin andother endogenous bloodcomponents. No interferencewith any of 52 drugs andsolvents tested.	No interference with CKBB andCKMM; no interference withhemoglobin, triglycerides andbilirubin.
Comparison withpredicate	Comparison with VIDASCreatine Kinase MB (CKMB)Assay.Whole blood vs VIDAS:POC Site 1 = 0.93x - 0.2; n =43; r² = 0.99POC Site 2 = 0.93x + 0.0; n =46; r² = 0.98POC Site 3 = 0.96x - 0.5; n =48; r² = 0.95Plasma vs VIDAS:POC Site 1 = 0.94x - 0.3; n =44; r² = 0.99POC Site 2 = 0.96x + 0.0; n =46; r² = 0.99POC Site 3 = 0.93x - 0.4; n =48; r² = 0.95	Comparison with Ciba-CorningMagic Lite CK-MB assay, 175samples in the range 0.8 -300ng/mLy = 0.83x - 0.66, r = 0.97.

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RADIOMETER B

510(k) Premarket Notification Submission

AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

Comparison of features for AQT90 FLEX CKMB CAL and predicate device, the VIDAS Creatine Kinase MB (CKMB) Calibrators

Item	AQT90 FLEX CKMB CAL	VIDAS Creatine Kinase MB(CKMB) Calibrator
Intended use	The AQT90 FLEX CKMB CALCartridge is for in vitrodiagnostic use and intendedfor the calibration of the CKMBtest on the AQT90 FLEXanalyzer by establishing pointsof reference to estimateCKMB values.	The VIDAS Creatine Kinase MB(CKMB) Calibrator is for invitro diagnostic use andintended for calibration of theVIDAS Creatine Kinase MB(CKMB) assay by verificationof the master calibrationcurve.
Constituents	Each CAL Cartridge containseight analyte-specificbackground cups and eightcups with added antigen.	1 x 3 mL (lyophilized)
Calibration adjustmentinterval	Once per lot of AQT90 FLEXCKMB Test cartridges and asoften as required by relevantregulations.	Upon receipt of new lot ofassay reagents and every 14days thereafter.
In-use stability	24 hours on-board up to 32 °C	24 hours at 2-8 °C whenreconstituted;until expiry date at 25±6 °Cwhen reconstituted
Storage temperature	2-8 °C	2-8 °C or -25±6 °C whenreconstituted

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AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

Comparison of features for AQT90 FLEX LQC Multi-CHECK and predicate device, the Liquicheck Cardiac Markers Plus Control LT

Item	AQT90 LQC FLEX Multi-CHECK	Liquicheck Cardiac MarkersPlus Control LT
Intended use	The AQT90 FLEX LQC Multi-CHECK, Levels 1-3, is for invitro diagnostic use. For usewith the AQT90 FLEX analyzeras a liquid quality controlserum (LQC) to monitor theprecision of laboratory testingprocedures for the analyteslisted on the specificationinsert.	Liquicheck Cardiac MarkersPlus Control LT is intended foruse as quality control serum tomonitor the precision oflaboratory testing procedureslisting in the package insert.
Analytes contained	CKMB, Myoglobin	B-type Natriuretic Peptide(BNP), Creatine Kinase (Total),C-Reactive Protein (CRP),Homocysteine, Digitoxin, N-terminal pro-B-type NatriureticPeptide (NT-proBNP), CKMB,Myoglobin, Troponin I,Troponin T.
Matrix	Human serum	Human serum
Storage temperature	≤ -18 ºC until expiration date;shelf life claim is 12 months.	-20 °C to -70 °C untilexpiration date.
In-use stability	4 days if stored unused at2-8 ºC; 2 hours if storedunused at room temperature15-32 °C.	20 days at 2-8 °C

Summary of clinical performance data

The AQT90 FLEX CKMB assay (y) was compared to the predicate device, the VIDAS Creatine Kinase MB (CKMB) Assay (x) using lithium-heparin plasma and whole blood samples in the range of 2.1 - 217 ng/mL (µg/L) and 1.5 - 277 ng/mL (µg/L), respectively. The relationship between the two methods was determined by Passing-Bablok regression. The regression lines and correlation coefficients for whole blood samples were for POC Site 1 = 0.93x - 0.2; n = 43; r2 = 0.99, for POC Site 2 = 0.93x + 0.0; n = 46; r² = 0.98 and for POC Site 3 = 0.96x - 0.5; n = 48; ~ = 0.95. For plasma samples the regressions lines and correlation coefficients were for POC Site 1 = 0.94x -0.3; n = 44; ~ = 0.99, for POC Site 2 = 0.96x + 0.0; n = 46; ~ = 0.99 and for POC Site 3 = 0.93x - 0.4; n = 48; r2 = 0.95.

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RADIOMETER B

510(k) Premarket Notification Submission

AQT90 FLEX CKMB Test Kit, CKMB CAL Cartridge and LQC Multi-CHECK

7. Conclusion

The products listed in the table are substantially equivalent based on their indications for use and performance characteristics. ,

New Device	Predicate Device
AQT90 FLEX CKMB Test Kit. Class II.Classification name: Creatinephosphokinase/creatine kinase orisoenzymes test system (21 CFR.862.1215), product code JHX	VIDAS Creatine Kinase MB (CKMB) Assay, 510(k)number K962549
AQT90 FLEX CKMB CAL Cartridge. Class II.Classification name: calibrator, secondary,(21 CFR. 862.1150), product code JIT	VIDAS Creatine Kinase MB (CKMB) Calibrators,510(k) number K042924
AQT90 FLEX LQC Multi-CHECK, Levels 1, 2and 3. Class I. Classification name: qualitycontrol material (assayed and unassayed)(21 CFR 862.1660), product code JJY	Liquicheck Cardiac Markers Plus Control LT, 510(k)number K050537

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 21, 2012

Radiometer Medical ApS c/o Gitte Friis Director, Regulatory Affairs Aakandejev 21 Bronshoj, Denmark DK 2700

K120326 Re:

Trade/Device Name: AQT90 FLEX CKMB Test Kit; AQT90 FLEX CKMB CAL Cartridge; AQT90 FLEX LQC Multi-CHECK, Levels 1-3 Regulation Number: 21 CFR 862.1215 Regulation Name: Creatine phosphokinase/creatine kinase or isoenzymes test system Regulatory Class: Class II Product Code: JHX, JIT, JIT, JJY Dated: October 26, 2012 Received: October 31, 2012

Dear Gitte Friis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) segulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Gitte Friis

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C? Benson

for

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K120326

AQT90 FLEX CKMB Test Kit Device Name: AQT90 FLEX CKMB CAL Cartridge AQT90 FLEX LQC Multi-CHECK, Levels 1-3

Indications for Use:

AOT90 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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Rutos Chube

Division Sian-Off Office of In Vitro Diagnostics and Radiological Health (OIR)

510(k) K120326

Regulation Number and Section

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.

(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.

RADIOMETER 16

510(k) Summary

Table of contents

1. Device names and classifications

2. Predicate device

3. Device description / test principle

4. Device intended use

5. Medical device to which substantial equivalence is claimed

6. Technological characteristics in comparison to predicate device

RADIOMETER B

510(k) Premarket Notification Submission

Summary of clinical performance data

7. Conclusion

DEPARTMENT OF HEALTH & HUMAN SERVICES

Carol C? Benson

Indications for Use

§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.